Pravamel 10mg Film-coated Tablets Pravamel 20mg Film-coated Tablets Pravamel 40mg Film-coated Tablets

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1 Package leaflet: Information for the user Pravamel 10mg Film-coated Tablets Pravamel 20mg Film-coated Tablets Pravamel 40mg Film-coated Tablets Pravastatin sodium 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 Pravamel is and what it is used for 2. What you need to know before you take Pravamel 3. How to take Pravamel 4. Possible side effects 5. How to store Pravamel 6. Contents of the pack and other information 1. WHAT PRAVAMEL IS AND WHAT IT IS USED FOR Pravastatin, the active substance of Pravamel, belongs to a group of medicines called statins which work by reducing high cholesterol levels in the blood. Cholesterol is a fatty substance (lipid) that can cause the narrowing of the heart muscle blood vessels (coronary heart disease). Pravamel is used - to lower a high cholesterol level in the blood when there is no sufficient response to diet, more exercise, weight reduction etcetera. - if you are at risk of narrowing of the blood vessels in your heart caused by too much cholesterol in your blood, as a supplement to your diet. - to reduce the chance of having another heart attack if you have had a heart attack or if you have chest pain attacks (unstable angina pectoris). - to lower the fatty substances (lipids) in the blood following an organ transplant. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAVAMEL Do NOT take Pravamel - if you are allergic to pravastatin, or any of the other ingredients of this medicine (listed in section 6). - if you suffer from a liver disease in an active stage or if liver function tests keep showing excessive values without any identifiable reason. - if you are pregnant or breastfeeding. Warnings and precautions Talk to your doctor or pharmacist before taking Pravamel: - if you suffer from a kidney disease or have a history of liver disease. - if you regularly drink large amounts of alcohol. - if you suffer from a low function of your thyroid gland. - if you use other medication (fibrates) to lower the fatty substances at the same time. Page 1 of 7

2 - if you experienced muscle problems during previous treatment medication to lower the fatty substances or if anyone in your family suffers from a hereditary muscle disease. 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 Pravamel - if you have severe respiratory failure. Consult your doctor if this applies to you or has applied to you in the past. - if certain parts of your body become unusually sensitive to touching during treatment. Consult your doctor immediately if, while using Pravamel, you get unexplained muscle ache, muscle weakness or muscle cramps, particularly in combination with tiredness and fever. These complaints may be caused by the use of Pravamel. If necessary, your doctor may decide to stop treatment. Pravamel should not be used if you suffer from a muscle disease or if you develop kidney problems which are probably a result of destruction of muscle tissue associated with muscle cramps, fever and red-brown discoloration of the urine (rhabdomyolysis). 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. Children Children younger than 8 years should not use this medicine, because safety and efficacy is not proven in this patient group. Other medicines and Pravamel Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you take Pravamel together with certain other medicines, the effect either of Pravamel or of the other medicine or of both may be influenced. Inform your doctor or pharmacist especially if you use or have recently used any of the following medicines: - gemfibrozil and fenofibrate (medicines known as fibrates, which decrease fat levels in the blood).the concomitant use with pravastatin, the active ingredient of Pravamel, may result in, sometimes severe, muscle disorders. - colestyramine and colestipol (medicines used for the treatment of a high cholesterol level). The effect of pravastatin is weakened when taken simultaneously with one of these medicines. - ciclosporin (a medicine used to suppress the immune system). The effect of pravastatin is highly intensified when being used together. - erythromycin and clarithromycin. These antibiotics intensify the effect of pravastatin. Pravamel with alcohol It is best not to drink any alcohol until your treatment with Pravamel has finished. 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 should not use Pravamel during pregnancy or breast-feeding. During pregnancy the active substance pravastatin is very likely to harm the foetus. During breastfeeding small amounts pass into the mother's milk which is bad for the baby's health. Before you start Page 2 of 7

