ARELIX Tablet Ref.[8907] Active ingredients: Piretanide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2017  Publisher: Sanofi-Aventis Ireland Ltd., T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Therapeutic indications

Arelix is a diuretic for the management of fluid retention and treatment of mild to moderate hypertension.

Posology and method of administration

Adults

Oedema

The usual initial adult dose is 6mg daily, adjusted according to response to a maximum of 30mg. An initial dose of 3mg may be sufficient in some patients.

Hypertension

The usual initial adult dose is 6mg daily in mild to moderate hypertension. This dose should be continued for 2-4 weeks then increased if necessary at 2-4 week intervals to a maximum of 18mg daily. The maintenance dose is usually 6mg daily.

Children

There is at present insufficient experience of the use of this product in children to enable dosage recommendations to be made.

Elderly

Piretanide may be excreted more slowly in the elderly. It may be appropriate to use a low (3mg) initial dose in the elderly.

Overdose

Symptoms of intoxication

Severe diuresis with the risk of dehydration and, during prolonged use, hypokalaemia. The rapid water and electrolyte loss can lead to a state of delirium.

A sudden flood of urine can lead to urinary retention with acute over-distension of the bladder in cases of prostatic hypertrophy, for instance.

Measures to be taken in the event of intoxication

Fluid and electrolyte replacement as well as repeated checks of the water-electrolyte balance and metabolic functions are required.

For patients with impaired micturition (patients with prostatic hypertrophy, disturbances of consciousness, etc.), it is essential to ensure that urinary excreation is adequate.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C.

Store in the original package in order to protect from light.

Nature and contents of container

Aluminium/PVC blister packs of 20 or 100 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.