Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
RAMIPRIL
TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany
C09AA05
RAMIPRIL 5 mg
TABLET
RAMIPRIL 5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2015-10-29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAMIPRIL TAD 1.25 MG TABLETS RAMIPRIL TAD 2.5 MG TABLETS RAMIPRIL TAD 5 MG TABLETS RAMIPRIL TAD 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 TAD is and what it is used for 2. What you need to know before you take Ramipril TAD 3. How to take Ramipril TAD 4. Possible side effects 5. How to store Ramipril TAD 6. Contents of the pack and other information 1. WHAT RAMIPRIL TAD IS AND WHAT IT IS USED FOR Ramipril TAD contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Convertin Enzyme inhibitors). Ramipril TAD 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 TAD 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 heart attack (myocardial infarction) complicated with heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL TAD DO NOT TAKE RAMIPRIL TAD: - if you are allergic to ramipril, any other ACE inhibitor medicine or any of the other ingredients of this medicine (listed in section 6). Signs of an allerg Lue koko asiakirja
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ramipril TAD 1.25 mg tablets Ramipril TAD 2.5 mg tablets Ramipril TAD 5 mg tablets Ramipril TAD 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 1.25 mg tablets: white to almost white, round, biconvex tablets with bevelled edges, engraved with mark 1.25 on one side of the tablet. Tablet diameter: 6.5 mm. 2.5 mg tablets: light brownish-yellow, capsule shaped tablets with bevelled edges, scored on both sides. On one side of the tablet is on one half engraved mark 2.5 and on the other half of the tablet mark KRK. Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses. 5 mg tablets: light pink with individual lighter and darker spots, capsule shaped tablets with bevelled edges, scored on both sides. On one side of the tablet is on one half engraved mark 5 and on the other half of the tablet mark KRK. Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses. 10 mg tablets: white to almost white capsule shaped tablets with bevelled edges, scored on both sides. On one side of the tablet is on one half engraved mark 10 and on the other half of the tablet mark KRK. Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: - manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or - diabetes with at least one cardiovascular risk factor. Treatment of renal disease: - incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria. - manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1) Lue koko asiakirja