Zomig 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zolmitriptan

Available from:

DE Pharmaceuticals

ATC code:

N02CC03

INN (International Name):

Zolmitriptan

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401

Patient Information leaflet

ZOMIG
® 2.5 MG TABLETS
(zolmitriptan)
PATIENT INFORMATION LEAFLET
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 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.
Your medicine is available using the above name but will be referred
to as
Zomig throughout this leaflet.
WHAT IS IN THIS LEAFLET
1. What Zomig is and what it is used for
2. What you need to know before you take Zomig
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 2.5 mg tablets contain 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 pressure over the chest.
- If you have had a stroke or short-last

Summary of Product characteristics

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