ZOCOR 10MG TABLETS
Active substance: SIMVASTATIN
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183 LEAFLET Zocor 20120716
Take special care with Zocor Tell your doctor about all your medical conditions including allergies. Tell your doctor if you drink large amounts of alcohol. Tell your doctor if you have ever had liver disease. Zocor may not be right for you. Tell your doctor if you are due to have an operation. You may need to stop taking Zocor tablets for a short time. Your doctor should do a blood test before you start taking 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOCOR 10mg TABLETS (simvastatin)
Your medicine is known as Zocor 10mg Tablets but will be referred to as Zocor throughout the following leaflet. Information for other strength of Zocor also may be present in this leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 80mg 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.
In this leaflet: 1. What Zocor is and what it is used for 2. Before you take Zocor 3. How to take Zocor 4. Possible side effects 5. How to store Zocor 6. Further information 1. WHAT ZOCOR IS AND WHAT IT IS USED FOR 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). You should stay on a cholesterollowering diet while taking this medicine. Zocor is member of the class of drugs called statins. Zocor is used along with 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.
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. Using other medicines It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Zocor with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section Do not take Zocor). ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis) medicines like itraconazole, ketoconazole, fluconazole, or posaconazole (medicines for fungal infections) fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol) erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS) nefazodone (a medicine for depression) amiodarone (a medicine for an irregular heartbeat) verapamil, diltiazem, or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions) colchicine (a medicine used to treat gout).
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. BEFORE YOU TAKE ZOCOR Do not take Zocor if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Zocor Tablets (see Section 6: Further Information). if you currently have liver problems if you are pregnant or breastfeeding if you are taking one or more than one of the following drugs at the same time: o o o itraconazole, ketoconazole, or posaconazole (medicines for fungal infections) erythromycin, clarithromycin, or telithromycin (antibiotics for infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) nefazodone (a medicine for depression) gemfibrozil (a medicine for lowering cholesterol) ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis).
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 any of the following: medicines to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants) fenofibrate (another medicine for lowering cholesterol) niacin (another medicine for lowering cholesterol) rifampicin (a medicine used to treat tuberculosis).
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese. You should also tell any doctor who is prescribing a new medicine for you that you are taking Zocor. Taking 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. Pregnancy and Breast-feeding 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.
o o o o
Ask your doctor if you are not sure if your medicine is listed above.
Children Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see HOW TO TAKE ZOCOR). Zocor has not been studied in children under the age of 10 years. For more information, talk to your doctor. Driving and using machines 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. Important information about some of the ingredients of 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. 3. HOW TO TAKE ZOCOR Always take Zocor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should stay on a cholesterol-lowering diet while taking Zocor. The dose is 1 Zocor 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day. 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. 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. Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Given below is the translation of days in Spanish as printed on blister strips. Lun= Mon Vie = Fri Mar = Tues Sab = Sat Mie = Wed Dom = Sun Jue = Thur
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)
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. Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine sleep disturbances, including nightmares memory loss sexual difficulties.
Additional possible side effects reported with some statins:
Laboratory Values Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE ZOCOR KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store your tablets above 25C. Protect from light. Do not use Zocor after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
Take Zocor in the evening. You can take it with or without food. 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. Keep taking Zocor unless your doctor tells you to stop. If your doctor has prescribed Zocor along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Zocor at least 2 hours before or 4 hours after taking the bile acid sequestrant. If you take more Zocor than you should please contact your doctor or pharmacist. If you forget to take Zocor do not take an extra dose, just take your normal amount of Zocor at the usual time the next day. your cholesterol may rise again.
If you stop taking Zocor If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Zocor can cause side effects, although not everybody gets them. The following terms are used to describe how often side effects have been reported: Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated) Very rare (occurring in less than 1 of 10,000 patients treated). Frequency not known
6. FURTHER INFORMATION What Zocor contains Each tablet contains 10mg of the active ingredient simvastatin. The other ingredients are: lactose, ascorbic acid, citric acid, butylated hydroxyanisole, microcrystalline cellulose, pregelatinised starch, magnesium stearate, methylhydroxypropylcellulose, hydroxypropylcellulose, titanium dioxide (E171), talc, carnauba wax, yellow iron oxide (E172) and red iron oxide (E172). Zocor tablets are peach, oval shaped, film-coated tablets marked MSD 735 on one side and plain on the other.
