MigraKind (Sumatriptan 50mg) MigraKind (Sumatriptan 50mg)

MigraKind 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.
• Before treating with sumatriptan, care should be taken to exclude potentially serious neurological conditions (e.g. CVA, TIA) if the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for sumatriptan use.
• Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat. 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.
• Sumatriptan should not be given to patients with risk factors for ischaemic heart disease, including those patients who are heavy smokers or users of nicotine substitution therapies, without prior cardiovascular evaluation.
• 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.
• Sumatriptan should be administered with caution to patients with mild controlled hypertension, since transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients.
• 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).
• If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised. Sumatriptan should be administered with caution to patients with conditions which may affect significantly the absorption, metabolism or excretion of drugs, e.g. impaired hepatic (Child Pugh grade A or B or renal function. A 50mg dose should be considered in patients with hepatic impairment.
• Sumatriptan should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold, as seizures have been reported in association with sumatriptan.
• 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Nervous System Disorders: Common: Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.

Vascular Disorders: Common: Transient increases in blood pressure arising soon after treatment. Flushing.

Respiratory, Thoracic and Mediastinal Disorders: Common: Dyspnoea.

Gastrointestinal Disorders: Common: Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition.

Musculoskeletal and Connective Tissue Disorders Common: Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat). Myalgia.

General Disorders and Administration Site Conditions: Common: 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).

Adults (18-65 years of age).

1. MigraKind is indicated for the acute intermittent treatment of migraine. It should not be used prophylactically. The recommended dose of MigraKind should not be exceeded.
2. It is advisable that MigraKind 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.
3. The recommended dose of oral MigraKind is a 50mg tablet. Some patients may require 100mg.
4. 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.
5. The tablets should be swallowed whole with water.

Patients who do not respond to the prescribed dose of MigraKind 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. MigraKind may be taken for subsequent attacks.

Each film coated tablet contains 50 mg sumatriptan (as the succinate).

Excipient with known effect: each tablet contains 180.02 mg of lactose, as the anhydrous and monohydrate forms.

Tablet core: Lactose monohydrate, Croscarmellose sodium, Microcrystalline cellulose, Lactose, Magnesium stearate.

Film coating: Lactose monohydrate, Mannitol (E421), Titanium dioxide (E171), Triacetin, Talc.