NATRILIX Prolonged-release tablet Ref.[27711] Active ingredients: Indapamide

Posology

One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed.

At higher doses the antihypertensive action of indapamide is not enhanced but the saluretic effect is increased.

Special populations

Renal impairment (see sections 4.3 and 4.4)

In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated.

Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired.

Hepatic impairment (see sections 4.3 and 4.4)

In severe hepatic impairment, treatment is contraindicated.

Elderly (see section 4.4)

In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Natrilix SR when renal function is normal or only minimally impaired.

Paediatric population

The safety and efficacy of Natrilix SR in children and adolescents have not been established. No data are available.

Method of administration

Oral use.

Symptoms

Indapamide has been found free of toxicity at up to 40 mg, i.e. 27 times the therapeutic dose.

Signs of acute poisoning take the form above all of water/electrolyte disturbances (hyponatraemia, hypokalaemia). Clinically, possibility of nausea, vomiting, hypotension, cramps, vertigo, drowsiness, confusion, polyuria or oliguria possibly to the point of anuria (by hypovolaemia).

Management

Initial measures involve the rapid elimination of the ingested substance(s) by gastric wash-out and/or administration of activated charcoal, followed by restoration of water/electrolyte balance to normal in a specialised centre.

2 years.

Store below 30°C.

10, 14, 15, 20, 30, 50, 60, 90, 100 tablets in blisters (PVC/aluminium).

Not all pack sizes may be marketed.

No special requirements.