What Zocor looks like and contents of the pack
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 inflammation of the blood vessels unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing shortness of breath and feeling unwell lupus-like disease picture (including rash, joint disorders, and effects on blood cells)
Zocor is available as blister packs of 28 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by either of the below manufacturers Frosst Iberica S.A., Via Complutense 140, 28805 Alcala de Henares, Madrid, Spain. Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. PL No: 08747/0183
POM
Leaflet revision date: 16 July 2012 Zocor is a registered trade mark of Merck & Co Inc, USA.
183 LEAFLET Zocor 20120716
inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare) inflammation of the pancreas often with severe abdominal pain.
183 LEAFLET Simvastatin 20120716
Take special care with Simvastatin Tablet Tell your doctor about all your medical conditions including allergies. Tell your doctor if you drink large amounts of alcohol. Tell your doctor if you have ever had liver disease. Simvastatin Tablet may not be right for you. Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin Tablet tablets for a short time. Your doctor should do a blood test before you start taking Simvastatin Tablet. 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 Tablet.
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 10mg TABLETS
Your medicine is known as Simvastatin 10mg Tablets but will be referred to as Simvastatin Tablet throughout the following leaflet. Information for other strength of Simvastatin Tablet also may be present in this leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 Tablet, particularly the 80mg 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.
In this leaflet: 1. What Simvastatin Tablet is and what it is used for 2. Before you take Simvastatin Tablet 3. How to take Simvastatin Tablet 4. Possible side effects 5. How to store Simvastatin Tablet 6. Further information 1. WHAT SIMVASTATIN TABLET IS AND WHAT IT IS USED FOR Simvastatin Tablet 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 Tablet raises levels of good cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin Tablet is member of the class of drugs called statins. Simvastatin Tablet is used along with 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 Tablet may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.
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. Using other medicines It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin Tablet with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section Do not take Simvastatin Tablet). ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis) medicines like itraconazole, ketoconazole, fluconazole, or posaconazole (medicines for fungal infections) fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol) erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS) nefazodone (a medicine for depression) amiodarone (a medicine for an irregular heartbeat) verapamil, diltiazem, or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions) colchicine (a medicine used to treat gout).
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. BEFORE YOU TAKE SIMVASTATIN TABLET Do not take Simvastatin Tablet if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Simvastatin Tablet Tablets (see Section 6: Further Information). if you currently have liver problems if you are pregnant or breastfeeding if you are taking one or more than one of the following drugs at the same time: o o o itraconazole, ketoconazole, or posaconazole (medicines for fungal infections) erythromycin, clarithromycin, or telithromycin (antibiotics for infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) nefazodone (a medicine for depression) gemfibrozil (a medicine for lowering cholesterol) ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis).
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 any of the following: medicines to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants) fenofibrate (another medicine for lowering cholesterol) niacin (another medicine for lowering cholesterol) rifampicin (a medicine used to treat tuberculosis).
o o o o
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese. You should also tell any doctor who is prescribing a new medicine for you that you are taking Simvastatin Tablet. Taking Simvastatin Tablet with food and drink Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin Tablet. Consuming grapefruit juice should be avoided. Pregnancy and Breast-feeding Do not take Simvastatin Tablet if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin Tablet, stop taking it immediately and contact your doctor. Do not take Simvastatin Tablet if you are breastfeeding, because it is not known if the medicine is passed into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
Ask your doctor if you are not sure if your medicine is listed above.
Children Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see HOW TO TAKE SIMVASTATIN TABLET). Simvastatin Tablet has not been studied in children under the age of 10 years. For more information, talk to your doctor. Driving and using machines Simvastatin Tablet 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 Tablet. Important information about some of the ingredients of Simvastatin Tablet Simvastatin Tablet 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. 3. HOW TO TAKE SIMVASTATIN TABLET Always take Simvastatin Tablet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should stay on a cholesterol-lowering diet while taking Simvastatin Tablet. The dose is 1 Simvastatin Tablet 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day. 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. 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. Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Given below is the translation of days in Spanish as printed on blister strips. Lun= Mon Vie = Fri Mar = Tues Sab = Sat Mie = Wed Dom = Sun Jue = Thur
inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare) inflammation of the pancreas often with severe abdominal pain. 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)
The following side effects have also been reported rarely:
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. Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine sleep disturbances, including nightmares memory loss sexual difficulties.
