Indapamid PMCS 2.5 mg, Indapamid PMCS 1.25 mg, Indapamid PMCS 0.625 mg

Basic information

Composition

Indapamide 2.5 mg or 1.25 mg or 0.625 mg in 1 tablet

Pharmacotherapeutic group

Antihypertensive diuretic agent, sulphonamides (ATC code: C03BA11)

Therapeutic indications

Essential hypertension.

Pharmacological properties

Indapamide is a sulphonamide diuretic. It reduces blood pressure mainly through the relaxation of the arterioles, while the diuretic effect appears only in higher doses. Indapamide does not affect the metabolism of lipids and carbohydrates. It absorbs quickly after oral administration, maximum concentration is achieved in 1—2 hours. Biological availability is up to 93 % and is not affected by food. 70 % of the drug administered is secreted in the urine mostly in the form of metabolites; biological half-life is 15—18 hours.

Pharmaceutical form

Tablets

More information

Posology and method of administration

The usual daily dosage of indapamide is 2.5 mg, best taken in the morning. The tablets may be taken before, with or after a meal and should be washed down with water.

Contraindications

Hypersensitivity to indapamide or to sulphonamides or to any excipient, severe liver insufficiency and liver encephalopathy, serious renal failure, hypokalemia, pregnancy and lactation, children and adolescents due to lack of safety and efficacy data.

Interactions

Concomitant administration of drugs supporting the secretion of potassium increase the risk of hypokalemia; before administering digitalis and antiarrhythmics (a risk of serious undesirable effects) kalemia must be regulated and further monitored. The level of lithium must be controlled in patients receiving lithium treatment. High doses of salicylates may reduce the antihypertensive effect of indapamide, tricyclic antidepressants and neuroleptics may enhance it.

Undesirable effects

Fatigue, dizziness, headaches, nausea, maculopapular rash, hypokalemia, hyperuricemia.

Special warnings and precautions for use

The level of potassium and uric acid in the plasma must be checked repeatedly during treatment. Kalemia needs to be regulated especially during concomitant administration of indapamide and some antiarrhythmics as well as products containing sulpiride, tiapride, mizolastine and erythromycin (in bradycardia and prolonged QT interval there is a risk of arrhythmias of the torsades de pointes type).

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, 50, 60 or 100 tablets of 2.5 mg, 1.25 mg or 0.625 mg each

Package available in the Czech Republic

30 or 100 tablets 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

10 April 2018

Product images

Indapamid PMCS 2.5 mg
Indapamid PMCS 2.5 mg
Indapamid PMCS 2.5 mg
Indapamid PMCS 0.625 mg
Indapamid PMCS 1.25 mg
Indapamid PMCS 2.5 mg