ZOLMITRIPTAN Orodispersible tablets Ref.[8080] Active ingredients: Zolmitriptan

Posology

For doses not realisable/practicable with this strength other strengths of this medicinal product are available.

The recommended dose of zolmitriptan to treat a migraine attack is 2.5mg. It is advisable that zolmitriptan is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage.

If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken. If a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not respond to the first dose, it is unlikely that a second dose will be of benefit in the same attack.

If a patient does not achieve satisfactory relief with 2.5mg doses, for subsequent attacks 5mg doses of zolmitriptan could be considered.

The total daily intake should not exceed 10mg. Not more than 2 doses of zolmitriptan should be taken in any 24-hour period.

Zolmitriptan is not indicated for prophylaxis of migraine.

Children (below 12 years of age)

Safety and efficacy of zolmitriptan tablets in paediatric patients have not been evaluated. Use of zolmitriptan in children is therefore not recommended.

Adolescents (12-17 years of age)

The efficacy of zolmitriptan tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of zolmitriptan in adolescents is therefore not recommended.

Use in patients aged over 65 years

The safety and efficacy of zolmitriptan in individuals aged over 65 years have not been evaluated. Use of zolmitriptan in older people is therefore not recommended.

Patients with hepatic impairment

Patients with mild or moderate hepatic impairment require no dose adjustment, however for patients with severe hepatic impairment, a maximum dose of 5mg in 24 hours is recommended.

Patients with renal impairment

No dosage adjustment required in patients with a creatinine clearance of more than 15 ml/min. (See section 4.3 and section 5.2)

Interactions requiring dose adjustment (see section 4.5)

For patients taking MAO-A inhibitors, a maximum dose of 5mg in 24 hours is recommended. A maximum dose of 5mg zolmitriptan in 24 hours is recommended in patients taking cimetidine.

A maximum dose of 5mg zolmitriptan in 24 hours is recommended in patients taking specific inhibitors of CYP 1A2 such as fluvoxamine and the quinolones (e.g. ciprofloxacin).

Method of administration

The tablet need not be taken with liquid; the tablet dissolves on the tongue and is swallowed with saliva. This formulation can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids. However, a delay in the absorption of zolmitriptan from the dispersible tablet can occur which may delay onset of action.

The blister pack should be peeled open (tablets should not be pushed through the foil). The tablet should be placed on the tongue, where it will dissolve and be swallowed with the saliva.

Volunteers receiving single oral doses of 50mg commonly experienced sedation.

The elimination half-life of zolmitriptan tablets is 2.5 to 3 hours, (see section 5.2) and therefore monitoring of patients after overdose with Zolmitriptan 5mg Orodispersible Tablets should continue for at least 15 hours or while symptoms or signs persist.

There is no specific antidote to zolmitriptan . In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.

It is unknown what effect haemodialysis or peritoneal dialysis has on the serum concentrations of zolmitriptan.

Shelf life: 3 years.

Do not store above 30°C.

Peelable aluminium/aluminium blisters.

Pack sizes: 2, 3, 6 or 12 tablets.

Not all pack sizes may be marketed.

No special requirements

Any unused product or waste material should be disposed of in accordance with local requirements.