Land: Malta
Språk: engelsk
Kilde: Medicines Authority
PERINDOPRIL TERT, BUTYLAMINE SALT, AMLODIPINE BESILATE
Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 München , Germany
C09BB04
PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg AMLODIPINE BESILATE 5 mg
TABLET
PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg AMLODIPINE BESILATE 5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-04-29
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL/AMLODIPINE DENK 4 MG/5 MG TABLETS PERINDOPRIL/AMLODIPINE DENK 4 MG/10 MG TABLETS PERINDOPRIL/AMLODIPINE DENK 8 MG/5 MG TABLETS PERINDOPRIL/AMLODIPINE DENK 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 Denk is and what it is used for 2. What you need to know before you take Perindopril/Amlodipine Denk 3. How to take Perindopril/Amlodipine Denk 4. Possible side effects 5. How to store Perindopril/Amlodipine Denk 6. Contents of the pack and other information 1. WHAT PERINDOPRIL/AMLODIPINE DENK IS AND WHAT IT IS USED FOR Perindopril/Amlodipine Denk 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 Denk which contains both ingredients. Perindopril/Amlodipine Denk 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 B Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Perindopril/Amlodipine Denk 4 mg/5 mg tablets Perindopril/Amlodipine Denk 4 mg/10 mg tablets Perindopril/Amlodipine Denk 8 mg/5 mg tablets Perindopril/Amlodipine Denk 8 mg/10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril/Amlodipine Denk 4 mg/5 mg tablets Each tablet contains 4 mg perindopril tert-butylamine (equivalent to 3.34 mg perindopril) and 5 mg amlodipine (as besilate). Perindopril/Amlodipine Denk 4 mg/10 mg tablets Each tablet contains 4 mg perindopril tert-butylamine (equivalent to 3.34 mg perindopril) and 10 mg amlodipine (as besilate). Perindopril/Amlodipine Denk 8 mg/5 mg tablets Each tablet contains 8 mg perindopril tert-butylamine (equivalent to 6.68 mg perindopril) and 5 mg amlodipine (as besilate). Perindopril/Amlodipine Denk 8 mg/10 mg tablets Each tablet contains 8 mg perindopril tert-butylamine (equivalent to 6.68 mg perindopril) and 10 mg amlodipine (as besilate). Excipient with known effect: These medicines contain less than 1 mmol (23 mg) sodium per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Perindopril/Amlodipine Denk 4 mg/5 mg tablets White to off-white, oval, biconvex tablets, marked with ‘4/5’ on one side. Perindopril/Amlodipine Denk 4 mg/10 mg tablets White to off-white, rectangular, biconvex tablets, marked with ‘4/10’ on one side. Perindopril/Amlodipine Denk 8 mg/5 mg tablets White to off-white, triangular, biconvex tablets, marked with ‘8/5’ on one side. Perindopril/Amlodipine Denk 8 mg/10 mg tablets White to off-white, round, biconvex tablets, marked with ‘8/10’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril/Amlodipine Denk 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 Oral route. On Les hele dokumentet