Zomigoro Rapimelt 2,5 mg Munsönderfallande tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

zolmitriptan

Tillgänglig från:

Teva Sweden AB

ATC-kod:

N02CC03

INN (International namn):

zolmitriptan

Dos:

2,5 mg

Läkemedelsform:

Munsönderfallande tablett

Sammansättning:

mannitol Hjälpämne; aspartam Hjälpämne; zolmitriptan 2,5 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Terapiområde:

Zolmitriptan

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2008-01-31

Bipacksedel

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOMIG RAPIMELT 2.5 MG AND 5 MG ORODISPERSIBLE TABLETS
zolmitriptan
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 Zomig Rapimelt is and what it is used for
2.
What you need to know before you take Zomig Rapimelt
3.
How to take Zomig Rapimelt
4.
Possible side effects
5.
How to store Zomig Rapimelt
6.
Contents of the pack and other information
1.
WHAT ZOMIG RAPIMELT IS AND WHAT IT IS USED FOR
Zomig Rapimelt contains zolmitriptan and belongs to a group of
medicines called triptans.
ZOMIG RAPIMELT IS USED TO TREAT MIGRAINE HEADACHE IN ADULTS AGED 18
YEARS AND OLDER
.

Migraine symptoms may be caused by the widening of blood vessels in
the head. Zomig
Rapimelt 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 Rapimelt 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 RAPIMELT
DO NOT TAKE ZOMIG RAPIMELT:
-
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

Produktens egenskaper

Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Zomig Rapimelt 2.5 mg orodispersible tablet
Zomig Rapimelt 5 mg orodispersible tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg orodispersible tablet contains 2.5 mg zolmitriptan.
Each 5 mg orodispersible tablet contains 5 mg zolmitriptan.
Excipients with known effect
Each 2.5 mg orodispersible tablet contains 5 mg aspartame.
Each 5 mg orodispersible tablet contains 10 mg aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
The 2.5 mg tablet is a white, flat-faced, round, bevelled edge
orodispersible tablet, intagliated with ‘Z’
on one side.
The 5 mg tablet is a white, flat-faced, round, bevelled edge
orodispersible tablet, intagliated with ‘Z 5’
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zomig Rapimelt is indicated in adults aged 18 years and older for
acute treatment of migraine
headache with or without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of 'Zomig Rapimelt' to treat a migraine attack is
2.5 mg. It is advisable that
‘Zomig Rapimelt’ 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 2.5 mg doses,
for subsequent attacks 5 mg doses of
'Zomig Rapimelt' could be considered.
The total daily intake should not exceed 10 mg. Not more than 2 doses
of ‘Zomig Rapimelt’ should be
taken in any 24-hour period.
Page 2 of 10
´Zomig Rapimelt´ is not indicated for prophylaxis of migraine.
_Paediatric population_
_Use in Children (under 12 years of age)_
The safety and efficacy of zolmitriptan tablets