Land: Israël
Taal: Engels
Bron: Ministry of Health
HYDROCHLOROTHIAZIDE; VALSARTAN
NOVARTIS ISRAEL LTD
C09DA03
FILM COATED TABLETS
VALSARTAN 160 MG; HYDROCHLOROTHIAZIDE 25 MG
PER OS
Required
NOVARTIS FARMA S.P.A., ITALY
VALSARTAN AND DIURETICS
VALSARTAN AND DIURETICS
Co-diovan is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled by monotherapy. This fixed combination should be used as second-line therapy.
2023-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only CO-DIOVAN 80/12.5 MG FILM-COATED TABLETS Each tablet contains: Valsartan 80 mg Hydrochlorothiazide 12.5 mg CO-DIOVAN 160/12.5 MG FILM-COATED TABLETS Each tablet contains: Valsartan 160 mg Hydrochlorothiazide 12.5 mg CO-DIOVAN 160/25 MG FILM-COATED TABLETS Each tablet contains: Valsartan 160 mg Hydrochlorothiazide 25 mg INACTIVE INGREDIENTS: See section 6 ”Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For the treatment of hypertension in patients who need combined treatment with two active ingredients. THERAPEUTIC GROUP: A combination of angiotensin II receptor antagonist with a thiazide diuretic. Co-Diovan contains two active ingredients, called Valsartan and Hydrochlorothiazide. These two ingredients help to control high blood pressure (hypertension). ∙ VALSARTAN belongs to a class of medicines known as “angiotensin II receptor antagonists” (acting to block the receptor), which help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to contract, thus causing the blood pressure to increase. Valsartan blocks the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. ∙ HYDROCHLOROTHIAZIDE belongs to a class of medicines called thiazide diuretics. Hydrochlorothiazide increases urine output, which helps to lower blood pressure. Co-Diovan is used to treat high blood pressure which is not adequately controlled by a single ingredient alone. Hypertension increases the workload of the heart and art Lees het volledige document
CO-DIO API APR22 V1 Page 1 of 18 Sweden SmPC 03.2022 1. NAME OF THE MEDICINAL PRODUCT CO-DIOVAN ® 80 mg/12.5 mg film-coated tablets CO-DIOVAN ® 160 mg/12.5 mg film-coated tablets CO-DIOVAN ® 160 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CO-DIOVAN ® 80 mg/12.5 mg each film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. CO-DIOVAN ® 160 mg/12.5 mg each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide CO-DIOVAN ® 160 mg/25 mg each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. CO-DIOVAN ® 80 mg/12.5 mg: Light orange, ovaloid tablet imprinted with HGH on one side and CG on the other side. CO-DIOVAN ® 160 mg/12.5 mg: Dark red, ovaloid tablet imprinted with HHH on one side and CG on the other side. CO-DIOVAN ® 160 mg/25 mg: Brown, ovaloid tablet imprinted with HXH on one side and NVR on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Co-Diovan ® 80mg/12.5mg is indicated for the treatment of hypertension for patients in whom combination therapy is appropriate. Co-Diovan 160mg/12.5mg, 160mg/25mg is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled by monotherapy. These fixed dose combinations should be used as second-line therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of Co-Diovan is 1 coated tablet per day. When clinically appropriate either 80 mg valsartan and 12.5 mg hydrochlorothiazide or 160 mg valsartan and 12.5 mg hydrochlorothiazide may be used. When necessary 160 mg valsartan and 25 mg may be used. The maximum daily dose is 320 mg/25 mg. The maximum antihypertensive effect is seen within 2 to 4 weeks. Co-Diovan must not be used in combination with aliskiren in patients with diabetes mellitus. _RENAL IMPAIRMENT _ No dosage adjustment is required for patients with mild to moderate rena Lees het volledige document