MicardisPlus 40 mg/12.5 mg tablets

MicardisPlus 80mg/12.5 mg tablets

Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide or 80 mg telmisartan and 12.5 mg hydrochlorothiazide.

Excipients (40 mg): Each tablet contains 112 mg of lactose monohydrate and 169 mg sorbitol (E420).

Excipients (80 mg): Each tablet contains 112 mg of lactose monohydrate and 338 mg sorbitol (E420).

For a full list of excipients, see section 6.1.

Tablet.

Red and white oval shaped two layer tablet of 5.2 mm or 6.2 mm engraved with the company logo and the code 'H4' or 'H8'.

Treatment of essential hypertension.

MicardisPlus fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.

Adults

MicardisPlus should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.

• MicardisPlus 40 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Micardis 40 mg

• MicardisPlus 80 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Micardis 80 mg

Special populations:

Renal impairment: Periodic monitoring of renal function is advised (see section 4.4).

Hepatic impairment: In patients with mild to moderate hepatic impairment the posology should not exceed MicardisPlus 40 mg/12.5 mg once daily. MicardisPlus is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4).

Elderly: No dosage adjustment is necessary.

Paediatric population:

The safety and efficacy of MicardisPlus in children and adolescents below age18 have not been established. No data are available.

Method of administration

MicardisPlus tablets are for once-daily oral administration and should be taken with liquid, with or without food.

Precautions to be taken before handling or administering the medicinal product

MicardisPlus should be kept in the sealed blister due to the hygroscopic property of the tablets. Tablets should be taken out of the blister shortly before administration.

• Hypersensitivity to any of the active substances or to any of the excipients (see section 6.1).

• Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).

• Second and third trimesters of pregnancy (see sections 4.4 and 4.6).

• Cholestasis and biliary obstructive disorders.

• Severe hepatic impairment.

• Severe renal impairment (creatinine clearance < 30 ml/min).

• Refractory hypokalaemia, hypercalcaemia.

Pregnancy

Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy s