BOOTS MIGRAINE RELIEF is a brand name for Sumatriptan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sumatriptan Tablets are indicated for the acute relief of migraine attacks, with or without aura. Sumatriptan 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.
Sumatriptan is indicated for the acute intermittent treatment of migraine. It 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 a migraine headache.
It is equally effective at whatever stage of the attack it is administered. Populations Adults (18-65 years of age) The recommended dose is a single 50 mg tablet that should be swallowed whole with water. Some patients may require 100 mg.
If there is no response to the first tablet, a second tablet 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 2 hours between the two doses. No more than 300 mg should be taken in any 24 hour period.
Paediatric population (under 18 years of age) 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 trials performed in this age group.
1). Elderly (over 65 years of age) Experience of the use of Sumatriptan Tablets in patients 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 in patients aged over 65 years is not recommended.
Summary of the safety profile 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) and 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.
Immune System Disorders Not known:
Hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylaxis.
Nervous System Disorders Common:
Tingling, dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.
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 (usually transient but includes reports of permanent defects). However, visual disorders may also occur during a migraine attack itself.
Cardiac Disorders Not known:
Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see Contra-indications, Special Warnings and special precautions for use).
Vascular Disorders Common:
Sumatriptan Tablets should only be used where a clear diagnosis of migraine has been made by a doctor or a pharmacist. For pharmacy supply, patients should have an established pattern of migraine (a history of five or more migraine attacks occurring over a period of at least 1 year).
Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions 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, Undesirable effects). Typically, such symptoms develop within 30 minutes of treatment and last for less than 2 hours. Where such symptoms are thought to indicate ischaemic heart disease, medical evaluation should be obtained immediately and no further doses of Sumatriptan Tablets should be taken until considered appropriate by a doctor and an appropriate evaluation should be carried out.
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. 3, Contra-indications). Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John’s wort (Hypericum perforatum).
1 or to sulphonamides. Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary vasospasm (Prinzmetal’s angina), cardiac arrhythmias, peripheral vascular disease or symptoms or signs consistent with ischaemic heart disease.
Sumatriptan should not be administered to patients with a history of cerebrovascular accident (CVA/stroke) or transient ischaemic attack (TIA/mini-stroke). Sumatriptan should not be administered to patients with severe hepatic or renal impairment.
The use of sumatriptan in patients with moderate and severe hypertension and mild uncontrolled hypertension is contraindicated. History of seizures or other risk factors which lower the seizure threshold. 5, Interactions). Monoamine oxidase inhibitors (MAOIs).
Sumatriptan Tablets must not be used within 2 weeks of discontinuation of therapy with MAOIs. Any 5- hydroxytryptamine1 (5-HT1) receptor agonist (triptan). Sumatriptan Tablets is not to be used to treat the following rare variants of migraine: Hemiplegic migraine - migraine with aura including unilateral motor weakness.
Basilar migraine - migraine with aura symptoms originating from the brain stem and/or both hemispheres such as double vision, difficulty in articulating words, clumsy and uncoordinated movements, tinnitus, reduced level of consciousness.
Ophthalmoplegic migraine – migraine headache with involvement of one or more ocular cranial nerves resulting in weakness of the muscles controlling eye movement.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Transient increases in blood pressure arising soon after treatment. Flushing.
Not known:
Hypotension, Raynaud’s phenomenon.
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.
Not known:
Ischaemic colitis, diarrhoea , dysphagia.
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.
Not known:
Neck stiffness, arthralgia.
Reproductive system and breast disorders Rare:
Breast pain Psychiatric disorders Not known: Anxiety.
Skin and subcutaneous tissue disorders Not known:
Hyperhidrosis.
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).
Not known:
Pain trauma activated, pain inflammation activated Investigations Very rare: Minor disturbances in liver function tests have occasionally been observed. 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.
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.
The recommended dose of Sumatriptan Tablets should not be exceeded. 3). Special consideration should be give 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 Tablets should not be taken concomitantly with other migraine therapies containing any triptan, ergotamine or derivative of ergotamine. If a migraineur fails to respond to the first tablet of Sumatriptan Tablets, the attack may be treated with simple analgesics.
Further, the diagnosis of migraine should be reconsidered with a doctor. Migraineurs whose typical headaches persist for longer than 24 hours should seek advice from their doctor. Migraineurs in whom the pattern of symptoms has changed, or whose attacks have become more frequent, more persistent, or more severe, or who do not recover completely between attacks, should seek advice from their doctor.
Anyone with atypical symptoms which include, but are not limited to, unilateral motor weakness, double vision, clumsy and unco-ordinated movements, tinnitus, reduced level of consciousness, seizure-like movements, or recent onset of rash with headache should seek advice from their doctor.
Patients whose migraine symptoms appear for the first time after age 50 should seek advice from their doctor as there may be a more serious underlying cause. Migraineurs who experience four or more migraine attacks per month should be referred to a doctor for ongoing management.
3, Contra-indications). Special consideration should be given to post-menopausal women and men over 40. Risk factors for heart disease include hypercholesterolaemia, regular smoking, marked obesity, diabetes or a family history of […]