Melatonin AGB 1 mg Tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

melatonin

Tillgänglig från:

AGB-Pharma AB

ATC-kod:

N05CH01

INN (International namn):

melatonin

Dos:

1 mg

Läkemedelsform:

Tablett

Sammansättning:

melatonin 1 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Burk, 30 tabletter (barnskyddande); Burk, 30 tabletter; Burk, 100 tabletter (barnskyddande); Burk, 100 tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2019-12-11

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MELATONIN AGB 1 MG TABLETS
MELATONIN AGB 2 MG TABLETS
MELATONIN AGB 3 MG TABLETS
MELATONIN AGB 4 MG TABLETS
MELATONIN AGB 5 MG TABLETS
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.
WHAT IS IN THIS LEAFLET
1.
What Melatonin AGB is and what it is used for
2.
What you need to know before you take Melatonin AGB
3.
How to take Melatonin AGB
4.
Possible side effects
5.
How to store Melatonin AGB
6.
Contents of the pack and other information
1.
WHAT MELATONIN AGB IS AND WHAT IT IS USED FOR
The active substance of Melatonin AGB, melatonin, belongs to a group
of natural hormones produced
by the body. The hormone helps regulate the body’s day- and night
rhythm.
Melatonin AGB is used for:
-
short-term treatment of jet lag in adults. Jet lag refers to the
symptoms caused by the time
difference when traveling across several time zones.
-
Insomnia in children and adolescents (6 to 17 years old) with ADHD,
where other healthy
sleeping routines has not worked well enough.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELATONIN AGB
DO NOT TAKE MELATONIN AGB:
-
if you are allergic to melatonin or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Melatonin AGB
if you have:
-
diabetes or impaired glucose tolerance, as this medicine may increase
the level of glucose in your
blood
-
liver or kidney problems
-
an autoimmune disease (where the body is ‘attacked’ by its own
immune

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Melatonin AGB 1 mg tablets
Melatonin AGB 2 mg tablets
Melatonin AGB 3 mg tablets
Melatonin AGB 4 mg tablets
Melatonin AGB 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 1 mg, 2 mg, 3 mg, 4 mg or 5 mg melatonin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
All strengths: White, round, biconvex tablets, diameter 9.5 mm.
Melatonin AGB 1 mg: marked 1
Melatonin AGB 2 mg: marked 2
Melatonin AGB 3 mg: marked 3
Melatonin AGB 4 mg: marked 4
Melatonin AGB 5 mg: marked 5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melatonin AGB is indicated for:

Short term treatment of jet lag in adults (see section 5.1).

Insomnia in children and adolescents aged 6-17 years with ADHD, where
sleep hygiene
measures have been insufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with jet lag_
The recommended dose is 1-5 mg for a maximum of 5 days.
The dose should be taken at the time of destination bedtime for
journeys of 5 time zones or longer,
especially when traveling in an easterly direction.
Due to the potential for incorrectly timed intake of melatonin to have
no effect, or an adverse effect,
on re-synchronisation following jet lag, Melatonin AGB tablets should
not be taken before 20:00 hr or
after 04:00 hr at destination.
2
As alcohol can impair sleep and potentially worsen certain symptoms of
jet lag (e.g. headache,
morning fatigue, concentration) it is recommended that alcohol is not
consumed when taking
Melatonin AGB tablets.
A maximum of 16 treatment cycles may occur per year.
_Insomnia in children and adolescents with ADHD_
Treatment should be initiated by physicians experienced in ADHD and/or
paediatric sleep medicine.
Recommended starting dose of Melatonin AGB tablet: 1-2 mg 30-60
minutes before bedtime.
The dose of melatonin can be increased by 1 mg every week until effect
up to a maximum 5 mg per
day, independent of age. The lowest effective dose should be sough