AMILORETIC Tablet Ref.[51293] Active ingredients: Amiloride Hydrochlorothiazide

Posology

Adults

AMILORETIC: One tablet daily.

AMILORETIC H.S. TABLETS: One to two tablets daily.

Special populations

Elderly population

Particular caution is needed in the elderly because of their susceptibility to electrolyte imbalance; the dosage should be carefully adjusted to renal function and clinical response.

Renal impairment

Renal function should be monitored because the use of AMILORETIC in impaired renal function may result in the rapid development of hyperkalaemia. Thiazide diuretics become ineffective when creatinine levels fall below 30 mL/min (see section 4.4).

Hepatic impairment

AMILORETIC should be used with caution in patients with impaired hepatic function or progressive liver disease (see section 4.3), since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Paediatric population

The safety and efficacy of AMILORETIC in children aged 18 years has not been established (see section 4.3).

Method of administration

For oral administration.

Symptoms

Dehydration, hypochloraemic alkalosis and hypokalaemia or hyperkalaemia (see section 4.4 and 4.8).

Treatment

Treatment is symptomatic and supportive. Therapy should be discontinued and the patient watched closely. Emesis should be induced and/or gastric lavage performed. The most common signs and symptoms of overdosage with amiloride hydrochloride are dehydration and electrolyte imbalance. Blood pressure should be monitored and corrected where necessary. If hyperkalaemia occurs, active measures should be taken to reduce the plasma potassium levels.

Electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration are the most common signs and symptoms of hydrochlorothiazide overdosage. If digitalis has been administered, hypokalaemia may accentuate cardiac arrhythmias.

24 months.

Store at or below 25°C.

Protect from light and moisture.

Keep in the original packaging until required for use.

AMILORETIC: 30 or 100 tablets are packed in clear polyvinylchloride blister strips with an aluminium backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

1.000 tablets are packed in a white polypropylene container with a white linear low density polyethylene cap together with a white foam insert and a leaflet.

The tablets are also packed in a metallised lay flat bag sealed with a zip-lock for lay-flat.

AMILORETIC H.S.TABLETS: 30 or 100 tablets are packed in clear polyvinylchloride blister strips with an aluminium backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

1.000 tablets are packed in a white polypropylene container with a white linear low density polyethylene cap together with a white foam insert and a leaflet.

The tablets are also packed in a metallised lay flat bag sealed with a zip-lock for lay-flat.

Not all packs and pack size are necessarily marketed.

No special requirements.