Zolmitriptan 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zolmitriptan

Available from:

Glenmark Pharmaceuticals Europe Ltd

ATC code:

N02CC03

INN (International Name):

Zolmitriptan

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401; GTIN: 5060204161469 5060204161476

Patient Information leaflet

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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 5 mg orodispersible tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg orodispersible tablet contains 5 mg zolmitriptan.
Excipient(s) with known effect: aspartame (8mg).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
White, round flat tablets with the diameter 9.5 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 is required, it should not be
taken within
2 hours of the initial dose.
If a patient does not achieve satisfactory relief with 2.5 mg doses,
subsequent attacks
can be treated with 5 mg 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