Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Perindopril tert-butylamine; Amlodipine besilate
KRKA, d.d., Novo mesto
C09BB; C09BB04
Perindopril tert-butylamine; Amlodipine besilate
4/10 milligram(s)
Tablet
ACE inhibitors and calcium channel blockers; perindopril and amlodipine
Not marketed
2017-08-18
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL/AMLODIPINE KRKA 4 MG/5 MG TABLETS PERINDOPRIL/AMLODIPINE KRKA 4 MG/10 MG TABLETS PERINDOPRIL/AMLODIPINE KRKA 8 MG/5 MG TABLETS PERINDOPRIL/AMLODIPINE KRKA 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/amlodipine Krka is and what it is used for 2. What you need to know before you take Perindopril/amlodipine Krka 3. How to take Perindopril/amlodipine Krka 4. Possible side effects 5. How to store Perindopril/amlodipine Krka 6. Contents of the pack and other information 1. WHAT PERINDOPRIL/AMLODIPINE KRKA IS AND WHAT IT IS USED FOR Perindopril/amlodipine Krka 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/amlodipine Krka which contains both ingredients. Perindopril/amlodipine Krka 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 TA Lire le document complet
Health Products Regulatory Authority 15 March 2024 CRN00D6F0 Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril/amlodipine Krka 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/amlodipine Krka 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/amlodipine Krka 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/amlodipine Krka 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 dosa Lire le document complet