ZOLMITRIPTAN TEVA 2.5 Milligram Orodispersible Tablet

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

ZOLMITRIPTAN

Disponible desde:

Teva Pharma B.V.

Código ATC:

N02CC03

Designación común internacional (DCI):

ZOLMITRIPTAN

Dosis:

2.5 Milligram

formulario farmacéutico:

Orodispersible Tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Selective serotonin (5HT1) agonists

Estado de Autorización:

Authorised

Fecha de autorización:

2010-04-23

Información para el usuario

inside margins
5 mm  minimum
175 mm
285 mm
37 mm

inside margins
5 mm  minimum
175 mm
285 mm
37 mm
22 mm
40 mm
17,5 mm
33,825 mm
113 mm
361-33-871267400
REV 00
208
PRODUCT:
AMENDS:
APPROVAL:
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT 
Harlow
Signed
Signed
35720
ZOLMITRIPTAN TEVA 2.5 MG OD 
TABS ALL (TEVA CANADA) TEI V2
18-8-14
285x175mm
2
21-8-14
YS
YS
Leafl et
CUTTER GUIDE
PMS PROCESS BLACK
PMS GREEN
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Last amend:
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The only exceptions to this are: bleeds, 
chokes, spreads or other adjustments required for print reproduction
purposes only. If you have any diffi culties 
please contact the Teva Artwork Team. We must receive a copy of the
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approval can be made. 
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WHAT IS IN THIS LEAFLET: 
1.  WHAT ZOLMITRIPTAN TEVA IS AND WHAT 
IT IS USED FOR
2.  WHAT YOU NEED TO KNOW BEFORE YOU 
TAKE ZOLMITRIPTAN TEVA  
3. HOW TO TAKE ZOLMITRIPTAN TEVA  
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZOLMITRIPTAN TEVA  
6.  CONTENTS OF THE PACK AND OTHER 
INFORMATION
1
   WHAT ZOLMITRIPTAN TEVA IS 
AND WHAT IT IS USED FOR
Zolmitriptan belongs to a group of 
medicines called “selective serotonin 
(5HT1) agonists” and works in your 
brain to relieve the symptoms of 
migraine.
Zolmitriptan Teva is used for the 
treatment of migraine. You should not 
take Zolmitriptan Teva to prevent 
migraines occuring.
2
   WHAT YOU NEED TO 
KNOW BEFORE YOU TAKE 
ZOLMITRIPTAN TEVA
DO NOT TAKE ZOLMITRIPTAN TEVA  
•  If you are allergic to zolmitriptan or 
to any of the other ingredients of this 
medicine (listed in section 6).
•  If you suffer from high blood pressure 
which is diffi cult to treat or have 
poorly controlled blood pressure. 
Speak to your doctor if unsure
•  If you have had a heart attack, have 
hear

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zolmitriptan Teva 2.5 mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg orodispersible tablet contains 2.5 mg zolmitriptan
Excipients with known effect:
Each 2.5 mg orodispersible tablet contains 17.00 mg lactose monohydrate, 2.00 mg aspartame, 0.50 to 1.00 mg sucrose
and < 0.02 mg soya lecithin.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Orodispersible tablet.
Zolmitriptan Teva 2.5 mg orodispersible tablets are white to off-white, round flat-face bevel edged, engraved with ‘93’
on one side and ‘8147’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of migraine headache with or without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose of Zolmitriptan Teva to treat a migraine attack is 2.5 mg. It is advisable that Zolmitriptan Teva
is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage.
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 2.5 mg doses, for subsequent attacks 5 mg doses of Zolmitriptan
Teva could be considered. Caution is advised due to an increased incidence of side effects. A controlled clinical study
failed to demonstrate superiority of the 5mg dose over the 2.5 mg dose.
Nevertheless a 5 mg dose may be of benefit in some patients.
The total daily intake shoul