Pravastatin Mylan 10 Mg, 20 Mg, 40 Mg Tablets Pravastatin Sodium

Package leaflet: Information for the patient Pravastatin Mylan 10 mg, 20 mg, 40 mg 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 of the 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 3. How to take Pravastatin Mylan 1. What Pravastatin Mylan is and what it 4. Possible side effects is used for 5. How to store Pravastatin Mylan 2. What you need to know before you 6. Contents of the pack and other take Pravastatin Mylan information

1. What Pravastatin Mylan is and what it - Medicines known as fibrates (e.g. gemfibrozil is used for and fenofibrate) which decrease fat levels in the blood or nicotinic acid (a B vitamin). Pravastatin, the active substance of Pravastatin Taking these medicines with pravastatin may Mylan, belongs to a group of medicines called cause severe muscle disorders. statins which work by reducing high cholesterol - Medicines such as colestyramine and levels in the blood. Cholesterol is a fatty substance colestipol used for the treatment of a high (lipid) that can cause the narrowing of blood vessels cholesterol level because they may reduce the in the heart causing coronary heart disease. effectiveness of pravastatin. Pravastatin Mylan Pravastatin Mylan is used should be taken at least one hour before or four - to lower high cholesterol levels in your blood hours after you have taken these medicines. if diet, exercise or weight loss has not lowered - Ciclosporin (a medicine used to suppress your cholesterol level the immune system) because the effect of - if you are at risk of narrowing of the blood vessels pravastatin may be increased and your doctor in your heart caused by too much cholesterol may need to change your dose. in your blood, as a supplement to your diet - Antibiotics such as erythromycin, - to lower the fatty substances (lipids) in your clarithromycin, roxithromycin and rifampicin blood if you have had an organ transplant because these increase the effect of pravastatin. - to reduce the chance of having another heart - If you are taking a drug used to treat and attack if you have previously had a heart prevent formation of blood clots called vitamin attack or if you suffer from chest pain attacks K antagonist, tell your doctor before taking (unstable angina pectoris) Pravastatin Mylan because the use of vitamin K antagonists concomitantly with Pravastatin 2. What you need to know before you take Mylan might increase the results of blood tests Pravastatin Mylan used to monitor the treatment with vitamin Do not take Pravastatin Mylan K antagonists. - if you are allergic to pravastatin, or any of the - Colchicine (used to treat gout). other ingredients of this medicine (listed in - Lenalidomide (used to treat a type of blood section 6) cancer called multiple myeloma). - if you suffer from liver disease or if liver If you need to take oral fusidic acid to treat function tests keep showing excessive values a bacterial infection you will need to temporarily without any identifiable reason (your doctor stop using this medicine. Your doctor will tell will advise you about this) you when it is safe to restart Pravastatin Mylan. - if you are pregnant or breastfeeding. Taking Pravastatin Mylan with fusidic acid may Warnings and precautions rarely lead to muscle weakness, tenderness or Talk to your doctor or pharmacist before taking pain (rhabdomyolysis). See more information Pravastatin Mylan: regarding rhabdomyolysis in section 4. - if you suffer from a kidney disease or have Pravastatin Mylan with alcohol a history of liver disease You should always keep your alcohol intake to - if you regularly drink large amounts of alcohol a minimum. If you are concerned about how much - if you suffer from a low function of your alcohol you can drink while you are taking this thyroid gland medicine, you should discuss this with your doctor. - if you are taking other medications Pregnancy and breast-feeding (e.g. fibrates) to lower fatty substances in Do not take Pravastatin Mylan during pregnancy your blood or whilst breast-feeding as pravastatin may harm - if