NARATRIPTAN

Posology Naratriptan should be taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. Naratriptan tablets are recommended as monotherapy for the acute treatment of a migraine attack.

5 mg tablet. In case of recurrence of the symptoms of migraine 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 it is unlikely to be of benefit. However, Naratriptan may be used for subsequent migraine attacks. Adolescents (12 to 17 years of age) In a clinical trial in adolescents, a very high placebo response was observed.

The efficacy of Naratriptan has not been demonstrated in this population and hence its use cannot be recommended. Elderly (over 65 years of age) The safety and effectiveness of Naratriptan in patients over 65 years have not been evaluated and therefore, its use in this age group cannot be recommended.

2). Renal impairment Naratriptan should be used with caution in patients with renal impairment. 5mg tablet. 2). Hepatic impairment Naratriptan should be used with caution in patients with hepatic impairment. 5mg tablet The use of Naratriptan is contraindicated in patients with severe hepatic impairment.

2). Children (under 12 years) Naratriptan is not recommended for use in children under 12 years, since no data on the safety and efficacy are available. Method of administration Naratriptan 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 reported as adverse events 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 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).

System Organ Class Adverse drug reactions Frequency Immune system disorders Hypersensitivity reactions ranging from cutaneous hypersensitivity to rare cases of anaphylaxis Rare Nervous system disorders Tingling sensation (this is usually of short duration, may be severe and may affect any part of the body including the chest or throat), Dizziness and drowsiness, somnolence.

4). Very rare Vascular disorders Peripheral vascular ischaemia. Very rare Nausea, vomiting CommonGastrointestinal disorders Ischaemic colitis Rare Skin and subcutaneous tissue disorders Rash, urticaria, pruritus, facial oedema Rare Sensations of heat, malaise/fatigue CommonGeneral disorders and administration site conditions Pain, sensation of heaviness, pressure or tightness.

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

, 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 men over 40 years of age 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 group and therefore there is a theoretical risk of hypersensitivity reactions in patients with known hypersensitivity to sulphonamides. The recommended dose of naratriptan should not be exceeded.

5). If concomitant treatment with other serotonergic agents (SSRI/SNRIs) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases, or with addition of another serotonergic medication.

Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.

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 due to) regular use of medications for headache.

Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St. John's Wort (Hypericum perforatum). This medicinal product contains anhydrous lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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

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 ischaemic heart disease, or Prinzmetal’s angina/coronary vasospasm, peripheral vascular disease or patients who have symptoms or signs consistent with ischaemic 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 hypertension, and mild uncontrolled hypertension is contraindicated.

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