Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Amlodipine
TAD Pharma GmbH
C09BB04
Perindopril arginine; Amlodipine
Tablet
perindopril and amlodipine
2022-04-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL ARGININE/AMLODIPINE TAD 5 MG/5 MG TABLETS PERINDOPRIL ARGININE/AMLODIPINE TAD 5 MG/10 MG TABLETS PERINDOPRIL ARGININE/AMLODIPINE TAD 10 MG/5 MG TABLETS PERINDOPRIL ARGININE/AMLODIPINE TAD 10 MG/10 MG 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 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 Perindopril arginine/amlodipine TAD is and what it is used for 2. What you need to know before you take Perindopril arginine/amlodipine TAD 3. How to take Perindopril arginine/amlodipine TAD 4. Possible side effects 5. How to store Perindopril arginine/amlodipine TAD 6. Contents of the pack and other information 1. WHAT PERINDOPRIL ARGININE/AMLODIPINE TAD IS AND WHAT IT IS USED FOR Perindopril arginine/amlodipine TAD 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 TAD which contains both ingredients. Perindopril arginine/amlodipine TAD 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 Прочитайте повний документ
Health Products Regulatory Authority 14 March 2024 CRN00D0PV Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril arginine/amlodipine TAD 10 mg/10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg perindopril arginine (equivalent to 6.79 mg perindopril) and 10 mg amlodipine (equivalent to 13.87 mg amlodipine besilate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Light brownish-yellow, oval, biconvex tablets with possible individual darker spots, scored on one side. One side of the breaker score is marked with S and the other with 4. Tablet dimensions: approx. 12 mm x 7 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril arginine/amlodipine TAD 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 Recommended dose is one tablet per day. The fixed dose combination is not suitable for initial therapy. If a change of posology is required, the dose of Perindopril arginine/amlodipine TAD 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. Perindopril arginine/amlodipine TAD 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 ar Прочитайте повний документ