Krajina: Malta
Jazyk: angličtina
Zdroj: Malta Medicines Authority
Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany
C09DB02
AMLODIPINE BESILATE 5 mg OLMESARTAN MEDOXOMIL 20 mg
FILM-COATED TABLET
AMLODIPINE BESILATE 5 mg OLMESARTAN MEDOXOMIL 20 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2023-09-29
1 PACKAGE LEAFLET: INFORMATION FOR THE USER OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 20 MG/5 MG OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 40 MG/5 MG OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 40 MG/10 MG FILM-COATED TABLETS olmesartan medoxomil/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 Olmesartan medoxomil/Amlodipine Ascend is and what it is used for 2. What you need to know before you take Olmesartan medoxomil/Amlodipine Ascend 3. How to take Olmesartan medoxomil/Amlodipine Ascend 4. Possible side effects 5. How to store Olmesartan medoxomil/Amlodipine Ascend 6. Contents of the pack and other information 1. WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND IS AND WHAT IT IS USED FOR Olmesartan medoxomil/Amlodipine Ascend contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both of these substances help to control high blood pressure. • Olmesartan medoxomil belongs to a group of medicines called “angiotensin-II receptor antagonists” which lower blood pressure by relaxing the blood vessels. • Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening thereby also reducing blood pressure. The actions of both of these substances contribute to stopping the tightening of blood vessels, so that blood vessels relax and blood pressure decreases. This medicine is used for the treatment of high blood pressure in pat Prečítajte si celý dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Olmesartan medoxomil/Amlodipine Ascend 20 mg/5 mg Film-coated tablets Olmesartan medoxomil/Amlodipine Ascend 40 mg/5 mg Film-coated tablets Olmesartan medoxomil/Amlodipine Ascend 40 mg/10 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olmesartan medoxomil/Amlodipine Ascend 20 mg/5 mg Film-coated tablets: Each film-coated tablet of Olmesartan medoxomil/Amlodipine Ascend contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate). Olmesartan medoxomil/Amlodipine Ascend 40 mg/5 mg Film-coated tablets: Each film-coated tablet of Olmesartan medoxomil/Amlodipine Ascend contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate). Olmesartan medoxomil/Amlodipine Ascend 40 mg/10 mg Film-coated tablets: Each film-coated tablet of Olmesartan medoxomil/Amlodipine Ascend contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate). Excipients with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 20 mg/5 mg Film-coated tablets: White to off white, round shaped, biconvex, film coated tablets debossed with “A22” on one side and plain on other side. The tablet diameter is approximately 6.10 mm. OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 40 mg/5 mg Film-coated tablets: Cream to light yellow, round shaped, biconvex, film coated tablets debossed with “A23” on one side and plain on other side. The tablet diameter is approximately 8.10 mm. OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 40 mg/10 mg Film-coated tablets: Brownish red, round shaped, biconvex, film coated tablets debossed with “A21” on one side and plain on other side. The tablet diameter is approximately 8.10 mm. 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmesartan medoxomil/Amlodipine Ascend is indicated in adult patients whose blood pressure is not adequately c Prečítajte si celý dokument