1. What Simvastatin is and what it is used for

2. What you need to know before you take Simvastatin

Warnings and precautions ______

Tell your doctor:

• about all your medical conditions including allergies.
• if you drink large amounts of alcohol.
• if you have ever had liver disease. Simvastatin may not be right for you.
• if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
• if you are Asian, because a different dose may be applicable to you.
• Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you take simvastatin. This is to check how well your liver is working.
• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin
• While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
• Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
• you or a close family member have a hereditary muscle disorder.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Children and adolescents

Safety and effectiveness of simvastatin have been studied in 10–17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Other medicines and Simvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking simvastatin with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin.”)

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• ciclosporin (often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient like itraconazole, ketoconazole, fluconazole posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin or telithromycin, (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapide (used to treat a serious and rare genetic cholesterol condition),
• colchicine (used to treat gout).

As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients:

• medicines with an active ingredient to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).
• fenofibrate (also used to lower cholesterol).
• niacin (also used to lower cholesterol)
• rifampicin ( used to treat tuberculosis)

You should also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.

Simvastatin with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin.

Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

Do not take Simvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.

Simvastatin contains lactose

Simvastatin tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take simvastatin

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking simvastatin.

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.

Adults:

The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day.

Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses. difficulty in breathing or dizziness (anaphylaxis)

• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
• muscle rupture
• gynecomastia (breast enlargement in men)

The following side effects have also been reported rarely:

• low red blood cell count (anaemia),
• numbness or weakness of the arms and legs,
• headache, tingling sensation, dizziness,
• digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• trouble sleeping (very rare),
• poor memory (very rare), memory loss, confusion.
• blurred vision and impaired vision

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

• erectile dysfunction,
• depression,
• tendon problems, sometimes complicated by rupture of the tendon,
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever.

Additional possible side effects reported with some statins:

• sleep disturbances, including nightmares,
• sexual difficulties,
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known).

Laboratory Values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Use in children and adolescents:

5. How to store Simvastatin

For children (10 –17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.

Method of administration:

Take simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more simvastatin than you should

• Please contact your doctor or pharmacist.
• Do not take extra double dose to make up for a forgotten tablet just take your normal amount of Simvastatin at the usual time the next day.
• Talk to your doctor or pharmacist because your cholesterol may rise again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported: Rare (may affect up to 1 of 1000 people) Very rare (may affect up to 1 of 10,000 people) Not known (frequency cannot be estimated from the available data)

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

• muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
• hypersensitivity (allergic) reactions including:
• swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema)
• severe muscle pain usually in the shoulders and hips,
• rash with weakness of limbs and neck muscles
• pain or inflammation of the joints (polymyalgia rheumatica),
• inflammation of the blood vessels (vasculitis),
• unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing,
• shortness of breath (dyspnoea) and feeling unwell,
• lupus-like disease picture (including rash, joint disorders, and effects on blood cells),
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite; liver failure (very rare),
• inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effect was reported:

• a serious allergic reaction which causes

(6001932) Date: 24/04/2020, 28/04/2020

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Simvastatin tablets contain

• – The active substance is simvastatin (10mg, 20mg, 40mg and 80mg).

Each film-coated tablet contains 10 mg simvastatin.

Each film-coated tablet contains 20 mg simvastatin.

Each film-coated tablet contains 40 mg simvastatin.

Each film-coated tablet contains 80 mg simvastatin.

• – The other ingredients are:

Tablet core:

Butylated hydroxyanisole (E320)

Ascorbic acid (E300)

Citric acid monohydrate (E330)

Microcrystalline cellulose (E460a)

Pregelatinised maize starch

Lactose monohydrate

Magnesium stearate (E470B)

Film coating:

Hypromellose (E464)

Hydroxypropyl cellulose (E463)

Titanium dioxide (E171)

Talc (E553b).

Iron oxide yellow (E 172) – For 10 and 20 mg

Iron oxide red (E 172) – For 10, 20, 40 and 80 mg

What Simvastatin tablets looks like and contents of the pack

Film-coated tablets

Simvastatin 10 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CS ’ on one side and plain on the other side

Simvastatin 20 mg film-coated tablets

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CT ’ on one side and plain on the other side

Simvastatin 40 mg film-coated tablets

Pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CU ’ on one side and plain on the other side

Simvastatin 80 mg film-coated tablets:

Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with’ CV ’ on one side and plain on the other side

Simvastatin 10, 20, 40 and 80 mg film-coated tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.

Simvastatin 10, 20 and 40 film-coated tablets are also available in bottle packs containing 250, 500 and 1000 tablets (for hospital or dose dispensing use only).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Accord Healthcare Limited,

Sage house, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom Manufacturer

Accord Healthcare Limited,

Sage house, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95–200 Pabianice, Poland Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands

a ccrd

Package leaflet: Information for the patient

Simvastatin 10 mg film-coated tablets

Simvastatin 20 mg film-coated tablets

Simvastatin 40 mg film-coated tablets

Simvastatin 80 mg film-coated tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Simvastatin is and what it is used for

• 2. What you need to know before you take Simvastatin

• 3. How to take Simvastatin

• 4. Possible side effects

• 5. How to store Simvastatin

• 6. Contents of the pack and other information

1. what simvastatin is and what it is used for

Simvastatin contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin is a member of the class of medicines called statins.