Additional possible side effects reported with some statins:
Laboratory Values Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE SIMVASTATIN TABLET KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Do not store your tablets above 25C. Protect from light. Do not use Simvastatin Tablet after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
Take Simvastatin Tablet in the evening. You can take it with or without food. 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. Keep taking Simvastatin Tablet unless your doctor tells you to stop. If your doctor has prescribed Simvastatin Tablet along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin Tablet at least 2 hours before or 4 hours after taking the bile acid sequestrant. If you take more Simvastatin Tablet than you should please contact your doctor or pharmacist. If you forget to take Simvastatin Tablet do not take an extra dose, just take your normal amount of Simvastatin Tablet at the usual time the next day. If you stop taking Simvastatin Tablet your cholesterol may rise again. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Simvastatin Tablet can cause side effects, although not everybody gets them. The following terms are used to describe how often side effects have been reported: Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated) Very rare (occurring in less than 1 of 10,000 patients treated). Frequency not known
6. FURTHER INFORMATION What Simvastatin Tablet contains Each tablet contains 10mg of the active ingredient simvastatin. The other ingredients are: lactose, ascorbic acid, citric acid, butylated hydroxyanisole, microcrystalline cellulose, pregelatinised starch, magnesium stearate, methylhydroxypropylcellulose, hydroxypropylcellulose, titanium dioxide (E171), talc, carnauba wax, yellow iron oxide (E172) and red iron oxide (E172). What Simvastatin Tablet looks like and contents of the pack Simvastatin Tablet tablets are peach, oval shaped, film-coated tablets marked MSD 735 on one side and plain on the other.
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 inflammation of the blood vessels unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing shortness of breath and feeling unwell lupus-like disease picture (including rash, joint disorders, and effects on blood cells)
Simvastatin Tablet is available as blister packs of 28 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by either of the below manufacturers Frosst Iberica S.A., Via Complutense 140, 28805 Alcala de Henares, Madrid, Spain. Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. PL No: 08747/0183
183 LEAFLET Simvastatin 20120716
POM
Leaflet revision date: 16 July 2012
Take special care with Zocor Tell your doctor about all your medical conditions including allergies. Tell your doctor if you drink large amounts of alcohol. Tell your doctor if you have ever had liver disease. Zocor may not be right for you. Tell your doctor if you are due to have an operation. You may need to stop taking Zocor tablets for a short time. Your doctor should do a blood test before you start taking 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOCOR 10mg TABLETS (simvastatin)
Your medicine is known as Zocor 10mg Tablets but will be referred to as Zocor throughout the following leaflet. Information for other strength of Zocor also may be present in this leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 80mg 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.
In this leaflet: 1. What Zocor is and what it is used for 2. Before you take Zocor 3. How to take Zocor 4. Possible side effects 5. How to store Zocor 6. Further information 1. WHAT ZOCOR IS AND WHAT IT IS USED FOR 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). You should stay on a cholesterollowering diet while taking this medicine. Zocor is member of the class of drugs called statins. Zocor is used along with 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.
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. Using other medicines It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Zocor with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section Do not take Zocor). ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis) medicines like itraconazole, ketoconazole, fluconazole, or posaconazole (medicines for fungal infections) fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol) erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS) nefazodone (a medicine for depression) amiodarone (a medicine for an irregular heartbeat) verapamil, diltiazem, or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions) colchicine (a medicine used to treat gout).
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. BEFORE YOU TAKE ZOCOR Do not take Zocor if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Zocor Tablets (see Section 6: Further Information). if you currently have liver problems if you are pregnant or breastfeeding if you are taking one or more than one of the following drugs at the same time: o o o itraconazole, ketoconazole, or posaconazole (medicines for fungal infections) erythromycin, clarithromycin, or telithromycin (antibiotics for infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) nefazodone (a medicine for depression) gemfibrozil (a medicine for lowering cholesterol) ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis).
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 any of the following: medicines to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants) fenofibrate (another medicine for lowering cholesterol) niacin (another medicine for lowering cholesterol) rifampicin (a medicine used to treat tuberculosis).
