ZOMIG 2.5 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-05-2024
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Active ingredient:
ZOLMITRIPTAN
Available from:
Clear Pharmacy
ATC code:
N02CC03
INN (International Name):
ZOLMITRIPTAN
Dosage:
2.5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Selective serotonin (5HT1) agonists
Authorization status:
Authorised
Authorization date:
2010-12-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zomig 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Zolmitriptan 2.5 mg
Excipients: lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
_Product imported from UK:_
Yellow in colour embossed with the letter Z on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of migraine headache with or without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of ‘Zomig’ to treat a migraine attack is 2.5 mg. It is advisable that ‘Zomig’ tablets are taken as
early as possible after the onset of migraine headache but they are also effective if taken at a later stage.
The tablets should be swallowed whole and with water.
If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken. If a
second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not respond to the first
dose, it is unlikely that a second dose will be of benefit in the same attack.
If a patient does not achieve satisfactory relief with 2.5mg doses, for subsequent attacks 5 mg doses of ‘Zomig’ could
be considered.
The total daily intake should not exceed 10 mg. Not more than 2 doses of ‘Zomig’ should be taken in any 24 hour
period.
‘Zomig’ is not indicated for prophylaxis of migraine.
USE IN CHILDREN (UNDER 12 YEARS OF AGE)
Safety and efficacy of zolmitriptan tablets in paedriatic patients have not been evaluated. Use of Zomig in children is
therefore not recommended.
ADOLESCENTS (12 - 17 YEARS OF AGE)
The efficacy of Zomig tablets was not demonstrated in a placebo controlled clinical trial for
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