Zolmitriptan 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zolmitriptan

Available from:

Sandoz Ltd

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

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zolmitriptan 2.5mg Orodispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5mg orodispersible tablet contains 2.5mg zolmitriptan.
Excipient with know effect:
Each 2.5mg orodispersible tablet contains 4mg aspartame.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
Zolmitriptan 2.5mg Orodispersible Tablets are white and 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
For doses not realisable/practicable with this strength other
strengths of this medicinal
product are available.
The recommended dose of zolmitriptan to treat a migraine attack is
2.5mg. It is
advisable that zolmitriptan 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 2.5mg doses,
for subsequent
attacks 5mg doses of zolmitriptan could be considered.
The total daily intake should not exceed 10mg. Not more than 2 doses
of zolmitriptan
should be taken in any 24-hour period.
Zolmitriptan is not indicated for prophylaxis of migraine.
_Children (below 12 years of age) _
Safety and efficacy of zolmitriptan tablets in paediatric patients
have not been
evaluated. Use of zolmitriptan in children is therefore not
recommended.
_Adolescents (12 - 17 years of age) _
The efficacy of zolmitriptan tablets was not demonstrated in a placebo
controlled
clinical trial for patients aged 12 to 17 years. Use of zolmitriptan
in adolescents is
therefore n