ZOMIG RAPIMELT MIGRAINE CONTROL

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. Zolmitriptan is equally effective whenever the tablets are taken during a migraine attack; although it is advisable that Zomig Rapimelt Migraine Control 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 Migraine Control in a 24 hour period should not exceed 5 mg. If no relief is obtained after taking 5 mg then the patient should be referred to a doctor.

Zomig Rapimelt Migraine Control is not indicated for prophylaxis of migraine. Paediatric population (Children below the age of 12 years) The safety and efficacy of Zomig Rapimelt Migraine Control in children aged 0-12 years has not yet been established.

No data are available. Use of Zomig Rapimelt Migraine Control in children is therefore not recommended. Adolescents (12 - 17 years of age) The efficacy of Zomig Rapimelt Migraine Control tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years.

Use of Zomig Rapimelt Migraine Control in adolescents is therefore not recommended. Elderly The safety and efficacy of Zomig Rapimelt Migraine Control in individuals aged over 65 years have not been established. Zomig Rapimelt Migraine Control tablets should not be used in patients aged over 65 years of age.

2. 2). No dosage adjustment is required for patients with moderate hepatic impairment. 2). 2). Method of administration Zomig Rapimelt Migraine Control is for oral use only. Zomig Rapimelt Migraine Control 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 Migraine Control. Zomig Rapimelt Migraine Control 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 to < 1/10); Uncommon (≥1/1,000 to < 1/100); Rare (≥1/10,000 to < 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. Cardiac disorders Uncommon Tachycardia. 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.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Zomig Rapimelt Migraine Control should only be used where a clear diagnosis of migraine has been established. Pharmacy supply of Zomig Rapimelt Migraine Control is therefore not appropriate if the patients’ first migraine attack occurred within the last 12 months; pharmacy supply is restricted to patients with an established pattern of at least five migraine attacks.

Patients having 4 or more migraines a month should be referred to a doctor. Care should be taken to exclude other potentially serious neurological conditions. Patients should be referred to a doctor for further assessment if any of the following apply: their migraine symptoms do not disappear between attacks (migraine is episodic); they are over the age of 50 and experiencing migraine for the first time; their migraine headache lasts for longer than 24 hours; they have a change in their usual migraine symptoms, or their migraines increase in frequency.

3). Migraneurs 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. 3). In very rare cases, as with other 5HT1B/1D agonists, coronary vasospasm, angina pectoris and myocardial infarction have been reported.

Patients should be assessed for risk of undiagnosed cardiovascular disease prior to receiving Zomig Rapimelt Migraine Control. The following risk factors for cardiovascular disease should be taken into account: • Diabetes mellitus • Regular smoker (10 or more daily) • Family history of Ischaemic Heart Disease • Hypercholesterolaemia • Post-menopausal female • Male aged over 40 years • Body Mass Index > 30 kg/m2 Patients with three or more of the above risk factors should not receive Zomig Rapimelt Migraine Control until they have been further assessed by a doctor.

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. A new diagnosis of migraine or change in severity of symptoms may imply contraindication to the combined oral contraceptive pill, especially in the presence of one or more cardiovascular risk factors or migraine with aura.

Women taking a combined oral contraceptive should consult a doctor if the onset of migraine is recent or if their symptoms become more severe. 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 Rapimelt Migraine Control tablets. Patients with phenylketonuria should be informed that Zomig Rapimelt Migraine Control contains phenylalanine (a component of aspartame).

81 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.

Serotonin syndrome has been reported with combined use of triptans and serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Serotonin Syndrome is a potentially life-threatening condition and diagnosis is likely when (in presence of a serotonergic agent) one of the following is observed: • Spontaneous clonus • Inducible or ocular clonus with agitation or diaphoresis, • Tremor and hyperreflexia • Hypertonia and body temperature >38°C and inducible or ocular clonus.

5). Withdrawal of the serotonergic drugs usually brings about a rapid improvement. Treatment depends on the type and severity of the symptoms. 5). 0000032 mg of benzyl alcohol in each orodispersible tablet. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

1. • Known hypertension. • Ischaemic heart disease (including previous myocardial infarction or angina). • Severe hepatic or severe renal impairment. • Epilepsy or a history of seizures. • Atypical migraine (including hemiplegic or basilar migraine).

• Peripheral vascular disease. • Coronary vasospasm/Prinzmetal’s angina. • A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). • Cardiac arrhythmias (including Wolff-Parkinson-White syndrome). • Concomitant administration of Zomig Rapimelt Migraine Control tablets with ergotamine or ergotamine derivatives or other 5-HT1 receptor agonists.