Pravastatin

• Reduces cholesterol levels
• Not to be used while pregnant or breastfeeding
• Tablet can be taken with or without food

Pravastatin belongs to a class of antibiotics called statins. It prevents the production of cholesterol by the liver and consequently reduces the levels of cholesterol and other fats (triglycerides) in your blood.

This medicine is used in the following situations:

• In the treatment of high levels of cholesterol and fats in the blood. Pravastatin is used to lower high levels of ‘bad’ cholesterol and to raise the levels of ‘good’ cholesterol in the blood when changes to diet and exercise have failed to adequately do this.
• In the prevention of heart and blood vessel diseases:
  • If you have high levels of cholesterol in your blood and risk factors favouring these diseases (if you smoke, are overweight, have high blood pressure or take little exercise), Pravastatin is used to reduce the risk of you having heart and blood vessel diseases.
  • If you have already had a stroke or if you have pains in the chest (angina pectoris), and even if you have normal cholesterol levels, Pravastatin is used to reduce the risk of you having another heart attack or stroke in the future, and to lower your risk of dying from these diseases.

Always take this medicine exactly as your doctor or pharmacist has told you. When in doubt, contact your doctor or pharmacist.

Dosage

The recommended dose is:

Adults

• In the treatment of high levels of cholesterol and fats in the blood: the usual dose is 10 to 40 mg once a day, preferably in the evening.
• In the prevention of heart and blood vessel diseases: the usual dose is 40 mg once a day, preferably in the evening.

The maximum daily dose of 40 mg should not be exceeded. The doctor will recommend the right dose for you.

Children (8-13 years of age) and adolescents (14-18 years of age) with a hereditary disease which increases the level of cholesterol in the blood:

• Children aged 8-13 years: 10 mg to 20 mg once a day.
• Adolescents aged 14-18 years: 10 to 40 mg once a day.

Pravastatin tablets should be taken with a drink of water and can be taken with or without food.

For conditions other than those listed above, the doctor may prescribe a different dose. The doctor may also adjust the dose if you are taking other medicines or for certain conditions. See the package leaflet for more information on the use Pravastatin.

If you take more Pravastatin than you should or miss a dose

If you have taken more Pravastatin than you should, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.

If you miss a dose of Pravastatin, skip the missed dose and continue with your regular dosing schedule. Never take a double dose to make up for the forgotten one.

Pravastatin is not suitable for everyone. Do not take this medicine if:

• You are allergic any of the ingredients in this medicine (see section ‘What Pravastatin contains').
• You are pregnant or think you may be pregnant.
• You have a liver disease (progressive liver disease).
• Several blood tests have shown abnormal functioning of your liver (increased levels of liver enzymes in the blood).

When should this medicine be used with caution?

Before you take this medicine, you should tell your doctor if you have or have had any medical problems such as:

• A kidney disease.
• An underactive thyroid (hypothyroidism).
• A liver disease or alcohol problems (drinking large amounts of alcohol).
• Muscle disorders caused by a hereditary disease.
• Muscle problems caused by another medicine belonging to the statins group or one belonging to the group known as fibrates.

The risk of muscle breakdown is greater in certain patients. Tell your doctor if any of the following applies to you:

• If you are taking or have taken in the last seven days a medicine called fusidic acid, orally or by injection.
• If you are older than 70 years.

If you have diabetes or are likely to be at risk of developing diabetes, your doctor will monitor you closely while you are on this medicine. 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.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant.

Pregnancy and breastfeeding

Do not take Pravastatin if you are pregnant. If you discover that you are pregnant, you should inform your doctor immediately.

Do not take Pravastatin if you intend to breastfeed as this treatment passes into breast milk.

Other medicines and Pravastatin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Pravastatin with any of these medicines can increase the risk of muscle problems:

• A medicine which lowers the cholesterol level in the blood (e.g., nicotine acid, and fibrates such as gemfibrozil or fenofibrate).
• Ciclosporin.
• Certain antibiotics such as erythromycin and clarithromycin.
• Oral fusidic acid.
• Colchicine.
• Rifampicin.
• Lenalidomide.

If you are also using a medicine which lowers the level of fat in your blood (of the resin-type such as

colestyramine or colestipol), this treatment should be taken at least one hour before or four hours after you have taken the resin.

See the package leaflet for more warnings associated with the use of Pravastatin. Consult a doctor if you are not sure if Pravastatin is suitable for you.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are uncommon and may affect up to 1 in 100 people:

• Effects on nervous system: dizziness, tiredness, headache or sleep disturbances, including insomnia.
• Effects on vision: blurred or double vision.
• Digestive effects: nausea, vomiting, stomach pain or discomfort, diarrhoea or constipation.
• Effects on skin and hair: itching, pimples, hives, rashes, scalp and hair problems (including hair loss).
• Urinary effects: bladder problems (painful or more frequent urination, having to pass water at night).
• Sexual difficulties.
• Muscle and joint pain.

For a list of uncommon and rare side effects, please see the package leaflet. Side effects should be reported to a doctor or pharmacist.

Stop taking Pravastatin and tell your doctor immediately if you have a severe allergic reaction, or develop any unexplained or persistent muscle pain, tenderness, weakness, or cramps, especially, if at the same time you feel unwell or have a high temperature. In very rare cases, muscle problems can be serious (rhabdomyolysis) and can lead to a serious, life-threatening kidney disease.

The active substance is pravastatin sodium. Each tablet contains 20 mg or 40 mg pravastatin sodium.

Read the package leaflet before use. The official package leaflet of Pravastatin is available for download here.