Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
rosuvastatin (rosuvastatin calcium)
Pharmaceutical Works Polpharma S.A.
C10AA07
rosuvastatin (rosuvastatin calcium)
20mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2019-01-18
_Rosuvastatin Denk 20 mg_ Film-coated tablet – oral use Lipid-lowering agent Active substance: rosuvastatin Package leaflet: Information for the patient 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 ROSUVASTATIN DENK 20 MG IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROSUVASTATIN DENK 20 MG 3. HOW TO TAKE ROSUVASTATIN DENK 20 MG 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ROSUVASTATIN DENK 20 MG 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. What Rosuvastatin Denk 20 mg is and what it is used for Rosuvastatin Denk 20 mg belongs to a group of medicines called statins. You have been prescribed Rosuvastatin Denk 20 mg because: • You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin Denk 20 mg is used in adults, ad - olescents and children 6 years or older to treat high cholesterol. You have been advised to take a statin, because changing your diet and getting more exercise were not enough to correct your cholesterol levels. You should continue with your choles - terol-lowering diet and exercise while you are taking Rosuvastatin Denk 20 mg. or • You have other factors that increase your risk of having a heart attack, stroke or related health problems. Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Ath - erosclerosis is due to build-up of fatty deposits in your arteries. Why it is important to keep taking Rosuvastatin Denk 20 mg Rosuvastatin Denk 20 mg is used to corre Прочитать полный документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rosuvastatin Denk 5 mg Rosuvastatin Denk 10 mg Rosuvastatin Denk 20 mg Rosuvastatin Denk 40 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: rosuvastatin _Rosuvastatin Denk 5 mg _ Each film-coated tablet of Rosuvastatin Denk 5 mg contains 5 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: Each film-coated tablet contains 41.572 mg of lactose monohydrate and less than 1 mmol sodium (23 mg). _Rosuvastatin Denk 10 mg _ Each film-coated tablet of Rosuvastatin Denk 10 mg contains 10 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: Each film-coated tablet contains 83.145 mg of lactose monohydrate and less than 1 mmol sodium (23 mg). _Rosuvastatin Denk 20 mg _ Each film-coated tablet of Rosuvastatin Denk 20 mg contains 20 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: Each film-coated tablet contains 166.29 mg of lactose monohydrate and less than 1 mmol sodium (23 mg). _Rosuvastatin Denk 40 mg _ Each film-coated tablet of Rosuvastatin Denk 40 mg contains 40 mg rosuvastatin (as rosuvastatin calcium). Excipient with known effect: Each film-coated tablet contains 332.58 mg of lactose monohydrate and less than 1 mmol sodium (23 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _Rosuvastatin Denk 5 mg _ White or almost white, round and biconvex film-coated tablets, engraving “5” on one side. _Rosuvastatin Denk 10 mg _ White or almost white, round and biconvex film-coated tablets, engraving “10” on one side. _Rosuvastatin Denk 20 mg _ White or almost white, round and biconvex film-coated tablets, engraving “20” on one side. 2 _Rosuvastatin Denk 40 mg _ White or almost white, oblong and biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypercholesterolaemia Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including hete Прочитать полный документ