you have experienced muscle problems your baby. during previous treatment to lower the fatty substances in your blood or if you or anyone Before you start using Pravastatin Mylan, you in your family suffers from a hereditary should inform your doctor if you are pregnant muscle disease, especially if you are aged over or intend to become pregnant. If you become 65 years of age pregnant during treatment, you should stop using - if you are taking or have taken in the Pravastatin Mylan and consult your doctor. last 7 days a medicine called fusidic acid Women of childbearing age should use a reliable (a medicine for bacterial infection), orally or contraceptive whilst taking this medicine. by injection. The combination of fusidic acid Ask your doctor or pharmacist for advice before and Pravastatin Mylan can lead to serious taking any medicine. muscle problems (rhabdomyolysis) Driving and using machines - if you have severe respiratory failure Pravastatin Mylan does not usually affect the If you have suffered from any of these problems, ability to drive and use machines. You may, your doctor will need to carry out a blood test however, feel a bit dizzy or your vision may be before and possibly during pravastatin treatment affected. Avoid driving or operating machines if to assess your risk of muscle-related side effects. you feel unwell after taking pravastatin. You may also need this blood test if you are Pravastatin Mylan contains lactose and sodium 70 years or older. If you have an intolerance to some sugars, contact Consult your doctor immediately if, while your doctor before taking this medicine. This using Pravastatin Mylan, you get unexplained medicine also contains less than 1 mmol sodium muscle ache, muscle weakness, muscle cramps (23 mg) per dosage unit, that is to say essentially or tenderness, particularly in combination with “sodium-free”. tiredness, fever and red‑brown discolouration of urine (rhabdomyolysis), which can be a sign of 3. How to take Pravastatin Mylan kidney problems. These symptoms may be caused Always take this medicine exactly as your doctor by the use of Pravastatin Mylan. or pharmacist has told you. Check with your Also tell your doctor or pharmacist if you have doctor or pharmacist if you are not sure. a muscle weakness that is constant. Additional For lowering an increased cholesterol level in tests and medicines may be needed to diagnose the blood and treat this. The recommended dose is 10‑40 mg pravastatin While you are on this medicine your doctor will taken once per day. The maximum daily dose is monitor you closely if you have diabetes or are 40 mg pravastatin. at risk of developing diabetes. You are likely To prevent heart and vessel disease to be at risk of developing diabetes if you have The recommended dose is 40 mg pravastatin high levels of sugars or fats in your blood, are taken once per day. overweight or have high blood pressure. Following a transplant Children The recommended dose is 20 mg pravastatin This medicine is not recommended for children taken once per day. The dosage can be adjusted younger than 8 years old. up to 40 mg pravastatin. Your doctor will tell you Other medicines and Pravastatin Mylan how much to take. Tell your doctor or pharmacist if you are taking, Use in children and adolescents with have recently taken or might take any other hereditary increased cholesterol in the blood medicines including medicines obtained without (heterozygous familial hypercholesterolaemia) a prescription. The recommended dose is 10‑20 mg pravastatin If you take Pravastatin Mylan together with taken once per day for children 8‑13 years of age certain other medicines, the effect either of and 10‑40 mg pravastatin taken once per day in Pravastatin Mylan or of the other medicine or of adolescents 14‑18 years of age. both may be influenced. Elderly Tell your doctor or pharmacist especially if you No dosage adjustment is required for this group. are taking or have recently taken any of the The same dosage as for adult patients can be following medicines: used. Your doctor will tell you how much to take. 50066348

