SUMATRIPTAN is a brand name for Sumatriptan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sumatriptan 50 mg Tablets are indicated for the acute relief of migraine attacks, with or without aura. Sumatriptan 50 mg Tablets should only be used where there is a clear diagnosis of migraine.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Sumatriptan 50 mg Tablets are indicated for the acute intermittent treatment of migraine. Sumatriptan should not be used prophylactically. The recommended dose of sumatriptan should not be exceeded. 3). It is advisable that sumatriptan be given as early as possible after the onset of migraine attack but it is equally effective at whatever stage of the attack it is administered.
Adults The recommended dose of oral sumatriptan is a single 50 mg tablet. Some patients may require 100 mg. If a patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. In these cases, the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs.
Sumatriptan tablets may be taken for subsequent attacks. If the patient has responded to the first dose but the symptoms recur a second dose may be given in the next 24 hours provided that there is a minimum interval of two hours between the two doses and no more than 300mg is taken in any 24 hour period.
Paediatric population The efficacy and safety of sumatriptan 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 tablets in children 10 to 17 years of age have not been demonstrated in the clinical studies performed in this age group.
1).
Elderly (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 Sumatriptan 50 mg Tablets in patients aged over 65 years is not recommended.
Method of administration For oral use. 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, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <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 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).
Investigations Very rare:
Sumatriptan tablets 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. The recommended doses of sumatriptan should not be exceeded.
g. CVA, TIA). If the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for sumatriptan use. g. cerebrovascular accident, transient ischaemic attack). 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). If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
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).
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 (CVA) 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.
The concomitant administration of ergotamine or derivatives of ergotamine (including methysergide) or any triptan/5-hydroxytryptamine1 (5-HT1) receptor agonist is contraindicated. 5) Concurrent administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated.
Sumatriptan tablets must not be used within two weeks of discontinuation of therapy with monoamine oxidase inhibitors.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Minor disturbances in liver function tests have occasionally been observed.
Post-Marketing Data Immune System Disorders Not known:
Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis.
Nervous System Disorders Not known:
Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures there are also reports in patients where no such predisposing factors are apparent. Tremor, dystonia, nystagmus, scotoma.
Eye Disorders Not known:
Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual disorders may also occur during a migraine attack itself. 4).
Vascular Disorders Not known:
Hypotension, Raynaud’s phenomenon.
Gastrointestinal Disorders Not known:
Ischaemic colitis, diarrhoea, dysphagia.
Musculoskeletal, Connective Tissue and Bone Disorders Not known:
Neck stiffness. Arthralgia.
Reproductive system and breast disorders Rare:
Breast pain.
General Disorders and Administration Site Conditions Not known:
Pain trauma activated, pain inflammation activated.
Psychiatric disorders Not known:
Anxiety.
Skin and subcutaneous tissue disorders Not known:
Hyperhidrosis. 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.
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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.
Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine as it contains lactose. Sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free '.