Simvastatin 80 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.
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
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1. WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR
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)
- 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, and for breast cysts in women).
- boceprevir or telaprevir ( used to treat hepatitis C virus infection)
• if you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infection)
Do not take more than 40 mg Simvastatin Tablets 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
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.
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.
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 or 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.
Other medicines and Simvastatin
It is particularly important to tell your doctor if you are taking medicine(s) with any of the following active ingredients. Taking Simvastatin with any of these medicines can increase the risk of muscle problems (some of these have already been listed in the above section "DO NOT take Simvastatin")
• 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, and for breast cysts in women)
• 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).
• nefazodone (used to treat depression)
• medicines with the active ingredient cobicistat
• amiodarone (used to treat an irregular heart beat)
• verapamil, amlodipine or diltiazem (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)
• colchicine (used to treat gout)
• lomitapide (used to treat a serious and rare genetic cholesterol condition)
• boceprevir or telaprevir (used to treat hepatitis C virus infection)
As well as medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any 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.
Children
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.
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.
is working.
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.
• Diabetes. This is more likely if you have high blood pressure, high levels of sugar and fats in your blood or if you are overweight (have a body mass index of more than 30kg/m2). Your doctor will monitor you while you are taking this medicine.
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 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 1 Simvastatin 10mg, 20mg, 40mg or 80mg 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 staring dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day. A dosage of 40mg cannot be accomplished with a Simvastatin 80mg film- coated tablet.
Method and duration of administration
Take Simvastatin in the evening with water. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.
Dosage for concomitant therapy with other medicines:
If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant,you should take Simvastatin at least two hours before or four hours after taking the bile acid sequestrant.
If you take more Simvastatin than you should
If you take more Simvastatin tablets than you should, talk to your doctor or pharmacist or contact with the nearest hospital.
If you forget to take Simvastatin
If you forget to take Simvastatin, just continue with your normal dose. Do not take a double dose to make up for a forgotten dose. Simply continue the treatment as usual the next day.
If you stop taking Simvastatin
Talk to your doctor or pharmacist because your cholesterol levels may rise again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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: 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
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 container. 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.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Simvastatin 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 1,000 patients)
Very rare (may affect up to 1 of 10,000 patients)
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,
• Bursitis (inflammation of the fluid filled sacs around different joints. You might feel pain, tenderness, redness, warmth, swelling and/or stiffness near the affected area).
• Muscle weakness that is constant
Additional possible side effects reported with some statins:
• sleep disturbances, including nightmares
• sexual difficulties
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Simvastatin contains
- The active substance is 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 red (E172)
What Simvastatin looks like and contents of the pack
Film-coated tablets
The tablets are pink, capsule-shaped and biconvex with the inscription “A" on one side and “04" on the other.
Simvastatin 80 mg film-coated tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 84, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dexcel-Pharma Limited 7 Sopwith Way Drayton Fields, Daventry Northamptonshire NN11 8PB UK
Manufacturer
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road, South Ruislip HA5 6QD, United Kingdom.
Tel: ++ 44 20 8845 8811, Fax: ++ 44 20 8845 8795
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Simvastatin Atid 80 mg Filmtabletten
United Kingdom: Simvastatin 80 mg film-coated tablets
This leaflet was last revised in August 2015.
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