Document: leaflet MAH GENERIC_PL 11311-0495 change

• leaflet MAH GENERIC_PL 00289-0407
• leaflet MAH GENERIC_PL 04416-0804
• leaflet MAH GENERIC_PL 11311-0495
• leaflet MAH GENERIC_PL 16363-0306

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Package leaflet: Information for the patient

Pravastatin sodium 10mg, 20mg and 40mg Tablets

What this medicine is and what it is used for

Pravastatin belongs to a group of medicines called statins (HMG-CoA reductase inhibitors). These work by helping to reduce cholesterol and fats (triglycerides) in the blood by inhibiting an enzyme called HMG-CoA reductase, which controls cholesterol production in the liver.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Other medicines and Pravastatin

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

Pravastatin is used to treat the following:

■    Primary hypercholesterolaemia, an inherited condition in which the level of cholesterol in the blood is higher than normal from birth. Pravastatin is used to treat this condition when diet, exercise and weight reduction have been insufficient to correct the condition

■    High levels of triglycerides, cholesterol and other fats in the blood (mixed dyslipidaemia). Pravastatin is used to treat this condition when diet, exercise and weight reduction have been insufficient to correct the condition

■    To prevent heart-related illness or death in patients with moderate to severely high cholesterol levels who are at high risk for first-time heart problems (primary prevention)

■    To prevent heart-related illness or death in patients with a history of heart problems (secondary prevention)

■    To reduce high concentration of triglycerides (fats) or cholesterol in the blood (hyperlipidaemia) in patients who have had an organ transplant and are taking medication to reduce the body's immunity (immunosuppressants)

What you need to know before you take Pravastatin

Do not take Pravastatin if:

■    You are allergic (hypersensitive) to Pravastatin, other HMG-CoA reductase inhibitors or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”)

■    You suffer from liver problems

■    You are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby (see “Pregnancy and breast-feeding” section)

Warnings and precautions

Talk to your doctor before taking Pravastatin:

■    If you suffer from an inherited condition that causes high levels of cholesterol in the blood (homozygous familial hypercholesterolaemia)

■    If you are taking medicines to lower cholesterol known as fibrates (such as gemfibrozil or fenofibrate) (see “Other medicines and Pravastatin” section)

■    If you are a pre-pubescent child

■    If you suffer from liver problems or have a history of liver disease

■    If you regularly drink a large amount of alcohol

■    If you develop symptoms of interstitial lung disease; difficulty in breathing (dysponea), non-productive cough, tiredness, weakness or lack energy (fatigue), weight loss or fever as your treatment should be discontinued (see section 4 “Possible side effects”)

■    If you have unexplained symptoms such as muscle pain or tenderness, muscle weakness, or muscle cramps (these symptoms usually resolve following discontinuation of treatment with Pravastatin)

■    If you have kidney problems

■    If you have an underactive thyroid (hypothyroidism)

■    If you have a history of muscle problems associated with taking other medicines used to lower cholesterol, such as statins or fibrates (see “Other medicines and Pravastatin” section).

■    If you have a personal or family history of suffering from hereditary muscular disorders

■    If you are over 70 years of age

■    If you are diabetic

■    If you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Pravastatin can lead to serious muscle problems (rhabdomyolysis).

Medicines which may interact with or be affected by Pravastatin:

■    Other medicines used to lower cholesterol known as fibrates (such as gemfibrozil or fenofibrate) or nicotinic acid

■    Medicines used to lower cholesterol such as cholestyramine and colestipol (bile acid-binding resin medicines). You should take Pravastatin at least 1 hour before or at least 4 hours after taking a bile acid-binding resin medicine

■    Erythromycin, clarithromycin, medicines used to treat bacterial infections (antibiotics)

■    Ciclosporin, a medicine used to reduce the body's immunity when receiving organ transplant (immunosuppressant), as treatment with Pravastatin should begin with 20mg once daily and slow increase to 40mg should be performed with caution

■    If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Pravastatin. Taking Pravastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

■    If you are taking a drug used to treat and prevent formation of blood clots called “vitamin K antagonist”, tell your doctor before taking Pravastatin because the use of vitamin K antagonists concomitantly with Pravastatin might increase the results of blood tests used to monitor the treatment with vitamin K antagonists.

Taking Pravastatin with food and drink and alcohol

■    During treatment with Pravastatin, a low-fat diet should be followed

■    These tablets may be taken with or without food • You should avoid or limit your intake of alcohol

whilst being treated with Pravastatin

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not take Pravastatin if you are pregnant, trying to become pregnant or think you may be pregnant.

If you plan to become pregnant or become pregnant, inform your doctor immediately as Pravastatin should be discontinued because of the potential risk to the baby.

Breast-feeding

Do not take Pravastatin if you are breast-feeding as Pravastatin is passed into breast milk.

Driving and using machines

Although unlikely, you may feel dizzy or experience visual disturbances whilst taking this medicine. If either of these symptoms are experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

How to take Pravastatin

Always take Pravastatin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Before taking Pravastatin, secondary causes of very high cholesterol levels in the blood (hypercholesterolemia) should be excluded and your doctor should put you on a standard low-fat diet, which should be continued during treatment.

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