PACKAGE LEAFLET: INFORMATION FOR THE USER

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Pravastatin Sodium 10 mg, 20 mg and 40 mg Tablets

(Pravastatin Sodium)

Read all of the leaflet carefully before you start taking this medicine

•    Keep this leaflet.You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Pravastatin is and what it is used for

2.    Before you take Pravastatin

3.    How to take Pravastatin

4.    Possible side effects

5.    How to store Pravastatin

6.    Further information

ASANDOZ

What Pravastatin is and what it is used for

Pravastatin belongs to a group of medicines called statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and consequently reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, the cholesterol accumulates on the walls of blood vessels and blocks them.

This condition is called hardening of the arteries or atherosclerosis and it may lead to:

•    chest pain (angina pectoris), when a blood vessel in the heart is partially blocked,

•    a heart attack (myocardial infarction), when a blood vessel in the heart is completely blocked,

•    a stroke (cerebrovascular accident), when a blood vessel in the brain is completely blocked.

If you have suffered from any of these problems, your doctor will need to carry out a blood test before and possibly during Pravastatin treatment to assess your risk of developing muscle-related side effects. You may also need this blood test if you are aged older than 70 years. If you feel any unexplained cramps or muscle pains during treatment, tell your doctor immediately.

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.

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.

Check with your doctor or pharmacist before taking Pravastatin if you have:

• severe respiratory failure.

This medicine is used in 3 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, if you have high blood sugar levels or high blood pressure, if you take little exercise), Pravastatin is used to reduce the risk of you having heart and blood vessel diseases and to lower your risk of dying from these diseases.

•    If you have already had a stroke or if you have pains in the chest (unstable angina), 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.

After organ transplants

If you have had an organ transplant and receive medication to prevent your body rejecting the transplant, Pravastatin is used to reduce increased levels of fats in the blood.

Before you take Pravastatin

Do not take Pravastatin Tablets:

•    if you are hypersensitive (allergic) to pravastatin sodium or any of the other ingredients of this medicine (see section 2 Important information about some of the ingredients and Further information);

•    if you are pregnant or trying to become pregnant or if you are breast-feeding (see Pregnancy and Breast-feeding);

•    if you have any liver disease (active liver diseases);

•    if several blood tests have shown abnormal functioning of your liver (increased levels of liver enzymes in the blood).

Take special care with Pravastatin

Tell your doctor if you have ever had any of the

following:

•    Kidney disease;

•    an underactive thyroid gland (hypothyroidism);

•    A liver disease or alcohol problems (regularly drinking large amounts of alcohol);

•    A hereditary muscle disorder in yourself or a blood relative;

•    Side effects affecting your muscles when taking another cholesterol lowering medicine such as a statin or a fibrate.

Using other medicines:

When combined with this treatment, the medicines stated below may result in an increased risk of developing muscle problems (see Possible side effects). It is important that you inform your doctor whether you are already being treated with:

•    a group of cholesterol lowering medicines called fibrates (e.g. gemfibrozil, fenofibrate);

•    medicines used to adjust or adapt the immune response, e.g. ciclosporin;

•    a medicine which treats the infections caused by bacteria (an antibiotic such as erythromycin or clarithromycin);

•    another medicine which lowers the level of cholesterol in your blood (nicotinic acid);

•    a resin-type lipid-lowering agent such as colestyramine or colestipol (Pravastatin should usually be taken at least one hour before or four hours after you have taken the resin. This is because the resin can affect the absorption of pravastatin if the two medicines are taken closely together);

•    Warfarin and other oral anticoagulants (agents that help in thinning the blood);

•    Product metabolized by cytochrome P450 (diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors and CYP2C9 inhibitors like fluconazole).

Please tell your doctor or pharmacist if you are using or have recently used other medicines, including medicines obtained without a prescription.

Taking Pravastatin with food and drink

This treatment can be taken with or without food, with half a glass of water.

You should always keep your alcohol intake to a minimum. If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor.

Pregnancy and Breast-feeding:

Do not take Pravastatin if you are pregnant, trying to become pregnant or suspect you may be pregnant, as the safety in pregnant women has not been established, if you become pregnant while using Pravastatin, you must stop taking tablets immediately and contact your doctor.

A small amount of the active substance of Pravastatin passes into breast milk. Therefore, you must not take Pravastatin while breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Pravastatin does not usually affect your ability to drive or use machines. If you experience any dizziness, blurred or double vision during treatment, make sure that you are fit to drive and operate machinery before attempting to do so.

Continued on the next page >>

Important information about some of the ingredients of Pravastatin Tablets:

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

How to take Pravastatin

Your doctor will advise you on a low fat diet which you should continue over the full treatment period.