3 using Pravamel, you should inform your doctor if you are pregnant or intend to become pregnant. Girls and women of childbearing age should use reliable contraceptives. If, however, you become pregnant during treatment, you should stop using Pravamel and consult your doctor. Driving and using machines Pravamel does not usually affect the ability to drive and use machines. You may, however, feel a bit dizzy. In this case make sure that you are fit to drive and operate machinery. Pravamel contains lactose If you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE PRAVAMEL Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take Pravamel once daily, preferably in the evening, whether or not during meals. Unless otherwise prescribed by the doctor, the recommended dose is: For lowering an increased cholesterol level in the blood mg pravastatin once daily. The maximum daily dosage is 40 mg pravastatin. To prevent heart and vessel diseases 40 mg pravastatin once daily. Following a transplant 20 mg pravastatin once daily. The dosage can be adjusted up to 40 mg pravastatin. Use in children and adolescents with hereditarily increased cholesterol in the blood (heterozygous familial hypercholesterolaemia) The recommended dose is mg pravastatin once daily for children 8 13 years of age and mg pravastatin once daily in adolescents years of age. Older people No dosage adjustment is required for this group. The same dosage as for adult patients can be used. Dosage adjustment in kidney or liver impairment Initial dosage 10 mg pravastatin once daily; the dosage can be adjusted, if necessary. Concomitant use with other medicines In case of concomitant use of other medicines with the active ingredients colestyramine or colestipol (medicines used for the treatment of high cholesterol levels), you should take Pravamel at least one hour before or four hours after these medicines. If at the same time you use other medicines with the active ingredient ciclosporin (a medicine used to suppress the immune system), the initial dosage is 20 mg pravastatin once daily. This can be adjusted to up to 40 mg pravastatin. Follow these instructions unless your doctor gave you different advice. Remember to take your medicine. Method of administration Swallow the tablets with a sufficient quantity of liquid (e.g. one glass of water). Duration of treatment Your doctor will tell you how long you have to continue using Pravamel. This depends on the disease you have. Page 3 of 7

4 If you take more Pravamel than you should If you have taken too many tablets, or if someone has accidentally swallowed some tablets, contact your doctor or pharmacist immediately. If you forget to take Pravamel 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 the one you have missed. If you stop taking Pravamel Take Pravamel as long as your doctor has told you. If you stop taking Pravamel, your cholesterol levels may increase again. 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. Contact your doctor immediately if you develop one of these symptoms during the use of Pravamel, because muscle disorders may be serious in rare cases (see also section 2. Warnings and precautions ): Very rare (may affect up to 1 in 10,000 people): Inflammation of a muscle, destruction of fibres in skeletal muscle (rhabdomyolysis) that may be associated with acute kidney failure. If you experience one or more of the following symptoms, contact your doctor or go to your nearest emergency department immediately! Hypersensitivity reactions (angiooedema, anaphylaxis) such as serious allergic reactions with swelling of the face, tongue and wind pipe [oedema] which can cause great difficulty in breathing. This is a very rare reaction which can be serious if it occurs. Further side effects may occur: Common: may affect up to 1 in 10 people Increased production of liver enzymes. Tender muscles and bones, painful joints (arthralgia), muscle cramps, muscle pain and muscle weakness. Uncommon: may affect up to 1 in 100 people Dizziness. Headache. Sleep disturbances. Lack of sufficient sleep. Vision disturbance (blurred vision or double vision). Digestive problems or slow digestion (dyspepsia)/heartburn. Abdominal pain. Nausea/vomiting. Constipation. Diarrhoea. Wind. Itching, rash, hives. Scalp and hair problems (including hair loss). Abnormal urination, e.g. pain, frequency, frequent urination at night (dysuria). Disturbed sexual functions. Tiredness. Page 4 of 7

