Zocor 40mg Tablets
1. What ZOCOR is and what it is used for
2. What you need to know before you take ZOCOR
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOCOR® 40mg
(simvastatin)
The name of your product is Zocor 40mg but will be referred to as Zocor throughout this leaflet.
This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.
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 ZOCOR is and what it is used for
2. What you need to know before you take ZOCOR
3. How to take ZOCOR
4. Possible side effects
5. How to store ZOCOR
6. Contents of the pack and other information
ZOCOR contains the active substance simvastatin. ZOCOR is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, ZOCOR raises levels of “good” cholesterol (HDL cholesterol). ZOCOR 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.
T riglycerides 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.
ZOCOR 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). ZOCOR 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.
Do not take ZOCOR
• 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:
o itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)
o erythromycin, clarithromycin, or telithromycin (used to treat infections)
o HIV protease inhibitors such as indinavir, nelfinavir,
ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)
o boceprevir or telaprevir (used to treat hepatitis C virus infection)
o nefazodone (used to treat depression) o cobicistat
o gemfibrozil (used to lower cholesterol) o ciclosporin (used in organ transplant patients) o 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, 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 ZOCOR 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. ZOCOR may not be right for you.
• if you are due to have an operation. You may need to stop taking ZOCOR 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 ZOCOR and if you have any symptoms of liver problems while you take ZOCOR. 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 ZOCOR.
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.
T ell 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 ZOCOR, 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.
Children and adolescents
Safety and effectiveness of ZOCOR 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 ZOCOR). ZOCOR has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Other medicines and ZOCOR
T ell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking ZOCOR 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 ZOCOR”).
• 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)
• boceprevir or telaprevir (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 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 ZOCOR.
ZOCOR with food and drink
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including ZOCOR. Consuming grapefruit juice should be avoided.
