SLENYTO 5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MELATONIN

Available from:

NEURIM PHARMACEUTICALS (1991) LTD, ISRAEL

ATC code:

N05CH01

Pharmaceutical form:

TABLETS PROLONGED RELEASE

Composition:

MELATONIN 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NEURIM PHARMACEUTICALS LIMITED

Therapeutic area:

MELATONIN

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.

Authorization date:

2020-11-15

Patient Information leaflet

[לוגו מדינת ישראל] [http://www.gov.il/]
[http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד
הבריאות] [*5400]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
הציבור הרחב עסקים ומוסדות עובדים
בבריאות חפש מידע
תפריט *
[סגירה]
סגור *
דף הבית [http://www.health.gov.il/] *
אודות *
אודות המשרד
[http://www.health.gov.il/About/Pages/about_us.aspx] *
תוכנית עבודה
[http://www.health.gov.il/About/Pages/Agenda.aspx] *
תקציב המשרד
[http://www.health.gov.il/About/Pages/budget.aspx] *
תרשים מבנה ארגוני
[http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] *
בעלי תפקידים
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] *
אמנת שירות
[http://www.health.gov.il/About/sla/Pages/default.aspx] *
אותות ופרסים
[http://www.health.gov.il/About/Awards/Pages/mifal.aspx] *
פרוייקטים תשתיתיים
[http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] *
דרושים
[http://www.health.gov.il/About/Careers/Pages/default.aspx] *
מנכ"לי משרד הבריאות לדורותיהם
[http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] *
יחידות המשרד *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] *
וועדות ומועצות
[http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] *
נושאים *
בריאות הנפש
[http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] *
בריאות הסביבה
[http://www.health.gov.il/Subjects/Environmental_Health/

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Slenyto 1 mg prolonged-release tablets
Slenyto 5 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Slenyto 1 mg prolonged-release tablets
Each prolonged-release tablet contains 1 mg melatonin.
Excipient with known effect
Each prolonged-release tablet contains lactose monohydrate equivalent
to 8.32 mg lactose.
Slenyto 5 mg prolonged-release tablets
Each prolonged-release tablet contains 5 mg melatonin.
Excipient with known effect
Each prolonged-release tablet contains lactose monohydrate equivalent
to 8.86 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged- release tablet.
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
Posology and method of administration
Posology
2
The recommended starting dose is 2 mg of Slenyto. If an inadequate
response has been observed, the
dose should be increased to 5 mg, with a maximal dose of 10 mg.
Slenyto should be taken once daily, 0.5-1 hour before bedtime and with
or after food.
Data are available for up to 2 years’ 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 prescriber should first consider a
down-titration to a lower dose before
deciding on a complete d