Melatonin Pharma Nord 3 mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Melatonin

Disponible desde:

Pharma Nord ApS

Código ATC:

N05CH01

Designación común internacional (DCI):

Melatonin

Dosis:

3 milligram(s)

formulario farmacéutico:

Film-coated tablet

Área terapéutica:

melatonin

Fecha de autorización:

2019-11-15

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MELATONIN PHARMA NORD 3 MG, FILM-COATED TABLETS
melatonin
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 have 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 or pharmacist. 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 Melatonin Pharma Nord is and what it is used for
2.
What you need to know before you take Melatonin Pharma Nord
3.
How to take Melatonin Pharma Nord
4.
Possible side effects
5.
How to store Melatonin Pharma Nord
6.
Contents of the pack and other information
1.
WHAT MELATONIN PHARMA NORD IS AND WHAT IT IS USED FOR
Melatonin Pharma Nord contains the active substance melatonin.
Melatonin Pharma Nord can be used for
treatment of short-term 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 Melatonin Pharma Nord works_
Melatonin is a hormone produced by the body that synchronizes the
body’s biological day-and-night
rhythm. The biological rhythm can be disturbed by travelling across
time zones. This is known as a jet-lag.
The symptoms and their severity vary between individuals, but are
generally worse and last longer the
more time zones are crossed. Melatonin Pharma Nord can help restore
the normal day-and-night rhythm
and reduce the symptoms.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELATONIN PHARMA NORD
DO NOT TAKE MELATONIN PHARMA NORD
•
if you are allergic to melatonin or an

Ficha técnica

Health Products Regulatory Authority
22 May 2023
CRN00D7T0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Melatonin Pharma Nord 3 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3 mg melatonin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‑coated tablet (tablet). Round, biconvex, clear-coated, white to
off-white tablet of 7.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of jet-lag in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The standard dose is 3 mg (1 tablet) daily for a maximum of 5 days.
The dose may be increased to 6 mg (2 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 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 reaction, on
re-synchronisation following jet-lag, Melatonin Pharma Nord should not
be taken before 20:00 hr or after 04:00 hr at
destination.
Food can enhance the increase in plasma melatonin concentration (see
section 5.2). Intake of melatonin with carbohydrate-rich
meals may impair blood glucose control for several hours (see section
4.4). It is recommended that food is not consumed 2 h
before and 2 h after intake of Melatonin Pharma Nord.
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
Pharma Nord.
Melatonin Pharma Nord 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 dose recommendations for elderly persons are provided (see
section 5.2).
Renal impairment
There is only limited e