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese. You should also tell any doctor who is prescribing a new medicine for you that you are taking Zocor. Taking 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. Pregnancy and Breast-feeding 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.
o o o o
Ask your doctor if you are not sure if your medicine is listed above.
Children Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see HOW TO TAKE ZOCOR). Zocor has not been studied in children under the age of 10 years. For more information, talk to your doctor. Driving and using machines 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. Important information about some of the ingredients of 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. 3. HOW TO TAKE ZOCOR Always take Zocor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should stay on a cholesterol-lowering diet while taking Zocor. The dose is 1 Zocor 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day. 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. 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. Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Given below is the translation of days in Spanish as printed on blister strips. Lun= Mon Vie = Fri Mar = Tues Sab = Sat Mie = Wed Dom = Sun Jue = Thur
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)
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. Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine sleep disturbances, including nightmares memory loss sexual difficulties.
Additional possible side effects reported with some statins:
Laboratory Values Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE ZOCOR KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store your tablets above 25C. Protect from light. Do not use Zocor after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
Take Zocor in the evening. You can take it with or without food. 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. Keep taking Zocor unless your doctor tells you to stop. If your doctor has prescribed Zocor along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Zocor at least 2 hours before or 4 hours after taking the bile acid sequestrant. If you take more Zocor than you should please contact your doctor or pharmacist. If you forget to take Zocor do not take an extra dose, just take your normal amount of Zocor at the usual time the next day. your cholesterol may rise again.
If you stop taking Zocor If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Zocor can cause side effects, although not everybody gets them. The following terms are used to describe how often side effects have been reported: Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated) Very rare (occurring in less than 1 of 10,000 patients treated). Frequency not known
6. FURTHER INFORMATION What Zocor contains Each tablet contains 10mg of the active ingredient simvastatin. The other ingredients are: lactose, ascorbic acid, citric acid, butylated hydroxyanisole, microcrystalline cellulose, pregelatinised starch, magnesium stearate, methylhydroxypropylcellulose, hydroxypropylcellulose, titanium dioxide (E171), talc, carnauba wax, yellow iron oxide (E172) and red iron oxide (E172). Zocor tablets are peach, oval shaped, film-coated tablets marked MSD 735 on one side and plain on the other.
What Zocor looks like and contents of the pack
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 inflammation of the blood vessels unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing shortness of breath and feeling unwell lupus-like disease picture (including rash, joint disorders, and effects on blood cells)
Zocor is available as blister packs of 28 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by either of the below manufacturers Frosst Iberica S.A., Via Complutense 140, 28805 Alcala de Henares, Madrid, Spain. Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. PL No: 08747/0183
POM
Leaflet revision date: 16 July 2012 Zocor is a registered trade mark of Merck & Co Inc, USA.
183 LEAFLET Zocor 20120716
inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare) inflammation of the pancreas often with severe abdominal pain.
183 LEAFLET Simvastatin 20120716
Take special care with Simvastatin Tablet Tell your doctor about all your medical conditions including allergies. Tell your doctor if you drink large amounts of alcohol. Tell your doctor if you have ever had liver disease. Simvastatin Tablet may not be right for you. Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin Tablet tablets for a short time. Your doctor should do a blood test before you start taking Simvastatin Tablet. 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 Tablet.
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 10mg TABLETS
Your medicine is known as Simvastatin 10mg Tablets but will be referred to as Simvastatin Tablet throughout the following leaflet. Information for other strength of Simvastatin Tablet also may be present in this leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 Tablet, particularly the 80mg 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.
In this leaflet: 1. What Simvastatin Tablet is and what it is used for 2. Before you take Simvastatin Tablet 3. How to take Simvastatin Tablet 4. Possible side effects 5. How to store Simvastatin Tablet 6. Further information 1. WHAT SIMVASTATIN TABLET IS AND WHAT IT IS USED FOR Simvastatin Tablet 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 Tablet raises levels of good cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin Tablet is member of the class of drugs called statins. Simvastatin Tablet is used along with 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 Tablet may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.
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. Using other medicines It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin Tablet with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section Do not take Simvastatin Tablet). ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis) medicines like itraconazole, ketoconazole, fluconazole, or posaconazole (medicines for fungal infections) fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol) erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS) nefazodone (a medicine for depression) amiodarone (a medicine for an irregular heartbeat) verapamil, diltiazem, or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions) colchicine (a medicine used to treat gout).