5 Very rare: may affect up to 1 in 10,000 people Problems with touch including burning/tingling sensation, numbness or pins and needles [paraesthesia] may occur which may be a sign of damage to the nerve endings (peripheral polyneuropathy). Inflammation of the pancreas (pancreatitis). Yellowish discoloration of the skin (jaundice), tissues and body fluids Liver inflammation (hepatitis), sudden rapid destruction of liver tissue (fulminant hepatic necrosis). A certain type of chronic skin disorder (lupus like syndrome). Inflammation of one or more muscles leading to pain or weakness in muscles (myositis or polymyositis). In some cases tendon disorders, sometimes associated with tearing. Not known: frequency cannot be estimated from the available data Nightmares. Memory loss. Depression. Breathing problems including persistent cough and/or shortness of breath or fever. Muscle weakness that is constant. Possible side effect reported with some statins (medicines of the same type): 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE PRAVAMEL 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 25 C. Store in the original package 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 Pravamel contains The active substance is: pravastatin sodium. Pravamel 10 mg film-coated tablets Each tablet contains 10 mg pravastatin sodium. Page 5 of 7

6 The other ingredients are: Tablet core: microcrystalline cellulose (E460), croscarmellose sodium (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), iron oxide red (E172), silica, colloidal anhydrous (E551). Tablet coating: hyprolose (E463), macrogol 400, macrogol 3350, hypromellose (E464). Pravamel 20 mg film-coated tablets Each tablet contains 20 mg pravastatin sodium. The other ingredients are: Tablet core: microcrystalline cellulose (E460), croscarmellose sodium (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), iron oxide yellow (E172), silica, colloidal anhydrous (E551). Tablet coating: hyprolose (E463), macrogol 400, macrogol 3350, hypromellose (E464). Pravamel 40 mg film-coated tablets Each tablet contains 40 mg pravastatin sodium. The other ingredients are: Tablet core: microcrystalline cellulose (E460), croscarmellose sodium (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), iron oxide yellow (E172), silica, colloidal anhydrous (E551). Tablet coating: hyprolose (E463), macrogol 400, macrogol 3350, hypromellose (E464). What Pravamel looks like and contents of the pack Pravamel 10 mg tablets: Pink-peach film-coated tablet with 10 on one side. Pravamel 20 mg tablets: Yellow film-coated tablet with 20 on one side. Pravamel 40 mg tablets: Yellow film-coated tablet with 40 on one side. The tablet can be divided into equal doses. Pravamel 10 mg tablets are available in blister packs with 7, 14, 20, 28, 30, 50, 56, 98, 100 and 200 tablets. Pravamel 20 mg tablets are available in blister packs with 7, 20, 28, 30, 50, 56, 84, 90, 98, 100 and 200 tablets. Pravamel 40 mg tablets are available in blister packs with 7, 20, 28, 30, 50, 56, 84, 90, 98, 100 and 200 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary Manufacturer Dragenopharm Apotheker Püschl GmbH, Göllstrasse 1, Tittmoning, Germany STADA Arzneimittel AG, Stadastrasse 2-18, Bad Vilbel, Germany Swiss Caps GmbH, Grassingerstraße 9, Bad Aibling, Germany Centrafarm Services B.V., Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands This medicinal product is authorised in the Member States of the EEA under the following names: The Netherlands: Pravastatine Na CF 10 mg, 20 mg, 40 mg filmomhulde tabletten Austria: Pravastatin Stada 20 mg, 40 mg - Filmtabletten Belgium: Pravastatine EG 10 mg, 20 mg, 40 mg filmomhulde tabletten Denmark: Pravastatin Stada France: Pravastatine EG 10 mg, 20 mg, 40 mg comprimé pelliculé sécable Germany: Pravastatin AL 10 mg, 20 mg, 40 mg Filmtabletten Ireland: Pravamel 10 mg, 20 mg, 40 mg film-coated tablets Luxembourg: PRAVASTATINE-EUROGENERICS Page 6 of 7

7 Portugal: Sweden: Pravastatin Stada Pravastatin Stada 10 mg, 20 mg, 40 mg filmdragerad tablett This leaflet was last revised in June Page 7 of 7