Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ZOLPIDEMTARTRAAT 10 mg/stuk

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

N05CF02

INN (Algemene Internationale Benaming):

ZOLPIDEMTARTRAAT 10 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Zolpidem

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

Zolpidem tartrate, NL/H/0267/001-002, 23.03.23
1
rvg 26427-8 EU PIL II/040 met NL info-clean
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLPIDEMTARTRAAT RATIOPHARM 5 MG, FILMOMHULDE TABLETTEN
ZOLPIDEMTARTRAAT RATIOPHARM 10 MG, FILMOMHULDE TABLETTEN
zolpidemtartraat
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is a sleeping tablet belonging to a group of medicines
known as benzodiazepine-like agents.
It is used for the short-term treatment of sleep disturbances in
adults.
is only prescribed for sleep disturbances that are
severe, disabling or cause extreme distress.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE :
•
if you are ALLERGIC TO ZOLPIDEM OR ANY OF THE OTHER INGREDIENTS of
this medicine (listed in section 6).
Signs of an allergic reaction include: rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue.
•
if you have ever experienced sleep walking or other behaviours which
are unusual while sleeping, (such as
driving, eating, making a phone call or having sex etc.) while not
being fully awake after taking or other medicines containing zolpidem.
•
if you suffer from severe muscle weakness (MYASTHEN

Productkenmerken

Zolpidem, NL/H/0267/001-002, 23.03.23
Rvg 26427-8 EU SPC II/040 met NL info-clean
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten
Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_˂Product_
_ _
_name˃_
_ 5 mg film-coated tablets_
One film-coated tablet contains 5 mg zolpidem tartrate.
Excipient with known effect: 43 mg lactose/film-coated tablet
_˂Product_
_ _
_name˃_
_ 10 mg film-coated tablets_
One film-coated tablet contains 10 mg zolpidem tartrate.
Excipient with known effect: 86 mg lactose/film-coated tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_˂_
_Product _
_name˃ 5 mg film_
_-coated tablets_
White, oval, biconvex, film-coated tablet, embossed with "ZIM" on one
side and "5" on the other side_._
_˂_
_Product _
_name˃_
_ 10 mg film-coated tablets _
White, oval, biconvex, film-coated tablet, scored on both sides and
embossed with "ZIM" and "10" on
one side_._
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term treatment of insomnia in adults.
Benzodiazepines or benzodiazepine-like agents are only indicated when
the disorder is severe,
disabling or subjecting the individual to extreme distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Treatment should be as short as possible. Generally the duration of
treatment varies from a few days to
two weeks with a maximum, including the tapering off process, of four
weeks. The tapering off
process should be tailored to the individual.
In certain cases extension beyond the maximum treatment period may be
necessary; if so, it should not
take place without re-evaluation of the patient's status since the
risk of abuse and dependence increases
with the duration of treatment (see section 4.4).
Zolpidem, NL/H/0267/001-002, 23.03.23
Rvg 26427-8 EU SPC II/040 met NL info-clean
The treatment should be taken in a single intake and not be
re-administered during the same night.