Country: Malta
Language: English
Source: Medicines Authority
ATORVASTATIN CALCIUM, TRIHYDRATE, PERINDOPRIL ARGININE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C10BX
ATORVASTATIN CALCIUM TRIHYDRATE 10.82 mg PERINDOPRIL ARGININE 5 mg
HARD CAPSULE
ATORVASTATIN CALCIUM TRIHYDRATE 10.82 mg PERINDOPRIL ARGININE 5 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2018-02-23
PACKAGE LEAFLET 2 _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EUVASCOR 10 MG/5 MG HARD CAPSULES EUVASCOR 20 MG/5 MG HARD CAPSULES EUVASCOR 40 MG/5 MG HARD CAPSULES EUVASCOR 10 MG/10 MG HARD CAPSULES EUVASCOR 20 MG/10 MG HARD CAPSULES EUVASCOR 40 MG/10 MG HARD CAPSULES atorvastatin / perindopril arginine 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 Euvascor is and what it is used for 2. What you need to know before you take Euvascor 3. How to take Euvascor 4. Possible side effects 5. How to store Euvascor 6. Contents of the pack and other information 1. WHAT EUVASCOR IS AND WHAT IT IS USED FOR Euvascor 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. Euvascor 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 Read the complete document
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 2 _ _ 1. NAME OF THE MEDICINAL PRODUCT Euvascor 10 mg/5 mg, hard capsules [Euvascor 20 mg/5 mg, hard capsules] [Euvascor 40 mg/5 mg, hard capsules] [Euvascor 10 mg/10 mg, hard capsules] [Euvascor 20 mg/10 mg, hard capsules] [Euvascor 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 Euvascor 10/5 mg, 46.8 mg for Euvascor 20/5 mg, 72.6 mg for Euvascor 40/5 mg, 54.9 mg for Euvascor 10/10 mg, 67.8 mg for Euvascor 20/10 mg, 93.6 mg for Euvascor 40/10 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, hard Euvascor 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. Euvascor 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. Euvascor 40/5 mg: S Read the complete document