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. BEFORE YOU TAKE SIMVASTATIN TABLET Do not take Simvastatin Tablet if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Simvastatin Tablet Tablets (see Section 6: Further Information). if you currently have liver problems if you are pregnant or breastfeeding if you are taking one or more than one of the following drugs at the same time: o o o itraconazole, ketoconazole, or posaconazole (medicines for fungal infections) erythromycin, clarithromycin, or telithromycin (antibiotics for infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) nefazodone (a medicine for depression) gemfibrozil (a medicine for lowering cholesterol) ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis).
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 any of the following: medicines to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants) fenofibrate (another medicine for lowering cholesterol) niacin (another medicine for lowering cholesterol) rifampicin (a medicine used to treat tuberculosis).
o o o o
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese. You should also tell any doctor who is prescribing a new medicine for you that you are taking Simvastatin Tablet. Taking Simvastatin Tablet with food and drink Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin Tablet. Consuming grapefruit juice should be avoided. Pregnancy and Breast-feeding Do not take Simvastatin Tablet if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin Tablet, stop taking it immediately and contact your doctor. Do not take Simvastatin Tablet if you are breastfeeding, because it is not known if the medicine is passed into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
Ask your doctor if you are not sure if your medicine is listed above.
Children Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see HOW TO TAKE SIMVASTATIN TABLET). Simvastatin Tablet has not been studied in children under the age of 10 years. For more information, talk to your doctor. Driving and using machines Simvastatin Tablet 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 Tablet. Important information about some of the ingredients of Simvastatin Tablet Simvastatin Tablet 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. 3. HOW TO TAKE SIMVASTATIN TABLET Always take Simvastatin Tablet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should stay on a cholesterol-lowering diet while taking Simvastatin Tablet. The dose is 1 Simvastatin Tablet 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day. 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. 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. Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Given below is the translation of days in Spanish as printed on blister strips. Lun= Mon Vie = Fri Mar = Tues Sab = Sat Mie = Wed Dom = Sun Jue = Thur
inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare) inflammation of the pancreas often with severe abdominal pain. 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)
The following side effects have also been reported rarely:
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. Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine sleep disturbances, including nightmares memory loss sexual difficulties.
Additional possible side effects reported with some statins:
Laboratory Values Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE SIMVASTATIN TABLET KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Do not store your tablets above 25C. Protect from light. Do not use Simvastatin Tablet after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
Take Simvastatin Tablet in the evening. You can take it with or without food. 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. Keep taking Simvastatin Tablet unless your doctor tells you to stop. If your doctor has prescribed Simvastatin Tablet along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin Tablet at least 2 hours before or 4 hours after taking the bile acid sequestrant. If you take more Simvastatin Tablet than you should please contact your doctor or pharmacist. If you forget to take Simvastatin Tablet do not take an extra dose, just take your normal amount of Simvastatin Tablet at the usual time the next day. If you stop taking Simvastatin Tablet your cholesterol may rise again. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Simvastatin Tablet can cause side effects, although not everybody gets them. The following terms are used to describe how often side effects have been reported: Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated) Very rare (occurring in less than 1 of 10,000 patients treated). Frequency not known
6. FURTHER INFORMATION What Simvastatin Tablet contains Each tablet contains 10mg of the active ingredient simvastatin. The other ingredients are: lactose, ascorbic acid, citric acid, butylated hydroxyanisole, microcrystalline cellulose, pregelatinised starch, magnesium stearate, methylhydroxypropylcellulose, hydroxypropylcellulose, titanium dioxide (E171), talc, carnauba wax, yellow iron oxide (E172) and red iron oxide (E172). What Simvastatin Tablet looks like and contents of the pack Simvastatin Tablet tablets are peach, oval shaped, film-coated tablets marked MSD 735 on one side and plain on the other.
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 inflammation of the blood vessels unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing shortness of breath and feeling unwell lupus-like disease picture (including rash, joint disorders, and effects on blood cells)
Simvastatin Tablet is available as blister packs of 28 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by either of the below manufacturers Frosst Iberica S.A., Via Complutense 140, 28805 Alcala de Henares, Madrid, Spain. Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. PL No: 08747/0183
183 LEAFLET Simvastatin 20120716
POM
Leaflet revision date: 16 July 2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