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

You should stay on a cholesterol-lowering diet while taking this medicine.

Simvastatin is used in addition to your cholesterol lowering diet if you have:

• a raised cholesterol level in your blood (primary hypercholeste­rolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia). a hereditary illness (homozygous familial hypercholeste­rolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

2. what you need to know before you take simvastatin

• Do not take Simvastatin

if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).

• if you currently have liver problems

if you are pregnant or breast-feeding

• if you are taking medicine(s) with one or more than one of the following active ingredients:

• – itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)

• – erythromycin, clarithromycin or telithromycin (used to treat infections)

• – HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)

• – boceprevir or telaprevir (used to treat hepatitis C virus infection)

• – nefazodone (used to treat depression)

• – cobicistat

• – gemfibrozil (used to lower cholesterol)

• – ciclosporin (used in organ transplant patients)

• – danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

• if you are taking or have taken in the last 7 days, a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin can lead to serious muscle problems (rhabdomyolysis)
• Do not take more than 40 mg Simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)
• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin
• While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likel to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
• Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
• you or a close family member have a hereditary muscle disorder.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Children and adolescents

Safety and effectiveness of simvastatin have been studied in 10–17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Other medicines and Simvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking simvastatin with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin.”)

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• ciclosporin (often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient like itraconazole, ketoconazole, fluconazole posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin or telithromycin, (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions), lomitapide (used to treat a serious and rare genetic cholesterol condition),
• colchicine (used to treat gout),
• As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients: medicines with an active ingredient to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).
• fenofibrate (also used to lower cholesterol).
• niacin (also used to lower cholesterol)
• rifampicin ( used to treat tuberculosis)

You should also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.

Simvastatin with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin.

Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

Do not take Simvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.

Simvastatin contains lactose

Simvastatin tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Ask your doctor if you are not sure if your medicine is listed above.

3. How to take Simvastatin

Warnings and precautions

Tell your doctor:

• about all your medical conditions including allergies.
• if you drink large amounts of alcohol.

if you have ever had liver disease. Simvastatin may not be right for you.

• if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
• if you are Asian, because a different dose may be applicable to you.

Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you take simvastatin. This is to check how well your liver is working.

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking simvastatin.

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.

Adults:

pie usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day.

lYour doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney ^conditions.

pie 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Lise in children and adolescents:

For children (10–17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended

dose is 40 mg a day.

Llethod of administration:

Take simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant, you [should take Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more simvastatin than you should

• Please contact your doctor or pharmacist.

If you forget to take simvastatin

|« Do not take extra double dose to make up for a forgotten tablet just take your normal amount of Simvastatin at the usual time the next day.

If you stop taking simvastatin

|« Talk to your doctor or pharmacist because your cholesterol may rise again.

.If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

[The following terms are used to describe how often side effects have been reported:

Rare (may affect up to 1 of 1000 people),

Very rare_(may affect up to 1 of 10,000 people),

Not known (frequency cannot be estimated from the available data),

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

I muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

t hypersensitivity (allergic) reactions including:

swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema)

• severe muscle pain usually in the shoulders and hips,

trash with weakness of limbs and neck muscles,

pain or inflammation of the joints (polymyalgia rheumatica),

• inflammation of the blood vessels (vasculitis),
• unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing,
• shortness of breath (dyspnoea) and feeling unwell,
• lupus-like disease picture (including rash, joint disorders, and effects on blood cells),
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite; liver failure (very rare),
• inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effect was reported:

• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis)
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
• muscle rupture
• gynecomastia (breast enlargement in men)

The following side effects have also been reported rarely:

• low red blood cell count (anaemia),
• numbness or weakness of the arms and legs,
• headache, tingling sensation, dizziness,

f digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),

rash, itching, hair loss,

• weakness,

f trouble sleeping (very rare),

poor memory (very rare), memory loss, confusion.

• blurred vision and impaired vision

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

f erectile dysfunction,

depression,

• tendon problems, sometimes complicated by rupture of the tendon,

|» inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath orfever.

Additional possible side effects reported with some statins:

I* sleep dis turbance s, includ ing nigh tmares ,

TsexuaTUifficuT­Ties,

• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Your doctor will monitor you while you are taking this medicine.

• muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known). Laboratory Values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store simvastatin

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Simvastatin tablets contain

• – The active substance is simvastatin (10mg, 20mg, 40mg and 80mg).

Each film-coated tablet contains 10 mg simvastatin.

Each film-coated tablet contains 20 mg simvastatin.

Each film-coated tablet contains 40 mg simvastatin.

Each film-coated tablet contains 80 mg simvastatin.

