Melatonine Orifarm 2 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

MELATONINE

Beschikbaar vanaf:

Orifarm Generics A/S Energivej 15 5260 ODENSE S (DENEMARKEN)

INN (Algemene Internationale Benaming):

MELATONIN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; SILICIUMDIOXIDE (E 551)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-10-20

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MELATONINE ORIFARM 2 MG, FILMOMHULDE TABLETTEN
melatonin
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
Only relevant for OTC:
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
WHAT IS IN THIS LEAFLET
1.
What Melatonine Orifarm is and what it is used for
2.
What you need to know before you take Melatonine Orifarm
3.
How to take Melatonine Orifarm
4.
Possible side effects
5.
How to store Melatonine Orifarm
6.
Contents of the pack and other information
1.
WHAT MELATONINE ORIFARM IS AND WHAT IT IS USED FOR
Melatonine Orifarm contains the active substance melatonin. Melatonine
Orifarm can be used for treatment
of jet-lag in adults. Jet-lag can be recognized by sleep disturbances,
daytime tiredness, fatigue, mild mental
impairment, irritability and digestive system disturbances experienced
after flying.
_How Melatonine Orifarm works _
Melatonin is a hormone produced by the body that synchronises the
body’s biological day-and-night rhythm.
T

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Melatonine Orifarm 2 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 2 mg melatonin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White/off-white to beige, biconvex, circular shaped film-coated tablet
with a score line and “2” on one side.
Diameter: 8 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of jet-lag in adults (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The standard dose is 2 mg (1 tablet) daily for a maximum of 5 days.
The dose may be increased to 4 mg (2
tablets taken together) or up to 6 mg (3 tablets taken together) if
the standard dose does not adequately
alleviate symptoms. The dose that adequately alleviates symptoms
should be taken for the shortest period.
The first dose should be taken on arrival at the destination at the
habitual bed-time.
Due to the potential for incorrectly timed intake of melatonin to have
no effect, or to cause an adverse effect,
on re-synchronisation following jet-lag, Melatonine Orifarm should not
be taken before 20:00 hr or after
04:00 hr at destination.
Melatonine Orifarm may be taken for a maximum of 16 treatment periods
per year.
_Elderly _
As the pharmacokinetics of melatonin (immediate release) is comparable
in young adults and elderly persons
in general, no specific dosage recommendations for elderly persons are
provided (see section 5.2).
_ _
_Renal impairment _
There is only limited experience regarding the use of melatonin in
patients with renal impairment. Caution
should be exercised if melatonin is used by patients with renal
impairment. Melatonine Orifarm is not
recommended for patients with severe renal impairment (see section
5.2).
_ _
2
_ _
_Hepatic impairment _
There is no experience regarding the use of melatonin in patients with
hepatic impairment. Limited da