Patient leaflet - Simvastatin 40 mg granules for oral suspension in sachet
1. WHAT SIMVASTATIN GRANULES FOR ORAL SUSPENSION ARE AND WHAT THEY ARE USED FOR
Simvastatin granules for oral suspension contain the active substance simvastatin.
Simvastatin granules for oral suspension 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 granules for oral suspension raise levels of “good” cholesterol (HDL cholesterol).
Simvastatin granules for oral suspension are 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 granules for oral suspension are 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 granules for oral suspension 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 GRANULES FOR ORAL SUSPENSION
DO NOT take Simvastatin granules for oral suspension and talk to your doctor if:
- you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6)
- you currently have severe liver problems
- you are pregnant or breast-feeding
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).
- you are taking or, in the last 7 days, have taken or been given 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 granules for oral suspension a day 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 granules for oral suspension:
- about all your medical conditions including allergies
- if you drink large amounts of alcohol
- if you have ever had liver disease. Simvastatin granules for oral suspension may not be right for you.
- if you are due to have an operation. You may need to stop taking Simvastatin granules for oral suspension for a short time.
- if you have a severe lung disease
- 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 granules for oral suspension and if you have any symptoms of liver problems while you take Simvastatin granules for oral suspension. 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 granules for oral suspension.
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.
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 granules for oral suspension, 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 test and medicines may be needed to diagnose and treat this.
Children and adolescents
Safety and effectiveness of Simvastatin granules for oral suspension 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 granules for oral suspension). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Other medicines and Simvastatin granules for oral suspension
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 granules for oral suspension 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 granules for oral suspension”):
- 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 restart Simvastatin granules for oral solution with fusidic acid may rarely lead to mucsle weakness, tenderness or pain (rhabdomyolysis). See more information regardinf 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, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine. Also see section 4 of this leaflet.
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)
- Hepatits C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir.
- 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 or 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 granules for oral suspension.
Simvastatin granules for oral suspension with food and drink
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin granules for oral suspension. Consuming grapefruit juice should be avoided.
Pregnancy and breast-feeding
Do NOT take Simvastatin granules for oral suspension if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin granules for oral suspension, stop taking it immediately and contact your doctor.
Do NOT take Simvastatin granules for oral suspension 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 granules for oral suspension are 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 granules for oral suspension.
Simvastatin granules for oral suspension contains:
Lactose and Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Benzyl alcohol E1519 Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice –
- if you are pregnant or breast‑ feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
- if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
3. HOW TO TAKE SIMVASTATIN GRANULES FOR ORAL SUSPENSION
Your doctor will determine the appropriate strength for you, depending on your condition, your current treatment and your personal risk status.
Always take this medicine exactly as your doctor 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 granules for oral suspension.
Dosage:
The recommended dose is simvastatin 5mg, 10mg, 20 mg, 40 mg, or 80 mg by mouth once a day.
Simvastatin granules for oral suspension should only be used by patients who are prescribed a 20mg or 40mg dose of simvastatin, respectively.
Adults:
The usual starting dose is simvastatin 10 mg , 20 mg 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. It is to be noted that Simvastatin granules for oral suspension are recommended for doses of 20 mg or more.
Method of administration:
Take Simvastatin granules for oral suspension in the evening. You can take it with or without food.
The granules should be mixed in half a glass of water (approx. 125ml) and should be taken immediately after mixing. If some granules remains in the glass add sufficient amount of water stir it and drink it completely in order to get the complete dose.
Keep taking Simvastatin granules for oral suspension unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin granules for oral suspension along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin granules for oral suspension at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Simvastatin granules for oral suspension than you should
Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital right away. Always take any leftover medicine with you, as well as the container and label, so that the medical staff knows what you have taken.
If you forget to take Simvastatin granules for oral suspension
Do not worry. If you remember later on that day, take that day’s dose as usual. If you miss a whole day’s dose, take the normal dose on the next day. Do NOT take a double dose to make up for a forgotten dose. If you are not sure, ask your doctor or pharmacist.
If you stop taking Simvastatin granules for oral suspension
Your doctor will tell you how long to take the treatment for. Do NOT stop earlier than you are told, because your cholesterol may rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Simvastatin granules for oral suspension 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
- 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 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.
The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):
- 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 tendon.
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 in very rare cases may not go away after stopping Simvastatin granules for oral suspension.
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE SIMVASTATIN GRANULES FOR ORAL SUSPENSION
Keep this medicine out of the sight and reach of children.
Do not use Simvastatin granules for oral suspension after the expiry date, which is stated on the pack. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.
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 granules for oral suspension contain
The active substance is simvastatin. Each sachet of Simvastatin 20 mg granules for oral suspension contains 20 mg of simvastatin. Each sachet of Simvastatin 40 mg granules for oral suspension contains 40 mg of simvastatin.
The other ingredients are: lactose monohydrate, butyl hydroxyanisole (E320), citric acid monohydrate, di-sodium phosphate anhydrous, sodium lauryl sulphate, sucrose, acesulfame potassium and strawberry flavour which also contains flavouring substances, natural flavouring substances, flavouring preparations, maltodextrin, arabic gum (E414), triethyl citrate (E1505), propylene glycol (E1520), ascorbic acid (E300), butylated hydroxyanisole (E320) and benzyl alcohol (E1519).
What Simvastatin granules for oral suspension looks like and contents of the pack
Simvastatin 20 mg and 40 mg granules for oral suspension are white to off white coloured granules and are available in packs containing 28 sachets.
Marketing Authorisation Holder and Manufacturer
Medipoint UK Ltd, 30 Hatfeild Mead, Morden, Surrey, SM4 5PE, United Kingdom.