Indap

Basic information

Composition

Indapamide 2.5 mg in 1 capsule

Pharmacotherapeutic group

Antihypertensive diuretic agent (ATC code: C03BA11)

Therapeutic indications

Arterial hypertension.

Pharmacological properties

Indapamide is a sulphonamide diuretic. It reduces blood pressure mainly through relaxation of arterioles; a diuretic effect is achieved in higher doses only. Indapamide does not interfere with lipid or carbohydrate metabolism. After oral administration indapamide is rapidly absorbed; the maximum concentration is achieved within 1–2 hours. Biological availability is up to 93% and is not influenced by food. From 60–80% of the administered dose is excreted in the urine, mainly in form of metabolites; the biological half-life is 14–24 hours.

Pharmaceutical form

Hard capsules

More information

Posology and method of administration

Usual dose is 1 capsule daily, preferably in the morning. If effects are not satisfactory, it is recommended not to increase the dose further and instead add another antihypertensive agent (except diuretics). Capsules should be swallowed unchewed with plenty of liquid.

Contraindications

Hypersensitivity to indapamide and sulphonamides or to excipients, severe hepatic insufficiency and hepatic encephalopathy, severe renal failure, hypokalaemia, pregnancy and lactation, children under 18 years of age.

Interactions

Concomitant administration of drugs promoting the excretion of potassium increases the risk of hypokalaemia; kalaemia should be regulated before administration of digitalis and anti-arrhythmics (risk of severe undesirable effects) and monitored. In patients with concurrent hypokalaemia and bradycardia and an existing prolonged QT interval, concomitant administration of astemizole, bepridil, erythromycin, halofantrine, sultoprid, terfenadine or vinkamin with indapamide may cause torsades de pointes. Lithium levels should be monitored in patients treated with lithium. High doses of salicylates may reduce the antihypertensive effect of indapamide, while tricyclic antidepressants and neuroleptic agents may enhance it. There is a risk of lactic acidosis with metformin.

Undesirable effects

Occasionally fatigue, dizziness, headaches, nausea or allergic skin reactions. Changes in laboratory values such as hypokalaemia and hyperuricaemia are dose dependant.

Special warnings and precautions for use

During treatment it is recommended to repeatedly check potassium, glucose and uric acid plasma levels regularly. Kalaemia must be regulated, especially if indapamide is administered concomitantly with certain other anti-arrhythmics and preparations containing agents such as astemizole, terfenadine and erythromycin.

For more detailed product information, see the Summary of Product Characteristics.

Availability

The medicinal product is available on prescription only and is partly covered by health insurance.

Contents of container

30 and 100 capsules of 2.5 mg each

Package available in the Czech Republic

30 and 100 capsules of 2.5 mg each

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

17 August 2020

Product images

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