ZOMIG RAPIMELT TABLET 2.5 MG [SIN11816P]

Product Info

ZOMIG RAPIMELT TABLET 2.5 MG

[SIN11816P]

4.1 Therapeutic indications
Zomig Rapimelt is indicated for the acute treatment of migraine with or without aura.

4.2 Posology and method of administration
The recommended dose of Zomig Rapimelt to treat a migraine attack is 2.5 mg.

The Zomig Rapimelt orodispersible tablet rapidly dissolves when placed on the tongue and is swallowed with the patient’s saliva. A drink of water is not required when taking the Zomig Rapimelt orodispersible tablet. Zomig Rapimelt orodispersible tablets can be taken when water is not available thus allowing early administration of treatment for a migraine attack. This formulation may also be beneficial for patients who suffer from nausea and are unable to drink during a migraine attack, or for patients who do not like swallowing conventional tablets.

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.

If a patient does not achieve satisfactory relief with 2.5 mg doses, subsequent attacks can be treated with 5 mg doses of Zomig Rapimelt.

Significant efficacy is apparent within 1 hour of dosing.

Zomig Rapimelt is equally effective whenever taken during a migraine attack; although it is advisable that Zomig Rapimelt tablets are 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 Rapimelt, in a 24 hour period, should not exceed 10 mg.

Zomig Rapimelt is not indicated for prophylaxis of migraine.

Use in Patient Subgroups
Zomig Rapimelt is consistently effective in migraine, with or without aura, and in menstrually associated migraine. The efficacy of Zomig Rapimelt is also unaffected by gender, duration of the attack, pre-treatment nausea and concomitant use of common prophylactic migraine drugs.

Use in Children (under 12 years of age)
Safety and efficacy of zolmitriptan tablets in paediatric patients have not been evaluated. Use of Zomig Rapimelt 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. The profile and frequency of adverse events are consistent with Zomig Rapimelt Tablet use in adults. Use of Zomig Rapimelt tablets in adolescents is therefore not recommended.

Use in Patients Aged Over 65 years
Safety and efficacy of ‘Zomig Rapimelt’ in individuals aged over 65 years have not been systematically evaluated.

Patients with Hepatic Impairment
Metabolism is reduced in patients with hepatic impairment (See Pharmacokinetic Properties section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore for patients with moderate or severe hepatic impairment a maximum dose of 5 mg in 24 hours is recommended.

Patients with Renal Impairment
No dosage adjustment required (see Pharmacokinetic Properties section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
Zomig Rapimelt is contraindicated in patients with:

• Known hypersensitivity to any component of the product.

• Uncontrolled hypertension.

• Ischaemic heart disease.

• Coronary vasospasm/Prinzmetal’s angina.

• A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

• Concomitant administration of Zomig Rapimelt with ergotamine or ergotamine derivatives or other 5-HT1 receptor agonists.