Melotin

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Melatonin 2mg;  

Prieinama:

Arrotex Pharmaceuticals (NZ) Limited

Dozė:

2 mg

Vaisto forma:

Modified release tablet

Sudėtis:

Active: Melatonin 2mg   Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Methacrylic acid copolymer Purified talc

Recepto tipas:

Prescription

Terapinės indikacijos:

Indicated as a monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 years and over.

Produkto santrauka:

Package - Contents - Shelf Life: Blister pack, Al/Al or PVC/PVDC/Al in outer cardboard carton - 7 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al in outer cardboard carton - 15 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al or PVC/PVDC/Al in outer cardboard carton - 21 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al or PVC/PVDC/Al in outer cardboard carton - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al in outer cardboard carton - 42 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al in outer cardboard carton - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/Al in outer cardboard carton - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Leidimo data:

2018-11-26

Pakuotės lapelis

MELOTIN PROLONGED RELEASE TABLET
_Melatonin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
MELATONIN.
IT IS PARTICULARLY IMPORTANT THAT
YOU READ THE SECTIONS "WHEN TO
TAKE IT" AND "HOW TO TAKE IT"
BEFORE YOU TAKE THIS MEDICINE.
The leaflet does not contain all
the information that is known
about
MELATONIN.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
MELATONIN against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT MELATONIN IS USED FOR
MELATONIN is used to improve
sleep quality and morning
alertness in patients over 55
years of age
with poor quality of
sleep.
The active substance of
MELATONIN, melatonin (not of
plant or animal origin), belongs to
a group of
naturally occurring
hormones produced in the body._ _
Melatonin works by controlling
the circadian rhythms and
increasing the propensity to
sleep.
Your doctor, however, may
prescribe MELATONIN for another purpose.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY QUESTIONS ABOUT
WHY IT HAS BEEN PRESCRIBED FOR
YOU.
This medicine is only available
with a doctor’s prescription. MELATONIN is not addictive.
BEFORE YOU USE MELATONIN
_WHEN YOU MUST NOT USE IT _
Do not take MELATONIN if you are
allergic to it or any of the
ingredients listed at the end of this
leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue
or other parts of the body, or rash,
itching or hives on the skin.
Do not take MELATONIN if you
have been drinking alcohol or
intend to drink alcohol or believe
that
you may have alcohol, in your
blood stream.
Do not take MELATONIN if you are
pregnant or breast-feeding.
MELATONIN has not been studied
in
pregnant or breast-feeding
women.
DO NO

Prekės savybės

1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Melotin 2mg Prolonged Release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg of melatonin.
Melotin contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Melotin 2 mg prolonged release tablets: White to off-white, round,
biconvex 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 is 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 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 is not recommended
for use in patients with hepatic impairment.
4.3
C
ONTRAINDICATIONS
Melatonin prolonged release tablets are contraindicated in patients
with a known hypersensitivity to
any ingredient of the product (see section 6.1 List of Excipients).
2
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
DROWSINESS
Melatonin 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 in individuals
with autoimmune diseases.
Therefore, Melatonin is not recommended for us