MELATONIN MR-TEVA 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:

Teva Pharma Australia Pty Ltd

formulario farmacéutico:

Tablet, modified release

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

15, 7, 30, 21, 60

tipo de receta:

(S3) Pharmacist Only Medicine, (S4) Prescription 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, oval, biconvex tablets.; Container Type: Blister Pack; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2022-02-15

Información para el usuario

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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 MR-TEVA?
Melatonin MR-TEVA contains the active ingredient melatonin. Melatonin
MR-TEVA is used to improve sleep quality and morning
alertness in patients over 55 years of age with primary insomnia with
poor quality of sleep. For more information, see Section 1. Why
am I using Melatonin MR-TEVA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MELATONIN MR-TEVA?
Do not use if you have ever had an allergic reaction to Melatonin
MR-TEVA or any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist 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 MR-TEVA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Melatonin MR-TEVA 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 MR-TEVA?
•
Take Melatonin MR-TEVA only when prescribed by your doctor or
pharmacist. Follow the instructions provided with the
medicine.
•
The standard dose of Melatonin MR-TEVA is one tablet once a day. Do
not exceed the recommended dosage.
More instructions can be found in Section 4. How do I use Melatonin
MR-TEVA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MELATONIN MR-TEVA?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
MELATONIN MR-TEVA.
•
IF YOU BECOME PREGNANT OR START BREASTFEEDING WHILE TAKING MELATONIN
MR-TEVA, STOP TAKING THE
TABLETS AND TELL YOUR DOCTOR OR PHARMACIST IMMEDIATELY.
THINGS YOU
SHOULD NOT DO
•
Do not give Melatonin MR-TEVA to anyone else, even if they have the
same c

Ficha técnica

Melatonin MR-TEVA (melatonin) version 2.0
1
AUSTRALIAN PRODUCT INFORMATION –
MELATONIN MR-TEVA
(MELATONIN)
MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Melatonin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Melatonin MR-TEVA 2 mg modified release tablets.
The active ingredient in Melatonin MR-TEVA modified release tablets is
a melatonin, NOT
of plant or animal origin.
Excipient with known effect: Contains Lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Modified release tablet.
White to off-white, oval, 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
with or soon after
food (or with a snack). This dosage may be continued for up to
thirteen weeks.
4.3
CONTRAINDICATIONS
Melatonin MR-TEVA modified release tablets are contraindicated in
patients with a
known hypersensitivity to any ingredient of the product (see Section
6.1 LIST OF
EXCIPIENTS.
Melatonin MR-TEVA (melatonin) version 2.0
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE DROWSINESS
Melatonin MR-TEVA 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.
AUTOIMMUNE DISEASES
No clinical data exist concerning the use of Melatonin MR-TEVA in
individuals with
autoimmune diseases. Therefore Melatonin MR-TEVA is not recommended
for use in patients
with autoimmune diseases.
EXCIPIENTS
The tablets contain lactose. Patients with rare hereditary problems of
galactose intolerance,
the LAPP lactase deficiency or glucose-galactose malabsorption should
not take this
medicine.
HEPATIC IMPAIRMENT
There is no experience of the use of Melatonin MR-TEVA in patients
with liver impairment.
Published data demonstrates markedly