TERIFLAGIO teriflunomide 14 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

teriflunomide, Quantity: 14 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; maize starch; microcrystalline cellulose; hyprolose; sodium starch glycollate type A; titanium dioxide; macrogol 8000; hypromellose; purified talc; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

28 tablets, 84 tablets, 14 tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

Product summary:

Visual Identification: Blue coloured, pentagonal shaped, film coated tablet, debossed with "T2" on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-05-24

Patient Information leaflet

TERIFLAGIO
Teriflagio
1
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
Teriflagio contains the active ingredient teriflunomide. Teriflagio is
used to treat relapsing forms of multiple sclerosis (MS).
For more information, see Section 1. Why am I using Teriflagio? in the
full CMI.
Do not use if you have ever had an allergic reaction to teriflunomide,
leflunomide or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR 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
Teriflagio? in the full CMI.
Some medicines may interfere with Teriflagio 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.
•
Follow all directions given to you by your doctor and pharmacist
carefully. The usual dose for this medicine is one 14 mg tablet
per day. Swallow the tablet whole with a glass of water.
More instructions can be found in Section 4. How do I use Teriflagio?
in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Teriflagio.
•
If you become pregnant while you are taking this medicine, stop taking
it and tell your doctor
or pharmacist immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking Teriflagio, or lower the dose, without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Teriflagio affects you.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol. The effects of alcohol could be
made worse while taking Teriflagio.
It is recommended that you minimise your alcohol intake while taking
Teriflagio.
LOOKING AFTER
YOUR MEDICINE
•
Keep the medicine in a cool dry place where the temperature stays
below 25°C.
•
Keep your tablets in the container until it is ti

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – TERIFLAGIO
(TERIFLUNOMIDE) TABLET
1
NAME OF THE MEDICINE
Teriflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Teriflunomide 14 mg per tablet
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_TERIFLAGIO _
_14 _
_mg _
_film-coated _
_tablets: _
Blue
coloured,
pentagonal
shaped,
film
coated
tablet,
debossed with "T2" on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Teriflagio is indicated for the treatment of patients with relapsing
forms of Multiple Sclerosis to reduce
the frequency of clinical relapses and to delay the progression of
physical disability.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose of Teriflagio is 14 mg orally once daily.
Teriflagio can be taken with or without
food.
SPECIAL POPULATIONS
_CHILDREN_
The safety and efficacy of teriflunomide in paediatric patients with
MS below the age of 18 years has
not yet been established.
_ELDERLY_
Clinical studies of teriflunomide did not include patients over 65
years old. Teriflunomide should be
used with caution in patients aged over 65 years.
2
_HEPATIC IMPAIRMENT _
No
dosage
adjustment
is
necessary
for
patients
with
mild
or
moderate
hepatic
impairment.
Teriflunomide is contraindicated in patients with severe hepatic
impairment (see section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE- Hepatic Impairment).
_RENAL IMPAIRMENT _
No dosage adjustment is necessary for patients with severe renal
impairment (see section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE – Renal impairment).
_SWITCHING PATIENTS FROM OR TO OTHER DISEASE MODIFYING THERAPIES _
For recommendations related to switching patients from other disease
modifying therapies to
Teriflagio (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE -
Switching to or from
Teriflagio and Plasma Monitoring).
4.3
C
ONTRAINDICATIONS
Teriflagio must not be given to:
-
patients with hypersensitivity to leflunomide, teriflunom