Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Amlodipine
Les Laboratoires Servier
C09BB
Perindopril arginine; Amlodipine
5 mg/10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers
Marketed
2008-06-13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACERYCAL 5MG / 5MG TABLETS ACERYCAL 10MG / 5MG TABLETS ACERYCAL 5MG / 10MG TABLETS ACERYCAL 10MG / 10MG TABLETS perindopril arginine / amlodipine 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Acerycal is and what it is used for 2. What you need to know before you take Acerycal 3. How to take Acerycal 4. Possible side effects 5. How to store Acerycal 6. Content of the pack and other information 1. WHAT ACERYCAL IS AND WHAT IT IS USED FOR Acerycal is prescribed for treatment of high blood pressure (hypertension) and/or treatment of stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked). Patients already taking perindopril and amlodipine from separate tablets may instead receive one tablet of Acerycal which contains both ingredients. Acerycal is a combination of two active ingredients, perindopril and amlodipine. Perindopril is an ACE (angiotensin converting enzyme) inhibitor. Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines). Together they work to widen and relax the blood vessels so that blood passes through them more easily and makes it easier for your heart to maintain a good blood flow. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACERYCAL DO NOT TAKE ACERYCAL - if you are allergic to perindopril or any other ACE inhibitor, or to amlodipine or any other calcium antagonists, or any of the other ingredients of this medicine (listed in Section Aqra d-dokument sħiħ
Health Products Regulatory Authority 08 August 2022 CRN00D0G8 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acerycal 5mg/10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, square-shaped tablet, 8mm long and 8mm wide, engraved with 5/10 on one face and on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acerycal is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Oral route. One tablet per day as a single dose, preferably to be taken in the morning and before a meal. The fixed dose combination is not suitable for initial therapy. If a change of posology is required, the dose of Acerycal could be modified or individual titration with free combination may be considered. _Special populations_ _Renal impairment and elderly (see sections 4.4 and 5.2)_ Elimination of perindoprilat is decreased in the elderly and in patients with renal failure. Therefore, the usual medical follow-up will include frequent monitoring of creatinine and potassium. Acerycal can be administered in patients with Clcr ≥ 60ml/min, and is not suitable for patients with Clcr < 60ml/min. In these patients, an individual dose titration with the monocomponents is recommended. Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable Aqra d-dokument sħiħ