Product Details

Product Information of Simvastatin 10mg Tablets

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)
– 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)
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 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 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.
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 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. simvastatin). Your doctor may decide that you stop taking simvastatin for a while,
• 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 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 blister and carton after EXP. 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.