Micardis 40mg (3 blisters x 10 tablets/box)

Indications

• Treatment of essential hypertension.
• Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage.

Contraindications

• Known hypersensitive to any of the active substance or excipients of the product.
• Second and third trimesters of pregnancy and lactation.
• Biliary obstructive disorders.
• Severe hepatic impairment.
• The concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).

Compositon/Ingredients

Dosage and administration

Adult:

• Hypertension: 40 mg once daily (may be 20 mg once daily, use of suitable dosage forms), increase to a maximum of 80 mg once daily if the target blood pressure is not achieved, may be used in combination with thiazide.
• Cardiovascular prevention: 80 mg once daily, close monitoring of blood pressure and if appropriate adjustment of medications that lower blood pressure may be necessary.

Severe renal impairment/ haemodialysis: An initial dose of 20 mg once daily.

Mild to moderate hepatic impairment: A daily maximum dose 40 mg once daily.

Adolescents aged < 18 years: The safety and efficacy have not been established.

Precaution

• When pregnancy is detected, telmisartan should be discontinued as soon as possible.
• Use with caution in patients: mild to moderate hepatic impairment; bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney; vascular tone and renal function depend predominantly on the activity of the RAAS; aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; diabetic patients; severe hypertension; ischaemic cardiovascular disease; > 70 years old.
• Telmisartan is not to be given to patients with cholestasis; fructose intolerance.
• When using in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
• Not recommended for patients with primary aldosteronism.
• Intravascular hypovolaemia and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting should be corrected before the administration of telmisartan.
• Risk of porphyria and hyperkalaemia.
• The dose of 80 mg contains 3.864 mg sodium. This is equivalent to approximately 0.2% of the recommended maximum daily intake of sodium for an adult.
• Gastroduodenal ulcer can work or other stomach problems (increased risk of gastrointestinal bleeding).
• It should be taken into account when driving vehicles or operating machinery.

Storage

Store at temperature below 30°C, protect from light.