BIPRETERAX Film-coated tablet Ref.[50602] Active ingredients: Indapamide Perindopril

Posology

One Bipreterax 10mg/2.5mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal.

Special populations

Elderly (see section 4.4)

In elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated if renal function is normal and after considering blood pressure response.

Renal impairment (see section 4.4)

In severe and moderate renal impairment (creatinine clearance below 60 ml/min), treatment is contraindicated.

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

Hepatic impairment (see sections 4.3, 4.4 and 5.2)

In severe hepatic impairment, treatment is contraindicated. In patients with moderate hepatic impairment, no dose modification is required.

Paediatric population

The safety and efficacy of Bipreterax 10mg/2.5mg in children and adolescents have not yet been established. No data are available. Bipreterax 10mg/2.5mg should not be used in children and adolescents.

Method of administration

Oral use.

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).

3 years.

Keep the container tightly closed in order to protect from moisture.

This medicinal product does not require any special storage conditions.

14, 20, 28, 30 or 50 tablets in polypropylene tablet container equipped with a low density polyethylene flow reducer and a low density polyethylene stopper containing a white desiccant gel.

Pack sizes:

1 × 14, 1 × 20, 1 × 28, 1 × 30 or 1 × 50 tablets
2 × 28, 2 × 30 or 2 × 50 tablets
3 × 30 tablets
10 × 50 tablets

Not all pack sizes may be marketed.

No special requirements.