Document: leaflet MAH GENERIC_PL 11311-0509 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 statins (HMG-CoA reductase inhibitors). It works by reducing the level of 'bad' cholesterol and fats (triglycerides) in your blood and raising the levels of 'good' cholesterol.

Pravastatin is used for the following:

■    To treat high levels of cholesterol (primary hypercholesterolaemia) and other fats (mixed dyslipidaemia) in the blood, if these cannot be lowered by diet and exercise alone

■    To reduce the risk of illness and death from heart disease in people with moderate to high cholesterol levels and at high risk of having a heart attack or stroke (primary prevention).

■    To reduce the risk of further illness and death from heart disease in people who have already had a heart attack or unstable angina (chest pain) and have normal or raised cholesterol levels (secondary prevention)

■    To reduce lipid levels in people who have had an organ transplant and are taking medication to stop the body rejecting the transplant

Having too much cholesterol in your blood can lead to coronary heart disease. It can clog blood vessels, leading to hardening of the arteries (atherosclerosis). Hardened arteries are less able to carry blood to the heart and around the body. This can lead to chest pain (angina) and heart attacks. Pravastatin can both prevent hardening of the arteries and slow it down.

If you have high levels of cholesterol you are more likely to get heart disease if you also:

■    Have high blood pressure (hypertension) or high blood sugar (diabetes)

■    Take little exercise

■    Smoke

■    Are overweight or eat a high fat diet When you take Pravastatin, your doctor will recommend other steps as part of your treatment, such as a low fat diet, exercise and weight reduction. Ask your doctor or pharmacist if you would like advice about any of the above factors.

Before you take Pravastatin

Do not take Pravastatin if:

■    If you are allergic (hypersensitive) to pravastatin or any of the other ingredients of Pravastatin (see Section 6: Further Information)

■    If you have liver problems

■    If you are pregnant, trying to become pregnant, or breastfeeding

(see Section 2: Pregnancy and Breast-feeding) Take special care with Pravastatin:

■    If you have had liver problems in the past

■    If you regularly drink a large amount of alcohol

■    If you have kidney problems

■    If you have muscle aches, pains, tenderness, weakness or cramps that you cannot explain

■    If you have previously experienced problems with your muscles as a result of taking other cholesterol l owering medicines, such as statins or fibrates

■    If you or your family members suffer from hereditary muscle disorders

■    If you are more than 70 years old

■    If you have an underactive thyroid gland

If you suffer or have ever suffered from any of these problems, your doctor will need to carry out a blood test before and possibly during treatment with Pravastatin to assess your risk of muscle related side effects. You may also need this blood test if you are over 70 years of age.

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 pravastatin if you:

■    Have severe respiratory failure

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

If you take Pravastatin at the same time as some other medicines, it may change the way that Pravastatin or the other medicines works.

Please check with your doctor if you are taking any of the following as taking any of these medicines with Pravastatin may increase the risk of muscle problems:

■    Other medicines to lower cholesterol known fibrates (such as gemfibrozil or fenofibrate) or niacin (nicotinic acid)

■    Ciclosporin (a medicine that suppresses the i mmune system)

■    Erythromycin or clarithromycin (antibiotics)

You should also tell your doctor if you are taking cholestyramine and colestipol (resin-type cholesterollowering agents). Care should be taken when taking Pravastatin with these medicines (see Section 3: How to take)

Pregnancy and Breast-feeding

Do not take Pravastatin if:

■    You are pregnant or planning to get pregnant

■    You are breast-feeding

If you get pregnant while taking Pravastatin, stop taking it and see your doctor straight away.

Driving and using machines

Pravastatin is unlikely to affect your ability to drive or operate machinery. However, if you experience dizziness you should not drive or operate machinery.

continued....

How to take Pravastatin

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

Before taking Pravastatin, secondary causes of high cholesterol levels should be excluded and your doctor should put you on a standard low-fat diet, which should be continued during treatment.

■    Pravastatin tablets are for oral administration

■    The tablets should be taken once daily, preferably in the evening, either with or without food

The usual doses are:

Adults: Treatment of high levels of cholesterol

The usual dose is 10-40 mg, once daily.

Your doctor will do periodic lipid tests and adjust your dose if necessary. The response to treatment is seen with a week, with full effect of a given dose within four weeks.

The maximum dose is 40mg.

Prevention of heart disease

The starting and maintenance dose is 40mg (based on heart disease prevention trials)

After organ transplantation

The usual starting dose is 20mg a day and may be increased to 40mg a day, under close medical supervision.

