NARATRIPTAN

Naratriptan should be taken as early as possible after the onset of a migraine headache but they are effective if taken at a later stage Naratriptan is recommended as monotherapy for the acute treatment of a migraine attack. Naratriptan should not be used prophylactically.

5 mg tablet. 5 mg tablets in any 24-hour period. 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. If a patient does not respond to a first dose of Naratriptan a second dose should not be taken for the same attack, as it is unlikely to be of benefit.

However, Naratriptan may be used for subsequent migraine attacks. Adolescents (12-17 years of age) In a clinical trial carried out in adolescents, a very significant response to the placebo 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) There are no data available on the use of naratriptan in children under 12 years of age therefore its use in this age group is not recommended. 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.

There is a moderate decrease in clearance with age. 2). Renal Impairment Naratriptan should be used with caution in patients with renal impairment. 5 mg tablet. The use of Naratriptan is contraindicated in patients with severe renal impairment (creatinine clearance < 15mL/min).

2). Hepatic Impairment Naratriptan should be used with caution in patients with hepatic impairment. 5 mg tablet. The use of Naratriptan is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C). 2). Method of administration Naratriptan tablets should be swallowed whole with water.

At therapeutic doses of naratriptan the incidence of side effects reported in clinical trials was similar to placebo. Some of the symptoms may be part of the migraine attack. Undesirable effects are ranked under headings of frequency using the following convention: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000).

MedDRA Classification Frequency Immune system disorders Rare Hypersensitivity reactions ranging from cutaneous hypersensitivity to rare cases of anaphylaxis. Nervous system disorders Common Tingling. This is usually of short duration, may be severe and may affect any part of the body including the chest or throat.

4) Vascular disorders Very rare Peripheral vascular ischaemia Common Nausea and vomitingGastrointestinal Rare Ischaemic colitis Skin and subcutaneous tissue Rare Rash, Urticaria, Pruritis, facial oedema MedDRA Classification Frequency disorders Common Sensations of heat.

Malaise/fatigueGeneral disorders and administration site conditions* Uncommon Pain, sensations of heaviness, pressure or tightness Investigations Uncommon Increase in blood pressure of approximately 5mmHg (systolic) and 3 mmHg (diastolic) in a period of up to 12 hours after administration.

* These symptoms are usually temporary, can be severe, and can affect any part of the body, including the chest and throat 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.

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.

It should be noted that migraineurs may be at risk of certain cerebrovascular events (eg. 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)/serotonin noradrenaline reuptake inhibitors (SNRIs).

5). Undesirable effects 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.

1. As with other 5-hydroxytryptamine1 (5-HT1) receptor agonists naratriptan should not be used in patients who have had a myocardial infarction or have ischemic heart disease, or coronary vasospasm/Prinzmetal's angina, peripheral vascular disease or patients with symptoms of ischemic heart disease or signs compatible with ischemic heart disease.

Naratriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). The use of naratriptan in patients with moderate or severe arterial hypertension, and mild uncontrolled hypertension is contraindicated.

Naratriptan is contraindicated in patients with severely impaired renal (creatinine clearance < 15 ml/min), severely impaired hepatic function (Child-Pugh grade C). 5).