• – The other ingredients are:

Tablet core:

Butylated hydroxyanisole (E320)

Ascorbic acid (E300)

Citric acid monohydrate (E330)

Microcrystalline cellulose (E460a)

Pregelatinised maize starch

Lactose monohydrate

Magnesium stearate (E470B)

Film coating:

Hypromellose (E464)

Hydroxypropyl cellulose (E463)

Titanium dioxide (E171)

Talc (E553b).

Iron oxide yellow (E 172) – For 10 and 20 mg

Iron oxide red (E 172) – For 10, 20, 40 and 80 mg

What Simvastatin tablets looks like and contents of the pack

Film-coated tablets

Simvastatin 10 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CS ’ on one side and plain on the other side Simvastatin 20 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CT ’ on one side and plain on the other side Simvastatin 40 mg film-coated tablets:

Pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CU ’ on one side and plain on the other side

Simvastatin 80 mg film-coated tablets:

Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with’ CV ’ on one side and plain on the other side

Simvastatin 10, 20, 40 and 80 mg film-coated tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.

Simvastatin 10, 20 and 40 film-coated tablets are also available in bottle packs containing 250, 500 and 1000 tablets (for hospital or dose dispensing use only).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage house, 319 Pinner Road, North Harrow,

Middlesex, HA1 4HF, United Kingdom

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95–200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

This leaflet was last revised in 02/2020

10 3854 1 6001936

• poor memory (very rare), memory loss, confusion.
• blurred vision and impaired vision

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

• erectile dysfunction,
• depression,
• tendon problems, sometimes complicated by rupture of the tendon,
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever.

Additional possible side effects reported with some statins:

• sleep disturbances, including nightmares,
• sexual difficulties,
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known).

Laboratory Values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store simvastatin

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Simvastatin tablets contain

– The active substance is simvastatin (1 Omg, 20mg, 40mg and 80mg).

Each film-coated tablet contains 10 mg simvastatin.

Each film-coated tablet contains 20 mg simvastatin.

Each film-coated tablet contains 40 mg simvastatin.

Each film-coated tablet contains 80 mg simvastatin.

– The other ingredients are:

Tablet core:

Butylated hydroxyanisole (E320)

Ascorbic acid (E300)

Citric acid monohydrate (E330)

Microcrystalline cellulose (E460a)

Pregelatinised maize starch

Lactose monohydrate

Magnesium stearate (E470B)

Film coating:

Hypromellose (E464)

Hydroxypropyl cellulose (E463)

Titanium dioxide (E171)

Talc (E553b).

Iron oxide yellow (E 172) – For 10 and 20 mg

Iron oxide red (E 172) – For 10, 20, 40 and 80 mg

What Simvastatin tablets looks like and contents of the pack

Film-coated tablets

Simvastatin 10 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CS ’ on one side and plain on the other side

Simvastatin 20 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CT ’ on one side and plain on the other side

Simvastatin 40 mg film-coated tablets:

Pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CU ’ on one side and plain on the other side

Simvastatin 80 mg film-coated tablets:

Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with’ CV ’ on one side and plain on the other side

Simvastatin 10, 20, 40 and 80 mg film-coated tablets are available in blister packs containing 10,14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.

Simvastatin 10, 20 and 40 film-coated tablets are also available in bottle packs containing 250, 500 and 1000 tablets (for hospital or dose dispensing use only).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Accord

Healthcare Limited, Sage house, 319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited, Sage house, 319

Pinner Road, North Harrow,

Middlesex, HA1 4HF,

United Kingdom

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95–200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht, The Netherlands

This leaflet was last revised in 02/2020.

a :ord

Package leaflet: Information for the patient Simvastatin 10 mg film-coated tablets Simvastatin 20 mg film-coated tablets Simvastatin 40 mg film-coated tablets Simvastatin 80 mg film-coated tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Simvastatin is and what it is used for

• 2. What you need to know before you take Simvastatin

• 3. How to take Simvastatin

• 4. Possible side effects

• 5. Howto store Simvastatin

• 6. Contents of the pack and other information

i.what simvastatin is and what it is used for

Simvastatin contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin is a member of the class of medicines called statins.

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

You should stay on a cholesterol-lowering diet while taking this medicine.

Simvastatin is used in addition to your cholesterol lowering diet if you have:

• a raised cholesterol level in your blood (primary hypercholeste­rolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia).
• a hereditary illness (homozygous familial hypercholeste­rolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

r

2. what you need to know before you take simvastatin

Do not take Simvastatin

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).
• if you currently have liver problems
• if you are pregnant or breast-feeding
• if you are taking medicine(s) with one or more than one of the following active ingredients: – itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)

• – erythromycin, clarithromycin ortelithromycin (used to treat infections)

• – HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) – boceprevir or telaprevir (used to treat hepatitis C virus infection)

• – nefazodone (used to treat depression)

• – cobicistat

• – gemfibrozil (used to lower cholesterol)

• – ciclosporin (used in organ transplant patients)

• – danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

• if you are taking or have taken in the last 7 days, a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin can lead to serious muscle problems (rhabdomyolysis)
• Do not take more than 40 mg Simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions including allergies.
• if you drink large amounts of alcohol.
• if you have ever had liver disease. Simvastatin may not be right for you.
• if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
• if you are Asian, because a different dose may be applicable to you.
• Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you take simvastatin. This is to check how well your liver is working.
• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin
• While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
• Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
• you or a close family member have a hereditary muscle disorder.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Children and adolescents

Safety and effectiveness of simvastatin have been studied in 10–17 year old boysand in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Other medicines and Simvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking simvastatin with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin.”)

