TEVA SUMATRIPTAN

Sumatriptan should not be used prophylactically. 3). Sumatriptan should be taken as early as possible after the onset of a migraine headache. Sumatriptan is equally effective at whatever stage of attack it is administered. The following recommended dosages should not be exceeded.

Adults The recommended dose for adults is a single dose of 50 mg. Some patients may require 100 mg. If the 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 film-coated 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 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. The tablets should be swallowed whole with water. Paediatric population The efficacy and safety of sumatriptan film-coated 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 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 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 in patients aged over 65 years is not recommended. Hepatic insufficiency Patients with mild to moderate liver insufficiency: low doses of 25-50 mg should be considered for patients with mild to moderate liver impairment.

4.

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) and very rare (<1/10,000 including isolated reports), not known (cannot be estimated from the available data)..

Immune system disorders Not known:

Hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylaxis.

Psychiatric disorders Not known:

Anxiety Nervous system disorders Common: 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, serotonin syndrome.

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 Common:

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:

Sumatriptan should only be used when there is a clear diagnosis of migraine. In case of doubt, patients should be referred to a neurologist. Before treatment with sumatriptan, it is important to rule out that the patient has a severe neurological condition (eg CVA, TIA) in case of atypical symptoms or that the patient has a diagnosis where the use of sumatriptan is not indicated.

g. CVA, TIA). Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. ). Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given and an appropriate evaluation should be carried out.

). Special consideration should be given to post-menopausal women and to men over the age of 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.

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 re-uptake inhibitors (SSRI) and sumatriptan.

Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs). 5). 2). 2 under Special patient populations). 8). Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan.

Reactions may range cutaneous hypersensitivity to anaphylaxis. Evidence of cross sensitivity is limited, however, caution should be exercised before using sumatriptan in these patients. If ergotamine is used, Sumatriptan should not be taken earlier than 24 hours after taking ergotamine.

1. Sumatriptan should not be given to patients who have had myocardial infarction or who have ischaemic heart disease, Prinzmetal’s variant angina/spasms of the coronary artery or 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 cerebovascular accident (CVA) or transient ischaemic attack (TIA). The use of sumatriptan in patients with moderate or severe hypertension or mild uncontrolled hypertension is contraindicated.

Sumatriptan should not be administered to patients with severe hepatic impairment. 5). Concurrent administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated. Sumatriptan must not be used within two weeks of discontinuation of therapy with monoamine oxidase inhibitors.