NARAMIG

Naramig tablets should be taken as early as possible after the onset of a migraine headache but they are effective if taken at a later stage. Naramig Tablets are recommended as monotherapy for the acute treatment of a migraine attack.

Naramig Tablets should not be used prophylactically. 5mg tablet. 5mg 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 Naramig Tablets a second dose should not be taken for the same attack, as it is unlikely to be of benefit. However Naramig Tablets may be used for subsequent migraine attacks. 5mg was not demonstrated to be greater than placebo in a placebo-controlled study in adolescents (12 to 17 years).

Therefore, the use of Naramig Tablets in patients under 18 years of age is not 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 (see Pharmacokinetics).

Renal Impairment Naramig should be used with caution in patients with renal impairment. 5mg tablet. The use of Naramig is contraindicated in patients with severe renal impairment (creatinine clearance < 15mL/min) (See Contraindications and Pharmacokinetics).

Hepatic Impairment Naramig should be used with caution in patients with hepatic impairment. 5mg tablet. The use of Naramig is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) (See Contraindications and Pharmacokinetics).

Method of administration Naramig 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).

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. Dizziness and somnolence.

Eye disorders Uncommon:

Visual disturbance.

Cardiac disorders Uncommon:

Bradycardia, tachycardia, palpitations. 4).

Vascular disorders Very rare:

Peripheral vascular ischaemia.

Gastrointestinal Common:

Nausea and vomiting.

Rare:

Ischaemic colitis.

Skin and subcutaneous tissue disorders Rare:

Rash, Urticaria, Pruritis, facial oedema General disorders and administration site conditions: The following symptoms are usually of short duration, may be severe and may affect any part of the body including the chest or throat: Common: Sensations of heat, malaise/fatigue.

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). 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). 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.

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 MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

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.

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