MELATONIN ARX melatonin 2 mg modified release tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

melatonin, Quantity: 2 mg

Disponible desde:

Apotex Pty Ltd

Designación común internacional (DCI):

Melatonin

formulario farmacéutico:

Tablet, modified release

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

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

tipo de receta:

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

indicaciones terapéuticas:

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

Resumen del producto:

Visual Identification: White to off-white, round, biconvex shaped tablet; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2017-04-04

Información para el usuario

MELATONIN ARX
1
MELATONIN ARX
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 MELATONIN ARX?
MELATONIN ARX contains the active ingredient Melatonin. MELATONIN ARX
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 MELATONIN ARX?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MELATONIN ARX?
Do not use if you have ever had an allergic reaction to MELATONIN ARX
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
MELATONIN ARX?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MELATONIN ARX 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 MELATONIN ARX?
•
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 MELATONIN
ARX?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MELATONIN ARX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
MELATONIN ARX.
•
If you become pregnant while taking MELATONIN ARX, stop taking the
tablets and tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not give MELATONIN ARX 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
•
Driving or operating machinery is not

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION
MELATONIN ARX (MELATONIN) MODIFIED RELEASE
TABLETS
1
NAME OF THE MEDICINE
Melatonin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Melatonin 2 mg.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM.
White to off-white, round, biconvex shaped 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
DOSAGE
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 _
Melatonin modified release tablets are not recommended for use in
children and adolescents
below 18 years of age due to insufficient data on safety and efficacy.
RENAL IMPAIRMENT
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 melatonin modified release
tablets 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, melatonin modified release tablets are not recommended for
use in patients with
hepatic impairment.
2
4.3
CONTRAINDICATIONS
Melatonin modified 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
PAEDIATRIC USE
Melatonin modified release tablets are not recommended for use in
children and adolescents
below 18 years of age due to insufficient data on safety and efficacy.
USE IN THE ELDERLY
Melatonin metabolism is known to decline with age. Across a range