MELOTIN melatonin 2 mg modified release tablet blister pack

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

melatonin, Quantity: 2 mg

Disponibbli minn:

Generic Partners Pty Ltd

INN (Isem Internazzjonali):

Melatonin

Għamla farmaċewtika:

Tablet, modified release

Kompożizzjoni:

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

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

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

Tip ta 'preskrizzjoni:

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

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

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; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2017-04-04

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

1
AUSTRALIAN PRODUCT INFORMATION – MELOTIN (MELATONIN) MODIFIED
RELEASE TABLETS
1
NAME OF THE MEDICINE
Melatonin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MELOTIN 2mg modified release tablets.
The active ingredient in MELOTIN prolonged release tablets is a
melatonin NOT of plant or animal
origin.
EXCIPIENTS WITH KNOWN EFFECTS
MELOTIN contains lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MELOTIN 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. 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 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
2
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.
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
produ