CIRCADIN

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

MELATONIN

Fáanlegur frá:

NEURIM PHARMACEUTICALS (1991) LTD, ISRAEL

ATC númer:

N05CH01

Lyfjaform:

TABLETS PROLONGED RELEASE

Samsetning:

MELATONIN 2 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

NEURIM PHARMACEUTICALS LIMITED

Meðferðarhópur:

MELATONIN

Lækningarsvæði:

MELATONIN

Ábendingar:

Short-term treatment for primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

Leyfisdagur:

2023-11-30

Upplýsingar fylgiseðill

29.06.2023
_Page 1 of 4 _
Patient Leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is sold only with a doctor’s prescription
_ _
Circadin
Prolonged-release tablets
Composition:
Each tablet contains 2 mg melatonin
(Melatonin 2mg)
Inactive ingredients:
See list in section 6 and also in the section "Important information
about some of the medicine's ingredients".
-
Read the leaflet in its entirety before using the medicine
. This leaflet contains
concise information about the medicine. If you have any further
questions, please
contact your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if you think that their medical condition is similar to
yours.
-
The medicine is intended for adults over the age of 55.
1.
What is the medicine intended for?
Melatonin, the active ingredient in Circadin, belongs to a group of
natural hormones produced
by the body.
Circadin is used for a short-term treatment of primary insomnia
(sleeplessness, difficulty
falling asleep or staying asleep or poor quality of sleep) in patients
aged 55 or over.
Insomnia is defined as 'primary' when it is not the result of an
identified cause, such as a
medical, mental or environmental condition.
Therapeutic group:
A hormone secreted by the body.
2.
Before you use the medicine
Do not use this medicine if -
you are sensitive (allergic) to the active ingredient or to
any of the other ingredients of this medicine
(a list of the inactive ingredients can be
found in section 6).
Special warnings regarding the use of this medicine:
Before treatment with Circadin , tell your doctor if:
-
You are pregnant or breastfeeding (see "Pregnancy and breastfeeding"
section)
.
-
You are suffering from liver or kidney disorders. Using Circadin is
not recommended
in these conditions since no studies on Circadin were conducted in
people with liver
or kidney diseases.
-
You are suffering from intolerance to certain sugars.
-
You are suffering from an autoimmune di

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
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 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.
No data are available.
_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
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Page 2 of 9
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.
4.4
Special warnings and precautions for use
Circadin may cause drowsiness. Therefore the product should be used
with caution if the effects of
drowsiness are likely to be associated with a risk to safety.
No clinical data