Mellozzan 1 mg Tablett

Land: Schweden

Sprache: Schwedisch

Quelle: Läkemedelsverket (Medical Products Agency)

Wirkstoff:

melatonin

Verfügbar ab:

EQL Pharma AB

ATC-Code:

N05CH01

INN (Internationale Bezeichnung):

melatonin

Dosierung:

1 mg

Darreichungsform:

Tablett

Zusammensetzung:

melatonin 1 mg Aktiv substans

Verschreibungstyp:

Receptbelagt

Produktbesonderheiten:

Förpacknings: Burk, 30 tabletter; Burk, 26 tabletter; Burk, 100 tabletter

Berechtigungsstatus:

Godkänd

Berechtigungsdatum:

2021-02-22

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MELLOZZAN 0.5 MG TABLETS
MELLOZZAN 1 MG TABLETS
MELLOZZAN 2 MG TABLETS
MELLOZZAN 3 MG TABLETS
MELLOZZAN 4 MG TABLETS
MELLOZZAN 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 Mellozzan is and what it is used for
2.
What you need to know before you take Mellozzan
3.
How to take Mellozzan
4.
Possible side effects
5.
How to store Mellozzan
6.
Contents of the pack and other information
1.
WHAT MELLOZZAN IS AND WHAT IT IS USED FOR
The active substance of Mellozzan, melatonin, belongs to a group of
natural hormones produced by
the body. The hormone helps regulate the body’s day and night
rhythm.
Mellozzan 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
(attention-deficit
hyperactivity disorder), where other healthy sleeping routines have
not worked well enough.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELLOZZAN
DO NOT TAKE MELLOZZAN
-
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- or pharmacist before taking Mellozzan:
-
if you have diabetes or impaired glucose tolerance, as this medicine
may increase the level of
glucose in your blood (see section 3);
-
if you have liver or kidney problems;
-
if you have an autoimmune disease (where th

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mellozzan 0.5 mg tablets
Mellozzan 1 mg tablets
Mellozzan 2 mg tablets
Mellozzan 3 mg tablets
Mellozzan 4 mg tablets
Mellozzan 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5 mg, 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 to yellowish, round biconvex tablet.
Mellozzan 0.5 mg: marked “0” on one side, tablet size, 7.5 mm
diameter
Mellozzan 1 mg: marked “1” on one side, tablet size, 9.5 mm
diameter
Mellozzan 2 mg: marked “2” on one side, tablet size, 7.0 mm
diameter
Mellozzan 3 mg: marked “3” on one side, tablet size, 8.0 mm
diameter
Mellozzan 4 mg: marked “4” on one side, tablet size, 9.0 mm
diameter
Mellozzan 5 mg: marked “5” on one side, tablet size, 10.0 mm
diameter
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mellozzan is indicated for:
-
Short-term treatment of jet lag in adults
-
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 0.5-5 mg for a maximum of 5 days. The maximum
daily dose is 5 mg once daily.
The dose that adequately alleviates symptoms should be taken for the
shortest period.
The dose should be taken before bedtime at the destination for
journeys of 5 time zones or longer, especially
when traveling in an easterly direction.
As incorrectly timed intake of melatonin may result in no effect or an
adverse effect on resynchronization of
jet lag, Mellozzan tablets should not be taken before 20:00 or after
04:00 at the destination time.
_Paediatric population_
The safety and efficacy of melatonin in children and adolescents less
than 18 years in jet lag has not been
established.
_Insomnia in children and adolescents aged 6-17 years with ADHD_
Treatment should be initiated by physicians experienced in ADHD and/or