ZOMIG RAPIMELT

5 mg. If symptoms persist or return within 24 hours, a second dose of zolmitriptan has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose. 5 mg doses, subsequent attacks can be treated with 5 mg doses of Zomig Rapimelt.

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

Zomig Rapimelt is not indicated for prophylaxis of migraine. Paediatric population (Children below the age of 12 years) The safety and efficacy of Zomig Rapimelt in children aged 0-12 years has not yet been established. No data are available.

Use of Zomig Rapimelt in children is therefore not recommended. Adolescents (12 - 17 years of age) The efficacy of Zomig Rapimelt was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of Zomig Rapimelt in adolescents is therefore not recommended.

Elderly The safety and efficacy of Zomig Rapimelt in individuals aged over 65 years have not been established. 2). Therefore for patients with moderate or severe hepatic impairment a maximum dose of 5 mg in 24 hours is recommended. 2).

Method of administration To be taken by oral administration. Zomig Rapimelt rapidly dissolves when placed on the tongue and is swallowed with the patient’s saliva. A drink of water is not required when taking Zomig Rapimelt. Zomig Rapimelt 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.

Summary of the safety profile Zomig is well tolerated. Adverse reactions are typically mild/moderate, transient, not serious and resolve spontaneously without additional treatment. Possible adverse reactions tend to occur within 4 hours of dosing and are no more frequent following repeated dosing.

Tabulated list of adverse reactions Adverse reactions are classified according to frequency and system organ class.

Frequency categories are defined according to the following convention:

Very common (≥1/10); Common (≥1/100 < 1/10); Uncommon (≥1/1,000 < 1/100); Rare (≥1/10,000 < 1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). The following undesirable effects have been reported following administration with zolmitriptan: System Organ Class Frequency Undesirable Effect Immune system disorders Rare Anaphylaxis/Anaphylactoid Reactions; Hypersensitivity reactions.

Nervous system disorder Common Abnormalities or disturbances of sensation; Dizziness; Headache; Hyperaesthesia; Paraesthesia; Somnolence; Warm sensation. Common Palpitations. Uncommon Tachycardia. Cardiac disorders Very rare Angina pectoris; Coronary vasospasm; Myocardial infarction.

Vascular disorders Uncommon Transient increases in systemic blood pressure. Gastrointestinal disorders Common Abdominal pain; Dry mouth; Nausea; Vomiting Dysphagia. Very rare Bloody diarrhoea; Gastrointestinal infarction or necrosis; Gastrointestinal ischaemic events; Ischaemic colitis; Splenic infarction.

Skin and subcutaneous tissue disorders Rare Angioedema; Urticaria. Musculoskeletal and connective tissue disorders Common Muscle weakness; Myalgia. Uncommon Polyuria; Increased urinary frequency. Renal and urinary disorders Very rare Urinary urgency.

General disorders and administration site conditions Common Asthenia; Heaviness, tightness, pain or pressure in throat, neck, limbs or chest. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Zomig Rapimelt should only be used where a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions. There are no data on the use of Zomig Rapimelt in hemiplegic or basilar migraine.

Migraineurs may be at risk of certain cerebrovascular events. Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists. Zomig Rapimelt should not be given to patients with symptomatic Wolff- Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathways.

In very rare cases, as with other 5HT1B/1D agonists, coronary vasospasm, angina pectoris and myocardial infarction have been reported. 3). These evaluations, however, may not identify every patient who has cardiac disease, and in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.

8) have been reported after the administration of zolmitriptan. If chest pain or symptoms consistent with ischaemic heart disease occur, no further doses of zolmitriptan should be taken until after appropriate medical evaluation has been carried out.

As with other 5HT1B/1D agonists transient increases in systemic blood pressure have been reported in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events.

As with other 5HT1B/1D agonists, there have been rare reports of anaphylaxis/anaphylactoid reactions in patients receiving Zomig. Patients with phenylketonuria should be informed that Zomig Rapimelt contains phenylalanine (a component of aspartame).

62 mg of phenylalanine. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued.

1. • 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 with ergotamine or ergotamine derivatives or other 5-HT1 receptor agonists.