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• ciclosporin (often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient like itraconazole, ketoconazole, fluconazole posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin or telithromycin, (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapide (used to treat a serious and rare genetic cholesterol condition),
• colchicine (used to treat gout),

As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients:

• medicines with an active ingredient to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).
• fenofibrate (also used to lower cholesterol).
• niacin (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis)

You should also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.

Simvastatin with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin. Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

Do not take Simvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breastmilk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.

Simvastatin contains lactose

Simvastatin tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take simvastatin

4. possible side effects

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking simvastatin.

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.

Adults:

The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day.

Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Use in children and adolescents:

For children (10–17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.

Method of administration:

Take simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more simvastatin than you should

• Please contact your doctor or pharmacist.
• Do not take extra double dose to make up for a forgotten tablet just take your normal amount of Simvastatin at the usual time the next day.
• Talk to your doctor or pharmacist because your cholesterol may rise again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

Rare (may affect up to 1 of 1000 people),

Very rare_(may affect up to 1 of 10,000 people), Not known (frequency cannot be estimated from the available data),

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

• muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
• hypersensitivity (allergic) reactions including:
• swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema)
• severe muscle pain usually in the shoulders and hips,
• rash with weakness of limbs and neck muscles,
• pain or inflammation of the joints (polymyalgia rheumatica),
• inflammation of the blood vessels (vasculitis),
• unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing,
• shortness of breath (dyspnoea) and feeling unwell,
• lupus-like disease picture (including rash, joint disorders, and effects on blood cells),
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite; liver failure (very rare),
• inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effect was reported:

• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis)
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
• muscle rupture
• gynecomastia (breast enlargement in men)

The following side effects have also been reported rarely:

• low red blood cell count (anaemia),
• numbness or weakness of the arms and legs,
• headache, tingling sensation, dizziness,
• digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• trouble sleeping (very rare),

a cc rd

Package leaflet: Information for the patient Simvastatin 10 mg film-coated tablets Simvastatin 20 mg film-coated tablets Simvastatin 40 mg film-coated tablets Simvastatin 80 mg film-coated tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Simvastatin is and what it is used for

• 2. What you need to know before you take Simvastatin

• 3. How to take Simvastatin

• 4. Possible side effects

• 5. How to store Simvastatin

• 6. Contents of the pack and other information

1. what simvastatin is and what it is used for

Simvastatin contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin is a 5 member of the class of medicines called statins.

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

i

LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

i

You should stay on a cholesterol-lowering diet while taking this medicine.

Simvastatin is used in addition to your cholesterol lowering diet if you have:

• a raised cholesterol level in your blood (primary hypercholeste­rolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia).
• a hereditary illness (homozygous familial hypercholeste­rolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

2. what you need to know before you take simvastatin

Do not take Simvastatin

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).
• if you currently have liver problems
• if you are pregnant or breast-feeding
• if you are taking medicine(s) with one or more than one of the following active ingredients:: – itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)

• – erythromycin, clarithromycin or telithromycin (used to treat infections)

• – HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)

• – boceprevir or telaprevir (used to treat hepatitis C virus infection)

• – nefazodone (used to treat depression)

• – cobicistat

• – gemfibrozil (used to lower cholesterol)

• – ciclosporin (used in organ transplant patients)

• – danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

• if you are taking or have taken in the last 7 days, a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin can lead to serious muscle problems (rhabdomyolysis)
• Do not take more than 40 mg Simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions including allergies.
• if you drink large amounts of alcohol.
• if you have ever had liver disease. Simvastatin may not be right for you.
• if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
• if you are Asian, because a different dose may be applicable to you.
• Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you take simvastatin. This is to check how well your liver is working.
• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin
• While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
• Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including i muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
• you or a close family member have a hereditary muscle disorder.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Children and adolescents

Safety and effectiveness of simvastatin have been studied in 10–17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Other medicines and Simvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking simvastatin with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin.”)

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• ciclosporin (often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient like itraconazole, ketoconazole, fluconazole posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin or telithromycin, (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapide (used to treat a serious and rare genetic cholesterol condition),
• colchicine (used to treat gout),

As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients:

• medicines with an active ingredient to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).
• fenofibrate (also used to lower cholesterol).
• niacin (also used to lower cholesterol)
• rifampicin ( used to treat tuberculosis)

You should also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.

Simvastatin with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin. Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

Do not take Simvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.

Simvastatin contains lactose

Simvastatin tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take simvastatin

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking simvastatin.

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.

I

Adults:

The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day.

Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Use in children and adolescents:

For children (10 –17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.

Method of administration:

Take simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more simvastatin than you should

• Please contact your doctor or pharmacist.
• Do not take extra double dose to make up for a forgotten tablet just take your normal amount of Simvastatin at the usual time the next day.
• Talk to your doctor or pharmacist because your cholesterol may rise again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

Rare (may affect up to 1 of 1000 people),

Very rarejmay affect up to 1 of 10,000 people), Not known (frequency cannot be estimated from the available data),

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

• muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
• hypersensitivity (allergic) reactions including:
• swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema)
• severe muscle pain usually in the shoulders and hips,
• rash with weakness of limbs and neck muscles,
• pain or inflammation of the joints (polymyalgia rheumatica),
• inflammation of the blood vessels (vasculitis),
• unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing,
• shortness of breath (dyspnoea) and feeling unwell,
• lupus-like disease picture (including rash, joint disorders, and effects on blood cells),
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite; liver failure (very rare),
• inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effect was reported:

• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis)
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
• muscle rupture
• gynecomastia (breast enlargement in men)

The following side effects have also been reported rarely:

• low red blood cell count (anaemia),
• numbness or weakness of the arms and legs,
• headache, tingling sensation, dizziness,
• digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• trouble sleeping (very rare),
• poor memory (very rare), memory loss, confusion.
• blurred vision and impaired vision

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

• erectile dysfunction,
• depression,
• tendon problems, sometimes complicated by rupture of the tendon,
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever.

Additional possible side effects reported with some statins:

• sleep disturbances, including nightmares,
• sexual difficulties,
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known).

Laboratory Values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store simvastatin

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Simvastatin tablets contain

• – The active substance is simvastatin (10mg, 20mg, 40mg and 80mg).

Each film-coated tablet contains 10 mg simvastatin.

Each film-coated tablet contains 20 mg simvastatin.

Each film-coated tablet contains 40 mg simvastatin.

Each film-coated tablet contains 80 mg simvastatin.

• – The other ingredients are:

What Simvastatin tablets looks like and contents of the pack

Film-coated tablets

Simvastatin 10 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CS ’ on one side and plain on the other side

Simvastatin 20 mg film-coated tablets

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CT ’ on one side and plain on the other side

Simvastatin 40 mg film-coated tablets

Pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CU ’ on one side and plain on the other side

Simvastatin 80 mg film-coated tablets:

Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with’ CV ’ on one side and plain on the other side

Simvastatin 10, 20, 40 and 80 mg film-coated tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.

Simvastatin 10, 20 and 40 film-coated tablets are also available in bottle packs containing 250, 500 and 1000 tablets (for hospital or dose dispensing use only).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Accord Healthcare Limited,

Sage house, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom Manufacturer

Accord Healthcare Limited,

Sage house, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95–200 Pabianice, Poland Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands

a ccrd

Package leaflet: Information for the patient

Simvastatin 10 mg film-coated tablets

Simvastatin 20 mg film-coated tablets

Simvastatin 40 mg film-coated tablets

Simvastatin 80 mg film-coated tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Simvastatin is and what it is used for

• 2. What you need to know before you take Simvastatin

• 3. How to take Simvastatin

• 4. Possible side effects

• 5. How to store Simvastatin

• 6. Contents of the pack and other information

1. what simvastatin is and what it is used for

Simvastatin contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin is a member of the class of medicines called statins.

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

You should stay on a cholesterol-lowering diet while taking this medicine.

Simvastatin is used in addition to your cholesterol lowering diet if you have:

• a raised cholesterol level in your blood (primary hypercholeste­rolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia). a hereditary illness (homozygous familial hypercholeste­rolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

2. what you need to know before you take simvastatin

• Do not take Simvastatin

if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).

• if you currently have liver problems

if you are pregnant or breast-feeding

• if you are taking medicine(s) with one or more than one of the following active ingredients:

• – itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)

• – erythromycin, clarithromycin or telithromycin (used to treat infections)

• – HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)

• – boceprevir or telaprevir (used to treat hepatitis C virus infection)

• – nefazodone (used to treat depression)

• – cobicistat

• – gemfibrozil (used to lower cholesterol)

• – ciclosporin (used in organ transplant patients)

• – danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

• if you are taking or have taken in the last 7 days, a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin can lead to serious muscle problems (rhabdomyolysis)
• Do not take more than 40 mg Simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)
• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin
• While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likel to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
• Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
• you or a close family member have a hereditary muscle disorder.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Children and adolescents

Safety and effectiveness of simvastatin have been studied in 10–17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Other medicines and Simvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking simvastatin with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin.”)

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• ciclosporin (often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient like itraconazole, ketoconazole, fluconazole posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin or telithromycin, (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions), lomitapide (used to treat a serious and rare genetic cholesterol condition),
• colchicine (used to treat gout),
• As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients: medicines with an active ingredient to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).
• fenofibrate (also used to lower cholesterol).
• niacin (also used to lower cholesterol)
• rifampicin ( used to treat tuberculosis)

You should also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.

