MICARDIS PLUS TABLET 80/12.5 mg

4.1 Indications

Treatment of essential hypertension.

As fixed dose combination MICARDIS PLUS is indicated in patients whose blood pressure is not adequately controlled on telmisartan or hydrochlorothiazide alone.

4.3 Contraindications

• Hypersensitivity to the active substances or, to any of the excipients, or to other sulphonamide-derived substances (hydrochlorothiazide is a sulphonamide-derived substance).
• Pregnancy
• Lactation
• Cholestasis and biliary obstructive disorders
• Severe hepatic impairment, coma hepatricum, hepatic precoma
• Severe renal impairment (creatinine clearance < 30 ml/min) or serum creatinine > 1.8 mg/100 ml), anuria, or acute glomerulonephritis
• Refractory hypokalaemia, hypercalcaemia
• Therapy-refractory hyponatraemia
• Hypovolaemia
• Symptomatic hyperuricaemia/ gout
• The concomitant use of MICARDIS PLUS with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2)

In case of rare hereditary conditions that may be incompatible with an excipient of the product (see “List of Excipients” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) the use of the product is contraindicated.

4.2 Dosage and administration

Adults

MICARDIS PLUS should be taken once daily. The dose of telmisartan could be up-titrated before switching to MICARDIS PLUS. Direct change from monotherapy to the fixed combinations may be considered.

• MICARDIS PLUS 40/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by MICARDIS 40 mg or hydrochlorothiazide.
• MICARDIS PLUS 80/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by MICARDIS 80 mg or by MICARDIS PLUS 40/12.5 mg.

Sodium or volume depletion should be corrected before treatment commencement with MICARDIS PLUS.

The maximum antihypertensive effect is generally attained with MICARDIS PLUS 4 – 8 weeks after the start of treatment.

When necessary, MICARDIS PLUS may be administered with another antihypertensive drug.

In patients with severe hypertension treatment with telmisartan at doses up to 160 mg alone and in combination with hydrochlorothiazide 12.5 – 25 mg daily was well tolerated and effective.

Special populations:

Geriatric patients

No dose adjustment is necessary for geriatric patients.

Paediatric patients

Safety and efficacy of MICARDIS PLUS have not been established in patients aged below 18 years.

Renal impairment

Due to the hydrochlorothiazide component, MICARDIS PLUS must not be used in patients with severe renal dysfunction (creatinine clearance < 30 ml/min). Loop diuretics are preferred to thiazides in this population. Experience in patients with mild to moderate renal impairment is modest but has not suggested adverse renal effects and dose adjustment is not considered necessary. Periodic monitoring of renal function is advised.

Telmisartan is not removed from blood by hemofiltration and is not dialyzable.

Hepatic impairment

In patients with mild to moderate hepatic impairment MICARDIS PLUS should be administered with caution. For telmisartan, the posology should not exceed 40 mg once daily (see Contraindications). Thiazides should be used with caution in patients with impaired hepatic function.

Method of Administration:

MICARDIS PLUS tablets are for once-daily oral administration and should be swallowed whole with liquid. MICARDIS PLUS can be taken with or without food.

Handling Instructions

Due to the hygroscopic property of the tablets, they should be taken out of the sealed blister shortly before administration.