Zolmitriptan 2.5mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Zolmitriptan

Tillgänglig från:

Accord-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: 5012617019479 5012617019486

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOMIG

(ZOLMITRIPTAN) 2.5MG TABLETS / ZOLMITRIPTAN 2.5MG TABLETS
This medicine is available under the above names but will be referred
to as Zomig
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
throughout the
following leaflet.
•
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 only. 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 Zomig
2. What you need to know before you take Zomig
is and what it is used for
3. How to take Zomig
4. Possible side effects
5. How to store Zomig
6. Contents of the pack and other information
1. WHAT ZOMIG IS AND WHAT IT IS USED FOR
Zomig contains zolmitriptan and belongs to a group of medicines called
triptans.
Zomig is used to treat migraine headache.
•
Migraine symptoms may be caused by swollen blood vessels in the head.
Zomig 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.
•
Zomig works only when a migraine attack has started. It will not stop
you from getting an
attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOMIG
DO NOT TAKE ZOMIG:
•
If you are allergic to zolmitriptan or any of the other ingredients of
this medicine (listed in
Section 6).
•
If you have high blood pressure.
•
If you have ever had heart problems, including a heart attack, angina
(chest pain caused by
exercise
or
effort),
Prinzmetal’s
angina
(chest
pain
which
happens
at
rest)
or
have
experienced heart related symptoms such as shortness of breath or
pressur

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