TERIFLUNOMIDE GH teriflunomide 14 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

teriflunomide, Quantity: 14 mg

Available from:

Generic Health Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

84 tablets, 28 tablets, 10 tablets, 14 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

Teriflunomide GH v4
1
TERIFLUNOMIDE GH
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 TAKING TERIFLUNOMIDE GH?
Aubagio Teriflunomide GH contains the active ingredient teriflunomide.
Aubagio Teriflunomide GH is used to treat relapsing
forms of multiple sclerosis (MS).
For more information, see Section 1. Why am I taking Teriflunomide GH?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE TERIFLUNOMIDE GH?
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 take
Teriflunomide GH? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Teriflunomide GH 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 TAKE TERIFLUNOMIDE GH?
•
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 take
Teriflunomide GH? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING TERIFLUNOMIDE GH?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Teriflunomide GH.
•
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
Teriflunomide GH, 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 Teriflunomide GH affects
you.
DRINKING
ALCOHOL
•

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – TERIFLUNOMIDE GH
(TERIFLUNOMIDE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Teriflunomide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 14 mg teriflunomide.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Teriflunomide GH 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 THERAPEUTIC INDICATIONS
Teriflunomide GH 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 DOSE AND METHOD OF ADMINISTRATION
The recommended dose of Teriflunomide GH is 14 mg orally once daily.
Teriflunomide GH 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.
Teriflunomide GH v5
Page 2 of 24
(teriflunomide) film-coated tablets
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 – USE IN RENAL IMPAIRMENT).
Switching Patients from or to Other Disease Modifying Therapies
For
recommendations
related
to
switching
patients
from
other
disease
modifying
therapies
to
Teriflunomide GH (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE – SWITCHING TO OR FROM
TERIFLUNOMIDE GH and SECTION 4.4 SPECIA