Zomig 2.5mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Zolmitriptan

Disponible depuis:

Necessity Supplies Ltd

Code ATC:

N02CC03

DCI (Dénomination commune internationale):

Zolmitriptan

Dosage:

2.5mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04070401

Notice patient

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

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zomig Rapimelt Migraine Control 2.5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 2.5 mg of zolmitriptan.
Excipient with known effect
Each orodispersible table contains 5 mg of aspartame (E951).
For the full list of excipients, see section 6.1._ _
3
PHARMACEUTICAL FORM
Oro-dispersible tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zomig Rapimelt Migraine Control is indicated for the acute treatment
of
migraine with or without aura.
Zomig Rapimelt Migraine Control should only be used where there is a
clear
diagnosis of migraine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (18-65 years of age) _
The recommended dose of Zomig Rapimelt Migraine Control 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 is required, it should not be
taken within
2 hours of the initial dose.
Zolmitriptan is equally effective whenever the tablets are taken
during a
migraine attack; although it is advisable that Zomig Rapimelt Migraine
Control 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
Zomig Rapimelt Migraine Control in a 24 hour period should not exceed
5 mg.
If no relief is obtained after taking 5 mg then the patient should be
referred to
a doctor.
Zomig Rapimelt Migraine Control is not indicated for prophylaxis of
migraine.
_Paediatric population (_Children below the age of 12 years)
The safety and efficacy of Zomig Rapimelt Migraine Control in children
aged
0-12 years has not yet been established. No data are available. Use of
Zomig Rapimelt
Migraine Control in children is therefore not recommended.
Adolescents (12 - 17 years of age)
The efficacy of Zomig Rapimelt Migraine Control tablets was not
demonstrated in a
placebo controlled clinical trial for patients aged 12 to 17 years.
Use of