NARATRIPTAN

5mg Film-coated Tablets should not be used prophylactically. 5mg Film-coated Tablets are recommended as monotherapy for the acute treatment of a migraine attack. 5mg. 5mg tablets in any 24 hour period. 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 Film-coated Tablets, a second dose should not be taken for the same attack, as it is unlikely to be of benefit. 5mg Film-coated Tablets may be used for subsequent migraine attacks. Special populations Elderly patients (over 65 years) 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). Patients with renal impairment Naratriptan should be used with caution in patients with renal impairment. 5mg tablet. 2). 5mg tablet. 2). Paediatric population Adolescents (12 to 17 years) 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. 5mg Film-coated Tablets is not recommended for use in children under 12 years, since no data on the safety and efficacy are available.

Method of administration Oral use. 5mg Film-coated Tablets should be taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. 5mg Film-coated 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 reported as adverse events may be part of the migraine attack.

The frequency data on adverse reactions are based on 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) 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, somnolence /drowsiness Common Eye disorders Visual disturbances Uncommon Bradycardia, tachycardia, palpitations UncommonCardiac disorders Coronary artery vasospasm, transient ischaemic ECG changes, angina pectoris, myocardial infarction 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 edema Rare Musculoskeletal, connective tissue and bone disorders Heaviness (usually transient, may be intense and can affect any part of the body, including chest and throat) Uncommon Sensations of heat, malaise/fatigue CommonGeneral disorders and administration site conditions Pain, sensation of 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 5mmHg (systolic) and 3mmHg Uncommon System Organ Class Adverse drug reactions Frequency (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.

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. 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 before the onset of headache phase 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 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 sulfonamide group and therefore there is a theoretical risk of hypersensitivity reactions in patients with known hypersensitivity to sulfonamides. 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- norepinephrine reuptake inhibitors (SNRIs).

5). 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 should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of medications for headache.

This medicinal product contains 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 (23mg) per tablet, this is to say essentially ‘sodium free’.

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

Moderate to severe hypertension, mild uncontrolled hypertension. Severely impaired renal (creatinine clearance <15ml / min) or hepatic (Child-Pugh grade C) function. 5).