CIRCADIN melatonin 2 mg prolonged release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

melatonin, Quantity: 2 mg

Available from:

RAD Data Australia Pty Ltd

INN (International Name):

Melatonin

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: ammonio methacrylate copolymer; calcium hydrogen phosphate dihydrate; lactose monohydrate; colloidal anhydrous silica; purified talc; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets, 60 tablets, 90 tablets, 15 tablets, 42 tablets, 7 tablets, 21 tablets

Prescription type:

(S3) Pharmacist Only Medicine, (S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to off-white, round, biconvex tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2009-11-25

Patient Information leaflet

CIRCADIN®
1
CIRCADIN®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CIRCADIN?
CIRCADIN contains the active ingredient Melatonin. CIRCADIN is used to
improve sleep quality and morning alertness in
patients over 55 years of age with poor quality of sleep.
For more information, see Section 1. Why am I using CIRCADIN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIRCADIN?
Do not use if you have ever had an allergic reaction to CIRCADIN or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CIRCADIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CIRCADIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CIRCADIN?
•
Adults 55 years and over: Take one tablet after food, 1-2 hours before
you go to bed.
More instructions can be found in Section 4. How do I use CIRCADIN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIRCADIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CIRCADIN.
•
If you become pregnant while taking CIRCADIN, stop taking the tablets
and tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not give CIRCADIN to anyone else, even if they have the same
condition as you.
•
Do not take more than the recommended dose unless your doctor tells
you to.
•
Do not use this medicine to treat any other complaints unless your
doctor tells you to.
•
Do not drink alcohol before or after taking this medicine.
DRIVING OR USING
MACHINES
•
CIRCADIN rarely causes drowsiness, nevertheless it is not recommended
to drive or operate
machinery for 8 hours a

Summary of Product characteristics

CIRCADIN_PI_20201111
1
AUSTRALIAN PRODUCT INFORMATION – CIRCADIN
®
(MELATONIN) PROLONGED RELEASE TABLETS
1
NAME OF THE MEDICINE
Melatonin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CIRCADIN 2 mg prolonged release tablets.
The active ingredient in CIRCADIN prolonged release tablets is a
melatonin NOT of plant or
animal origin.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Prolonged release tablet.
White to off-white, round, biconvex tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
DOSE AND METHOD OF ADMINISTRATION
Oral use. Tablets should be swallowed whole.
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 USE
CIRCADIN is not recommended for use in children and adolescents below
18 years of age
due to insufficient data on safety and efficacy.
CIRCADIN_PI_20201111
2
RENAL INSUFFICIENCY
The effect of any stage of renal insufficiency 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.
4.3
CONTRAINDICATIONS
CIRCADIN prolonged release tablets are contraindicated in patients
with a known
hypersensitivity to any ingredient of the product (see Section 6.1
List of excipients).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
DROWSINESS
CIRCADIN may cause drowsiness. Therefore the product should be used
with caution if the
effects of drowsiness are likely to be associated with a