Pravastatin Sodium 40mg Tablets

Document: leaflet MAH GENERIC_PL 17780-0209 change

Package leaflet: Information for the patient

Pravastatin Sodium 10mg, 20mg and 40mg Tablets

Pravastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pravastatin is and what it is used for

2. What you need to know before you take Pravastatin

3. How to take Pravastatin

4. Possible side effects

5. How to store Pravastatin

6. Contents of the pack and other information

1. What pravastatin is and what it is used for

The name of your medicine is Pravastatin Sodium 10mg, 20mg, and 40mg Tablets. Each tablet contains 10mg, 20mg or 40mg of pravastatin sodium (referred to as pravastatin throughout this leaflet).

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.

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.

2. What you need to know before you take pravastatin

Do not take Pravastatin:

• if you are allergic to pravastatin or any of the other ingredients of this medicine (listed in section 6)

• if you have liver disease (active liver disease)

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking pravastatin:

• if you have or have had kidney disease

• if you have or have had an under-active thyroid gland (hypothyroidism)

• if you have or have had a liver disease or alcohol problems (drinking large amounts of alcohol)

• if you have or have had muscle disorders caused by a hereditary disease

• if you have or have had 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 Other medicines and Pravastatin)

• if you have or have had severe respiratory failure

• 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).

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.

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.

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);

• a medicine to treat a bacterial infection (fusidic acid). If you need to take oral fusidic acid 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 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 pravastatin if the two medicines are taken too closely together.

Pravastatin with food, drink and alcohol

Pravastatin 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, breast-feeding and fertility

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

Pregnancy

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

Breast-feeding

Do not take pravastatin if you intend to breast-feed as this treatment passes into the mother's milk.

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 you are fit to drive and use machines before attempting to do so.

3. How to take pravastatin

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

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

Pravastatin 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.

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 mg to 20 mg once a day between 8 and 13 years and from 10 mg 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 pravastatin 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 pravastatin. 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 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 appropriate advice. Take the carton and any tablets left with you so that the doctors know what you have taken.

If you forget to take pravastatin

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 stop taking pravastatin

Keep taking pravastatin until your doctor tells you to stop.

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

4. Possible side effects

Like all medicines, this medicine 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.

Uncommon (may affect up to 1 in 100 people)

• dizziness, tiredness, headache or sleep disturbances, including insomnia

• blurred or double vision

• indigestion/heartburn, nausea, vomiting, stomach pain or discomfort, diarrhoea or constipation and wind

• itching, pimples, hives, rashes, scalp and hair problems (including hair loss)

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

• muscle and joint pain

Very rare (may affect up to 1 in 10,000 people)

• problems with touch including burning or tingling sensations or numbness which may indicate damage to nerves a severe skin disease (lupus erythematous-like syndrome)

• 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)

• 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

• 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

Not known (frequency cannot be estimated from the available data)

• muscle weakness that is constant

Other 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store pravastatin

• Keep this medicine out of the sight and reach of children.

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

• Do not store above 30°C. Store in the original package in order to protect from light and moisture.

• If you notice any of the tablets are broken or chipped, talk to your pharmacist before taking them.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pravastatin Sodium 10mg, 20mg, and 40mg Tablets contains

Each tablet contains 10mg, 20mg or 40 mg pravastatin sodium as the active substance.

Each tablet also contains mannitol, microcrystalline cellulose, hydrogenated castor oil, calcium lactate pentahydrate, calcium carbonate, crospovidone, red iron oxide (E172) and magnesium stearate.

What Pravastatin Sodium 10mg, 20mg, and 40mg Tablets looks like and contents of the pack

Pravastatin sodium 10mg tablets are pale mauve-coloured, marbled, flat bevelled edged round tablets, marked ‘10’ on one side.

Pravastatin sodium 20mg tablets are pale mauve-coloured, marbled, flat bevelled edged round tablets, marked ‘20’ on one side.

Pravastatin sodium 40mg tablets are pale mauve-coloured, marbled, flat bevelled edged round tablets, marked ‘40’ on one side.

Pack sizes: 10, 14, 28, 30, 50, 56, 60, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Winthrop Pharmaceuticals, PO Box 611, Guildford, Surrey, GU1 4YS, UK

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.

Manufacturer

Chinoin Pharmaceutical & Chemical Works Co Ltd, H-2112 Veresegyhaz, Levai u. 5, Hungary or

Chinoin Pharmaceutical & Chemical Works Co Ltd, H-1045 Budapest, To u 1-5, Hungary. (Final leaflet to state actual manufacturing site)

This leaflet was last revised in December 2015.