Zolmitriptan 2.5mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Zolmitriptan

Tillgänglig från:

Torrent Pharma (UK) Ltd

ATC-kod:

N02CC03

INN (International namn):

Zolmitriptan

Dos:

2.5mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04070401; GTIN: 5060623371920

Bipacksedel

COLOUR BLACK
Reviewed By
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
LOCATION :
SUPERSEDES A/W NO.:
-
COUNTRY : UK
QUALITY
Approved By
REMARK :
SIZE
: 175 X 380 MM_FRONT/BACK SIDE
CODE : 8068214-7803
FONT TYPE: HELVETICA CONDENSED_FONT SIZE: 9PT
8068214-7803
DATE : 05-06-2020
SUBSTRATE :
THIS COLOUR PROOF IS NOT COLOUR BINDING. FOLLOW PANTONE SHADE
REFERENCE FOR ACTUAL COLOUR MATCHING.
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLMITRIPTAN 2.5 MG AND 5 MG ORODISPERSIBLE TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their signs of illness
are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zolmitriptan tablets are and what they are used for
2.
Before you take Zolmitriptan tablets
3.
How to take Zolmitriptan tablets
4.
Possible side effects
5.
How to store Zolmitriptan tablets
6.
Further information 1. WHAT ZOLMITRIPTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Zolmitriptan orodispersible tablets contain zolmitriptan and belong to
a group of medicines called triptans.
Zolmitriptan is used to treat migraine headache.
•
Migraine symptoms may be caused by the widening of blood vessels in
the head. Zolmitriptan is thought to reduce
the widening of these blood vessels. This helps to take away the
headache and other symptoms of a migraine attack,
such as feeling or being sick (nausea or vomiting) and being sensitive
to light and sound.
•
Zolmitriptan works only when a migraine attack has started. It will
not stop you from getting an attack. 2. BEFORE YOU TAKE ZOLMITRIPTAN TABLETS
DO NOT TAKE ZOLMITRIPTAN
-
if you are allergic (hypersensitive) to

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zolmitriptan 2.5 mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg orodispersible tablet contains 2.5 mg zolmitriptan.
Excipient(s) with known effect: aspartame (4 mg).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
White, round flat tablets with the diameter 7.5 mm.
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 to treat a migraine attack is 2.5
mg.
If symptoms persist or return within 24 hours, a second dose of
zolmitriptan
has been shown to be effective. If a second dose if required, it
should not be
taken within 2 hours of the initial dose.
If a patient does not achieve satisfactory relief with 2.5mg doses,
subsequent
attacks can be treated with 5mg doses of zolmitriptan.
Zolmitriptan is equally effective whenever the tablets are taken
during a
migraine attack; although it is advisable that zolmitriptan is taken
as early as
possible after the onset of migraine headache.
In the event of recurrent attacks, it is recommended that the total
intake of
zolmitriptan in a 24-hour period should not exceed 10 mg.
Zolmitriptan is not indicated for prophylaxis of migraine._ _
_ _
_Paediatric population (_Children below the age of 12 years)
The safety and efficacy of zolmitriptan in children aged 0-12 years
has not
yet been established. No data are available. Use of zolmitriptan in
children is
therefore not recommended.
Adolescents (12 - 17 years of age)
The efficacy of zolmitriptan was not demonstrated in a placebo
controlled
clinical trial for patients aged 12 to 17 years. Use of zolmitriptan
in
adolescents is therefore not recommended.
_Elderly _
The safety and efficacy of zolmitriptan in individuals aged over 65
years
have not been established. Use of zolmitriptan in the elderly is
therefore not
recommended.
_Hepatic impairmen