TRIPLIXAM Film-coated tablet Ref.[107764] Active ingredients: Amlodipine Indapamide Perindopril Perindopril, Amlodipine and Indapamide

Posology

One Triplixam film-coated tablet per day as a single dose, preferably to be taken in the morning and before a meal.

The fixed dose combination is not suitable for initial therapy. If a change of the posology is required, titration should be done with the individual components.

Special population

Renal impairment (see section 4.3 and 4.4)

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

In patients with moderate renal impairment (creatinine clearance 30-60 mL/min), Triplixam at the doses 10mg/2.5mg/5mg and 10mg/2.5mg/10mg is contraindicated. It is recommended to start treatment with the adequate dosage of the free combination.

Usual medical follow-up will include frequent monitoring of creatinine and potassium.

Concomitant use of perindopril with aliskiren-containing products is contraindicated in patients with renal impairment (GFR <60 ml/min/1.73 m²) (see section 4.3).

Hepatic impairment (see sections 4.3, 4.4 and 5.2)

In severe hepatic impairment, Triplixam is contraindicated.

In patients with mild to moderate hepatic impairment, Triplixam should be administrated with caution, as dosage recommendations for amlodipine in these patients have not been established.

Elderly (see section 4.4)

Elimination of perindoprilat is decreased in the elderly (see section 5.2).

Elderly can be treated with Triplixam according to renal function (see section 4.3).

Paediatric population

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

Method of administration

Oral use.

There is no information on overdosage with Triplixam in humans.

For perindopril/indapamide combination

Symptoms

The most likely adverse reaction in cases of overdose is hypotension, sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, oliguria which may progress to anuria (due to hypovolaemia). Salt and water disturbances (low sodium levels, low potassium levels) may occur. Management

The first measures to be taken consist of rapidly eliminating the product(s) ingested by gastric lavage and/or administration of activated charcoal, then restoring fluid and electrolyte balance in a specialised centre until they return to normal.

If marked hypotension occurs, this can be treated by placing the patient in a supine position with the head lowered. If necessary an intravenous infusion of isotonic saline may be given, or any other method of volaemic expansion may be used.

Perindoprilat, the active form of perindopril, can be dialysed (see section 5.2).

For amlodipine

Experience with intentional overdose in humans is limited.

Symptoms

Available data suggest that gross overdosage could result in excessive peripheral vasodilation 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.

Management

Clinically significant hypotension due to amlodipine overdosage 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.

3 years.

For the container of 10 and 30 film-coated tablet, the in-use stability after first opening is 30 days.

Store below 30°C.

10 or 30 film-coated tablets in polypropylene tablet container equipped with a low density polyethylene flow reducer and a low density polyethylene stopper containing a desiccant.

Not all pack sizes may be marketed.

No special requirements.