Meladura 2 mg prolonged-release tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Melatonin

Dostupno od:

Bluefish Pharmaceuticals AB

ATC koda:

N05CH01

INN (International ime):

Melatonin

Farmaceutski oblik:

Prolonged-release tablet

Područje terapije:

melatonin

Status autorizacije:

Not marketed

Datum autorizacije:

2024-01-05

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
MELADURA 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, 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 Meladura is and what it is used for
2.
What you need to know before you take Meladura
3.
How to take Meladura
4.
Possible side effects
5.
How to store Meladura
6.
Contents of the pack and other information
1.
WHAT MELADURA IS AND WHAT IT IS USED FOR
The active substance of Meladura is melatonin and it belongs to a
natural group of hormones produced
by the body.
Meladura 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 MELADURA
DO NOT TAKE MELADURA
-
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 Meladura:
-
If you have liver problems. No studies on the use of melatonin in
people with liver diseases
have been performed, you should speak to your doctor before taking
Meladura as its use is not
recommended.
-
If you have kidney problems, you should speak to your doctor before
taking
Meladura.
-
If you have an intolerance to some sugars.
-
If you have an autoimmune disease (where the body is ‘attacked’ by
its

Svojstava lijeka

Health Products Regulatory Authority
09 January 2024
CRN00DXSP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meladura 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 85 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white, 8 mm diameter, round, biconvex shaped, uncoated
tablets plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meladura is indicated as monotherapy for the short-term treatment of
primary insomnia characterized 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 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 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, Meladura 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.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipient