Rayvow

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

lasmiditan succinate

Tillgänglig från:

Eli Lilly Nederland B.V.

ATC-kod:

N02CC08

INN (International namn):

lasmiditan

Terapeutisk grupp:

Analgesics

Terapiområde:

Migraine Disorders

Terapeutiska indikationer:

RAYVOW is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.

Bemyndigande status:

Authorised

Tillstånd datum:

2022-08-17

Bipacksedel

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAYVOW 50
MG FILM-COATED TABLETS
RAYVOW 100
MG FILM-COATED TABLETS
RAYVOW 200
MG FILM-COATED TABLETS
lasmiditan
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 RAYVOW is and what it is used for
2.
What you need to know before you take RAYVOW
3.
How to take RAYVOW
4.
Possible side effects
5.
How to store RAYVOW
6.
Contents of the pack and other information
1.
WHAT RAYVOW IS AND WHAT IT IS USED FOR
RAYVOW contains the active substance lasmiditan, which is used to
treat the headache phase of
migraine attacks with or without aura in adults.
RAYVOW helps to reduce or get rid of the pain and other symptoms
associated with a migraine
headache. Pain relief may be felt from as early as 30 minutes after
taking RAYVOW.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAYVOW
DO NOT TAKE RAYVOW
-
if you are allergic to lasmiditan or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Do not take part in activities requiring your full attention, such as
driving or operating machinery,
within 8 hours of taking each dose of RAYVOW, even if you feel well
enough to do so, because it can
affect your ability to drive or operate machinery safely. If you
cannot do this, you should not take
R

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
RAYVOW 50 mg film-coated tablets
RAYVOW 100 mg film-coated tablets
RAYVOW 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RAYVOW 50 mg film-coated tablets
Each film-coated tablet contains 50 mg lasmiditan (as succinate).
RAYVOW 100
mg film-coated tablets
Each film-coated tablet contains 100 mg lasmiditan (as succinate).
RAYVOW 200 mg film-coated tablets
Each film-coated tablet contains 200 mg lasmiditan (as succinate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
RAYVOW 50 mg film-coated tablets
Light grey, oval tablet of 8.9 x 4.9 mm, debossed with “4312” on
one side and “L-50” on the other.
RAYVOW 100
mg film-coated tablets
Light purple, oval tablet of 11.2 x 6.15 mm, debossed with “4491”
on one side and “L-100” on the
other.
RAYVOW 200 mg film-coated tablets
Grey, oval tablet of 14.1 x 7.75 mm, debossed with “4736” on one
side and “L-200” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RAYVOW is indicated for the acute treatment of the headache phase of
migraine attacks, with or
without aura in adults.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In general, recommended initial dose in adults is 100 mg lasmiditan
for acute treatment of migraine
attacks. If necessary, the dose can be increased to 200 mg for greater
efficacy or can be decreased to
50 mg for greater tolerability.
If the migraine headache recurs within 24 hours of an initial response
after taking 50 mg or 100 mg
lasmiditan, a second dose of the same strength may be taken. The
second dose should not be taken
within 2 hours of the initial dose.
No more than 200 mg should be taken in 24 hours.