ZOMIG Film-coated tablet Ref.[50369] Active ingredients: Zolmitriptan

The recommended dose of ‘Zomig’ tablets to treat a migraine attack is 2.5 mg. It is advisable that ‘Zomig’ tablets are taken as early as possible after the onset of migraine headache but they are also effective if taken at a later stage.

The tablets should be swallowed whole and with water.

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 2.5 mg doses, for subsequent attacks 5 mg doses of ‘Zomig’ could be considered.

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

‘Zomig’ is not indicated for prophylaxis of migraine.

Use in Children (under 12 years of age)

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

Adolescents (12-17 years of age)

The efficacy of Zomig tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of ´Zomig´ tablets 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 established. Use of ´Zomig´ in the elderly 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 5 mg 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 5 mg in 24 hours is recommended.

A maximum dose of 5 mg zolmitriptan in 24 hours is recommended in patients taking cimetidine.

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

Volunteers receiving single oral doses of 50 mg 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 ‘Zomig’ 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.

3 years.

Do not store above 25ºC.

Tablets of 2.5 in blister packs, containing 3 or 6 tablets.

The blister strip is polyamide Al-PVC/Al.

Not all pack sizes may be marketed.

No special requirements.