• 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.

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

• 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),
  • 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 Zocor can lead to serious muscle problems (rhabdomyolysis).

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.

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.

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 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.

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.

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.

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 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”).

• 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 Zocor. Taking Zocor 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 (e.g. Zocor). Your doctor may decide that you stop taking Zocor 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 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.

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Zocor. Consuming grapefruit juice should be avoided.

Do not take Zocor if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Zocor, stop taking it immediately and contact your doctor. Do not take Zocor 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.

Zocor 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 Zocor.

Zocor 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.

• please contact your doctor or pharmacist.

• do not take a double dose to make up for a forgotten tablet. Just take your normal amount of Zocor at the usual time the next day.

• talk to your doctor or pharmacist because your cholesterol may rise again.

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 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.

The active substance is simvastatin (10 mg, 20 mg or 40 mg)

The other ingredients are: butylated hydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460), pregelatinised starch, magnesium stearate (E572), and lactose monohydrate. The tablet coating contains hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), and talc (E553b). The 10 mg and 20 mg tablets also contain yellow ferric oxide (E172) and red ferric oxide (E172). The 40 mg tablets also contain red ferric oxide.

10 mg simvastatin tablet: Peach, oval film-coated tablet marked ‘MSD 735’ on one side and plain on the other side.

20 mg simvastatin tablet: Tan, oval film-coated tablet marked ‘MSD 740’ on one side and plain on the other side.

40 mg simvastatin tablet: Brick red, oval film-coated tablet marked ‘MSD 749’ on one side and plain on the other side.

Zocor Tablets are available in packs containing 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium, Finland, France, Germany, Greece, Ireland, Luxembourg, Netherlands, Norway, Portugal, Spain, United Kingdom: ZOCOR.

Austria, Sweden: ZOCORD.

Italy: SINVACOR.