Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

ZOLPIDEMTARTRAAT

Verfügbar ab:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-Code:

N05CF02

INN (Internationale Bezeichnung):

ZOLPIDEMTARTRAAT

Darreichungsform:

Filmomhulde tablet

Zusammensetzung:

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),

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Zolpidem

Produktbesonderheiten:

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

Berechtigungsdatum:

2001-03-13

Gebrauchsinformation

Sandoz B.V.
Page 1/10
Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg
RVG 25108
1313-v15
1.3.1.3 Package Leaflet
Maart 2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOLPIDEMTARTRAAT SANDOZ
® 5, FILMOMHULDE TABLETTEN 5 MG
zolpidem tartrate
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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is used for the short-term treatment of
insomnia in adults.
Do not use it for long-term treatment. The duration of treatment
should be as short as possible because the
risk of dependence increases with increasing treatment duration.
It is used only when the sleep disorders are severe, disabling or
causing extreme distress for the patient.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
-
if you are
ALLERGIC
to zolpidem or any of the other ingredients of this medicine (listed
in section 6)
-
if you suffer from certain forms of
PATHOLOGIC MUSCLE WEAKNESS
(myasthenia gravis)
-
in case of
SHORT-TERM RESPIRATORY ARREST
while you are sleeping (sleep apnoea syndrome)
-
if you suffer from
ACUTE AND/OR SEVERE BREATHING WEAKNESS
(respiratory impairment)
-
if you suffer from
SEVERE LIVER

Fachinformation

Sandoz B.V.
Page 1/12
Zolpidemtartraat Sandoz
®
5, filmomhulde tabletten 5 mg
RVG 25108
1311-v16
1.3.1.1 Summary of Product Characteristics
Maart 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of zolpidem tartrate.
Excipients with known effect:
Each film-coated tablet contains 42.9 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, biconvex, film-coated tablets embossed with "ZIM" on one
side and "5" on the other side
_. _
4
CLINICAL PARTICULAR
4.1
THERAPEUTIC INDICATIONS
Zolpidem is indicated for short-term treatment of insomnia in adults.
Treatment is indicated only when
the disorder is severe, disabling or subjecting the individual to
extreme distress
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The duration of treatment should be as short as possible. It should
not exceed 4 weeks, including the
gradual discontinuation phase.
In certain cases treatment beyond this period may be necessary; if so,
it should not take place without
re-evaluation of the patient's condition, as the risk of abuse and
dependency increases with the
duration of the treatment (see section 4.4).
Posology
_ _
_Adults _
The treatment should be taken in a single intake and not be
re-administered during the same night.
The recommended daily dose for adults
is 10 mg (2 film-coated tablets) to be taken immediately at
bedtime. The lowest effective daily dose of zolpidem should be used
and
must not exceed 10 mg.
_Elderly and debilitated patients _
In elderly and debilitated patients who may be especially sensitive to
the effects of zolpidem a daily
dose of 5 mg (1 film-coated tablet) is recommended. This dose should
only be increased to 10 mg (2
film-coated tablets) where the clinical response is inadequate and the
medicinal product is well
Sandoz B.V.
Page 2/12
Zolpidemtartraat Sandoz
®
5, filmomhulde t