Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE, AMLODIPINE
IMED Healthcare Ltd.
C09BB04
PERINDOPRIL ARGININE, AMLODIPINE
5/10 mg/mg
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers
Authorised
2012-08-31
PACKAGE LEAFLET - INFORMATION FOR THE USER ACERYCAL® 5MG/5MG TABLETS ACERYCAL® 5MG/10MG TABLETS ACERYCAL® 10MG/5MG TABLETS ACERYCAL® 10MG/10MG TABLETS PERINDOPRIL ARGININE/AMLODIPINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. -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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. -If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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. FURTHER 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 (angiotension 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 (hypersensitive) to perindopril or any o Izlasiet visu dokumentu
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 : lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Poland and Hungary:_ White, square-shaped tablet 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 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_ _Patients with 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 t Izlasiet visu dokumentu