SLENYTO melatonin 1 mg prolonged release tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

melatonin, Quantity: 1 mg

Sẵn có từ:

RAD Data Australia Pty Ltd

Dạng dược phẩm:

Tablet, modified release

Thành phần:

Excipient Ingredients: ammonio methacrylate copolymer; calcium hydrogen phosphate dihydrate; lactose monohydrate; colloidal anhydrous silica; purified talc; magnesium stearate; titanium dioxide; glucose monohydrate; maltodextrin; iron oxide yellow; iron oxide red; lecithin; carmellose sodium

Tuyến hành chính:

Oral

Các đơn vị trong gói:

30 tablets (Starter pack), 30 tablets (Trade pack), 60

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

SLENYTO is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

Tóm tắt sản phẩm:

Visual Identification: Pink, round, bi-convex, 3 mm diameter tablets with no imprint.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2020-05-22

Tờ rơi thông tin

SLENYTO
®
1
SLENYTO®
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 DO I OR MY CHILD NEED SLENYTO?
SLENYTO contains the active ingredient melatonin. SLENYTO is used for
the treatment of insomnia in children and adolescents
aged 2-18 with Autism Spectrum Disorder (ASD) and or Smith-Magenis
syndrome. For more information, see Section 1. Why do I
or my child use SLENYTO? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I OR MY CHILD TAKE SLENYTO?
Do not use if you or your child ever had an allergic reaction to
SLENYTO or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAS ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, IF YOU ARE PREGNANT OR PLAN
TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section 2. What should I know before I or my child use
SLENYTO? in the full CMI.
3.
WHAT IF I OR MY CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with SLENYTO and affect how it works. A
list of these medicines is in Section 3. What if I or my
child is taking other medicines? in the full CMI.
4.
HOW DO I TAKE SLENYTO?
•
The recommended starting dose is 2 mg (two 1 mg tablets) once daily.
If there is no improvement in you/your child’s
symptoms, your doctor may increase the dose of SLENYTO to find the
most suitable dose for you/your child.
•
SLENYTO is for oral use. Swallow your tablet whole with a full glass
of water. If your child has difficulty swallowing tablets,
the whole tablets can be put into food like yoghurt, orange juice or
ice-cream to help with swallowing.
More instructions can be found in Section 4. How do I use SLENYTO? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE I OR MY CHILD IS TAKING SLENYTO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you or your
child is using SLENYTO.
•
If you become pregnant while taking SLENYTO, stop taking the tablets
and tell

Đặc tính sản phẩm

SLENYTO_PI_28 June 2021
1
AUSTRALIAN PRODUCT INFORMATION – SLENYTO
® PROLONGED
RELEASE TABLETS (MELATONIN)
1
NAME OF THE MEDICINE
Melatonin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SLENYTO 1 mg and 5 mg prolonged release tablets.
The active ingredient in SLENYTO prolonged release tablets is a
melatonin NOT of plant or
animal origin.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SLENYTO 1 mg prolonged release tablets:
Pink, film coated, round, biconvex, 3 mm diameter tablets with no
imprint.
SLENYTO 5 mg prolonged release tablets:
Yellow, film coated, round, biconvex, 3 mm diameter tablets with no
imprint.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SLENYTO is indicated for the treatment of insomnia in children and
adolescents aged 2-18
with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome,
where sleep
hygiene measures have been insufficient.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended starting daily dose is 2 mg of SLENYTO. If an
inadequate response has
been observed, the daily dose should be increased to 5 mg, with a
maximal dose of 10 mg. In
the clinical study, the treatment with 10 mg of melatonin was required
only for a small group
of children. The magnitude of increase in Total Sleep Time with 10 mg
was not the same as
SLENYTO_PI_28 June 2021
2
with 2 mg and 5 mg doses of melatonin
(see also section 5.1 Pharmacodynamic properties,
Clinical trials).
SLENYTO should be taken once daily, 0.5-1 hour before bedtime and with
or after food.
Data is available for up to 2 year’s treatment. The patient should
be monitored at regular
intervals (at least every 6 months) to check that SLENYTO is still the
most appropriate
treatment. After at least 3 months of treatment, the physician should
evaluate the treatment
effect and consider stopping treatment if no clinically relevant
treatment effect is seen. If a
lower treatment effect is seen after titration to a higher dose, the
prescribe