Hetlioz

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

tasimelteon

Διαθέσιμο από:

Vanda Pharmaceuticals Netherlands B.V.

Φαρμακολογική κατηγορία (ATC):

N05CH

INN (Διεθνής Όνομα):

tasimelteon

Θεραπευτική ομάδα:

Psycholeptics

Θεραπευτική περιοχή:

Sleep Disorders, Circadian Rhythm

Θεραπευτικές ενδείξεις:

Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.,

Περίληψη προϊόντος:

Revision: 9

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-07-03

Φύλλο οδηγιών χρήσης

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HETLIOZ 20 MG HARD CAPSULES
tasimelteon
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What HETLIOZ is and what it is used for
2.
What you need to know before you take HETLIOZ
3.
How to take HETLIOZ
4.
Possible side effects
5.
How to store HETLIOZ
6.
Contents of the pack and other information
1.
WHAT HETLIOZ IS AND WHAT IT IS USED FOR
HETLIOZ contains the active substance tasimelteon. This type of
medicine is called a “melatonin agonist”
that acts as a regulator of daily body rhythms.
It is used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
who are totally blind.
HOW HETLIOZ WORKS
In sighted people, the change in light levels between day and night
helps to synchronise internal body
rhythms, including feeling sleepy at night and being active during the
day. The body controls these rhythms
through many pathways including increases and decreases in the
production of the hormone melatonin.
Patients with Non-24 who are totally blind cannot see light, so their
body rhythms shift out of alignment with
the 24-hour world, resulting in periods of feeling sleepy during the
day and the inability to sleep at night. The
active substance in HETLIOZ, tasimelteon, is able to act as a
time-keeper for the body rhythms and resets
them each day. It aligns body rhythms with the usual 24-hour day and
night cycle and so improve sleep
patterns. Because of individual differences in each person’s body
rhythms, it could take weeks or up t

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
HETLIOZ 20 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 20 mg tasimelteon.
Excipients with known effect
Each hard capsule contains 183.25 mg of lactose (as anhydrous) and
0.03 mg of Orange Yellow S (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Dark blue opaque, hard capsule (dimensions 19.4 mm x 6.9 mm) marked
with ‘VANDA 20 mg’ in white
ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake
Disorder (Non-24) in totally blind
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Dose and timing _
The recommended dose is 20 mg (1 capsule) tasimelteon per day taken
one hour before bedtime, at the same
time every night.
HETLIOZ is intended for chronic use.
_Elderly _
No dose adjustment is recommended for individuals older than 65 years
of age (see section 5.2).
_Renal impairment _
No dose adjustment is recommended for patients with renal impairment
(see section 5.2).
_Hepatic impairment _
3
No dose adjustment is necessary for patients with mild or moderate
hepatic impairment (see section 5.2).
Tasimelteon has not been studied in patients with severe hepatic
impairment (Child-Pugh Class C); therefore
caution is recommended when prescribing tasimelteon to patients with
severe hepatic impairment.
_ _
_Paediatric population _
The safety and efficacy of tasimelteon in children and adolescents
aged 0 to 18 years have not been
established. No data are available.
Method of administration
Oral use. Hard capsules should be swallowed whole. Avoid breaking as
the powder has an unpleasant taste.
Tasimelteon should be taken without food; if patients eat a high-fat
meal, it is recommended to wait at least 2
hours before taking tasimelteon (see section 5.2).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNIN