MIZART Tablet Ref.[50304] Active ingredients: Telmisartan

MIZART is available as tablets for oral administration.

Treatment of Hypertension

Adults: The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to 80 mg once daily. When considering raising the dose, it must be borne in mind that, while reduction in blood pressure is achieved after the first dose, the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. Telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide or calcium-channel blockers such as amlodipine, which have been shown to have an additive blood pressure lowering effect with telmisartan.

Prevention of Cardiovascular Morbidity and Mortality

The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in preventing cardiovascular morbidity and mortality.

When initiating telmisartan therapy for the prevention of cardiovascular morbidity and mortality, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary.

Telmisartan may be administered with or without food.

Special populations

Elderly: No dose adjustment is necessary.

Renal impairment: No dose adjustment is required for patients with renal impairment, including those on haemodialysis. Telmisartan is not removed from blood by haemofiltration and is not dialysable.

Hepatic impairment: In patients with mild to moderate hepatic impairment, MIZART should be administered with caution. For telmisartan, the dosage should not exceed 40 mg once daily (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Limited information is available with regard to overdose in humans.

Symptoms

The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia also occurred.

Therapy

If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by haemofiltration and is not dialysable.

36 months.

Store below 30°C. Protect from light and moisture.

MIZART tablets should not be removed from their foil pack until required for administration.

Blister Pack (Alu silver/Alu HSL) of 28 tablets.

Australian Register of Therapeutic Goods (ARTG)

AUST R 230974 MIZART telmisartan 40mg tablets blister pack

AUST R 230975 MIZART telmisartan 80mg tablet blister pack

Not all strengths, pack types and/or pack sizes may be available.

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.