Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
FOSINOPRIL NATRIUM ; HYDROCHLOORTHIAZIDE
Teva Pharma B.V. Swensweg 5 2031 GA HAARLEM
C09BA09
FOSINOPRIL SODIUM ; HYDROCHLOROTHIAZIDE
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON (E 1201),
Oraal gebruik
Fosinopril And Diuretics
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 0-WATER; NATRIUMLAURILSULFAAT (E 487); POVIDON (E 1201);
2005-07-14
Fosinopril/HCT, tablets, NL/H/0780/001, 04.11.2021 PACKAGE LEAFLET: INFORMATION FOR THE USER FOSINOPRILNATRIUM/HYDROCHLOORTHIAZIDE 20/12,5 TEVA, TABLETTEN 20/12,5 MG fosinopril sodium 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 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 Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA is and what it is used for 2. What you need to know before you take Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA 3. How to take Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA 4. Possible side effects 5. How to store Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA 6. Contents of the pack and other information 1. WHAT FOSINOPRIL SODIUM/HYDROCHLOROTHIAZIDE 20/12.5 TEVA IS AND WHAT IT IS USED FOR • Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA contains two active ingredients: fosinopril sodium and hydrochlorothiazide. • Fosinopril sodium belongs to the group of medicines called antihypertensives (which are used to lower blood pressure) and is an angiotensin converting enzyme inhibitors (ACE-inhibitors). • Hydrochlorothiazide belongs to a group of drugs called diuretics (“water tablets”) and is an antihypertensive (lowers blood pressure) • Fosinopril sodium/hydrochlorothiazide is used as a treatment for high blood pressure when treatment with fosinopril on its own has proven ineffective. It may also be used to replace separate tablets containing 20 mg of fosinopril and 12.5 mg of hydrochlorothiazide. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL SODIUM/HYDROCHLOROTHIAZ Perskaitykite visą dokumentą
Fosinopril/HCT, tablets, NL/H/0780/001, 015.08.2022 rvg 31564 EU SPC IB-046 met NL info-clean 2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Fosinoprilnatrium/Hydrochloorthiazide 20/12,5 Teva, tabletten 20/12,5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide. Excipient with known effect: Each tablet contains 210.7 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Mottled peach, capsule shaped tablet, scored on one side and debossed with "9" on one side of score, and "3" on the other side of the score, debossed with "7344" on the other side of tablet. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fosinopril Sodium/Hydrochlorothiazide 20/12.5 Teva is indicated for the treatment of essential hypertension in patients who have inadequately responded to treatment with fosinopril as monotherapy. This fixed dose may also replace the combination of 20 mg fosinopril and 12.5 mg hydrochlorothiazide in patients who have been stabilised on the individual active substances given in the same proportions as separate medications. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This fixed dose combination is not suitable for initial therapy. Individual dose titration with the monocomponents is recommended. If clinically appropriate, a direct change from monotherapy to combination therapy may be considered. Posology ADULTS The usual dose is one tablet of fosinopril sodium/hydrochlorothiazide 20/12.5 Teva once daily. SPECIAL POPULATIONS _Patients with hepatic impairment _ Adjustment of the usual dose is not necessary. Fosinopril/HCT, tablets, NL/H/0780/001, 015.08.2022 rvg 31564 EU SPC IB-046 met NL info-clean 2 _Patients with renal impairment _ In patients with renal impairment (creatinine clearance > 30 ml/min and < 80 ml/min) dose adjustment should be carried out with special care and individual dose titration with the monocomponents is recommen Perskaitykite visą dokumentą