CLARANTIN Hard capsule Ref.[50022] Active ingredients: Naftidrofuryl

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: Medochemie Ltd, 1-10 Constantinopoleos Street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Clarantin is indicated for the treatment of peripheral vascular disorders like intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud’s Syndrome, diabetic arteriopathy and acrocyanosis.

Clarantin is also indicated for the treatment of cerebral vascular disorders including cerebral insufficiency and cerebral atherosclerosis. Particularly, it is indicated where these conditions manifest themselves as mental deterioration and confusion in the elderly.

4.2. Posology and method of administration

Posology

Adults

Peripheral vascular disorders: one or two 100mg capsules three times daily for a minimum of three months, or as the physician directed.

Cerebral vascular disorders: one 100mg capsule there times daily for a minimum of three months, or as the physician directed.

Paediatric population

Use in children is not recommended.

Method of administration

The capsules should be swallowed whole during meals with an adequate quantity of water-minimum one glass.

4.9. Overdose

Depression of cardiac conduction and convulsions may occur in the case of overdose. There is no specific antidote of naftidrofuryl oxalate. Gastric lavage and emesis should be done in order to empty the stomach. If necessary activated charcoal may be used. Cardiovascular function and respiration should be monitored. In severe cases, electrical pacemaking or the use of isoprenaline should be considered. Convulsions may be managed by diazepam.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Stored below 25ºC in the original package, in order to protect from light and moisture.

6.5. Nature and contents of container

The capsules are packed in PVC/Al blisters, PVDC/Al blisters or securitainers.
Cartons of 20, 60, 100, 500 and 1000 capsules are available. Securitainers of PVC of 100, 500 and 1 000 capsules are available.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

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