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June 30, 2016


Company: Actavis Ireland Ltd.
Legal category: Prescritption. GMS. Sport permitted.
Active ingredient: Ramipril 2.5mg, 5mg, 10mg.
Description: Size 4 hard capsules containing white powder, with light grey body and light green (2.5mg), green (5mg) or dark green (10mg) cap, marked R on cap and strength on body.
Presentation: 2.5mg-28, 5mg-28, 10mg-28. Prices available on request.
Indications: Hypertension. Reduces mortality when administered to patients surviving acute myocardial infarction (MI) with clinical evidence of HF. Prevention of MI, stroke or cardiovascular death in patients with an increased cardiovascular risk, already taking standard therapy. Prevention of MI, stroke or cardiovascular death in type 2 diabetic patients with increased cardiovascular risk. Prevention of progression of microalbuminuria to overt nephropathy.

Pharmacology: Administration of ramipril causes an increase in plasma renin activity and a decrease in plasma concentrations of angiotensin II and aldosterone. The beneficial haemodynamic effects resulting from ACE inhibition are a consequence of reduction in angiotensin II causing dilatation of peripheral vessels and reduction in vascular resistance.
Dosage: Adult: Hypertension: Without diuretics and without CHF, initially 2.5mg once daily. Increase dose incrementally at intervals of 1-2 weeks up to maximum 10mg once daily. Usual effective dose: 2.5-10mg. Combination treatment recommended if response unsatisfactory at 10mg. Diuretic-treated patients, discontinue the diuretic 2-3 days before initiating. MI, stroke, cardiovascular death prevention: Initially, 2.5mg once daily. Double dose after 1 week, after 3 further weeks increase to 10mg. Maintenance: 10mg daily. Post MI: Initiate in hospital between day 3 and day 10 following AMI. Initially, 2.5mg twice daily for 2 days. Then increase to 5mg twice a day. Withdraw treatment if dose cannot be increased to 2.5mg twice daily. Maintenance: 2.5mg-5mg twice daily. Prevention of nephropathy: Initially, 2.5mg once daily. Double dose after 1 week, after 3 further weeks increase to 10mg. Maintenance: 10mg daily. Renal/hepatic impairment, see SPC. Elderly: Caution.
Contraindications: Hypersensitivity to ramipril. History of angioneurotic oedema relating to previous treatment with an ACE inhibitor. Pregnancy, lactation. Use in children.
Special precautions: Not for use in patients with aortic stenosis or outlaw obstruction. Renal impairment risk (dosage reduction and/or discontinue); assess renal function prior to and during treatment. Caution: Impaired liver function, volume- and salt-depletion (symptomatic hypotension risk), anaesthesia, surgery. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell count, haemoglobin content and platelet count, hyperkalaemia, hyperkalaemia (hypertensive patients), angioneurotic oedema. Avoid haemodialysis using high flux polyacrylonitrile membranes and low-density lipoprotein apheresis with dextran sulphate.
Drug interactions: Caution: Antidiabetics (insulin, oral hypoglycaemics), NSAIDs (e.g. acetylsalicylic acid, indomethacin).
Adverse drug reactions: Nausea, dizziness, headache, symptomatic hypotension, MI, cerebrovascular accident, chest pain, palpitations, rhythm disturbances, angina pectoris, impaired renal function, GI disorders, hypersensitivity reactions, cutaneous and mucosal reactions, vasculitis, muscle and joint pains, fever or eosinophilia, dry tickling cough, disturbances of balance, nervousness, restlessness, terror, sleep disorders, confusion, loss of appetite, depressed mood, feeling of anxiety, paraesthesiae, taste change/reduction/loss, muscle cramps, erectile impotence, reduced sexual desire, increased blood urea nitrogen and serum creatinine, deterioration of pre-existing proteinuria.
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: (021) 4619040. Fax: (021) 4619049. E-mail: contact@actavis.ie