inTervieW - Green Cross Publishing
inTervieW - Green Cross Publishing
inTervieW - Green Cross Publishing
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Date of preparation: April 2010<br />
Tevirl PO4/04/10<br />
•Effective at reducing headache recurrence 1<br />
PHARMACEUTICALS<br />
IRELAND<br />
Naramerg<br />
Naratriptan 2.5mg<br />
•Well tolerated with a lower incidence of adverse events<br />
than sumatriptan 2 and zolmitriptan 3<br />
For further information, please contact: Teva Pharmaceuticals Ireland, Unit 1, The Business Centre, Blackthorn Business Park, Coe’s Road, Dundalk, Co Louth Tel 042 939 5892 Fax 042 939 5898 www.teva.ie Freephone 1800 201700<br />
Abbreviated Prescribing Information<br />
Naramerg 2.5 mg Film-Coated Tablets<br />
Refer to Summary of Product Characteristics before prescribing.<br />
Presentation: Each tablet contains 2.5 mg naratriptan (as naratriptan hydrochloride). Indications: Acute treatment of<br />
the headache phase of migraine attacks with or without aura.<br />
Dosage and Administration: Naramerg should be taken as early as possible after the onset of a migraine headache,<br />
but is effective if taken at a later stage. Do not use prophylactically. Swallow whole with water. Adults (18-65 years of<br />
age): Single dose of 2.5 mg. A second dose as required, with minimum interval of 4 hours between doses. Do not<br />
exceed two 2.5 mg tablets in any 24 hour period. Children and adolescents 65 years: Not recommended. Renal impairment: Mild or moderate renal impairment - maximum total daily dose of<br />
2.5 mg. Severe renal impairment - Do not use. Hepatic impairment: Mild or moderate impairment - maximum total<br />
daily dose of single 2.5 mg tablet. Severe impairment - Do not use. Contraindications: Hypersensitivity to any of<br />
the ingredients, heart disease, myocardial infarction, vascular disease, cerebrovascular accident, transient ischaemic<br />
attack, hypertension, severely impaired renal/hepatic function, concomitant administration of ergotamine, derivatives of<br />
ergotamine (including methysergide) and any triptan/5-hydroxytryptamine 1 (5-HT 1 ) receptor agonist with naratriptan.<br />
Special Warnings and Precautions for Use: Only use where there is a clear diagnosis of migraine. Not indicated<br />
for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. Not be used in patients with risk factors<br />
for ischaemic heart disease. Following administration, naratriptan can be associated with transient symptoms including<br />
chest pain and tightness. There is a theoretical risk of a hypersensitivity reaction in patients with known hypersensitivity<br />
to sulphonamides. Should not be used with products containing St John’s Wort. There is a risk of medication-overuse<br />
headache with prolonged use. Contains Lactose. Drug Interactions: Theoretical possibility of increased risk of<br />
coronary vasospasm with co-administrations of ergotamine, ergotamine-containing preparations, dihydroergotamine,<br />
sumatriptan and 5-HT 1 receptor agonists, risk of serotonin syndrome following the use of selective serotonin reuptake<br />
inhibitors or serotonin noradrenaline reuptake inhibitors and triptans. Pregnancy and Lactation: Safety in pregnancy<br />
has not been established. Balance risks against benefits. Avoid breast-feeding for 24 hours after treatment. Effects on<br />
Ability to Drive and Operate Machines: Drowsiness and other symptoms of migraine may reduce ability to perform<br />
skilled tasks. Adverse Reactions: Some of the symptoms reported as adverse events may be part of the migraine<br />
attack. Common (≥1/100,