Description Pravastatin Sodium 40 mg,10 mg,20 mg 28 Date: 13 Mar 2018 Time: 15:59

Component Type Leaflet Pharma Code 5445 No. of colours 1 Page Count 1/2

Afﬁliate Item Code 1453025 SAP No. NA Colours Black Superceded Afﬁliate Item Code 1124545 Vendor Job No. 335871 Non-Print TrackWise PR No. 1453025 Trackwise Proof No. 2 Colours MA No. NA Client Market Ireland Equate CMYK Packing Site/Printer Komarom Keyline/Drawing No. NA with Supplier Code 50066348 Barcode Info NA Main Font Times New Roman Body Text Size 10 pt 3D Render ID NA Dimensions 170 x 480 mm Min Text Size used 10 pt Sign-offs

v3/July 2017 Dosage adjustment in kidney or liver disorder • itching, rash, hives, scalp and hair problems The typical dose is 10 mg pravastatin taken once (inclusive of hair loss) per day but may be higher. Your doctor will tell • abnormal urination, e.g. pain, frequency, you how much to take. frequent urination at night Use with other medicines • problems with sexual functions If you take pravastatin and other medicines • tiredness containing colestyramine or colestipol (medicines • inflamed tendons, sometimes associated with also used for the treatment of high cholesterol tearing levels), you should take Pravastatin Mylan at least Rare (may affect up to 1 in 1,000 people) one hour before or four hours after these medicines. • increased sensitivity to light (photosensitivity) If you are also taking a medicine which lowers The following side effects have been seen with the body’s immune system (ciclosporin), your other medicines similar to pravastatin, and doctor may prescribe a starting dose of 20 mg may be seen with this medicine. once a day. The dose may be adjusted up to Not known (cannot be estimated from the 40 mg by your doctor. Your doctor will tell you available data) how much to take. • nightmares Take Pravastatin Mylan once daily, preferably • memory loss in the evening, with or without food. Swallow the • depression tablets with a sufficient quantity of liquid (e.g. Reporting of side effects one glass of water). If you get any side effects, talk to your doctor or 20 mg and 40 mg Tablets: The tablet can be pharmacist. This includes any possible side effects divided into equal doses not listed in this leaflet. You can also report side Your doctor will tell you how long you have to effects directly via HPRA Pharmacovigilance, take Pravastatin Mylan. This depends on why you Earlsfort Terrace, IRL - Dublin 2; are taking this medicine. Tel: +353 1 6764971 FREE Fax: +353 1 6762517. Website: www.hpra.ie; E‑mail: [email protected]. If you have the impression that the effect of By reporting side effects you can help provide Pravastatin Mylan is too strong or too weak, talk more information on the safety of this medicine. to your doctor or pharmacist. If you take more Pravastatin Mylan than you 5. How to store Pravastatin Mylan should Keep this medicine out of the sight and reach of If you have taken too many tablets, or if someone children. has accidentally taken your tablets, contact your Do not use this medicine after the expiry date doctor or pharmacist immediately. which is stated on the carton and blister after If you forget to take Pravastatin Mylan “EXP”. The expiry date refers to the last day of If you miss a dose do not worry. Simply take that month. your normal dose when it is next due. Do not take Store in the original packaging in order to protect a double dose to make up for a forgotten dose. from moisture. If you stop taking Pravastatin Mylan Do not throw away any medicines via wastewater Take Pravastatin Mylan as long as your doctor or household waste. Ask your pharmacist how to has told you. If you stop taking Pravastatin Mylan, throw away medicines you no longer use. These your cholesterol levels may increase again. measures will help protect the environment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 6. Contents of the pack and other information 4. Possible side effects What Pravastatin Mylan contains Like all medicines, this medicine can cause side - The active substance is pravastatin sodium. effects, although not everybody gets them. Pravastatin Mylan 10 mg tablets: each tablet Contact your doctor immediately if you develop contains 10 mg of pravastatin sodium. one of these side effects during the use of Pravastatin Mylan 20 mg tablets: each tablet Pravastatin Mylan: contains 20 mg of pravastatin sodium. Pravastatin Mylan 40 mg tablets: each tablet Very rare (may affect up to 1 in 10,000 people) contains 40 mg of pravastatin sodium. • hypersensitivity