Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM TRIHYDRATE; PERINDOPRIL ARGININE
SERVIER MALAYSIA SDN BHD
ATORVASTATIN CALCIUM TRIHYDRATE; PERINDOPRIL ARGININE
30 Capsules
LES LABORATOIRES SERVIER INDUSTRIE
_Consumer Medication Information Leaflet (RIMUP)_ EUVALCOR HARD CAPSULES Atorvastatin / Perindopril arginine (10mg/5mg, 20mg/5mg, 40mg/5mg, 10mg/10mg, 20mg/10mg & 40mg/10mg) 1 WHAT IS IN THIS LEAFLET 1. What is Euvalcor used for 2. How Euvalcor works 3. Before you use Euvalcor 4. How to use Euvalcor 5. While you are using Euvalcor 6. Side effects 7. Storage and Disposal of Euvalcor 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT EUVALCOR IS USED FOR Euvalcor is intended for adult patients already on treatment with atorvastatin and perindopril arginine as single tablets as part of cardiovascular risk management. Instead of taking atorvastatin and perindopril arginine as single tablets you will receive one capsule of Euvalcor which contains the two active ingredients in the same strength. You should maintain a standard cholesterol lowering diet during treatment. HOW EUVALCOR WORKS Euvalcor contains two active ingredients, atorvastatin and perindopril arginine in one capsule. Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin is used to lower lipids known as cholesterol and triglycerides in the blood when a low-fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, atorvastatin can also be used to reduce such risk even if your cholesterol levels are normal. Perindopril arginine is an angiotensin converting enzyme (ACE) inhibitor. In patients with high blood pressure, it works by widening the blood vessels, which makes it easier for your heart to pump blood through them. BEFORE YOU USE EUVALCOR - _When you must not use it _ DO NOT TAKE EUVALCOR - if you are allergic to atorvastatin or to any similar medicines used to lower blood lipids, to perindopril or any other ACE inhibitor, or to any of the other ingredients of this medicine, - if you have a disease which affects the liver, - if you have any unexplained abnormal blood tests fo Läs hela dokumentet
1 _ _ 1. NAME OF THE MEDICINAL PRODUCT Euvalcor 10 mg/5 mg, hard capsules Euvalcor 20 mg/5 mg, hard capsules Euvalcor 40 mg/5 mg, hard capsules Euvalcor 10 mg/10 mg, hard capsules Euvalcor 20 mg/10 mg, hard capsules Euvalcor 40 mg/10 mg, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 10.82 mg atorvastatin calcium trihydrate equivalent to 10 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.395 mg perindopril Each hard capsule contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.395 mg perindopril Each hard capsule contains 43.28 mg atorvastatin calcium trihydrate equivalent to 40 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.395 mg perindopril Each hard capsule contains 10.82 mg atorvastatin calcium trihydrate equivalent to 10 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril Each hard capsule contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril Each hard capsule contains 43.28 mg atorvastatin calcium trihydrate equivalent to 40 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril Excipient with known effect: sucrose (33.9 mg for Euvalcor 10/5 mg, 46.8 mg for Euvalcor 20/5 mg, 72.6 mg for Euvalcor 40/5 mg, 54.9 mg for Euvalcor 10/10 mg, 67.8 mg for Euvalcor 20/10 mg, 93.6 mg for Euvalcor 40/10 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, hard Euvalcor 10/5 mg: Size 2 hard gelatin capsule, with black imprint “10 5” on light blue body and black imprint “ ” on light blue cap, containing white to slightly white spherical pellets. Euvalcor 20/5 mg: Size 2 hard gelatin capsule, with black imprint “20 5” on light blue body and black imprint “ ” on blue cap, containing white to slightly white spherical pellets. Euvalcor 40/5 mg: Size 2 hard gelatin capsule, with black imprint “40 5” on Läs hela dokumentet