DIXARIT Coated tablet Ref.[50231] Active ingredients: Clonidine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS, United Kingdom

4.1. Therapeutic indications

  • The prophylactic management of migraine or recurrent vascular headache.
  • The management of vasomotor conditions commonly associated with the menopause and characterised by flushing.

4.2. Posology and method of administration

Adults (including elderly patients)

Initially 2 tablets twice daily. If after two weeks there has been no remission, increase to 3 tablets twice daily.

The duration of treatment depends upon the severity of the condition.

If symptoms continue to occur the patient should be informed that it may take 2-4 weeks until Dixarit is fully effective.

Paediatric population

There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years.

Renal insufficiency

Dixarit should be used with caution in patients with renal insufficiency. Careful monitoring of blood pressure is required.

4.9. Overdose

Symptoms

Manifestations of intoxication are due to generalised sympathetic depression and include pupillary constriction, somnolence including coma, hypotension, orthostatic hypotension, bradycardia, hypothermia, respiratory depression including apnoea, occasionally vomiting, very occasionally hypertension, dryness of the mouth.

Treatment

Gastric lavage and/or administration of activated charcoal should be performed where appropriate. In most cases all that is required are general supportive measures.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C.

Keep the blisters in the outer carton.

6.5. Nature and contents of container

PVC/aluminium blister packs of 84, 100, 112.

Currently the 112 pack is the only marketed pack.

6.6. Special precautions for disposal and other handling

No special requirements.

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