Simchol 5 mg/10 mg/20 mg/40 mg/80 mg Tablets

SIMCHOL is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, SIMCHOL raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking SIMCHOL. SIMCHOL is a member of the class of medicine called statins. SIMCHOL 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).

SIMCHOL may prolong your life by reducing the risk of heart disease, ir 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.

Do not take SIMCHOL:

• If you are hypersensitive (allergic) to simvastatin, other HMG-CoA reductase inhibitors, or any of the ingredients of SIMCHOL.
• If you have acute or chronic liver disease.
• If you are pregnant or breast-feeding.
• If you suffer from porphyria (a group of rare disorders passed down through families, in which an important part of hemoglobin, called heme, is not made properly).

Take special care with SIMCHOL:

• SIMCHOL should not be used by female patients of child-bearing potential.
• If you suffer from kidney or liver disease, and if you consume substantial amounts of alcohol and/or have a history of liver disease.
• If you develop unexplained muscle pain, tenderness or weakness, report this promptly to your doctor or pharmacist.

Pregnancy and Breast-feeding: Safety of SIMCHOL in pregnant and breast-feeding women has not been established. SIMCHOL is not advised in women who are pregnant or breast-feeding. If you are pregnant or breast-feeding your baby, please consult your doctor, pharmacist or other health care professional for advice before taking this medicine.

Driving and using machinery: SIMCHOL may cause dizziness. In such a case, do not drive or operate machinery.

Important information about some of the ingredients of SIMCHOL: SIMCHOL contains lactose, which is a type of sugar. So before taking SIMCHOL, please consult your doctor for advice if you have an intolerance to some sugars.

Taking other medicines with SIMCHOL:

• Cytochrome P450 isoenzyme CYP3A4 inhibitors: SIMCHOL interacts with ciclosporin, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV-protease inhibitors, nefazodone, danazol, amiodarone and verapamil. There may also be similar interaction with grapefruit juice.
• Bile acid sequestrants: SIMCHOL should be taken 1 hour before or 4 hours after cholestyramine.
• Please consult your doctor if you are using immunosuppressants, fibrates or niacin.
• Amiodarone (antiarrhythmic), erythromycin and clarithromycin (antibacterial) increases the plasma concentrations of SIMCHOL.
• Itraconazole and ketoconazole (antifungal) and HIV-protease inhibitors also increase the plasma concentrations of SIMCHOL and may therefore increase the effect of SIMCHOL.

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)

Always take SIMCHOL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of SIMCHOL is too strong or too weak, talk to your doctor or pharmacist. You must follow a cholesterol-lowering diet before starting, and while on SIMCHOL therapy.

If you suffer from hypercholesterolaemia i.e. the presence of an abnormal amount of cholesterol in the cells and plasma of the blood:

• Initial dose: 10 mg daily as a single dose in the evening.

If you suffer from coronary heart disease:

• Initial dose: 20 mg/day as a single dose in the evening.

If you are taking cholestyramine which is also used to lower your cholesterol: you should take SIMCHOL 1 hour before or 4 hours after taking cholestyramine. SIMCHOL can be taken with meals or on an empty stomach.

If you take more SIMCHOL than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

If you forget to take SIMCHOL: Do not take a double dose to make up for forgotten individual doses.

SIMCHOL can have side effects. If any of the following happen, stop taking SIMCHOL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat.
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
• Severe itching of the skin (with raised lumps).

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Increased blood sugar levels
• Myalgia (pain in the muscles)
• Muscle cramps

Tell your doctor as soon as possible if you notice any of the following:

• Headache
• Pain in the feet and hands
• Cognitive impairment such as memory loss, confusion, forgetfulness and amnesia
• Myopathy (any pathology of the muscles that is not attributable to nerve dysfunction)
• Myositis (inflammation of a voluntary muscle)
• Rhabdomyolysis (the rapid disintegration of skeletal muscle tissue following injury) presenting as muscle pain.
• Hypersensitivity reactions may include the following: Arthritis (inflammation of a joint), Arthralgia (pain in a joint), urticaria (an itchy skin eruption characterized by weals with pale interiors and well-defined red margins; usually the result of an allergic response to insect bites, food or medicines), abnormal responses of your skin or eyes to the sunlight, fever, flushing (Redness of the face lasting a short time), malaise (a vague feeling of bodily discomfort and fatigue), and dyspnoea (difficulty in breathing).
• Weight gain
• Dizziness
• Fatigue (Temporary loss of strength and energy resulting from hard physical or mental work)
• Asthenia (abnormal loss of strength)
• Paraesthesia (abnormal touch sensation as tingling, tickling, itching or burning)
• Diarrhoea (frequent and watery bowel movements)
• Constipation (infrequent or difficult evacuation of faeces)
• Nausea (feeling sick)
• Vomiting
• Flatulence
• Abdominal pain and cramps
• Skin rash
• Alopecia (hair loss)

Not all side effects reported for SIMCHOL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SIMCHOL, please consult your doctor, pharmacist or other health care professional for advice.

Store all medicines out of reach of children. Store at or below 30 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).