Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Perindopril tosilate; Amlodipine
Teva B.V.
C09BB04
Perindopril tosilate; Amlodipine
5 mg/10 milligram(s)
Tablet
perindopril and amlodipine
Not marketed
2021-11-19
PACKAGE LEAFLET: INFORMATION FOR THE USER PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. 5 MG/5 MG TABLETS PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. 5 MG/10 MG TABLETS PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. 10 MG/5 MG TABLETS PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. 10 MG/10 MG TABLETS perindopril tosilate/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 Tosilate/Amlodipine Teva B.V. is and what it is used for 2. What you need to know before you take Perindopril Tosilate/Amlodipine Teva B.V. 3. How to take Perindopril Tosilate/Amlodipine Teva B.V. 4. Possible side effects 5. How to store Perindopril Tosilate/Amlodipine Teva B.V. 6. Contents of the pack and other information 1. WHAT PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. IS AND WHAT IT IS USED FOR Perindopril Tosilate/Amlodipine Teva B.V. is a combination of two active ingredients, perindopril and amlodipine. Perindopril Tosilate/Amlodipine Teva B.V. 5 MG/5 MG TABLETS contains 5 mg of perindopril tosilate and 5 mg of amlodipine. Perindopril Tosilate/Amlodipine Teva B.V. 5 MG/10 MG TABLETS contains 5 mg of perindopril tosilate and 10 mg of amlodipine. Perindopril Tosilate/Amlodipine Teva B.V. 10 MG/5 MG TABLETS contains 10 mg of perindopril tosilate and 5 mg of amlodipine Perindopril Tosilate/Amlodipine Teva B.V. 10 MG/10 MG TABLETS contains 10 mg of perindopril tosilate and 10 mg of amlodipine Perindopril Tosilate/Amlodipine Teva B.V. is prescribed for treatment of high blood pressure (hypertension) and/or treatment of sta Citiți documentul complet
Health Products Regulatory Authority 08 August 2022 CRN00D051 Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril Tosilate/Amlodipine Teva B.V. 5 mg/10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg perindopril tosilate equivalent to 3.408 mg perindopril converted _in situ_ to perindopril sodium and 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine. Excipient with known effect Each Perindopril Tosilate/Amlodipine Teva B.V. 5 mg/10 mg tablet contains 86.6 mg of isomalt: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, biconvex tablet, debossed "5/10" on one side and plain on the other side. Dimensions: Approx. 7 mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril Tosilate/Amlodipine Teva B.V. 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 One tablet per day as a single dose, preferably 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 the perindopril and amlodipine combination 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 routine medical follow-up will include frequent monitoring of creatinine and potassium. The combination of perindopril and amlodipine can be administered in patients with Clcr ≥ 60ml/min, but is not recommended in patients with a Clcr < 60ml/min. In these patients, an individual dose titration with the mono-components is recommended. Amlodipine used at similar doses in elderly or younger patient Citiți documentul complet