MELOTIN MR melatonin 2 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

melatonin, Quantity: 2 mg

Available from:

Generic Partners Pty Ltd

INN (International Name):

Melatonin

Pharmaceutical form:

Tablet, modified release

Composition:

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

Administration route:

Oral

Units in package:

30 tablets, 7 tablets, 21 tablets, 15 tablets

Prescription type:

(S3) Pharmacist 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 shaped tablet; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-04-04

Patient Information leaflet

MELOTIN MR
1
MELOTIN MR
ACTIVE INGREDIENT(S): _Melatonin _
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
MELOTIN MR. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING MELOTIN
MR.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
Why am I using MELOTIN MR?
2.
What should I know before I use MELOTIN MR?
3.
What if I am taking other medicines?
4.
How do I use MELOTIN MR?
5.
What should I know while using MELOTIN MR?
6.
Are there any side effects?
7.
Product details
1.
WHY AM I USING MELOTIN MR?
MELOTIN MR CONTAINS THE ACTIVE INGREDIENT MELATONIN.
Melatonin is a naturally occurring hormone produced in
the body.
It works by controlling the circadian rhythms and
increasing the propensity to sleep.
MELOTIN MR IS USED for the short term treatment of
primary insomnia characterized by poor quality of sleep in
patients who are aged 55 years of age or over
2.
WHAT SHOULD I KNOW BEFORE I USE
MELOTIN MR?
WARNINGS
DO NOT USE MELOTIN MR IF:
•
you are allergic to melatonin, or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can
use this medicine.
•
Do not use in adults or children under 55 years of age.
•
Alcohol should not be taken with melatonin. Do not
take melatonin if you have been drinking alcohol,
intend to drink alcohol or believe that you may have
alcohol in your blood stream.
CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU:
•
have any other medical conditions:
•
Liver problems
•
Kidney problems
•
An autoimmune disease
•
A hereditary problem of galactose intolerance,
LAP lactase deficiency or glucose-galactose
malabsorption
•
take any medicines for any other condition
During treatment, you may be at risk of developing certain
side effects. It is important you understand these risks and
how to monitor for them. See additional information
under Section 6. Are there any side effects?
PREGNANCY AND BREASTFEEDING
Check with y

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – MELOTIN MR (MELATONIN) MODIFIED
RELEASE TABLETS
1
NAME OF THE MEDICINE
Melatonin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MELOTIN MR 2mg modified release tablets.
The active ingredient in MELOTIN MR modified release tablets is a
melatonin NOT of plant or animal
origin.
EXCIPIENTS WITH KNOWN EFFECTS
MELOTIN MR contains lactose monohydrate
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MELOTIN MR modified release tablets 2 mg: White to off-white, round,
biconvex shaped tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE 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.
_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 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
C
ONTRAINDICATIONS
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
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
DROWSINESS
Melatonin modified release tablets 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 modified
release tablets