Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AZILSARTANMEDOXOMIL KALIUM 42,68 mg/stuk SAMENSTELLING overeenkomend met ; AZILSARTANMEDOXOMIL 40 mg/stuk ; CHLOORTALIDON 25 mg/stuk
Takeda Pharma A/S Dybendal Alle 10 2630 TAASTRUP (DENEMARKEN)
C09DA09
AZILSARTANMEDOXOMIL KALIUM 42,68 mg/stuk SAMENSTELLING overeenkomend met ; AZILSARTANMEDOXOMIL 40 mg/stuk ; CHLOORTALIDON 25 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; FUMAARZUUR (E 297) ; GRIJZE INKT ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; FUMAARZUUR (E 297) ; GRIJZE INKT ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Azilsartan medoxomil and diuretics
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); FUMAARZUUR (E 297); GRIJZE INKT; HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171);
2015-11-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EDARCLOR 40 MG/12,5 MG, FILMOMHULDE TABLETTEN EDARCLOR 40 MG/25 MG, FILMOMHULDE TABLETTEN azilsartan medoxomil/chlortalidone 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 Edarclor is and what it is used for 2. What you need to know before you take Edarclor 3. How to take Edarclor 4. Possible side effects 5. How to store Edarclor 6. Contents of the pack and other information 1. WHAT EDARCLOR IS AND WHAT IT IS USED FOR Edarclor contains two active substances, azilsartan medoxomil and chlortalidone, that are used for treating high blood pressure (hypertension) in adult patients (over 18 years of age): - Azilsartan medoxomil belongs to a class of medicines called angiotensin II receptor blockers. It lowers the blood pressure by relaxing the blood vessels. - Chlortalidone belongs to a class of medicines called diuretics. It lowers the blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. You will only be given Edarclor if treatment with azilsartan medoxomil alone has not adequately controlled your blood pressure. When given together, the two active substances in Edarclor help to lower the blood pressure more than if either of them were given alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EDARCLOR DO NOT TAKE EDARCLOR IF YOU: - are ALLERGIC (hypersensitive) to azilsartan medoxomil or to chlortalidone, or any of the other ingredients of this medicine (listed in section 6). - are PREGNANT. (Edarclor should Read the complete document
1 SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAME OF THE MEDICINAL PRODUCT Edarclor 40 mg/12,5 mg, filmomhulde tabletten Edarclor 40 mg/25 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Edarclor 40 mg/12.5 mg film-coated tablets: Each tablet contains 40 mg of azilsartan medoxomil (as potassium) and 12.5 mg chlortalidone. Edarclor 40 mg/25 mg film-coated tablets: Each tablet contains 40 mg of azilsartan medoxomil (as potassium) and 25 mg chlortalidone. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Edarclor 40 mg/12.5 mg film-coated tablets: Pale red, round, (approximately 9.7 mm in diameter), biconvex, film-coated tablet with A/C 40/12.5 on one side. Edarclor 40 mg/25 mg film-coated tablets: Light red, round, (approximately 9.7 mm in diameter), biconvex, film coated tablet with A/C 40/25 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension in adults. Edarclor is a fixed-dose combination indicated in adults whose blood pressure is not adequately controlled by azilsartan medoxomil monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ Adults The recommended starting dose is 40 mg/12.5 mg once daily in patients whose blood pressure is not adequately controlled with current antihypertensive monotherapy such as Edarbi 40 mg or Edarbi 80 mg. If needed the dose may be increased to a maximum of 40 mg/25 mg once daily. Near-maximal antihypertensive effect is usually evident within 1-2 weeks of dosing, with maximal effects attained by 4 weeks. 2 Special populations Older people (65 years and over) No initial dose adjustment with Edarclor is necessary in elderly patients; caution should be exercised and close medical monitoring is recommended in the very elderly (≥ 75 years), who may be at increased risk of adverse events (see section 5.2). Renal impairment Chlortalidone, a component drug of Edarclor, should not be used in patients with severe renal impairment (GFR <30 mL/min/1.73m 2 ) and anuria (see section Read the complete document