Simvastatin with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin.

Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

Do not take Simvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.

Simvastatin contains lactose

Simvastatin tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions including allergies.
• if you drink large amounts of alcohol.

if you have ever had liver disease. Simvastatin may not be right for you.

• if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
• if you are Asian, because a different dose may be applicable to you.

Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you take simvastatin. This is to check how well your liver is working.

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking simvastatin.

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.

Adults:

pie usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day.

lYour doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney ^conditions.

pie 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Lise in children and adolescents:

For children (10–17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended

dose is 40 mg a day.

Llethod of administration:

Take simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant, you [should take Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more simvastatin than you should

• Please contact your doctor or pharmacist.

If you forget to take simvastatin

|« Do not take extra double dose to make up for a forgotten tablet just take your normal amount of Simvastatin at the usual time the next day.

If you stop taking simvastatin

|« Talk to your doctor or pharmacist because your cholesterol may rise again.

.If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

[The following terms are used to describe how often side effects have been reported:

Rare (may affect up to 1 of 1000 people),

Very rare_(may affect up to 1 of 10,000 people),

Not known (frequency cannot be estimated from the available data),

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

I muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

t hypersensitivity (allergic) reactions including:

swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema)

• severe muscle pain usually in the shoulders and hips,

trash with weakness of limbs and neck muscles,

pain or inflammation of the joints (polymyalgia rheumatica),

• inflammation of the blood vessels (vasculitis),
• unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing,
• shortness of breath (dyspnoea) and feeling unwell,
• lupus-like disease picture (including rash, joint disorders, and effects on blood cells),
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite; liver failure (very rare),
• inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effect was reported:

• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis)
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
• muscle rupture
• gynecomastia (breast enlargement in men)

The following side effects have also been reported rarely:

• low red blood cell count (anaemia),
• numbness or weakness of the arms and legs,
• headache, tingling sensation, dizziness,

f digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),

rash, itching, hair loss,

• weakness,

f trouble sleeping (very rare),

poor memory (very rare), memory loss, confusion.

• blurred vision and impaired vision

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

f erectile dysfunction,

depression,

• tendon problems, sometimes complicated by rupture of the tendon,

|» inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath orfever.

Additional possible side effects reported with some statins:

I* sleep dis turbance s, includ ing nigh tmares ,

TsexuaTUifficuT­Ties,

• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Your doctor will monitor you while you are taking this medicine.

• muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known). Laboratory Values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store simvastatin

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Simvastatin tablets contain

• – The active substance is simvastatin (10mg, 20mg, 40mg and 80mg).

Each film-coated tablet contains 10 mg simvastatin.

Each film-coated tablet contains 20 mg simvastatin.

Each film-coated tablet contains 40 mg simvastatin.

Each film-coated tablet contains 80 mg simvastatin.

• – The other ingredients are:

Tablet core:

Butylated hydroxyanisole (E320)

Ascorbic acid (E300)

Citric acid monohydrate (E330)

Microcrystalline cellulose (E460a)

Pregelatinised maize starch

Lactose monohydrate

Magnesium stearate (E470B)

Film coating:

Hypromellose (E464)

Hydroxypropyl cellulose (E463)

Titanium dioxide (E171)

Talc (E553b).

Iron oxide yellow (E 172) – For 10 and 20 mg

Iron oxide red (E 172) – For 10, 20, 40 and 80 mg

What Simvastatin tablets looks like and contents of the pack

Film-coated tablets

Simvastatin 10 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CS ’ on one side and plain on the other side Simvastatin 20 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CT ’ on one side and plain on the other side Simvastatin 40 mg film-coated tablets:

Pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CU ’ on one side and plain on the other side

Simvastatin 80 mg film-coated tablets:

Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with’ CV ’ on one side and plain on the other side

Simvastatin 10, 20, 40 and 80 mg film-coated tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.

Simvastatin 10, 20 and 40 film-coated tablets are also available in bottle packs containing 250, 500 and 1000 tablets (for hospital or dose dispensing use only).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage house, 319 Pinner Road, North Harrow,

Middlesex, HA1 4HF, United Kingdom

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95–200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

This leaflet was last revised in 02/2020

10 3854 1 6001936

• poor memory (very rare), memory loss, confusion.
• blurred vision and impaired vision

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

• erectile dysfunction,
• depression,
• tendon problems, sometimes complicated by rupture of the tendon,
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever.

Additional possible side effects reported with some statins:

• sleep disturbances, including nightmares,
• sexual difficulties,
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known).

Laboratory Values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store simvastatin

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Simvastatin tablets contain

– The active substance is simvastatin (1 Omg, 20mg, 40mg and 80mg).

Each film-coated tablet contains 10 mg simvastatin.

Each film-coated tablet contains 20 mg simvastatin.

Each film-coated tablet contains 40 mg simvastatin.

Each film-coated tablet contains 80 mg simvastatin.

