ZAARIO Film-coated tablet Ref.[108829] Active ingredients: Losartan

Posology

ZAARIO may be administered with other antihypertensive medicines of a different class.

Hypertension

The usual starting and maintenance dose is 50 mg once daily for most patients. The maximum antihypertensive effect is achieved 3 to 6 weeks after initiation of therapy. The dose may be increased to 100 mg once daily.

For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4).

Another formulation should be used for patients requiring a dose of 25 mg.

No initial dosage adjustment is necessary for elderly patients including patients on dialysis. ZAARIO is contraindicated in patients with renal impairment,

A lower dose should be considered for patients with a history of hepatic impairment (see section 4.4).

Renal protection in type 2 diabetic patients with hypertension and proteinuria

The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily if blood pressure response indicates that it is required. ZAARIO may be administered with other antihypertensive medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycaemic medicines (e.g. sulphonylureas, glitazones and glucosidase inhibitors).

Special populations

Use in Elderly

Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.

Method of administration

Losartan tablets should be swallowed whole with a glass of water.

ZAARIO may be administered with or without food.

Symptoms

The symptoms of an overdosage of ZAARIO would be hypotension and tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation.

Treatment

If symptomatic hypotension should occur, supportive treatment should be instituted.

Measures are depending on the time of medicinal product intake and kind and severity of symptoms.

Stabilisation of the cardiovascular system should be given priority. After oral intake, the administration of a sufficient dose of activated charcoal is indicated. Afterwards, close monitoring of the vital parameters should be performed. Vital parameters should be corrected if necessary.

Neither ZAARIO nor the active metabolite can be removed by haemodialysis.

24 months.

Store at or below 25°C.

Protect from moisture.

Keep the blister strips in the outer carton until required for use.

ZAARIO 50: White opaque PVC/PE/PVdC silver aluminium blisters, containing 10 tablets per blister, in an outer cardboard carton. 30 tablets per outer carton pack.

ZAARIO 100: White opaque PVC/PE/PVdC silver aluminium blisters, containing 10 tablets per blister, in an outer cardboard carton. 30 tablets per outer carton pack.

No special requirements.