TERIFLUNOMIDE SANOFI teriflunomide 14 mg film-coated tablets blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

teriflunomide

Beschikbaar vanaf:

Sanofi-Aventis Australia Pty Ltd

INN (Algemene Internationale Benaming):

Teriflunomide

Autorisatie-status:

Registered

Bijsluiter

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

Productkenmerken

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Teriflunomide Sanofi-ccdsv8-piv9-17sep20
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION – TERIFLUNOMIDE
SANOFI (TERIFLUNOMIDE)
1
NAME OF THE MEDICINE
Teriflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Teriflunomide Sanofi tablet contains 14 mg teriflunomide.
Excipient with known effect: lactose monohydrate
For full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Teriflunomide is formulated as film-coated tablets for oral
administration
Teriflunomide Sanofi is available as
pale blue to pastel blue, pentagonal film-coated tablets
with “14” imprinted on one side and engraved with a logo on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teriflunomide Sanofi 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 Sanofi is 14mg orally once
daily. Teriflunomide
Sanofi can be taken with or without food.
SPECIAL POPULATIONS
_CHILDREN _
The safety and efficacy of Teriflunomide Sanofi in paediatric patients
with MS below the age
of 18 years has not yet been established.
_ELDERLY _
Clinical studies of Teriflunomide Sanofi did not include patients over
65 years old.
Teriflunomide Sanofi should be used with caution in patients aged over
65 years.
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Teriflunomide Sanofi-ccdsv8-piv9-17sep20
Page 2 of 27
_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 o