देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BENAZEPRILHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; BENAZEPRIL 18,42 mg/stuk ; HYDROCHLOORTHIAZIDE 25 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
C09BA07
BENAZEPRILHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; BENAZEPRIL 18,42 mg/stuk ; HYDROCHLOORTHIAZIDE 25 mg/stuk
Filmomhulde tablet
CASTOROLIE, GEHYDREERD ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CASTOROLIE, GEHYDREERD ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Benazepril And Diuretics
Hulpstoffen: CASTOROLIE, GEHYDREERD; CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2003-12-22
Sandoz B.V. Page 1/10 Benazepril HCl/Hydrochloorthiazide 10/12,5 en 20/25, filmomhulde tabletten RVG 28629-30 V13 1.3.1.3 Package leaflet Februari 2022 Note: Yellow highlighted ongoing IA variation NL/H/0529/IA/030 and NL/H/0530/IA/029 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BENAZEPRIL HCL/HYDROCHLOORTHIAZIDE 10/12,5, FILMOMHULDE TABLETTEN 10 MG/12,5 MG BENAZEPRIL HCL/HYDROCHLOORTHIAZIDE 20/25, FILMOMHULDE TABLETTEN 20 MG/25 MG benazepril hydrochloride and hydrochlorothiazide 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] is used to treat: • HIGH BLOOD PRESSURE , which cannot be adequately lowered using other medicines containing benazepril alone. Benazepril contains two active substances. Benazepril belongs to the medicine group called ACE inhibitors. It relieves the heart by reducing blood pressure and widening blood vessels. Hydrochlorothiazide is known as a “water tablet” and increases urine output. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME]: • if you are ALLERGIC to benazepril hydrochloride and hydrochlorothiazide or any of the other ingredients पूरा दस्तावेज़ पढ़ें
Sandoz B.V. Page 1/19 Benazepril HCl/Hydrochloorthiazide 10/12,5 en 20/25, filmomhulde tabletten RVG 28629-30 V14 1.3.1.1 Summary of Product Characteristics Februari 2022 Note: Yellow highlighted ongoing IA variation NL/H/0529/IA/030 and NL/H/0530/IA/029 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Benazepril HCl/Hydrochloorthiazide 10/12,5, filmomhulde tabletten 10 mg/12,5 mg Benazepril HCl/Hydrochloorthiazide 20/25, filmomhulde tabletten 20 mg/25 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains benazepril hydrochloride 10 mg and hydrochlorothiazide 12.5 mg. Excipient with known effect Each film-coated tablet contains 106.9 mg lactose (as monohydrate). Each film-coated tablet contains benazepril hydrochloride 20 mg and hydrochlorothiazide 25 mg. Excipient with known effect Each film-coated tablet contains 213.6 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 10/12.5 mg: round, pink, film-coated tablet, convex with a breaking notch on one side. 20/25 mg: white to off white, round film-coated tablet, convex with a cross breaking notch on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients with essential hypertension who have insufficiently responded to treatment with benazepril as monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The administration of the fixed combination of benazepril and hydrochlorothiazide is usually recommended after dose titration with the individual components. When clinically appropriate a direct change from monotherapy to the fixed combination may be considered. In patients who do not respond to monotherapy with benazepril (10 or 20 mg) once daily, therapy should be converted to half a tablet of Benazepril HCl/Hydrochlorothiazide 10/12.5. If the blood pressure cannot sufficiently be controlled after 3 to 4 weeks, a dose increase up to 10 mg benazepril HCl and 12.5 mg hydroch पूरा दस्तावेज़ पढ़ें