NARATRIPTAN

Naratriptan should be taken as early as possible after the onset of a migraine headache but it is effective if taken at a later stage. Naratriptan should not be used prophylactically. 5mg tablet. If symptoms of migraine should recur, following an initial response, a second dose may be taken provided that there is a minimum interval of four hours between the two doses.

5mg tablets in any 24-hour period. If a patient does not respond to the first dose of naratriptan, a second dose should not be taken for the same attack as no benefit has been shown. Naratriptan may be used for subsequent migraine attacks.

Special populations Paediatric Population Adolescents (12-17 years of age) In a clinical trial in adolescents, a very high placebo response was observed. The efficacy of naratriptan in this population has not been demonstrated and its use cannot be recommended.

Children (under 12 years of age) Naratriptan is not recommended for use in children below 12 years due to a lack of data on safety and efficacy. Elderly (over 65 years of age) The safety and effectiveness of naratriptan in individuals over age 65 have not been evaluated and therefore, its use in this age group cannot be recommended.

5mg tablet. 2). 5 mg tablet. 2). Method of administration The tablets should be swallowed whole with water.

Some of the symptoms reported as adverse events may be part of the migraine attack. Adverse events/reactions are ranked under headings of frequency using the following convention: 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).

Immune system disorders Rare:

Anaphylaxis Nervous system disorders Common: Sensations of tingling, dizziness, drowsiness Eye disorders Uncommon: Visual disturbance Cardiac disorders Uncommon: Bradycardia, tachycardia, palpitations Very rare: Coronary artery vasospasm, angina, myocardial infarction Vascular disordersery rare: Peripheral vascular ischaemia Gastrointestinal disorders Common: Nausea, vomiting Rare: Ischaemic colitis Skin and subcutaneous tissue disorders Rare: Rash, urticaria, pruritis, facial oedema Musculoskeletal and connective tissue disorders Uncommon: Sensations of heaviness (usually transient, may be intense and can affect any part of the body, including the chest and throat) General disorders and administration site disorders Common: Sensations of heat, malaise/fatigue Uncommon: Pain, sensations of pressure or tightness.

These symptoms are usually transient, may be intense and can affect any part of the body, including the chest and throat Investigations Uncommon: Increase in blood pressure of approximately 5 mmHg (systolic) and 3 mmHg (diastolic) in a period of up to 12 hours after administration.

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

Naratriptan should only be used where there is a clear diagnosis of migraine. Naratriptan 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.

g. CVA or TIA). The safety and efficacy of naratriptan when administered during the aura phase, prior to the onset of migraine headache, has yet to be established. 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 when 5-HT1 agonists have been administered.

8). 8). Naratriptan contains a sulphonamide component therefore there is a theoretical risk of a hypersensitivity reaction in patients with known hypersensitivity to sulphonamides. The recommended dose of naratriptan should not be exceeded.

Serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) has been reported following concomitant treatment with triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs).

5). Adverse events 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 products. Excipients Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. Previous myocardial infarction, ischaemic heart disease, Prinzmetal’s angina/coronary vasospasm, peripheral vascular disease, patients who have symptoms or signs consistent with ischaemic heart disease. History of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

Moderate or severe hypertension, mild uncontrolled hypertension. Severely impaired renal (creatinine clearance < 15 ml/min) or hepatic function (Child-Pugh grade C). Concomitant administration of ergotamine, derivatives of ergotamine (including methysergide) and any triptan/5-hydroxytryptamine 1 (5-HT1) receptor agonist with naratriptan.