Frovatriptan DOC Generici 2,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FROVATRIPTAN SUCCINAAT 1-WATER 3,9 mg/stuk SAMENSTELLING overeenkomend met ; FROVATRIPTAN 2,5 mg/stuk

Beschikbaar vanaf:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC-code:

N02CC07

INN (Algemene Internationale Benaming):

FROVATRIPTAN SUCCINAAT 1-WATER 3,9 mg/stuk SAMENSTELLING overeenkomend met ; FROVATRIPTAN 2,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Frovatriptan

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 0-WATER; LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

Page 1 of 5
July 22: approval var 08 – Proposed var 10
1.
WHAT _ 2.5 MG FILM-COATED TABLETS _IS AND WHAT IT IS
USED FOR
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _ 2.5 MG
FILM-COATED _
_TABLETS _
2.
PACKAGE LEAFLET: INFORMATION FOR THE USER
FROVATRIPTAN DOC GENERICI 2,5 MG, FILMOMHULDE
TABLETTEN [FROVATRIPTAN (AS FROVATRIPTAN SUCCINATE
MONOHYDRATE)]
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
_ _
2.5 mg film-coated tablets is and what it is used for
2.
What you need to know before you take
_ _
2.5 mg film-coated tablets
3.
How to take
_ _
2.5 mg film-coated tablets
4.
Possible side effects
5.
How to store
_ _
2.5 mg film-coated tablets
6.
Contents of the pack and other information
_ _
2.5
mg
film-coated
tablets
contain
frovatriptan
(as
frovatriptan
succinate monohydrate), which belongs to a group of medicines called
triptans (also
known as 5-HT
1
receptor agonists)
_. _
_ _
_ _
2.5 mg film-coated tablets are used to treat migraine with or without
aura (a
temporary subjective feeling before a migraine attack, which varies
greatly from person to person
and which can affect vision, sense of smell, or hearing).
2.5 mg film-coated tablets should not be used to
prevent migraines.
The diagnosis of a migraine episode must have been clearly established
by your doctor.
DO NOT TAKE _ _2.5 MG FILM-COATED TABLETS:
•
If you are allergic to frov

Productkenmerken

ID: S 169M - NL/H/2758/01/DC
VERSION: 0
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Frovatriptan DOC Generici 2,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg of frovatriptan (as
frovatriptan succinate monohydrate).
_Excipient(s) with known effect: _Contains approximately 107 mg of
lactose per
tablet. For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white round film-coated tablet, plain on both sides.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks with or
without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Frovatriptan should be taken as early as possible after the onset of a
migraine attack but it is also
effective when taken at a later stage.
Frovatriptan should not be used prophylactically.
If a patient does not respond to the first dose of frovatriptan, a
second dose should not be taken
for the same attack, since no benefit has been shown.
Frovatriptan may be used for subsequent migraine attacks.
Adults (18-65 years of age)
The recommended dose of frovatriptan is 2.5 mg.
If the migraine recurs after initial relief, a second dose may be
taken, providing there is an
interval of at least 2 hours between the two doses.
The total daily dose should not exceed 2 tablets of 2.5 mg per 24
hours.
Paediatric population
No data are available.
Therefore, its use in this age group is not recommended.
Older people (over 65 years of age)
Frovatriptan data in patients over 65 years remain limited. Therefore,
its use in this category of
patients is not recommended.
Renal Impairment
No dosage adjustment is required in patients with renal impairment
(see section 5.2).
Hepatic Impairment
No dosage adjustment is required in patients with mild to moderate
hepatic impairment (see
section 5.2)
Frovatriptan is contraindicated in patients with severe hepatic
impairment (see section 4.3).
ID: S 169M - NL/H/2758/01/DC
VERSIO