SIMVASTATIN TABLETS BP 20 MG

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE ITCONTAINS 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 mayharm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist.

WHAT IS IN THIS LEAFLET

What Simvastatin is and what it is usedfor
What you need to know before you take Simvastatin
How to take Simvastatin
Possible side effects
How to store Simvastatin
Contents of the pack and other information

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 othertreatments.
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 yourblood.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN DO NOT USE 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 liverproblems
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)

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 dis order.
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 section4.
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 ingredientcobicistat
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 (e.g. simvastatin). Your doctor may decide that you stop taking simvastatin for awhile
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.

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.

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.