Informations for option: Lipostat 40mg, show other option

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1. Lipostat 40mg
2. Lipostat 40mg

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

The usual dose is 10-20 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 transplant:

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 suffer from kidney or severe liver disease, your doctor may prescribe a lower dose of LIPOSTAT to you.

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

Duration of treatment

Your doctor will indicate the duration of your treatment with LIPOSTAT. This medicine must be used very regularly and for as long as your doctor advises, even if it is for a very long time. Do not stop your treatment by yourself.

If you take more LIPOSTAT than you should

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

If you forget to take LIPOSTAT

If you miss a dose, simply take your usual dose when it is next due.

Do not take a double dose to make up for a forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

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

Stop taking LIPOSTAT 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);

•    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.

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.

Possible side effects

•    Nightmares

•    Memory loss

Bristol-Myers Squibb Anagni (FR)

PACKAGE LEAFLET: INFORMATION FOR THE USER

LIPOSTAT 10MG, 20MG AND 40MG tablets

Pravastatin sodium

In this leaflet:

1.    What LIPOSTAT is and what it is used for

2.    Before you take LIPOSTAT

3.    How to take LIPOSTAT

4.    Possible side effects

5.    How to store LIPOSTAT

6.    Further information

1.    WHAT LIPOSTAT IS AND WHAT IT IS USED FOR

LIPOSTAT 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.

This medicine is used in 3 situations:

In the treatment of high levels of cholesterol and fats in the blood

LIPOSTAT 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), LIPOSTAT 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, LIPOSTAT 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, LIPOSTAT is used to reduce increased levels of fats in the blood.

2.    BEFORE YOU TAKE LIPOSTAT

Do not take LIPOSTAT

•    if you are allergic (hypersensitive) to pravastatin or any of the other ingredients of this medicine (see Further Information);

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

•    if you have a liver disease (active liver disease);

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

Take special care with LIPOSTAT

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

•    kidney disease;

•    an underactive thyroid (hypothyroidism);

FRONT

•    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 (HMG-CoA reductase inhibitor drugs) or one belonging to the group known as fibrates (see Taking other medicines).

If you have suffered from any of these problems, or if you are older than 70 years, your doctor will need to carry out a blood test before and possibly during your treatment. These blood tests will be used to evaluate your risk of muscle-related side effects.

If you feel any unexplained cramps or muscle pains during treatment, tell your doctor immediately. 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 LIPOSTAT if you:

•    Have severe respiratory failure 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 medicine which lowers the cholesterol level in the blood (fibrates, e.g. gemfibrozil, fenofibrate);

•    a medicine which lowers the body’s immune defences (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).

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. This is because the resin can affect the absorption of LIPOSTAT if the two medicines are taken too closely together.

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

Taking LIPOSTAT 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

Do not take LIPOSTAT during pregnancy. If you discover that you are pregnant, you should inform your doctor immediately.

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

Breast-feeding

Do not take LIPOSTAT if you intend to breast-feed as this treatment passes into the mother's milk. Driving and using machines

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

Important information about some of the ingredients of LIPOSTAT

LIPOSTAT contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE LIPOSTAT

Your doctor will advise you on a lowfat diet which you should continue over the full treatment period. Always take this treatment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

Dosage

Adults:

•    In the treatment of high levels of cholesterol and fats in the blood: the usual dose is 10-40 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 of pravastatin should not be exceeded. Your doctor shall tell you which dose suits you.

•    Depression

•    Breathing problems including persistant 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.

5. HOW TO STORE LIPOSTAT

Keep out of the reach and sight of children.

Do not use this treatment after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not store above 25°C.

Store in the original package in order to protect from moisture and light.

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.

6. FURTHER INFORMATION

What LIPOSTAT contains:

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

•    The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate, heavy magnesium oxide, yellow iron oxide (E172).

What LIPOSTAT looks like and contents of the pack

LIPOSTAT 10mg is a yellow, capsule-shaped, biconvex, scored tablet with a "10" engraved on one side. = LIPOSTAT 20mg is a yellow, capsule-shaped, biconvex, scored tablet with a "20" engraved on one side. LIPOSTAT 40mg is ayellow, capsule-shaped, biconvex, scored or unscored tablet with a "40" engraved on one side.

They come in blister packs in boxes of 28 tablets.

Marketing Authorisation Holder and Manufacturer:

Bristol Myers Squibb Pharmaceuticals Ltd.,

Uxbridge Business Park,

Sanderson Road, Uxbridge,

Middlesex UB8 1DH, England Tel: 0800 7311736

Ireland

Bristol Myers Squibb Pharmaceuticals Ltd.,

Swords,

County Dublin,

Ireland

Tel: 1 800 749 749

Manufacturer

Bristol-Myers Squibb, S.r.l.

Contrada Fontana del Ceraso

03012 Anagni

Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

Name of the Member States

Belgium

Denmark

Finland

France

Germany

Greece

Iceland

Ireland

Italy

Luxembourg

Netherlands

Norway

Portugal

Spain

Sweden

UK

Name of the medicinal product

Pravasine

Pravachol

Pravachol

Elisor

Pravasin protect

Pravachol

Pravachol

Lipostat

Selectin

Pravasine

Selektine

Pravachol

Pravacol

Lipemol

Pravachol

Lipostat

This leaflet was last approved in April 2013

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PAG. 4