Melatonin Evolan 1 mg/ml Oral lösning

Land: Schweden

Sprache: Schwedisch

Quelle: Läkemedelsverket (Medical Products Agency)

Wirkstoff:

melatonin

Verfügbar ab:

Evolan Pharma AB

ATC-Code:

N05CH01

INN (Internationale Bezeichnung):

melatonin

Dosierung:

1 mg/ml

Darreichungsform:

Oral lösning

Zusammensetzung:

propylenglykol Hjälpämne; melatonin 1 mg Aktiv substans; bensylalkohol Hjälpämne

Verschreibungstyp:

Receptbelagt

Produktbesonderheiten:

Förpacknings: Flaska, 150 ml; Flaska, 100 ml; Flaska, 200 ml

Berechtigungsstatus:

Godkänd

Berechtigungsdatum:

2022-07-01

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
MELATONIN EVOLAN 1 MG/ ML ORAL SOLUTION
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 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 Melatonin Evolan is and what it is used for
2.
What you need to know before you take Melatonin Evolan
3.
How to take Melatonin Evolan
4.
Possible side effects
5.
How to store Melatonin Evolan
6.
Contents of the pack and other information
1.
WHAT MELATONIN EVOLAN IS AND WHAT IT IS USED FOR
Melatonin Evolan contains the active substance melatonin, which
belongs to a group of natural hormones produced
by the body. Melatonin helps regulate the body’s day and night
rhythm.
Melatonin Evolan can be used for:
-
short-term treatment of jet lag in adults. Jet lag is characterized by
sleep disturbances, daytime fatigue,
exhaustion, mild cognitive symptoms, irritability and gastrointestinal
disturbances after a flight.
-
insomnia in children and adolescents aged 6-17 years with ADHD where
other sleep-supporting measures
has not worked well enough.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELATONIN EVOLAN
DO NOT TAKE MELATONIN EVOLAN
-
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 Melatonin Evolan, if
you have:
-
epilepsy, as melatonin might increase or decrease the frequency of
seizures.
-
an autoimmune disease (where the body is ‘attacked’ by its own
immune system).
-
diabetes or impaired glucose tolerance, as this medicine m

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Melatonin Evolan 1 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains 1 mg melatonin.
Excipients with known effect:
Benzyl alcohol 6 mg/ml
Propylene glycol 52 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, pale yellow to yellow coloured solution with strawberry taste.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 1-5 mg (1-5 ml) and should be taken at
bedtime, for 4-7 days.
The dose may be increased up to 5 mg (5 ml) if symptoms are not
sufficiently relieved at lower doses.
The first dose should be taken on arrival at the destination, at the
usual bedtime.
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 Evolan should not
be taken before 20:00 or after
04:00 at destination.
A maximum of 16 treatment cycles of jet lag with Melatonin Evolan may
occur per year.
_Insomnia in children and adolescents with ADHD _
The treatment must be initiated by physicians with experience in ADHD
and/or the treatment of sleep
disorders in children.
The standard dose is 1-2 mg (equivalent to 1-2 ml) 30 to 60 minutes
before bedtime.
The dose of melatonin can be increased by 1 mg (1 ml) per week until
an effect is achieved to a
maximum of 5 mg (5 ml) daily, regardless of age. The lowest effective
dose should be sought.
Limited data are available for up to 3 years of treatment. After at
least 3 months of treatment, the
physician should evaluate the treatment effect and consider stopping
treatment if no clinically relevant
2
treatment effect is seen. The patient should be monitored at regular
intervals (at least ev