País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE; AMLODIPINE BESILATE
HCS bvba
C09BB04
PERINDOPRIL TERT-BUTYLAMINE; AMLODIPINE BESILATE
4mg/10mg Milligram
Tablets
Product subject to prescription which may be renewed (B)
perindopril and amlodipine
Not Marketed
2017-08-18
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS 4 MG/5 MG TABLETS PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS 4 MG/10 MG TABLETS PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS 8 MG/5 MG TABLETS PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS 8 MG/10 MG TABLETS Perindopril tert-butylamine/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 tert-butylamine/amlodipine HCS is and what it is used for 2. What you need to know before you take Perindopril tert-butylamine/amlodipine HCS 3. How to take Perindopril tert-butylamine/amlodipine HCS 4. Possible side effects 5. How to store Perindopril tert-butylamine/amlodipine HCS 6. Contents of the pack and other information 1. WHAT PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS IS AND WHAT IT IS USED FOR Perindopril tert-butylamine/amlodipine HCS 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 tert-butylamine/amlodipine HCS which contains both ingredients. Perindopril tert-butylamine/amlodipine HCS 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 wide Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril tert-butylamine/amlodipine HCS 4 mg/10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg perindopril tert-butylamine (equivalent to 3.34 mg perindopril) and 10 mg amlodipine (as besilate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to almost white, capsule shaped, biconvex tablets scored on one side. The tablets are engraved with mark U on one side and mark 2 on the other side of the breaker score. Dimensions: 12.5 mm × 5.5 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 tert-butylamine/amlodipine HCS 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 tert-butylamine/amlodipine HCS 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. Perindopril tert-butylamine/amlodipine HCS 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 pla Llegiu el document complet