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.
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.
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.
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.
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
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
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
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.
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:
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
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.
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.
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.
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