GRAMEGRAN

Posology Adults (18-65 years of age) Gramegran is indicated for the acute intermittent treatment of migraine. It should not be used prophylactically. The recommended dose of Gramegran should not be exceeded. It is advisable that Gramegran 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 oral Gramegran 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 Gramegran 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.

Gramegran 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 Gramegran 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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and 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 were 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:

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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Sumatriptan should only be used where there is a clear diagnosis of migraine has been made by a doctor or a pharmacist. 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.

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 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, the attack may be treated with simple analgesics. Further, the diagnosis of migraine should be reconsidered with a doctor. The recommended dose of Sumatriptan should not be exceeded.

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 uncoordinated 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.

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 should be taken until considered appropriate by a doctor.

3, Contraindications). Special consideration should be given to post- menopausal women and males over 40. Risk factors for heart disease include hypercholesterolaemia, regular smoking, marked obesity, diabetes or a family history of early heart disease (father/brother developed heart disease before the age of 55, mother/sister developed heart disease before the age of 65).

Anyone who has three or more of these risk factors is not suitable for pharmacy supply of sumatriptan. 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). Migraineurs should be warned to see their doctor if they develop symptoms of serotonin syndrome.

g. 2). A 50mg dose should be considered in patients with hepatic impairment. 8). Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John’s wort (Hypericum perforatum). 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 […]

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. - Gramegran must not be used within 2 weeks of discontinuations of therapy with MAOIs. 5).