Pravastatin sodium 10 mg tablets

• 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

1. What Pravastatin sodium is and what it is used for
2. What you need to know before you take Pravastatin sodium
3. How to take Pravastatin sodium
4. Possible side effects
5. How to store Pravastatin sodium
6. Contents of the pack and other information

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

Check with your doctor or pharmacist before taking your medicine if:

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);
• 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).

Your doctor should do a blood test before you start taking Pravastatin Sodium and if you have any symptoms of liver problems while you take Pravastatin. This is to check how well your liver is working.

Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Pravastatin Sodium.

The risk of muscle breakdown is greater in certain patients. Tell your doctor if any of the following applies to you

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.

Talk to your doctor before taking Pravastatin Sodium.

If you have or have had myasthenia (a disease with general muscle weakness including in some cases muscles used when breathing), or ocular myasthenia (a disease causing eye muscle weakness) as statins may sometimes aggravate the condition or lead to the occurrence of myasthenia (see section 4).

• Have severe respiratory failure

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

Taking Pravastatin Sodium with any of these medicines can increase the risk of muscle problems:

• 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);
• If you need to take oral fusidic acid to treat a bacterial infection 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.
• Colchicine (used to treat gout)
• Nicotinic acid (used to treat high blood cholesterol)
• Rifampicin (used to treat an infection called tuberculosis)
• Lenalidomide (used to treat a type of blood cancer called multiple myeloma)

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 sodium if the two medicines are taken too closely together.

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 Pravastatin sodium 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 Pravastatin sodium if you intend to breast-feed as this treatment passes into the mother’s milk.

Pravastatin sodium 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.

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

Adults:

• In the treatment of high levels of cholesterol and fats in the blood: the usual dose is 10 to 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 sodium should not be exceeded.

Your doctor shall tell you which dose suits you.

Children (8-13 years of age) and adolescents (14-18 years of age) 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 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 sodium 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.

Your doctor will indicate the duration of your treatment with Pravastatin sodium. 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 have taken too many tablets, or if someone accidentally swallows some, contact your doctor or the nearest hospital for appropriate advice.

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.

• Nightmares
• Memory loss
• 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.

The following side effects are not known (frequency cannot be estimated from available data):

• Muscle rupture
• Muscle weakness that is constant, liver failure.
• Myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used when breathing).
• Ocular myasthenia (a disease causing eye muscle weakness).

Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath.

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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.. By reporting side effects you can help provide more information on the safety of this medicine.

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

The other ingredients are: Microcrystalline cellulose, lactose monohydrate, heavy magnesium oxide, croscarmellose sodium, iron oxide yellow (E172), povidone K30, magnesium stearate.

Pravastatin sodium 10 mg Tablets:

10 mg Tablet: Yellow, capsule shaped, biconvex, mottled, uncoated tablets with notched sides at double bisect, debossed with a “Y” on one side and “60” on other side.

The tablet can be divided into equal doses.

Pravastatin sodium 20 mg Tablets:

20 mg Tablet: Yellow, capsule shaped, biconvex, mottled, uncoated tablets with notched sides at double bisect, debossed with a “Y” on one side and “61” on other side.

The tablet can be divided into equal doses.

Pravastatin sodium 40 mg Tablets:

40mg Tablet: Yellow, capsule shaped, biconvex, mottled, uncoated tablets with notched sides at double bisect, debossed with a “Z” on one side and “18” on other side.

The tablet can be divided into equal doses.

Pravastatin sodium tablets are available in Polyamide/Aluminium/PVC/Aluminium blisters and HDPE bottle with polypropylene closure.

Pack sizes:

10 mg:

Blister pack: 1, 10, 14, 20, 28, 30, 50, 60, 84, 100 and 500 tablets.

HDPE bottle pack: 30, 100, 500 and 1000 (hospital pack) tablets.

20 mg & 40 mg:

Blister pack: 1, 10, 14, 20, 28, 30, 50, 60, 84, 90, 100 and 500 tablets.

HDPE bottle pack: 30, 100, 250, 500 and 1000 (hospital pack) tablets.

Not all pack sizes may be marketed.

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