BELSOMRA suvorexant 20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

suvorexant, Quantity: 20 mg

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

suvorexant

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; copovidone; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; triacetin

Administration route:

Oral

Units in package:

30 tablets, 10 tablets, 3 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BELSOMRA is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. Following initiation of treatment, continuation should be re-evaluated after 3 months [see Pharmacodynamic Properties, Clinical trials and Adverse Effects (Undesirable Effects) for clinical trial durations].

Product summary:

Visual Identification: White, round, biconvex, film coated tablet, marked with MSD logo and 335 on one side, and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-11-16

Patient Information leaflet

BELSOMRA
®
_Suvorexant_
CONSUMER MEDICINE INFORMATION SUMMARY
This summary answers some common questions about BELSOMRA. It does not
contain all the available information.
Comprehensive Consumer Medicine Information follows this summary.
WHAT BELSOMRA IS
USED FOR AND HOW
BELSOMRA WORKS
BELSOMRA is a medicine called
Orexin Receptor Antagonist.
BELSOMRA is used to treat a sleep
problem called insomnia, which
includes problems falling asleep and/
or staying asleep. BELSOMRA helps
you to go to sleep and stay asleep by
temporarily blocking wakefulness,
enabling sleep to occur.
BEFORE YOU TAKE
BELSOMRA
DO NOT TAKE BELSOMRA IF:
•
YOU FALL ASLEEP OFTEN AT
UNEXPECTED TIMES (NARCOLEPSY).
•
YOU ARE ALLERGIC TO SUVOREXANT
OR ANY OF THE OTHER INGREDIENTS
OF BELSOMRA LISTED AT THE
END OF THIS LEAFLET.
BEFORE STARTING BELSOMRA, TELL
YOUR DOCTOR ABOUT ALL OF YOUR
HEALTH CONDITIONS, INCLUDING IF YOU:
•
have a history of a sudden onset
of muscle weakness (cataplexy)
•
have a history of falling asleep
often at unexpected times
(narcolepsy) or daytime
sleepiness
•
have a history of depression,
mental illness, or suicidal
thoughts
•
have a history of drug or alcohol
abuse or addiction. BELSOMRA
may be abused or misused
•
have liver disease
•
have a lung disease or breathing
problems
TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR IF YOU ARE
BREASTFEEDING OR PLAN TO BREAST-
FEED.
Your doctor will discuss with you the
risks and benefits involved.
TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE TAKING ANY OTHER
MEDICINES, INCLUDING MEDICINES,
VITAMINS AND HERBAL SUPPLEMENTS
THAT YOU BUY WITHOUT A
PRESCRIPTION.
Medicines that should not be taken
with BELSOMRA include but are
not limited to clarithromycin,
erythromycin, fluconazole,
itraconazole, diltiazem, verapamil
and certain medicines to treat HIV.
HOW TO TAKE
BELSOMRA
TAKE BELSOMRA EXACTLY AS YOUR
DOCTOR TELLS YOU.
•
The recommended dose for non-
elderly adults (younger than 65
years) is one 20 mg tablet.
•
The recommended dose for
elde

Summary of Product characteristics

Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
BELSOMRA
® (SUVOREXANT)
1
NAME OF THE MEDICINE
suvorexant
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BELSOMRA tablets contain the active ingredient suvorexant.
BELSOMRA is available for oral use as film-coated tablets containing
15 or 20 mg of
suvorexant.
List of excipients with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
BELSOMRA (suvorexant) 15 mg: is a white, oval, biconvex, film coated
tablet, marked with "
" on one side and 325 on the other side.
BELSOMRA (suvorexant) 20 mg: is a white, round, biconvex, film coated
tablet, marked with
"
" and 335 on one side, and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BELSOMRA is indicated for the treatment of insomnia, characterised by
difficulties with sleep
onset and/or sleep maintenance.
Following initiation of treatment, continuation should be re-evaluated
after 3 months [see
Section 5.1 Pharmacodynamic Properties, Clinical trials and Section
4.8 Adverse Effects
(Undesirable Effects) for clinical trial durations].
4.2
DOSE AND METHOD OF ADMINISTRATION
BELSOMRA may be taken with or without food.
BELSOMRA should be taken no more than once per night and within 30
minutes of going to
bed, with at least 7 hours remaining before the planned time of
awakening.
FOR DOSAGE IN NON-ELDERLY ADULTS (<65YEARS) AND ELDERLY ADULTS (≥65
YEARS):
The recommended dose is 20 mg for non-elderly adults and 15 mg for
elderly adults.
This dose should not be exceeded. Higher doses (30 mg and 40 mg) were
found to have
similar efficacy to lower doses (15 mg and 20 mg) but significantly
more adverse effects were
reported at the higher doses [see Section 5.1 Pharmacodynamic
Properties, Clinical trials and
Section 4.8 Adverse Effects (Undesirable Effects)].
FOR USE WITH STRONG OR MODERATE CYP3A INHIBITORS:
BELSOMRA is not recommended for patients taking concomitant strong or
moderate CYP3A
inhibitors as the exposure to suvorexant is incre