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. You should stay on a cholesterol-lowering diet while taking this medicine.
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.
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 measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.
How to take ZOCOR
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 has told you. Check with your doctor or pharmacist if you are not sure. You should stay on a cholesterol-lowering diet while taking ZOCOR.
The recommended dose is ZOCOR 10 mg, 20 mg, or 40 mg 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 40 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 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 ZOCOR in the evening. You can take it with or without food. Keep taking ZOCOR unless your doctor tells you to stop. If your doctor has prescribed ZOCOR along with another medicine for lowering cholesterol containing any bile acid sequestrant, 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 a double dose to make up for a forgotten tablet. Just take your normal amount of ZOCOR at the usual time the next day.
If you stop taking ZOCOR: Talk to your doctor or pharmacist because your cholesterol may rise again. If you have any further questions on the use of this product, ask your doctor or pharmacist.
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 (may affect up to 1 of 1000 people).
- Very rare (may affect up to 1 of 10.000 people).
- Not known (frequency cannot be estimated from the available data).
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 (polymyalgia rheumatica).
- Inflammation of the blood vessels (vasculitis).
- Unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing.
- Shortness of breath (dyspnoea) and feeling unwell.
- Lupus-like disease picture (including rash, joint disorders, and effects on blood cells).
Inflammation of the liver with the following symptoms; yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite, liver failure (very rare).
Inflammation of the pancreas often with severe abdominal pain.
The following side effects have also been reported rarely:
- Low red blood cell count ( anaemia).
- Numbness a weakness of the arms and legs.
- Headache, tingling sensation, dizziness.
- Digestive disturbances (abdominal pain, constipation, flatulence. indigestion. diarrhoea, nausea, vomiting).
- Rash. itching, hair loss.
- Trouble sleeping (very rare).
- Poor memory (very rare, memory loss, confusion
What ZOCOR looks like
ZOCOR is available as 10 mg, 20 mg & 40 mg.
- ZOCOR 10 mg: Carton box containing 1, 2, or 4 (PVC/PE/PVCD-AL) blisters, each of 7 tablets.
- ZOCOR 20mg & 40 mg: Carton box containing 1, 2, or 4 (PVC- AL) blisters. each of 7 tablets.
Marketing Authorization Holder and Manufacturer Marketing Authorization Holder: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands.
- Manufacturer of Zocor 10: Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington, Northumberland NE23 3JU, United Kingdom. Packed by: Global Napi Pharmaceuticals.
- Manufacturer of Zocor 20 mg & 40 mg: Global Napi Pharmaceuticals under license of Merck & Co., Inc., USA and its branches in Netherlands.
|C10AA01||simvastatin||LIPID MODIFYING AGENTS||Global Napi Pharmaceuticals||Merck Sharp & Dohme Ltd|
Zocor – Information Leaflet
|Council of Arab Health Ministers and Union of Arab pharmacists|
|Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.|
|Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sells the medicament.|
|The doctor and the pharmacist are experts in medicine, its benefits and risks.|
|Do not by yourself intenupt the period of treatment prescribed for you.|
|Do not repeat the same prescription without consulting your doctor.|
|Keep medicament out of children reach.|
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