VALOID Tablet Ref.[50280] Active ingredients: Cyclizine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Amdipharm Limited,Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

4.1. Therapeutic indications

Valoid is indicated in adults and children aged 6 years and over for the prevention and treatment of nausea and vomiting, including:

  • Motion sickness.
  • Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period.
  • Vomiting associated with radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels.

Valoid may be of value in relieving vomiting and attacks of vertigo associated with Meniere’s disease and other forms of vestibular disturbance.

4.2. Posology and method of administration

Posology

To prevent motion sickness Valoid Tablets should be taken about one to two hours before departure.

Elderly

There have been no specific studies of Valoid Tablets in the elderly. Experience has indicated that normal adult dosage
is appropriate.

Paediatric population

Children less than 6 years of age: Valoid Tablets are not recommended for children less than 6 years of age.

Children 6 to 12 years of age: 25 mg orally, which may be repeated up to three times a day.

Children over 12 years of age: 50 mg orally, which may be repeated up to three times a day.

Adults

50 mg orally, which may be repeated up to three times a day.

Method of Administration

Oral.

4.9. Overdose

Symptoms

Symptoms of acute toxicity from cyclizine arise from peripheral anticholinergic effects and effects on the central nervous system.

Peripheral anticholinergic symptoms include dry mouth, nose and throat, blurred vision, tachycardia and urinary retention. Central nervous system effects include drowsiness, dizziness, incoordination, ataxia, weakness, hyperexcitability, disorientation, impaired judgement, hallucinations, hyperkinesia, extrapyramidal motor disturbances, convulsions, hyperpyrexia and respiratory depression.

An oral dose of 5mg/kg is likely to be associated with at least one of the clinical symptoms stated above. Younger children are more susceptible to convulsions. The incidence of convulsions in children less than 5 years is about 60% when the oral dose ingested exceeds 40mg/kg.

Management

In the management of acute overdosage with Valoid Tablets, gastric lavage and supportive measures for respiration and circulation should be performed if necessary. Convulsions should be controlled in the usual way with parenteral anticonvulsant therapy.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Amber glass or polyethylene bottles with polyethylene tamper-evident caps for pack size 100 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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