MICARDIS Tablet (2022)

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Περιεχόμενα

Name of the medicinal product

Micardis 20 mg tablets. Micardis 40 mg tablets. Micardis 80 mg tablets.

Qualitative and quantitative composition

Micardis 20 mg tablets: Each tablet contains 20 mg telmisartan. Micardis 40 mg tablets: Each tablet contains 40 mg telmisartan. Micardis 80 mg tablets: Each tablet contains 80 mg telmisartan. ...

Pharmaceutical form

Tablet. Micardis 20 mg tablets: White round tablets of 2.5 mm engraved with the code number 50H on one side and the company logo on the other side. Micardis 40 mg tablets: White oblong tablets ...

Therapeutic indications

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: manifest atherothrombotic cardiovascular disease (history of ...

Posology and method of administration

Posology Treatment of essential hypertension The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second and third trimesters of pregnancy (see sections 4.4 and 4.6). Biliary obstructive disorders. Severe hepatic ...

Special warnings and precautions for use

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

Interaction with other medicinal products and other forms of interaction

Digoxin When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and discontinuing ...

Fertility, pregnancy and lactation

Pregnancy The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated ...

Effects on ability to drive and use machines

When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Micardis.

Undesirable effects

Summary of the safety profile Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000), and acute renal failure. The overall incidence ...

Overdose

There is limited information available with regard to overdose in humans. Symptoms The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia dizziness, increase ...

Pharmacodynamic properties

Pharmacotherapeutic group: Angiotensin II Antagonists, plain ATC Code: C09CA07 Mechanism of action Telmisartan is an orally active and specific angiotensin II receptor (type AT1 ...

Pharmacokinetic properties

Absorption Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute bioavailability for telmisartan is about 50%. When telmisartan is taken with food, the reduction in ...

Preclinical safety data

In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal ...

List of excipients

Povidone (K25) Meglumine Sodium hydroxide Sorbitol (E420) Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Micardis 20 mg tablets: 3 years. Micardis 40 mg and 80 mg tablets: 4 years.

Special precautions for storage

Telmisartan 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. Any unused medicinal product or ...

Nature and contents of container

Aluminium/aluminium blisters (PA/Al/PVC/Al or PA/PA/Al/PVC/Al). One blister contains 7 or 10 tablets. Micardis 20 mg tablets: Pack sizes: Blister with 14, 28, 56 or 98 tablets. Micardis 40 mg ...

Special precautions for disposal and other handling

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany

Marketing authorization number(s)

Micardis 20 mg tablets: EU/1/98/090/009 (14 tablets) EU/1/98/090/010 (28 tablets) EU/1/98/090/011 (56 tablets) EU/1/98/090/012 (98 tablets) Micardis 40 mg tablets: EU/1/98/090/001 (14 tablets) ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 December 1998 Date of last renewal: 16 December 2008

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