Children and adolescents under 18 years

Pravastatin should not be used in anybody under the age of 18 years.

Elderly patients

No dose adjustment is required unless any of the conditions listed in Section 2: Take special care apply.

Patients with kidney or liver problems

The usual starting dose is 10mg a day in patients with moderate to severe kidney or significant liver problems. Your doctor will adjust the dose according to the response of your lipid values. This will be done under medical supervision.

Taking another medicine for lowering your cholesterol at the same time as Pravastatin

Your doctor may ask you to take another medicine for lowering your cholesterol at the same time as taking Pravastatin. This includes medicines such as cholestyramine and colestipol (resin-type medicines). This type of medicine can change the way Pravastatin works. You should take Pravastatin either one hour before or at least four hours after taking a resin-type medicine.

If you take more Pravastatin than you should

If take more Pravastatin than you should, tell your doctor or go to your nearest hospital straight away. Take the carton and any Pravastatin tablets left with you so that the doctors know what you have taken.

If you forget to take Pravastatin

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose.

Do not take a double dose.

If you stop taking Pravastatin

Continue taking Pravastatin, unless your doctor tells you to stop.

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

Possible side effects

Like all medicines, Pravastatin can cause side effects,

although not everybody gets them.

Stop taking Pravastatin and see a doctor or go to a

hospital straight away if:

■    You experience symptoms of an allergic reaction such as difficulty in breathing or dizziness, swelling of the face or throat, joint pain, skin rashes and fever

■    You get unexplained pain, tenderness or weakness in your muscles or pain in your joints, high temperature, tiredness or rust coloured urine. In very rare cases this has progressed in to a serious and potentially life-threatening condition which causes abnormal muscle breakdown (Rhabdomyolysis) and can lead to kidney problems

■    You get liver problems such as yellowing of the skin or whites of the eyes (jaundice) or tiredness, pains in abdomen, muscle and joint aches (hepatitis) The side effects above are very rare but serious.

Uncommon side effects (affect less than 1 in a 100

people)

■    Dizziness    ■ Headache

■    Sexual difficulties    ■    Tiredness

■    Runny nose    ■    Cough

■    Indigestion or heartburn ■ Abdominal pain

■    Constipation    ■    Diarrhoea

■    Skin rash or itching    ■    Wind

■    Scalp or hair problems including hair loss

■    Disturbed sleep or difficulty in sleeping

■    Problems with sight such as blurred vision or double vision

■    Feeling or being sick (nausea or vomiting)

■    Bladder problems including painful or frequent urination and having to pass water at night

Very rare side effects (affecting less than 1 in 10,000

people)

■    Damage to nerve endings (usually feet and hands), particularly if this medicine is used for a long time. It may cause a feeling of burning, tingling or numbness and walking or standing may become unsteady

■    Inflammation of the pancreas, which causes severe pain in the abdomen and back

■    Tendon disorders, occasional rupturing

■    Joint pain, muscle cramps, pain and weakness. Also increased creatine kinase (CK) levels (blood test which indicates damage to muscles)

■    Increase in serum transaminases (blood test which i ndicates liver damage)

Other possible 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 medicine.

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.

How to store Pravastatin

Keep out of reach and sight of children.

All foil blister

Do not store above 30°C. Store in the original package. Plastic foil backed blister

Do not store above 25°C. Store in the original package. Container

Keep the tablet container tightly closed

Do not use Pravastatin Tablets after the expiry date which is stated on the packaging after 'EXP'. The expiry date refers to the last day of the 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.

Further information

What Pravastatin contains

■    Active substance: 10mg, 20mg, 30mg or 40mg pravastatin sodium

■    The other ingredients are: anhydrous calcium hydrogen phosphate, sodium starch glycolate microcrystalline cellulose, trometamol, disodium phosphate dihydrate, povidone, magnesium stearate and yellow ferric oxide (E172).

What Pravastatin looks like and content of the pack

Pravastatin Tablets are yellow, oblong, convex, side wall scored tablets marked P10, P20, P30 or P40, depending on the strength of the tablet.

They are supplied in blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100x1 and 100 tablets or containers of 28, 30, 98, 100 and 250 tablets.

Not all pack sizes or pack types may be marketed

Marketing Authorisation Holder and Manufacturer

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

Product Licence Numbers:

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

Date of last revision October 2012

Till-Ver.2.1s