Zolmitriptan 2.5mg orodispersible tablets sugar free

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Preparatomtale Preparatomtale (SPC)
19-06-2018

Aktiv ingrediens:

Zolmitriptan

Tilgjengelig fra:

Accord-UK Ltd

ATC-kode:

N02CC03

INN (International Name):

Zolmitriptan

Dosering :

2.5mg

Legemiddelform:

Orodispersible tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04070401; GTIN: 5012617019455

Informasjon til brukeren

                                ZOLMITRIPTAN 2.5MG AND 5MG
ORODISPERSIBLE TABLETS
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.
WHAT IS IN THIS LEAFLET:
1
WHAT ZOLMITRIPTAN TABLETS ARE AND WHAT
THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ZOLMITRIPTAN TABLETS
3
HOW TO TAKE ZOLMITRIPTAN TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ZOLMITRIPTAN TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT ZOLMITRIPTAN TABLETS ARE AND WHAT
THEY ARE USED FOR
Zolmitriptan tablets contain zolmitriptan and belongs
to a group of medicines called triptans.
Zolmitriptan is used to treat migraine headache.
Migraine symptoms may be caused by the widening
of blood vessels in the head. Zolmitriptan 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.
Zolmitriptan 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
ZOLMITRIPTAN TABLETS
DO NOT TAKE ZOLMITRIPTAN TABLETS IF YOU
•
are ALLERGIC to zolmitriptan or any of the other
ingredients of this medicine (listed in section 6)
•
have HIGH BLOOD PRESSURE
•
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
•
have circulatory problems (restr
                                
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Preparatomtale

                                OBJECT 1
ZOLMITRIPTAN 2.5MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 20-Nov-2015 | Accord-UK Ltd
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 
                                
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