SIMVASTATIN 20 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - SIMVASTATIN 20 MG TABLETS

SIMVASTATIN 10 MG TABLETS

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 illnessare 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 Tablets are and what they are used for
2. What you need to know before you take Simvastatin Tablets
3. How to take Simvastatin Tablets
4. Possible side effects
5. How to store Simvastatin Tablets
6. Contents of the pack and other information.

1. What Simvastatin Tablets are and what they are used for

Simvastatin Tablets belongs to a group of medicines known as ‘statins’ or ‘HMG-CoA reductase inhibitors’. Simvastatin Tablets are used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin Tablets raises levels of “good” cholesterol (HDL cholesterol). 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.

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 levels in your blood (Primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia).
A hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol levels 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 tablets

Do not take Simvastatin Tablets:

if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6)
if youare pregnant or breast feeding.
if you currently have liver problems
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

Talk to your doctor or pharmacist before taking Simvastatin Tablets

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 a 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

weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Safety and effectiveness has been studied in 10–17 years 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 10years. For more information, talk to your doctor.

Other medicines and Simvastatin Tablets

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

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)
daptomycin (a drug used to treat complicated skin and skin structure infections and bacteraemia). It is possible that side effects affecting the muscles may be higher when this medicine is taken during treatment with simvastatin.

Your doctor may decide that you stop taking simvastatin for a while,

colchicine (used to treat gout).
ticagrelor (antiplatelet medicine).

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

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 (a medicine used to treat tuberculosis)

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

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.

Simvastatin Tablets 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

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 Tablets contain Lactose

If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

3. how to take simvastatin tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

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

The usual dosages are as follows:

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg 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 Tablets than you should

Please contact your doctor or pharmacist

If you forget to take Simvastatin Tablets

Just take your normal amount of Simvastatin at the usual time the next day.

DO NOT TAKEA DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.

If you stop taking Simvastatin Tablets

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 efects ~|

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

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, muscle rupture or cramp. 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 (dermatomyositis)
– rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
– 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, liver failure (very rare), feeling tired or weak, loss of appetite;
inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effect was reported:

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

The following side effects have also been reported:

Rare (may affect up to 1 in 1,000 people)

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

Very rare (may affect up to 1 in 10,000 people)

trouble sleeping poor memory

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

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

Additional possible side effects reported with some statins:

Sexual difficulties
sleep disturbances, including nightmares ,
muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known).
Diabetes: This is more likely if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure.

Your doctor will monitor you while you are taking this medicine

Laboratory Values

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

Increases in HbA1c and fasting serum glucose levels have been reported with statins, including simvastatin.

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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

| 5. how to store simvastatin tablets ~|

Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the carton (EXP.). The expiry date refers to the last day of that month.
Store below 250C. Store in the original package.
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 your environment.

6. Contents of the pack and other information

What Simvastatin Tablets contain

The active substance is simvastatin.
Simvastatin Tablets come in three strengths 10 mg, 20 mg and 40 mg. Each tablet contains either 10 mg, 20mg, or 40mg of the active ingredient.
The other ingredients are lactose, cellulose (microcrystalline), maize starch (pregelatinised), butylhydroxyanisole (E320), magnesium stearate, talc, hyprolose, hypromellose, titanium dioxide (E171).

What Simvastatin Tablets look like and contents of the pack

Simvastatin 10mg Tablets are white, oblong, biconvex tablets, scored on one side, embossed with “10” on the scored side and with “SVT” on the opposite side.
Simvastatin 20mg Tablets are white, oblong, biconvex tablets, scored on one side, embossed with “20” on the scored side and with “SVT” on the opposite side.
Simvastatin 40mg Tablets are white, oblong, biconvex tablets, scored on one side, embossed with “40” on the scored side and with “SVT” on the opposite side.
Simvastatin tablets are supplied to your pharmacist containing 14, 28, 30, 56, 60, 100 or 500 tablets. Not all pack sizes may be marketed.