Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BETAXOLOLHYDROCHLORIDE SAMENSTELLING overeenkomend met ; BETAXOLOL
Mylan B.V.
C07AB05
BETAXOLOLHYDROCHLORIDE COMPOSITION corresponding to ; BETAXOLOL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Betaxolol
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2016-10-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BETAXOLOL HCL MYLAN 20 MG, FILMOMHULDE TABLETTEN _ _ betaxolol hydrochloride 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 Betaxolol hydrochloride is and what it is used for 2. What you need to know before you take Betaxolol hydrochloride 3. How to take Betaxolol hydrochloride 4. Possible side effects 5. How to store Betaxolol hydrochloride 6. Contents of the pack and other information 1. WHAT BETAXOLOL HYDROCHLORIDE IS AND WHAT IT IS USED FOR Betaxolol hydrochloride belongs to a group of medicines called beta-blockers. These medicines lower blood pressure, slow heart rate and reduce the heart oxygen consumption. Betaxolol hydrochloride is used for the treatment of high blood pressure (hypertension) in adults, of mild to moderate forms. It is also used for long-term treatment of attacks of stable angina pectoris (chest pain resulting from insufficient blood supply to the heart muscle due to exertion or stress) in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAXOLOL HYDROCHLORIDE DO NOT TAKE BETAXOLOL HYDROCHLORIDE IF YOU: are allergic to betaxolol or any of the other ingredients of this medicine (listed in section 6) have severe asthma and another serious breathing problem called chronic obstructive lung disease (COPD), which makes you breathless when active with a cough with phlegm and suffer from frequent chest infections have severe heart failure have cardiogenic shock (failure of the heart to pump effectively) have hear Read the complete document
1. NAME OF THE MEDICINAL PRODUCT Betaxolol HCl Mylan 20 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg betaxolol hydrochloride (equivalent to 17.88 mg betaxolol). Excipient with known effect Each film-coated tablet contains 100.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex film-coated tablets with a break-line on one face. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betaxolol Hydrochloride is indicated in adults for: Treatment of essential hypertension. Chronic, stable angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ _Essential hypertension_ _ _ The initial dose is 10 mg once daily. In case of insufficient effect this dosage can be increased to 20 mg per day. In moderate hypertension the standard dose is 20 mg once daily. In certain cases it could be necessary to increase the daily dose to 40 mg. _Stable angina pectoris _ The dosage should be adjusted individually. The starting dose is 10 mg a day, which can be increased to the usual dose of 20 mg once daily. In certain cases it could be necessary to increase the daily dose to 40 mg. _Patients with impaired renal or liver function _ In patients with renal impairment (creatinine clearance up to 20 ml/minute) there is no need to adjust the daily dose, however, clinical monitoring at the beginning of the treatment until steady plasma levels of the medicinal product are attained (over 4 days on average) is recommended. In patients with severe renal impairment (creatinine clearance below 20 ml/minute) and in patients with haemo- or peritoneal dialysis the dose of 10 mg/day should not be exceeded. In patients on dialysis the daily dose can be given independent of the time of dialysis. In patients with liver failure there is no need to adjust the dose. Careful clinical monitoring is recommended at the beginning of the treatment. _Elder Read the complete document