Country: Malta
Language: English
Source: Medicines Authority
RAMIPRIL
Amneal Pharma Europe Limited
C09AA05
RAMIPRIL
TABLET
RAMIPRIL 2.5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2012-12-05
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER RAMIPRIL AMNEAL 1.25 MG TABLETS RAMIPRIL AMNEAL 2.5 MG TABLETS RAMIPRIL AMNEAL 5 MG TABLETS RAMIPRIL AMNEAL 10 MG TABLETS Ramipril 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 Ramipril Amneal is and what it is used for 2. What you need to know before you take Ramipril Amneal 3. How to take Ramipril Amneal 4. Possible side effects 5. How to store Ramipril Amneal 6. Contents of the pack and other information 1. WHAT RAMIPRIL AMNEAL IS AND WHAT IT IS USED FOR Ramipril Amneal contains the active substance called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Ramipril Amneal works by: Decreasing your body’s production of substances that could raise your blood pressure Making your blood vessels relax and widen Making it easier for your heart to pump blood around your body Ramipril Amneal can be used: To treat high blood pressure (hypertension) To reduce the risk of you having a heart attack or stroke To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) To treat your heart when it cannot pump enough blood to the rest of your body (heart failure) As treatment following a heart attack (myocardial infarction) complicated with heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL AMNEAL DO NOT TAKE RAMIPRIL AMNEAL: - If you are allergic to ramipril, any other ACE inhibitor medicine or any of the in Read the complete document
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramipril Amneal 1.25 mg tablets Ramipril Amneal 2.5 mg tablets Ramipril Amneal 5 mg tablets Ramipril Amneal 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.25 mg of ramipril. Each tablet contains 2.5 mg of ramipril. Each tablet contains 5 mg ramipril. Each tablet contains 10 mg ramipril. _ _ _Excipients with known effect: _ Each tablet contains 12.1 mg lactose monohydrate. Each tablet contains 10.8 mg lactose monohydrate. Each tablet contains 21.7 mg lactose monohydrate. Each tablet contains 43.4 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Ramipril Amneal 1.25 mg tablets: _ White to off-white colored, flat faced bevel edged round uncoated tablet debossed with “H” and “17” on one side and plain on other side. _ _ _Ramipril Amneal 2.5 mg tablets: _ Light yellow to yellow colored flat faced bevel edged, round uncoated tablet debossed with “H” and “18” separated by score line on one side and plain on other side. The tablet can be divided into two equal doses. _ _ _Ramipril Amneal 5 mg tablets: _ Light pink colored mottled, flat faced bevel edged round uncoated tablet debossed with “H” and “19” separated by score line on one side and plain on other side. The tablet can be divided into two equal doses. _Ramipril Amneal 10 mg tablets: _ White to off-white colored, flat faced bevel edged round uncoated tablet debossed with “H” and “20” separated by score line on one side and plain on other side. The tablet can be divided into two equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of hypertension. - Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or Page 2 of 17 o diabetes with at least one cardiovascular risk factor (see Read the complete document