Document: leaflet MAH GENERIC_PL 11311-0273 change

• leaflet MAH GENERIC_PL 11311-0273
• leaflet MAH GENERIC_PL 11311-0509

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PATIENT INFORMATION LEAFLET

Pravastatin sodium 10mg, 20mg, 30mg and 40mg Tablets

(Each tablet contains 10mg, 20mg, 30mg or 40mg pravastatin sodium)

What Pravastatin is and what it is used for

Pravastatin belongs to a group of medicines called HMG-CoA reductase inhibitors (or statins) which work by reducing your body's production of "bad cholesterol" and raising the levels of "good" cholesterol. Cholesterol is a lipid that can cause coronary heart disease by narrowing the vessels that supply the heart with blood. This condition, called hardening of the arteries or atherosclerosis, may lead to chest pain (angina pectoris), a heart attack (myocardial infarction) or stroke.

If you have already had a heart attack or have chest pain at rest (unstable angina pectoris), Pravastatin reduces the risk of having another heart attack or stroke in the future, regardless of your cholesterol levels.

If you have raised levels of cholesterol but do not have coronary heart disease, Pravastatin reduces the risk of this occurring or of you having a heart attack in the future.

When you use Pravastatin, your doctor will recommend other actions as part of your treatment, such as a low-fat diet, exercise and weight reduction.

If you have had an organ transplant and are taking medication to stop your body rejecting the transplant, Pravastatin reduces increased lipid levels.

Before you take Pravastatin

Do not take Pravastatin:

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

■    if you are pregnant or if there is a possibility that you may become pregnant;

■    if you are breast feeding;

■    if you have liver problems.

Ask your doctor if you are uncertain whether you can

take Pravastatin.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Pravastatin if you have ever had any of the following:

■    Kidney disease or an underactive thyroid

■    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 fibrate.

■    If you have had a history of liver problems.

■    If you have severe respiratory failure.

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 muscle-related side effects. You may also need this blood test if you are aged older than 70 years.

Go back to your doctor as soon as possible to discuss your concerns and follow the advice given.

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.

Children and adolescents

In children before puberty, the benefit/risk of treatment should be carefully evaluated by physicians before treatment initiation.

Other medicines and Pravastatin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is important that you inform your doctor if you are already being treated with any of the following:

■    other cholesterol lowering drugs called fibrates(e.g. gemfibrozile, fenofibrate). The combination may increase the risk of side effects.

■    medicines used to adjust or adapt the immune response, e.g. ciclosporin. The combination may increase the risk of side effects.

■    the antibiotics erythromycin or clarithromycin. The combination may result in an increased risk of developing muscle problems.

■    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 too closely together).

Pravastatin with food, drink and alcohol

Pravastatin can be taken with or without food. Inform your doctor if you regularly consume larger quantities of alcohol.

If you are not sure about this please follow your doctor's guidelines.

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 or pharmacist for advice before taking this medicine.

You must not take Pravastatin during pregnancy. Doctors will take special care when prescribing this medicine to young women that might become pregnant and they will properly explain the potential risk associated with pravastatin therapy during pregnancy. If you have plans to become pregnant or if you have become pregnant, you should stop taking Pravastatin and inform your doctor immediately (see Section 2: Do not take Pravastatin).

You must not take Pravastatin during breast- feeding, as Pravastatin passes into the mother's milk (see Section 2: Do not take Pravastatin).

Driving and using machines

Pravastatin does not usually affect your ability to drive but if you experience any dizziness, blurred or double vision make sure you are fit to drive and operate machinery before attempting to do so.

How to take Pravastatin

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

Adults

The usual dose of Pravastatin is 10 - 40mg once a day, preferably in the evening. Pravastatin can be taken with or without food, with half a glass of water.

Use in children and adolescents (from 8 to 18 years of age) with heterozygous familial hypercholesterolemia

Use in children and adolescents (8 - 13 years of age): The recommended dose range is 10 - 20 mg once a day.

Use in children and adolescents (14 - 18 years of age): The recommended dose range of is 10 - 40 mg once a day.

Renal and hepatic impairment

The usual dose is 10 mg once a day in patients with renal or hepatic impairment.

Following organ transplantation

The usual starting dose is 10-20mg once a day. The dose may be increased up to 40 mg under close medical supervision.

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Other medicines

Pravastatin should usually be taken at least one hour before or four hours after you have taken the Colestyramin or Colestipol.

