देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Pravastatin sodium
WPR Healthcare Limited
C10AA; C10AA03
Pravastatin sodium
10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; pravastatin
Authorised
2014-11-14
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER PRAVASTATIN SODIUM 10 MG TABLETS PRAVASTATIN SODIUM 20 MG TABLETS PRAVASTATIN SODIUM 40 MG TABLETS Pravastatin Sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. – Keep this leaflet. You may need to read it again. – If you have further questions, please ask your doctor or pharmacist. – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. – 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. IN THIS LEAFLET: 1. What Pravastatin Sodium Tablets is and what it is used for 2. Before you take Pravastatin Sodium Tablets 3. How to take Pravastatin Sodium Tablets 4. Possible side effects 5. How to store Pravastatin Sodium Tablets 6. Further information 1. WHAT PRAVASTATIN SODIUM TABLETS IS AND WHAT IT IS USED FOR Pravastatin Sodium Tablets belongs to a group of medicines called statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and consequently reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, the cholesterol accumulates on the walls of blood vessels and block them. This condition is called hardening of the arteries or atherosclerosis, may lead to: chest pain (angina pectoris), when a blood vessels in the heart is partially blocked, a heart attack (myocardial infraction), when a blood vessels in the heart is completely blocked, a stroke (cerebrovascular accident), when a blood vessel in the brain is completely blocked. This medicine is used in 3 situations: In the treatment of high levels of cholesterol and fats in the blood. Pravastatin Sodium Tablets is used to lower high levels of "bad" cholesterol and to raise the levels of "good" cholesterol in the blood when changes to diet and exercise have failed to adequately do th पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pravastatin Sodium 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg pravastatin sodium. Excipient: Lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK:_ Pravastatin Tablets 10 mg: Yellow coloured, rounded rectangular shaped, biconvex, uncoated tablets debossed ‘PDT’ on one side and ‘10’ on the other side. 4 CLINICAL PARTICULARS As per PA1390/002/001 5 PHARMACOLOGICAL PROPERTIES As per PA1390/002/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS lactose monohydrate croscarmellose sodium magnesium stearate light magnesium oxide microcelac povidone yellow ferric oxide (E172). 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Keep out of the reach and sight of children. Store below 25 °C. Store in the original package in order to protect from light and moisture. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _7_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _2_ _4_ _0_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 28 tablets contained in an over labelled outer cardboard carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND पूरा दस्तावेज़ पढ़ें