CINNARON Tablet Ref.[28181] 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

Cinnaron is indicated for:

  • the maintenance therapy for symptoms of labyrinthine disorders, including vertigo, dizziness, tinnitus, nystagmus, nausea and vomiting.
  • the prophylaxis of motion sickness.
  • the prophylaxis of migraine.
  • the maintenance therapy for symptoms of cerebrovascular origin, including dizziness, ear buzzing (tinnitus), vascular headache, unsociability and irritability disorders, loss of memory and lack of concentration.
  • the maintenance therapy for symptoms of peripheral circulatory disorders, including Raynaud’s phenomenon, acrocyanosis, intermittent claudication, trophic disturbances, trophic and varicose ulcers, paraesthesia, nocturnal cramps, cold extremities.

4.2. Posology and method of administration

Posology

Adults and children over the age of 12

Cerebral circulatory disorders: 1 tablet three times daily.

Peripheral circulatory disorders: 2-3 tablets three times daily.

Disorders of balance: 1 tablet three times daily.

Motion Sickness:

  • In adults and children over 12 years: 1 tablet half an hour before travelling, to be repeated every 6 hours.
  • In children 6-12 years of age: half of the adult dose is recommended.

The maximum recommended dosage should not exceed 225 mg (9 tablets) daily. As the effect of Cinnaron on vertigo is dose dependent, the dosage should be increased progressively.

Cinnaron should preferably be taken after meals.

The tablets should be swallowed with water.

Method of administration

Oral administration.

4.9. Overdose

Symptoms

Acute cinnarizine overdoses have been reported with doses ranging from 90 to 2,250 mg. The most commonly reported signs and symptoms associated with overdose of cinnarizine include: alterations in consciousness ranging from somnolence to stupor and coma, vomiting, extrapyramidal symptoms, and hypotonia. In a small number of young children, seizures developed. Clinical consequences were not severe in most cases, but deaths have been reported after single and polydrug overdoses involving cinnarizine.

Treatment

There is no specific antidote. For any overdose, the treatment is symptomatic and supportive care. Activated charcoal may be given if considered appropriate.

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 50 and 500 tablets.

PP containers with PE closures. Pack sizes of 50, 500 and 1000 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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