reactions: ○ serious allergic reaction causing swelling of - The other ingredients are lactose monohydrate the face, lips, throat, tongue and excessive (see section 2 “Pravastatin Sodium contains fluid in your body which can produce lactose”), dihydroxy aluminium sodium difficulty in swallowing or breathing carbonate, sodium stearyl fumarate, iron oxide (angioedema, anaphylaxis) red (E172) (for the 10 mg and 40 mg tablets ○ skin rash, possibly with pain in the joints only) and iron oxide yellow (E172) (for the (Lupus erythematous-like syndrome) 20 mg tablet only). • destruction of muscle fibres (rhabdomyolysis) What Pravastatin Mylan looks like and that may be associated with acute kidney contents of the pack failure (see also section 2. “What you 10 mg Tablets: Light pink colour, mottled, round, need to know before you take Pravastatin flat, bevelled tablets debossed with “10” on one Mylan”), inflammation of the muscles/many side and plain on the other. muscles (myositis/polymyositis). This may cause aching muscles, muscle tenderness or 20 mg Tablets: Light yellow colour, mottled, weakness not caused by exercise, decreased round tablet debossed with “20” on one side and urine, dark coloured urine and increased break line on the other side. The tablet can be creatinine kinase which can be seen in a blood divided into equal halves. test. Presence of myoglobin in the urine which 40 mg Tablets: Light pink colour, mottled, round can be seen in a urine test (myoglobinuria). tablet debossed with “40” on one side and break • serious liver problems including yellowish line on the other side. The tablet can be divided discoloration of the skin and/or eyes into equal halves. (jaundice), tissues and body fluids, liver Pravastatin Mylan is available in blister packs inflammation (hepatitis) sudden rapid with 10, 14, 20, 28, 30, 50, 60, 84, 90, 98 or destruction of liver tissue (fulminant hepatic 100 tablets. Not all pack sizes may be marketed. necrosis). This may cause you to feel or be sick, lose appetite, feel generally unwell, fever, Marketing Authorisation Holder itchy skin, dark urine, pale stools McDermott Laboratories Ltd. t/a Gerard • inflammation of the pancreas. This causes Laboratories, moderate to severe pain in the stomach, which 35/36 Baldoyle Industrial Estate, spreads to the back (pancreatitis) Grange Road, • problems with touch including burning/tingling Dublin 13, sensation, numbness or pins and needles Ireland (paresthesia) may occur which may be a sign Manufacturer of damage to the nerve endings (peripheral Mylan Hungary Kft., polyneuropathy) H‑2900 Komárom, • a condition characterised by an inflammation Mylan utca 1, of the muscles and the skin (dermatomyositis) Hungary Not known (cannot be estimated from the This medicinal product is authorised in the available data) Member States of the EEA under the following • diabetes. This is more likely if you have high names: levels of sugars or fats in your blood, are Belgium Pravastatine Mylan Pharma overweight or have high blood pressure. Your 10 mg, 20 mg, 40 mg Tablets doctor will monitor you while you are taking France Pravastatine Mylan Pharma this medicine. 10 mg, 20 mg, 40 mg Tablets • breathing problems including persistent Ireland Pravastatin Mylan 10 mg, cough with shortness of breath and/or fever 20 mg, 40 mg Tablets (interstitial lung disease) Italy Pravastatina Mylan 20 mg, • muscle weakness that is constant 40 mg compresse (Immune –mediated necrotising myopathy) Netherlands Pravastatinenatrium Mylan Other possible side effects include: 10 mg, 20 mg, 40 mg Tabletten Portugal Pravastatina Mylan 10 mg, Common (may affect up to 1 in 10 people) 20 mg, 40 mg comprimidos • painful joints (arthralgia) Romania Pravastatină Mylan 10 mg, • increased production of liver enzymes which 20 mg, 40 mg comprimate can be seen in a blood test. Spain Pravastatina Mylan Uncommon (may affect up to 1 in 100 people) Pharmaceuticals 10 mg, • dizziness, headache, sleep disturbances, 20 mg, 40 mg comprimidos difficulty sleeping EFG • problems with eyesight, blurred vision or United Kingdom Pravastatin Sodium 10 mg, double vision 20 mg, 40 mg Tablets • digestive problems or slow digestion, This leaflet was last revised in February 2018. indigestion/heartburn, abdominal pain, feeling/being sick, difficulty or delay emptying bowels, diarrhoea, wind

1453025 50066348

Description Pravastatin Sodium 40 mg,10 mg,20 mg 28 Date: 13 Mar 2018 Time: 15:59

Component Type Leaflet Pharma Code 5445 No. of colours 1 Page Count 2/2

v3/July 2017