CINNARON Hard capsule Ref.[28182] Active ingredients: Cinnarizine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Cerebral circulatory disorders:

  • Prophylaxis from migraine.

Disorders of balance:

  • Vertigo.

Peripheral circulatory disorders:

  • Raynaud’s phenomenon.
  • Probably effective in peripheral angiopathy.

4.2. Posology and method of administration

Posology

Adults

Cerebral circulatory disorders: 1 capsule once daily.

Disorders of balance: 1 capsule once daily.

Peripheral circulatory disorders: 2-3 capsules once daily.

The maximum recommended dosage should not exceed 225 mg daily.

Paediatric population (6-12 years of age)

Half of the adult dose is recommended.

Method of administration

Oral administration.

4.9. Overdose

Symptoms and signs

The signs and symptoms are mainly due to the anticholinergic (similar to atropine) effect of cinnarizine. Acute overdoses have been reported with cinnarizine in doses ranging from 90 to 2.250 mg. The most commonly reported signs and symptoms associated with overdose with cinnarizine include: changes in level of consciousness ranging from drowsiness to lethargy and coma, vomiting, extrapyramidal symptoms and hypotonia. In a small number of young children, seizures were reported. Clinical effects were not severe in most cases, however, deaths have been reported after a single overdose or overdose of multiple drugs including cinnarizine.

Treatment

There is no specific antidote. For each overdose, treatment is symptomatic and supportive care. If considered appropriate, activated charcoal may be administered.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C.

Protect from light and moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack sizes of 20 and 1000 hard capsules.

PP containers with PE closures. Pack size of 1000 hard capsules.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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