NATRIXAM Modified-release tablet Ref.[51086] Active ingredients: Amlodipine Indapamide

Posology

One tablet per day as single dose, preferably to be taken in the morning, to be swallowed whole with water and not chewed.

The fixed dose combination is not suitable for initiation therapy.

If a change of the posology is required, titration should be done with the individual components.

Special populations

Paediatric population

The safety and efficacy of Natrixam in children and adolescents have not been established.

No data are available.

Patients with renal impairment (see sections 4.3 and 4.4)

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

In patients with mild to moderate renal impairment, no dose adjustment is needed.

Older people (see section 4.4 and 5.2)

Older people can be treated with Natrixam according to renal function.

Patients with hepatic impairment (see sections 4.3 and 4.4)

In severe hepatic impairment, treatment is contraindicated.

Dosage recommendations of amlodipine have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2).

Method of administration

Oral administration.

There is no information on overdose with Natrixam in humans.

For indapamide

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).

Treatment

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.

For amlodipine

In humans experience with intentional overdose is limited.

Symptoms

Available data suggest that gross overdose could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.

Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.

Treatment

Clinically significant hypotension due to amlodipine overdose calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output.

A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.

Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine. Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.

2 years.

Store below 30°C.

PVC/Aluminium blisters: 1x15 (15) tablets, 2x15 (30) tablets, 4x15 (60) tablets, 6x15 (90) tablets

High density polyethylene bottles equipped with a screw tamper evident polypropylene cap: 1x100 (100) tablets, 5x100 (500) tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.