Zolmitriptan 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

2
1
Artwork No.
Barcode
mind when you drive or use any tools or machines.
Zolmitriptan Tablets is unlikely to affect driving or using tools or
machines.
However, it is best to wait to see how Zolmitriptan Tablets affects
you before you
try these activities.
ZOLMITRIPTAN TABLETS CONTAIN ASPARTAME (E951)
Zolmitriptan 2.5mg orodispersible tablets contains 0.250mg of
aspartame in
each tablet.
Zolmitriptan 5mg orodispersible tablets contains 0.500mg of aspartame
in each
tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have
phenylketonuria (PKU), a rare genetic disorder in which phenylalanine
builds up
because the body cannot remove it properly.
3. HOW TO TAKE ZOLMITRIPTAN TABLETS
Always take this medicine exactly as your doctor has told you. You
should check
with your doctor or pharmacist if you are not sure.
You can take Zolmitriptan Tablets as soon as a migraine headache
starts. You
can also take it once an attack is underway.
Ÿ
The usual dose is one tablet (either 2.5mg or 5mg).
Ÿ
You can take another tablet if the migraine is still present after two
hours or if
it returns within 24 hours.
If the tablets did not give you enough help with your migraine, tell
your doctor.
Your doctor may raise the dose to 5mg or change your treatment. You
are more
likely to get side effects with the higher dose (5mg).
DO NOT use more than the dose prescribed for you.
DO NOT use more than two doses in one day. If you have been prescribed
the
2.5mg tablet, the maximum daily dose is 5mg. If you have been
prescribed the
5mg tablet, the maximum daily dose is 10mg.
_Instruction for use_
1.
Peel the blister pack open. Do not push the tablet through the foil.
2.
Place the tablet on your tongue, where it will dissolve and be
swallowed with
the saliva.
You do not have to take a drink of water in order to swallow your
tablet.
IF YOU TAKE MORE ZOLMITRIPTAN TABLETS THAN YOU SHOULD
If you have taken more Zolmitriptan Tablets than prescribed by your
doctor, tell
your doctor or go to the nearest hospital STRAIGHT AWAY. Take

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