Naramig

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Naramig Tablets are indicated for the acute treatment of migraine attacks with or without aura.

Contraindications
Hypersensitivity to any component of the preparation.

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 uncontrolled hypertension is contraindicated.

As with other 5-HT1 receptor agonists the concomitant use of naratriptan and other 5HT1 agonists is contraindicated.

Naratriptan is contraindicated in patients with severely impaired renal or hepatic function.


Special warnings and precautions for use
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).

As with other 5-HT1 receptor agonists, naratriptan should not be given to patients in whom unrecognised cardiac disease is likely without a prior evaluation for underlying cardiovascular disease. Such patients include postmenopausal women, males over 40 and patients with risk factors for coronary artery disease.

If symptoms consistent with ischaemic heart disease occur appropriate evaluation should be carried out.

The concomitant administration of ergotamine and derivatives of ergotamine (including methysergide) with naratriptan is not recommended.

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.

Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John's Wort (Hypericum perforatum).


Interaction with other medicinal products and other forms of Interaction
There is no evidence of interactions with â-blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors, alcohol or food.

Co-administration of naratriptan with ergotamine, dihydroergotamine, or sumatriptan did not result in clinically significant effects on blood pressure, heart rate or ECG or affect naratriptan exposure.

Naratriptan does not inhibit monoamine oxidase enzymes; therefore interactions with monoamine oxidase inhibitors are not anticipated. In addition, the limited metabolism of naratriptan and the wide range of cytochrome P450 isoenzymes involved suggest that significant drug interactions with naratriptan are unlikely (see Pharmacokinetics).