1. Name of the medicinal product
Co-Diovan® 80/12.5 mg film-coated tablets.

Co-Diovan® 160/12.5 mg film-coated tablets.

Co-Diovan® 160/25 mg film-coated tablets.

Valsartan Hydrochlorothiazide 80 mg/12.5 mg film-coated tablets

Valsartan Hydrochlorothiazide 160 mg/12.5 mg film-coated tablets

Valsartan Hydrochlorothiazide 160 mg/25 mg film-coated tablets

2. Qualitative and quantitative composition
Co-Diovan 80/12.5 mg Tablets: Each tablet contains 80mg valsartan and 12.5mg hydrochlorothiazide.

Co-Diovan 160/12.5 mg Tablets: Each tablet contains 160mg valsartan and 12.5mg hydrochlorothiazide.

Co-Diovan 160/25 mg Tablets: Each tablet contains 160mg valsartan and 25mg hydrochlorothiazide.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form
Co-Diovan 80/12.5 mg Tablets:

Oval, non-divisible, film-coated tablets measuring approx. 10.2 to 5.4mm in diameter and 3.7mm in thickness, and weighing approx. 156mg. The tablets are coloured light orange and imprinted with HGH on one side and CG on the other side.

Co-Diovan 160/12.5 mg Tablets:

Oval, non-divisible, film-coated tablets measuring approximately 15.2 mm by 6.2 mm and 4.4 mm in thickness, and weighing approximately 312 mg. The tablets are coloured dark red and imprinted with HHH on one side and CG on the other side.

Co-Diovan 160/25 mg Tablets:

Oval, non-divisible, film-coated tablets measuring approximately 14.2 mm by 5.7 mm and 4.5 mm in thickness, and weighing approximately 310 mg. The tablets are coloured brown orange and imprinted with HXH on one side and NVR on the other side.

4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension in adults.

Co-Diovan fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.

4.2 Posology and method of administration
Posology

The recommended dose of Co-Diovan 80/12.5mg or 160/12.5mg or 160/25mg is one film-coated tablet once daily. Dose titration with the individual components is recommended. In each case, up- titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events.

When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed.

The clinical response to Co-Diovan should be eva luated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Co-Diovan 320 mg/25 mg.

The antihypertensive effect is substantially present within 2 weeks.

In most patients, maximal effects are observed within 4 weeks. However, in some patients, 4-8 weeks treatment may be required. This should be taken into account during dose-titration.

Method of administration

Co-Diovan can be taken with or without food and should be administered with water.

Special populations

Renal impairment

No dose adjustment is required for patients with mild to moderate renal impairment (Glomerular Filtration Rate (GFR) ≥ 30 ml/min). Due to