NATRILIX Tablet Ref.[107804] Active ingredients:

Posology

Adults

The dosage is one tablet, containing 2.5 mg indapamide hemihydrate, daily, to be taken in the morning. The action of Natrilix is progressive and the reduction in blood pressure may continue and not reach a maximum until several months after the start of therapy. A larger dose than 2.5 mg Natrilix daily is not recommended as there is no appreciable additional antihypertensive effect but a diuretic effect may become apparent. If a single daily tablet of Natrilix does not achieve a sufficient reduction in blood pressure, another antihypertensive agent may be added; those which have been used in combination with Natrilix include beta-blockers, ACE inhibitors, methyldopa, clonidine and other adrenergic blocking agents. The co-administration of Natrilix with diuretics which may cause hypokalaemia is not recommended. There is no evidence of rebound hypertension on withdrawal of Natrilix.

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 when renal function is normal or only minimally impaired.

Paediatric population

The safety and efficacy of Natrilix 2.5mg 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.

5 years.

Do not store above 25°C.

30 tablet pack: 1 blister strip (PVC/Aluminium) of 30 tablets per carton.

60 tablet pack: 2 blister strips (PVC/Aluminium) of 30 tablets per carton.

Not all pack sizes may be marketed.

No special requirements.