BRINTELLIX vortioxetine (as hydrobromide) 5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vortioxetine hydrobromide, Quantity: 6.355 mg (Equivalent: vortioxetine, Qty 5 mg)

Available from:

Lundbeck Australia Pty Ltd

INN (International Name):

Vortioxetine hydrobromide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; hyprolose; sodium starch glycollate type A; mannitol; titanium dioxide; hypromellose; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

28 film-coated tablets - trade pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depressive disorder in adults including prevention of relapse. Vortioxetine is not indicated for paediatric use.

Product summary:

Visual Identification: Almond-shaped, biconvex, film-coated pink tablets engraved "TL" on one side and "5" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-03-31

Patient Information leaflet

BRINTELLIX
®
B
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t
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®
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 AM I USING BRINTELLIX?
Brintellix contains the active ingredient vortioxetine. Brintellix is
used to treat major depression in adults.
For more information, see Section 1. Why am I using Brintellix? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BRINTELLIX?
Do not use if you have ever had an allergic reaction to vortioxetine
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR
PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Brintellix? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Brintellix and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE BRINTELLIX?
•
Follow all directions given to you by your doctor or pharmacist
carefully.
•
Swallow the tablets whole with a full glass of water
More instructions can be found in Section 4. How do I use Brintellix?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BRINTELLIX?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Brintellix.
If you become pregnant while being
given this medicine, tell your doctor immediately.
THINGS YOU
SHOULD NOT DO
•
This medicine is prescribed to you by your doctor. Do not stop your
treatment without talking to your
doctor first
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Brintellix affects you.
DRINKING
ALCOHOL
•
Tell your doctor or pharmacist if you drink alcohol.
•
Avoid alcohol while you are taking Brintellix.
LOOKING AFTER
YOUR MEDICINE
•
Keep Brintellix in the blister pack until it is time to take

Summary of Product characteristics

BRINTELLIX
®
(vortioxetine hydrobromide)
1 of 25
REG_00032939
v. 29.0
AUSTRALIAN PRODUCT INFORMATION – BRINTELLIX
®
(VORTIOXETINE (AS HYDROBROMIDE)) FILM-COATED
TABLET
1
NAME OF THE MEDICINE
Vortioxetine hydrobromide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BRINTELLIX tablet contains 6.355, 12.71, 19.065, or 25.42 mg of
vortioxetine
hydrobromide equivalent to 5, 10, 15, or 20 mg of vortioxetine,
respectively.
BRINTELLIX film-coated tablets contain mannitol, microcrystalline
cellulose, hyprolose,
sodium starch glycollate type A, magnesium stearate, hypromellose,
titanium dioxide,
Macrogol 400, iron oxide red (5, 15 and 20 mg tablets) and iron oxide
yellow (10 and 15 mg
tablets). BRINTELLIX does not contain lactose, gluten, sucrose,
tartrazine or any other azo
dyes.
3
PHARMACEUTICAL FORM
_5 mg_
: Pink, almond-shaped, biconvex film-coated tablet engraved with
“TL” on one side and
“5” on the other side.
_10 mg_
: Yellow, almond-shaped, biconvex film-coated tablet engraved with
“TL” on one side
and “10” on the other side.
_15 mg_
: Orange, almond-shaped, biconvex film-coated tablet engraved with
“TL” on one side
and “15” on the other side.
_20 mg_
: Red, almond-shaped biconvex film-coated tablet engraved with
“TL” on one side and
“20” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder in adults including prevention
of relapse.
Vortioxetine is not indicated for paediatric use.
4.2
DOSE AND METHOD OF ADMINISTRATION
The starting and recommended dose of BRINTELLIX in adults less than 65
years of age is
10 mg once daily, taken with or without food. Depending on individual
patient response, the
dose may be increased to a maximum of 20 mg daily or reduced to a
minimum of 5 mg daily.
An antidepressant effect of BRINTELLIX based on the primary efficacy
measure was
generally observed starting at week 2. If the depressive symptoms
resolve, treatment for at
least 6 months is recommended for consolidation of the antidepressive
res