The usual starting-dose for person who uses medicines which adjust or adapt the immune response, (Ciclosporin) is 20 mg once a day. The dose may be increased up to 40 mg under close medical supervision.

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

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 do not worry. Simply take your normal dose when it is next due. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Pravastatin

Always tell your doctor if you want to stop the

treatment.

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

How to store Pravastatin

Keep out of reach and sight of children.

Blister (Al/OPA/Al/PVC):

Do not store above 30°C.

Store in the original package.

Blister (Al/PVC/COC/PVdC):

Do not store above 25°C.

Store in the original package.

Tablet container:

Do not store above 30°C.

Keep the tablet container tightly closed.

Do not use Pravastatin after expiry date which is stated on the outer carton and blister/container after 'EXP'. The expiry date refers to the last day of that month.

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.

□ Contents of the pack and other information

Possible side effects

What Pravastatin contains

The active substance is pravastatin sodium

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

Serious side effects which occur very rarely (may affect up to 1 in 10,000 people)

Contact your doctor as soon as possible and stop taking Pravastatin 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 this has progressed to become a serious and potentially life-threatening condition (called rhabdomyolysis).

You should stop taking Pravastatin and see your doctor immediately if you experience symptoms of anaioedema. such as:

■    swollen face, tongue or pharynx

■    difficulty to swallow

■    hives and difficulties to breathe

These are symptoms of a serious allergic reaction which must be treated immediately, usually in a hospital.

Other side effects

Uncommon side effects (may affect up to 1 in 100

people):

■    dizziness, headache, sleep disturbances, difficulty in sleep

■    problems with sight such as blurred or double vision

■    stomach and bowel problems such as indigestion, abdominal pain, the pain of heartburn, sickness, vomiting, diarrhoea or constipation and wind

■    skin reactions such as itching and rashes, hives (urticaria) or scalp and hair problems including hair loss

■    bladder problems (painful or frequent urination, having to pass water at night)

■    tiredness

■    sexual difficulties

■    muscle and joint pain.

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

■    problems with touch including burning/tingling sensations or numbness which may indicate damage to nerve endings

■    allergic condition which causes joint pain, skin rashes and fever (lupus erythematosus), acute and severe hypersensitivity reaction (anaphylaxis)

■    inflammation of the liver (which may cause yellowing of the skin or the whites of the eyes) or pancreas (which may cause stomach pain)

■    muscle damage (myopathy)

■    isolated cases of tendon disorders, sometimes complicated by rupture

■    inflammation of the muscles (myositis, polymyositis)

■    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)

The following side effects have been reported with some statins (medicines of the same type):

■    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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

10 mg tablets:

Each tablet contains pravastatin sodium 10 mg 20 mg tablets:

Each tablet contains pravastatin sodium 20 mg 30 mg tablets:

Each tablet contains pravastatin sodium 30 mg 40 mg tablets:

Each tablet contains pravastatin sodium 40 mg.

The other ingredients are:

Calcium hydrogen phosphate, anhydrous, Sodium starch glycolate, Cellulose, microcrystalline, Trometamol, Disodium phosphate dehydrate, Povidone, Magnesium stearate, Ferric oxide, yellow (E172)

What Pravastatin looks like and contents of the pack

Pravastatin 10 mg tablets

A yellow, oblong, biconvex, side wall scored tablet encoded P 10 Pravastatin 20 mg tablets

A yellow, oblong, biconvex, side wall scored tablet encoded P 20 Pravastatin 30 mg tablets

A yellow, oblong, biconvex, side wall scored tablet encoded P 30 Pravastatin 40 mg tablets

A yellow, oblong, biconvex, side wall scored tablet encoded P 40

Blister (Al/PVC/COC/PVdC)

Blister (Al/OPA/Al/PVC)

Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100x1 and 100 tablets.

Polyethylene tablet container and polypropylene cap with desiccant (silica gel) insert.

Pack sizes: 28, 30, 98, 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Tillomed Laboratories Ltd 3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire PE19 8ET, UK

Manufacturer

Salutas Pharma GmbH,

Otto-Von-Guericke-Allee 1,

39179 Barleben, Germany

Product Licence Numbers:

Pravastatin sodium 10mg Tablets: PL 11311/0271 Pravastatin sodium 20mg Tablets: PL 11311/0272 Pravastatin sodium 30mg Tablets: PL 11311/0273 Pravastatin sodium 40mg Tablets: PL 11311/0274

Date of last revision August 2012.

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Pravastatin sodium 10mg, 20mg, 30mg and 40mg Tablets

Tablets

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Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK