TENORET Film-coated tablet Ref.[28069] Active ingredients: Atenolol Chlortalidone

Posology

Adults

One tablet daily.

Elderly

One tablet daily. The elderly with hypertension who do not respond to low dose therapy with a single agent should have a satisfactory response to a single tablet daily of Tenoret. Where hypertensive control is not achieved, addition of a small dose of a third agent e.g. as a vasodilator, may be appropriate.

Paediatric population

The use of Tenoret is not recommended in children. The safety and efficacy of Tenoret in children has not yet been established.

Renal Impairment

Due to the properties of the chlortalidone component, Tenoret has reduced efficacy in the presence of renal insufficiency. This fixed dose combination should thus not be administrated to patients with severe renal impairment (see section 4.3).

Method of administration

Tenoret 50 mg/12.5 mg film-coated tablets are administered orally.

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

General treatment should include: close supervision, treatment in an intensive care ward, the use of gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract, the use of plasma or plasma substitutes to treat hypotension and shock. The possible use of haemodialysis or haemoperfusion may be considered.

Excessive bradycardia can be countered with atropine 1-2 mg intravenously and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1-10 mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta-adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion may be given.

Dobutamine, because of its positive inotropic effect, could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta-blocker blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.

Bronchospasm can usually be reversed by bronchodilators.

Excessive diuresis should be countered by maintaining normal fluid and electrolyte balance.

36 months.

Do not store above 25°C.

Store in the original package. Keep blister in the outer carton.

Blister packs of 28 tablets contained in a carton.

No special requirements for disposal.