Circadin

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

melatonin

MAH:

RAD Neurim Pharmaceuticals EEC SARL

ATC_code:

N05CH01

INN:

melatonin

therapeutic_group:

Psycholeptics

therapeutic_area:

Sleep Initiation and Maintenance Disorders

therapeutic_indication:

Circadin 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.

leaflet_short:

Revision: 34

authorization_status:

Authorised

authorization_date:

2007-06-29

PIL

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIRCADIN 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 Circadin is and what it is used for
2.
What you need to know before you take Circadin
3.
How to take Circadin
4.
Possible side effects
5.
How to store Circadin
6.
Contents of the pack and other information
1.
WHAT CIRCADIN IS AND WHAT IT IS USED FOR
The active substance of Circadin, melatonin, belongs to a natural
group of hormones produced by the
body.
Circadin 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 CIRCADIN
DO NOT TAKE CIRCADIN
-
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 Circadin.
-
If you suffer from liver or kidney problems. No studies on the use of
Circadin in people with
liver or kidney diseases have been performed, you should speak to your
doctor before taking
Circadin as its use is not recommended.
-
If you have been told by your doctor that you have an intolerance to
some sugars.
-
If you have been told you suffer from an autoimmune disease (where the
body is ‘attacked

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Circadin 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
Circadin 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 Circadin 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 Circadin 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, Circadin 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 excipients
listed in section 6.1.
3
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Circadin may cause drowsiness. Therefore