Always take Pravastatin exactly as your doctor has instructed you.

You should check with your doctor or pharmacist if you are not sure.

•    Effects on liver: inflammation of the liver or pancreas; jaundice (recognisable by a yellowing of the skin and of whites of the eyes; very rapid death of liver cells (fulminant hepatic necrosis);

•    Effects on muscles and bones: inflammation of one or more muscles leading to pain or weakness in muscles (myositis or polymyositis); pain or weakness in muscles, inflammation of tendons which may be complicated by rupture of tendons;

•    Abnormal blood tests: increases in transaminases (a group of enzymes occurring naturally in the blood) which may be a sign of liver problems. Your doctor may want to perform tests periodically to check these.

Side effects of unknown frequency (frequency cannot

be estimated from the available data)

•    muscle weakness that is constant

Pravastatin can be taken with or without food, with half a glass of water.

Dosage

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

The usual dose is 10 to 20 mg once a day between 8 and 13 years and from 10 to 40 mg once a day between 14 and 18 years.

After organ transplantation:

Your doctor may prescribe a starting dose of 20 mg once a day. The dose may be adjusted up to 40 mg by your doctor.

If you are also taking a medicine which lowers the body's immune system (ciclosporin), your doctor may prescribe a starting dose of 20 mg once a day. The dose may be adjusted up to 40 mg by your doctor.

If you have the impression that the effect of Pravastatin is too strong or too weak, talk to your doctor or pharmacist.

Prevention of heart attack or stroke:

The usual dose is 40 mg.

If you suffer from kidney or severe liver disease, your doctor may prescribe a lower dose (usually 10 mg once a day) of Pravastatin to you.

If you take more Pravastatin than you should:

If you have taken too many tablets, or if someone accidentally swallows some, contact your doctor or the nearest hospital for advice.

If you forget to take Pravastatin:

If you miss a dose, simply take your normal dose when it is next due. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pravastatin

Always tell your doctor or pharmacist if you want to stop the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

•    Nightmares

•    Memory loss

•    Depression

•    Breathing problems including persistent cough and/or shortness of breath or fever.

Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

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How to store Pravastatin

Keep all medicines out of the reach and sight of children.

Do not take Pravastatin Tablets after the expiry date shown on the pack.

The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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Further information

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Possible side effects

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

Stop taking Pravastatin and tell your doctor immediately if you 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 (rhabdomylosis) and can lead to a serious, life-threatening kidney disease.

Sudden severe allergic reactions including swelling of the face, lip, tongue or wind pipe which can cause great difficulty in breathing. This is a very rare reaction which can be serious if it occurs. You should tell your doctor immediately if it happens.

The following side effects are uncommon and may affect more than 1 out of 1,000 persons:

•    Effects on nervous system: dizziness, tiredness, headache or sleep disturbances, including insomnia;

•    Effects on vision: blurred or double vision;

•    Digestive effects: indigestion, nausea, vomiting, stomach pain or discomfort, diarrhoea or constipation and wind;

•    Effects on skin and hair: itching, pimples, hives, rashes, scalp and hair problems (including hair loss);

•    Urinary and genital effects: bladder problems (painful or more frequent urination, having to pass water at night) and sexual difficulties;

•    Effects on muscles and joints: muscle and joint pain.

The following side effects are very rare and may affect less than 1 out of 10,000 persons:

•    Effects on nervous system: problems with touch including burning or tingling sensations or numbness which may indicate damage to nerves;

•    Effects on skin: a severe skin disease (lupus erythematous-like syndrome);

The active ingredient is pravastatin sodium. Each tablet contains 10 mg, 20 mg or 40 mg of pravastatin sodium.

The other ingredients are: lactose monohydrate (see section 2 Important information about some of the ingredients), sodium phosphate, sodium lauryl sulphate, povidone, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, ferric oxide, brown (E 172).

What Pravastatin looks like and contents ofthe pack

Pravastatin 10 mg tablets are light brown, mottled, oval, scored on both sides and debossed with “P 10” on one side.

Pravastatin 20 mg tablets are light brown, mottled, oval, scored on both sides and debossed with “P 20” on one side.

Pravastatin 40 mg tablets are light brown, mottled, oval, scored on both sides and debossed with “P 40” on one side.

Pravastatin tablets are available in blister packs of20, 28, 50, 98, and 100.

Not all pack sizes may be marketed.

Marketing Authorisation holder:

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Lek Pharmaceuticals,

Verovskova 57, SI-1526 Ljublijana,

Slovenia.

This leaflet was last revised in 03/2015

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