Melatonin Neurim

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

melatonin

Beschikbaar vanaf:

RAD Neurim Pharmaceuticals EEC SARL

ATC-code:

N05CH01

INN (Algemene Internationale Benaming):

melatonin

Therapeutische categorie:

Psycholeptics

Therapeutisch gebied:

Sleep Initiation and Maintenance Disorders

therapeutische indicaties:

Melatonin Neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.

Product samenvatting:

Revision: 1

Autorisatie-status:

Authorised

Autorisatie datum:

2022-11-07

Bijsluiter

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MELATONIN NEURIM 2 MG PROLONGED-RELEASE 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 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 Neurim is and what it is used for
2.
What you need to know before you take Melatonin Neurim
3.
How to take Melatonin Neurim
4.
Possible side effects
5.
How to store Melatonin Neurim
6.
Contents of the pack and other information
1.
WHAT MELATONIN NEURIM IS AND WHAT IT IS USED FOR
The active substance of Melatonin Neurim, melatonin, belongs to a
natural group of hormones
produced by the body.
Melatonin Neurim is used on its own for the short-term treatment of
primary insomnia (persistent
difficulty in getting to sleep or staying asleep, or poor quality of
sleep) in patients aged 55 years and
older. ‘Primary’ means that the insomnia does not have any
identified cause, including any medical,
mental or environmental cause.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELATONIN NEURIM
DO NOT TAKE MELATONIN NEURIM
-
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 Neurim.
-
If you suffer from liver or kidney problems. No studies on the use of
Melatonin Neurim in
people with liver or kidney diseases have been performed, you should
speak to your doctor
before taking Melatonin Neurim as its use is not recommended.
-
If you have been told by your doctor that you have an intolerance to
s

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Melatonin Neurim 2 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 2 mg melatonin.
Excipient with known effect: each prolonged-release tablet contains 80
mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white, round, biconvex tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melatonin Neurim is indicated as monotherapy for the short-term
treatment of primary insomnia
characterised by poor quality of sleep in patients who are aged 55 or
over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2 mg once daily, 1-2 hours before bedtime and
after food. This dosage may
be continued for up to thirteen weeks.
_Paediatric population _
The safety and efficacy of Melatonin Neurim in children aged 0 to 18
years has not yet been
established.
Other pharmaceutical forms/strengths may be more appropriate for
administration to this population.
Currently available data are described in section 5.1.
_Renal impairment _
The effect of any stage of renal impairment on melatonin
pharmacokinetics has not been studied.
Caution should be used when melatonin is administered to such
patients.
_Hepatic impairment _
There is no experience of the use of Melatonin Neurim in patients with
liver impairment. Published
data demonstrates markedly elevated endogenous melatonin levels during
daytime hours due to
decreased clearance in patients with hepatic impairment. Therefore,
Melatonin Neurim is not
recommended for use in patients with hepatic impairment.
Method of Administration
Oral use. Tablets should be swallowed whole to maintain prolonged
release properties. Crushing or
chewing should not be used to facilitate swallowing.
3
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
M