Simvastatin

• Reduces cholesterol levels
• Take tablet in the evening
• Avoid drinking too much alcohol, grapefruit and grapefruit juice
• Not to be used while pregnant or breastfeeding

Simvastatin is a medicine used to lower fatty substances in the blood, including cholesterol. Some fatty substances, such as LDL cholesterol and triglycerides, increase the risk of cardiovascular disease. Simvastatin is a medicine used to lower levels of these substances, which in turn reduces the risk of cardiovascular disease.

Statins, such as Simvastatin, are prescribed 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.
• Coronary heart disease (CHD) or are at high risk of CHD.

Take Simvastatin in the evening. The tablet should be swallowed with a drink of water. Simvastatin can be taken with or without food. Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin. Consuming grapefruit or grapefruit juice should be avoided.

This medicine may be used alongside another medicine. Simvastatin is usually used in combination with a cholesterol-lowering diet.

Dosage

Simvastatin is suitable for adults and children aged 10 years and above. This medicine is available in tablets of 5 mg, 10 mg, 20 mg, 40 mg and 80 mg. Dosage varies per person and is determined by a doctor for each specific patient. General dosage guidelines are listed in the package leaflet.

Alcohol/driving

Avoid drinking too much alcohol while taking this medicine. Do not drive if you experience symptoms such as dizziness.

If you use too much/forget to use/stop using Simvastatin

If you take more Simvastatin than you were told to, tell your doctor immediately or contact your nearest hospital casualty department. Take the package with you, so that the medical staff know exactly what you have taken.

If you forget to take a dose of Simvastatin, you should take it as soon as you remember

unless it is almost time for your next scheduled dose. Do not take a double dose to make up for the forgotten one.

Do not stop using Simvastatin without consulting a doctor first.

Simvastatin is not suitable for everyone. Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section 'What Simvastatin contains').
• You have a liver disease.
• You are pregnant or breastfeeding.
• You are taking certain medicines (see section ‘Other medicines and Simvastatin’).

Always consult a doctor if you fall into one of the above-mentioned categories.

When should this medicine be used with caution?

Talk to you doctor before using Simvastatin if:

• You consume large amounts of alcohol.
• You have ever had a liver disease.
• You are due to have an operation. You may need to stop taking this medicine for a short time.
• You are Asian, because a different dose may be applicable to you.
• You have diabetes or at risk of developing diabetes. Your doctor will need to monitor you closely.
• You have a severe liver disease.

Note: 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 this medicine. 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.

For more information, see the package leaflet.

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or breastfeeding.

Other medicines and Simvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Do not use Simvastatin and talk to your doctor if you are taking:

• Cyclosporine (medicine used after transplantation).

• Danazol (a man-made hormone used to treat endometriosis).
• Medicines with an active ingredient like itraconazole, ketoconazole, fluconazole, or posaconazole (used to treat fungal infections).
• Fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol).
• High dose of niacin or nicotinic acid (used to lower cholesterol).
• Erythromycin, clarithromycin, telithromycin or fusidic acid (used to treat bacterial infections).
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir.
• Nefazodone (used to treat depression).
• Amiodarone (used to treat an irregular heartbeat), and verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions).

Taking Simvastatin with any of these medicines can increase the risk of muscle problems.

As well as the medicines listed above, be sure to tell your doctor if you are taking:

• Medicines to prevent blood clots, such as warfarin (anticoagulants).
• Colchicine (used to treat gout).
• Rifampicin (used for treatment of tuberculosis).

Talk to your doctor if you are Chinese or have Chinese ancestry and are taking niacin (nicotine acid) or a product containing niacin (also used to lower cholesterol).

For more information, see the package leaflet.

Medicines can cause side effects, although some people may not experience any. If any of these serious side effects happen, stop taking the medicine and go to the emergency room at your nearest hospital:

• Severe allergic reactions including swelling of the face, tongue, lips and throat which may cause difficulty in breathing (angioedema), severe itching with hives. You need medical assistance immediately.
• Unexplained muscle problems, such as muscle pain, tenderness or weakness. On rare occasions, these muscle problems can be very serious, including muscle breakdown resulting in kidney damage, and very rare deaths have occurred.
• Inflammation of the liver with the symptoms such as yellowing of the skin and eyes (jaundice).

Talk to your doctor or pharmacist if the following side effects are severe or get worse, or if you experience any side effects that are not listed in this list:

• Diabetes. Your doctor will need to monitor you closely during treatment with this medicine.
• Low red blood cell count (anaemia).
• Numbness or weakness of the arms and legs.
• Headache or dizziness.
• Digestive disturbances (nausea, vomiting, constipation, flatulence, indigestion, diarrhoea, abdominal pain).
• Rash, itching, hair loss.
• Disturbed sleep (insomnia, nightmares).
• Poor memory.
• Sexual problems such as erectile dysfunction.
• Depression.
• Pneumonia.

See the package leaflet for a complete list of side effects.

The active substance of Simvastatin PCH 5/10/20/40 mg is simvastatin. Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg simvastatin.

The other ingredients are:

• Tablet core: lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose, citric acid, ascorbic acid, butylated hydroxyanisole, magnesium stearate.
• Tablet coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol 3000, triacetin, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172).

The active substance of Simvastatin PCH 80 mg is simvastatin. Each tablet contains 80 mg simvastatin.

The other ingredients are: ascorbic acid (E300), butylated hydroxyanisole (E320), citric acid monohydrate (E330), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), pregelatinised maize starch, hypromellose (E464), macrogol 3000, glycerol triacetate, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

The manufacturer of Simvastatin PCH 5/10/20/40 mg is:

Teva UK Ltd Brampton Road, Hampden Park
Eastbourne
East Sussex, BN22 9AG
England

The manufacturer of Simvastatin PCH 80 mg is:

TEVA Pharmaceutical Works Pallagi ùt 13
4042 Debrecen
Hungary

Read the package leaflet before use. The official package leaflet of Simvastatin PCH 5/10/20/40 mg is available for download here. You can find the package leaflet of Simvastatin PCH 80 mg here.