SUMIBRIL

Posology Adults (18-65 years of age) This medicine is indicated for the acute intermittent treatment of migraine. It should not be used prophylactically. The recommended dose of this medicine should not be exceeded. It is advisable that this medicine be taken as early as possible after the onset of a migraine attack but it is equally effective at whatever stage of the attack it is administered.

The recommended dose of this oral medicine is a 50mg tablet. Some patients may require 100mg. If the patient has responded to the first dose but the symptoms recur, a second dose may be taken provided that there is a minimum interval of 2 hours between the two doses.

Not more than two 50 mg tablets (total dose 100mg) may be taken in any 24 hour period or to treat the same attack. Patients who do not respond to the prescribed dose of this medicine should not take a second dose for the same attack.

In these cases the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. This medicine may be taken for subsequent attacks. 3). Paediatric population The efficacy and safety of sumatriptan (film-coated) tablets/dispersible tablets in children aged less than 10 years have not been established.

No clinical data are available in this age group. The efficacy and safety of sumatriptan (film-coated) tablets/dispersible tablets in children 10 to 17 years of age have not been demonstrated in the clinical trials performed in this age group.

1). Elderly (over 65 years of age) Not to be used in those over 65 years of age. Experience of the use of sumatriptan in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population but until further clinical data are available, the use of this medicine in patients aged over 65 years is not recommended.

Method of administration Oral. The tablets should be swallowed whole with water.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Some of the symptoms reported as undesirable effects may be associated symptoms of migraine. Clinical Trial Data System Organ Class Common ≥ 1/100 to < 1/10 Rare ≥1/10,000 to <1/1000 Very rare (<1/10,000) Not Known* (cannot be estimated from the available data) Nervous system disorders Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia Vascular Transient disorders increases in blood pressure arising soon after treatment.

Flushing. Respiratory, thoracic and mediastinal disorder Dyspnoea Gastro- intestinal disorders Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition. Musculo- skeletal and connective tissue disorders Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat).

Myalgia Reproductive system and breast disorders Breast pain General disorders and administratio n site conditions Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and may be intense and can affect any part of the body including the chest and throat).

Feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and transient) Investigations Minor disturbances in liver function tests have occasionally been observed. Post-Marketing Data System Organ Class Common ≥ 1/100 to < 1/10 Rare ≥1/10,000 to <1/1000 Very rare (<1/10,000) Not Known* (cannot be estimated from the available data) Immune System Disorders Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis.

4 Special Warnings and Special Precautions for Use This medicine should only be used where there is a clear diagnosis of migraine. Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine.

g. CVA, TIA) if the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for sumatriptan use. 8). Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given and appropriate evaluation should be carried out.

3). Special consideration should be given to postmenopausal women and males over 40 with these risk factors. 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.

3). There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan.

Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs). 5). g. 2). A 50mg dose should be considered in patients with hepatic impairment. 8). Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan.

Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross-sensitivity is limited, however, caution should be exercised before using sumatriptan in these patients. Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John’s Wort (Hypericum perforatum).

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. The diagnosis of Medication Overuse Headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

1 • Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or patients who have symptoms or signs consistent with ischaemic heart disease.

• Sumatriptan should not be administered to patients with a history of cerebrovascular accident (stroke) or transient ischaemic attack (TIA). • Sumatriptan should not be administered to patients with severe hepatic impairment • The use of sumatriptan in patients with moderate and severe hypertension and mild uncontrolled hypertension is contraindicated • Concurrent administration of monoamine oxidase inhibitors and sumatriptan is contraindicated.

• Sumibril/Migraitan must not be used within 2 weeks of discontinuation of therapy with MAOIs. 5).