Simvastatin 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 raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is a member of the class of drugs called statins.
Simvastatin 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 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.
Always take this medicine 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.
The dose is 1 Simvastatin 5mg, 10mg, 20mg 40mg or 80 mg tablet by mouth once a day.
The 80mg 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.
Take the tablets in the evening. You can take it with or without food. The usual starting dose is 10, 20 or, in some cases, 40mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80mg a day. Do not take more than 80mg 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 unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin at least two hours before or four hours after taking the bile acid sequestrant.
Like all medicines, Simvastatin 80mg 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
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)
- 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.
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
- 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
- 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.
Additional possible side effects reported with some statins:
- sleep disturbances, including nightmares
- memory loss
- sexual difficulties
- diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure. You doctor will monitor you while you are taking this medicine.
Do not take Simvastatin 80mg:
- if you are allergic to simvastatin or to any of the other ingredients of this medicine (listed in Section 6)
- if you currently have liver problems
- if you are pregnant or breast-feeding
- if you are taking one or more than one of the following drugsat the same time:
- Itraconazole, ketoconazole or posaconazole (medicines for fungal infections)
- Erythromycin, clarithromycin or telithromycin (antibiotics for infections)
- HIV-protease inhibitors, such as indnavir, 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).
Ask your doctor if you are not sure if your medicine is listed above.
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin 80mg:
- Tell your doctor about all your medical conditions includingallergies.
- Tell your doctor if you drink large amounts of alcohol
- Tell your doctor if you have ever had liver disease. Simvastatin may not be right for you.
- Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
- Your doctor should do a blood test before you start taking 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.
- 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 old 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.
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.
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