Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Amlodipine besylate
Les Laboratoires Servier
C09BB; C09BB04
Perindopril arginine; Amlodipine besylate
10mg/5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers; perindopril and amlodipine
Not marketed
2008-07-04
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Perindopril arginine/Amlodipine Servier 5MG / 5MG TABLETS Perindopril arginine/Amlodipine Servier 10MG / 5MG TABLETS Perindopril arginine/Amlodipine Servier 5MG / 10MG TABLETS Perindopril arginine/Amlodipine Servier 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 Perindopril arginine/Amlodipine Servier is and what it is used for 2. What you need to know before you take Perindopril arginine/Amlodipine Servier 3. How to take Perindopril arginine/Amlodipine Servier 4. Possible side effects 5. How to store Perindopril arginine/Amlodipine Servier 6. Content of the pack and other information 1. WHAT PERINDOPRIL ARGININE/AMLODIPINE SERVIER IS AND WHAT IT IS USED FOR Perindopril arginine/Amlodipine Servier 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 Perindopril arginine/Amlodipine Servier which contains both ingredients. Perindopril arginine/Amlodipine Servier 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 ve Perskaitykite visą dokumentą
Health Products Regulatory Authority 26 November 2018 CRN008L3G Page 1 of 30 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril Arginine/Amlodipine Servier 10 mg/5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, triangular-shaped tablet, 9.5 mm x 8.8 mm x 8.8 mm, engraved with 10/5 on one face and on the other face 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril arginine/Amlodipine Servier 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 Perindopril arginine/Amlodipine Servier could be modified or individual titration with free combination may be considered. Special populations Health Products Regulatory Authority 26 November 2018 CRN008L3G Page 2 of 30 _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. Perindopril arginine/Amlodipine Servier 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 r Perskaitykite visą dokumentą