FRUMERON Coated tablet Ref.[28207] Active ingredients: Indapamide

Adults

The dosage is one tablet, containing 2.5 mg indapamide, daily, to be taken in the morning. The action of Frumeron is progressive and the reduction in blood pressure may continue and not reach a maximum until several months after the start of the therapy. A larger dose than 2.5 mg Frumeron 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 Frumeron does not achieve a sufficient reduction in blood pressure, another antihypertensive agent may be added; those which have been used in combination with indapamide include beta-blockers, ACE inhibitors, methyldopa, clonidine and other adrenergic blocking agents. The co-administration of Frumeron with diuretics may cause hypokalaemia and is not recommended.

There is no evidence of rebound hypertension on the withdrawal of indapamide.

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 creatine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Frumeron hen renal function is normal or only minimally impaired.

Paediatric population

The safety and efficacy of Frumeron 2.5 mg 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. 16 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.

Store below 25°C. Protect from light and moisture.

PVC/Aluminium blisters. Pack sizes of 30 and 1000 coated tablets.

PP containers with PE closure. Pack size of 1000 coated tablets.

Not all pack sizes may be marketed.

No special requirements.