Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; LISINOPRIL 2-WATER SAMENSTELLING overeenkomend met ; ; LISINOPRIL 10 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
C09BA03
HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; LISINOPRIL 2-WATER SAMENSTELLING overeenkomend met ; ; LISINOPRIL 10 mg/stuk
Tablet
CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; SILICIUMDIOXIDE (E 551),
Oraal gebruik
Lisinopril And Diuretics
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MANNITOL (D-) (E 421); SILICIUMDIOXIDE (E 551);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER LISINOPRIL/HYDROCHLOROTHIAZIDE STADA 10/12.5 MG, TABLETTEN lisinopril 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 gets, 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 Lisinopril/Hydrochlorothiazide <...> is and what it is used for 2. What you need to know before you take Lisinopril/Hydrochlorothiazide <...> 3. How to take Lisinopril/Hydrochlorothiazide <...> 4. Possible side effects 5. How to store Lisinopril/Hydrochlorothiazide <...> 6. Contents of the pack and other information 1. WHAT LISINOPRIL/HYDROCHLOROTHIAZIDE <...> IS AND WHAT IT IS USED FOR Lisinopril/Hydrochlorothiazide <...> is a combination of lisinopril and hydrochlorothiazide. Lisinopril is a blood pressure lowering (antihypertensive) drug. It belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. It works by relaxing the blood vessels, making it easier for the blood to flow through them. Hydrochlorothiazide is a water tablet belonging to the class of the thiazide diuretics. It makes the kidneys produce more urine and reduces thereby the blood volume. LISINOPRIL/HYDROCHLOROTHIAZIDE <...> IS USED TO: • treat high blood pressure (essential hypertension). Lisinopril/Hydrochlorothiazide <...> should be used in patients whose blood pressure is not adequately controlled on lisinopril alone (or hydrochlorothiazide alone). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL/HYDROCHLOROTHIAZIDE <...> DO NOT TAKE LISINOPRIL/HYDROCHLOROTHIAZIDE <...> • if you are allergic to lisinopri Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lisinopril/Hydrochloorthiazide STADA 10/12,5 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lisinopril/Hydrochlorothiazide <...> 10 mg/12.5 mg; each tablet contains: lisinopril dihydrate equivalent to lisinopril 10 mg and hydrochlorothiazide 12.5 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 10 mg /12.5 mg White, round, biconvex scored tablets with imprint C 10 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Lisinopril/Hydrochlorothiazide <...> fixed dose combination (10 mg lisinopril and 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on lisinopril alone (or hydrochlorothiazide alone). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The selection of a suitable antihypertensive dose of lisinopril and hydrochlorothiazide will depend upon the clinical evaluation of the patient. Lisinopril/Hydrochlorothiazide <...> should be taken once daily. The tablets should be administered every day at roughly the same time. The administration of the fixed combination lisinopril and hydrochlorothiazide is usually recommended after dosage titration with the individual components. When clinically appropriate a direct change from monotherapy to fixed combination may be considered. 10 mg/12.5 mg tablets may be administrated in patients whose blood pressure is not adequately controlled by 10 mg lisinopril alone. 20 mg/12.5 mg tablets may be administrated in patients whose blood pressure is not adequately controlled by 20 mg lisinopril alone. A maximum daily dose of 40 mg lisinopril/ 25 mg hydrochlorothiazide should not be exceeded. _Diuretic Pre-treatment _ The diuretic therapy should be stopped two to three days prior to the start of a treatment with Lisinopril/Hydrochlorothiazide. If this is not possible, treatment should be started with lisinopril alone, in a 5 mg dose. _Renal impairments: _ The combinati Les hele dokumentet