ZOMIG Nasal spray Ref.[8083] Active ingredients: Zolmitriptan

Posology

The recommended dose of Zomig Nasal Spray to treat a migraine attack is 5 mg.

Zomig Nasal Spray is administered as a single dose into one nostril. Zomig Nasal Spray provides particularly rapid onset of relief of migraine with the first signs of efficacy apparent within 15 minutes of dosing.

Zomig Nasal Spray provides an alternative non–oral formulation of zolmitriptan to that of Zomig oral tablets and orodispersible tablets. This formulation may also be beneficial where a non–oral route of treatment is either needed or preferred.

If symptoms persist or return within 24 hours a second dose has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose.

Zomig Nasal Spray is effective whenever the nasal spray is administered during a migraine attack; although it is advisable that Zomig Nasal Spray is taken as early as possible after the onset of migraine headache.

In the event of recurrent attacks, it is recommended that the total intake of Zomig Nasal Spray in a 24 hour period should not exceed 10 mg.

Zomig Nasal Spray is not indicated for prophylaxis of migraine.

Paediatric population (under 12 years of age)

The safety and efficacy of Zomig Nasal Spray in children aged 12 years or under has not yet been established. Use of Zomig Nasal Spray in children is therefore not recommended.

Use in adolescents (12-17 years of age)

The safety and efficacy of Zomig Nasal Spray in adolescents has not yet been established. Use of Zomig Nasal Spray in adolescents is therefore not recommended.

Elderly

The safety and efficacy of Zomig Nasal Spray in individuals aged over 65 years have not been systematically evaluated.

Hepatic Impairment

The effect of hepatic disease on the pharmacokinetics of zolmitriptan nasal spray has not been evaluated. However, for patients with moderate or severe hepatic impairment metabolism after oral dosing is reduced and a maximum dose of 5 mg oral zolmitriptan in 24 hours is recommended (see Section 5.2).

Renal Impairment

No dosage adjustment required (see Section 5.2).

Method of administration

For nasal inhalation.

Symptoms

There has been no experience of overdose with zolmitriptan nasal spray. Volunteers receiving single oral doses of 50 mg commonly experienced sedation.

Management

The elimination half-life of zolmitriptan following intranasal administration is 3 hours, (see Section 5.2) and therefore monitoring of patients after overdose with Zomig Nasal Spray 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.

Shelf life: 30 months.

Do not store above 25°C.

Ph Eur Type I glass vials which are closed with chlorobutyl rubber stoppers. The vials are assembled into a unit dose nasal spray device, comprising of a vial holder, an actuation device and a protection cover.

Packs containing 1, 2, or 6 single use devices.

Not all pack sizes may be marketed.

The protection cover must not be removed until immediately before use. For instructions for use see the patient information leaflet.

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