Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Perindopril tosilate; Amlodipine
Teva Pharma B.V.
C09BB; C09BB04
Perindopril tosilate; Amlodipine
5 mg/5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers; perindopril and amlodipine
Marketed
2014-06-13
Perindopril/Amlodipine, NL/H/2842/001-004, 28.06.2021 PACKAGE LEAFLET: INFORMATION FOR THE USER [INVENTED NAME] 5 MG/5 MG TABLETS [INVENTED NAME] 5 MG/10 MG TABLETS [INVENTED NAME] 10 MG/5 MG TABLETS [INVENTED NAME] 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 [invented name] is and what it is used for 2. What you need to know before you take [invented name] 3. How to take [invented name] 4. Possible side effects 5. How to store [invented name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR [invented name] is a combination of two active ingredients, perindopril and amlodipine. [invented name] 5 MG/5 MG TABLETS contains 5 mg of perindopril tosilate and 5 mg of amlodipine. [invented name] 5 MG/10 MG TABLETS contains 5 mg of perindopril tosilate and 10 mg of amlodipine. [invented name] 10 MG/5 MG TABLETS contains 10 mg of perindopril tosilate and 5 mg of amlodipine [invented name] 10 MG/10 MG TABLETS contains 10 mg of perindopril tosilate and 10 mg of 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. [invented name] is prescribed for treatment of high blood pressure (hypertension) and/or treatment of stable Izlasiet visu dokumentu
Health Products Regulatory Authority 09 August 2022 CRN00D0GK Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril tosilate/Amlodipine Teva 5mg/5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg perindopril tosilate equivalent to 3.4 mg perindopril converted _in situ_ to perindopril sodium and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine. Excipient with known effect: Each tablet contains 41.672 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, oval, biconvex tablet, debossed “5/5” on one side and plain on the other side. Dimensions: Approx. 4.3 mm width and 8.1 mm length. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril tosilate/Amlodipine Teva 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 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_ _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. The combination of perindopril and amlodipine 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 mono-components 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 place with ca Izlasiet visu dokumentu