– The other ingredients are:

Tablet core:

Butylated hydroxyanisole (E320)

Ascorbic acid (E300)

Citric acid monohydrate (E330)

Microcrystalline cellulose (E460a)

Pregelatinised maize starch

Lactose monohydrate

Magnesium stearate (E470B)

Film coating:

Hypromellose (E464)

Hydroxypropyl cellulose (E463)

Titanium dioxide (E171)

Talc (E553b).

Iron oxide yellow (E 172) – For 10 and 20 mg

Iron oxide red (E 172) – For 10, 20, 40 and 80 mg

What Simvastatin tablets looks like and contents of the pack

Film-coated tablets

Simvastatin 10 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CS ’ on one side and plain on the other side

Simvastatin 20 mg film-coated tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CT ’ on one side and plain on the other side

Simvastatin 40 mg film-coated tablets:

Pink coloured, round shaped, biconvex, film coated tablets, debossed with’ CU ’ on one side and plain on the other side

Simvastatin 80 mg film-coated tablets:

Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with’ CV ’ on one side and plain on the other side

Simvastatin 10, 20, 40 and 80 mg film-coated tablets are available in blister packs containing 10,14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.

Simvastatin 10, 20 and 40 film-coated tablets are also available in bottle packs containing 250, 500 and 1000 tablets (for hospital or dose dispensing use only).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Accord

Healthcare Limited, Sage house, 319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited, Sage house, 319

Pinner Road, North Harrow,

Middlesex, HA1 4HF,

United Kingdom

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95–200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht, The Netherlands

This leaflet was last revised in 02/2020.

a :ord

Package leaflet: Information for the patient Simvastatin 10 mg film-coated tablets Simvastatin 20 mg film-coated tablets Simvastatin 40 mg film-coated tablets Simvastatin 80 mg film-coated tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Simvastatin is and what it is used for

• 2. What you need to know before you take Simvastatin

• 3. How to take Simvastatin

• 4. Possible side effects

• 5. Howto store Simvastatin

• 6. Contents of the pack and other information

i.what simvastatin is and what it is used for

Simvastatin contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin is a member of the class of medicines called statins.

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

You should stay on a cholesterol-lowering diet while taking this medicine.

Simvastatin is used in addition to your cholesterol lowering diet if you have:

• a raised cholesterol level in your blood (primary hypercholeste­rolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia).
• a hereditary illness (homozygous familial hypercholeste­rolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

r

2. what you need to know before you take simvastatin

Do not take Simvastatin

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).
• if you currently have liver problems
• if you are pregnant or breast-feeding
• if you are taking medicine(s) with one or more than one of the following active ingredients: – itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)

• – erythromycin, clarithromycin ortelithromycin (used to treat infections)

• – HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) – boceprevir or telaprevir (used to treat hepatitis C virus infection)

• – nefazodone (used to treat depression)

• – cobicistat

• – gemfibrozil (used to lower cholesterol)

• – ciclosporin (used in organ transplant patients)

• – danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

• if you are taking or have taken in the last 7 days, a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin can lead to serious muscle problems (rhabdomyolysis)
• Do not take more than 40 mg Simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions including allergies.
• if you drink large amounts of alcohol.
• if you have ever had liver disease. Simvastatin may not be right for you.
• if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
• if you are Asian, because a different dose may be applicable to you.
• Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you take simvastatin. This is to check how well your liver is working.
• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin
• While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
• Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
• you or a close family member have a hereditary muscle disorder.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Children and adolescents

Safety and effectiveness of simvastatin have been studied in 10–17 year old boysand in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Other medicines and Simvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking simvastatin with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin.”)

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• ciclosporin (often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient like itraconazole, ketoconazole, fluconazole posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin or telithromycin, (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapide (used to treat a serious and rare genetic cholesterol condition),
• colchicine (used to treat gout),

As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients:

• medicines with an active ingredient to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).
• fenofibrate (also used to lower cholesterol).
• niacin (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis)

You should also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.

Simvastatin with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin. Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

Do not take Simvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breastmilk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.

Simvastatin contains lactose

Simvastatin tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking simvastatin.

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.

Adults:

The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day.

Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Use in children and adolescents:

For children (10–17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.

Method of administration:

Take simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more simvastatin than you should

• Please contact your doctor or pharmacist.
• Do not take extra double dose to make up for a forgotten tablet just take your normal amount of Simvastatin at the usual time the next day.
• Talk to your doctor or pharmacist because your cholesterol may rise again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

Rare (may affect up to 1 of 1000 people),

Very rare_(may affect up to 1 of 10,000 people), Not known (frequency cannot be estimated from the available data),

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

• muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
• hypersensitivity (allergic) reactions including:
• swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema)
• severe muscle pain usually in the shoulders and hips,
• rash with weakness of limbs and neck muscles,
• pain or inflammation of the joints (polymyalgia rheumatica),
• inflammation of the blood vessels (vasculitis),
• unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing,
• shortness of breath (dyspnoea) and feeling unwell,
• lupus-like disease picture (including rash, joint disorders, and effects on blood cells),
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite; liver failure (very rare),
• inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effect was reported:

• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis)
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
• muscle rupture
• gynecomastia (breast enlargement in men)

The following side effects have also been reported rarely:

• low red blood cell count (anaemia),
• numbness or weakness of the arms and legs,
• headache, tingling sensation, dizziness,
• digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• trouble sleeping (very rare),

a cc rd

Package leaflet: Information for the patient Simvastatin 10 mg film-coated tablets Simvastatin 20 mg film-coated tablets Simvastatin 40 mg film-coated tablets Simvastatin 80 mg film-coated tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Simvastatin is and what it is used for

• 2. What you need to know before you take Simvastatin

• 3. How to take Simvastatin

• 4. Possible side effects

• 5. How to store Simvastatin

• 6. Contents of the pack and other information

1. what simvastatin is and what it is used for

Simvastatin contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin is a 5 member of the class of medicines called statins.

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

i

LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

i

You should stay on a cholesterol-lowering diet while taking this medicine.

Simvastatin is used in addition to your cholesterol lowering diet if you have:

• a raised cholesterol level in your blood (primary hypercholeste­rolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia).
• a hereditary illness (homozygous familial hypercholeste­rolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

2. what you need to know before you take simvastatin

Do not take Simvastatin

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).
• if you currently have liver problems
• if you are pregnant or breast-feeding
• if you are taking medicine(s) with one or more than one of the following active ingredients:: – itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)

• – erythromycin, clarithromycin or telithromycin (used to treat infections)

• – HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)

• – boceprevir or telaprevir (used to treat hepatitis C virus infection)

• – nefazodone (used to treat depression)

• – cobicistat

• – gemfibrozil (used to lower cholesterol)

• – ciclosporin (used in organ transplant patients)

• – danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

• if you are taking or have taken in the last 7 days, a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin can lead to serious muscle problems (rhabdomyolysis)
• Do not take more than 40 mg Simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions including allergies.
• if you drink large amounts of alcohol.
• if you have ever had liver disease. Simvastatin may not be right for you.
• if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
• if you are Asian, because a different dose may be applicable to you.
• Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you take simvastatin. This is to check how well your liver is working.
• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin
• While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
• Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including i muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
• you or a close family member have a hereditary muscle disorder.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Children and adolescents

Safety and effectiveness of simvastatin have been studied in 10–17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Other medicines and Simvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking simvastatin with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin.”)

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• ciclosporin (often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient like itraconazole, ketoconazole, fluconazole posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin or telithromycin, (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapide (used to treat a serious and rare genetic cholesterol condition),
• colchicine (used to treat gout),

As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients:

• medicines with an active ingredient to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).
• fenofibrate (also used to lower cholesterol).
• niacin (also used to lower cholesterol)
• rifampicin ( used to treat tuberculosis)

You should also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.

Simvastatin with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin. Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

Do not take Simvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.

Simvastatin contains lactose

Simvastatin tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take simvastatin

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking simvastatin.

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.

I

Adults:

The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day.

Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Use in children and adolescents:

For children (10 –17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.

Method of administration:

Take simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more simvastatin than you should

• Please contact your doctor or pharmacist.
• Do not take extra double dose to make up for a forgotten tablet just take your normal amount of Simvastatin at the usual time the next day.
• Talk to your doctor or pharmacist because your cholesterol may rise again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

Rare (may affect up to 1 of 1000 people),

Very rarejmay affect up to 1 of 10,000 people), Not known (frequency cannot be estimated from the available data),

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

• muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
• hypersensitivity (allergic) reactions including:
• swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema)
• severe muscle pain usually in the shoulders and hips,
• rash with weakness of limbs and neck muscles,
• pain or inflammation of the joints (polymyalgia rheumatica),
• inflammation of the blood vessels (vasculitis),
• unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing,
• shortness of breath (dyspnoea) and feeling unwell,
• lupus-like disease picture (including rash, joint disorders, and effects on blood cells),
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite; liver failure (very rare),
• inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effect was reported:

• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis)
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
• muscle rupture
• gynecomastia (breast enlargement in men)

The following side effects have also been reported rarely:

• low red blood cell count (anaemia),
• numbness or weakness of the arms and legs,
• headache, tingling sensation, dizziness,
• digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• trouble sleeping (very rare),
• poor memory (very rare), memory loss, confusion.
• blurred vision and impaired vision

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

• erectile dysfunction,
• depression,
• tendon problems, sometimes complicated by rupture of the tendon,
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever.

Additional possible side effects reported with some statins:

• sleep disturbances, including nightmares,
• sexual difficulties,
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known).

Laboratory Values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store simvastatin

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Simvastatin tablets contain

• – The active substance is simvastatin (10mg, 20mg, 40mg and 80mg).

Each film-coated tablet contains 10 mg simvastatin.

Each film-coated tablet contains 20 mg simvastatin.

Each film-coated tablet contains 40 mg simvastatin.

Each film-coated tablet contains 80 mg simvastatin.

• – The other ingredients are: