AUBAGIO teriflunomide 14 mg film-coated tablets blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

teriflunomide, Quantity: 14 mg

Disponible depuis:

Sanofi-Aventis Australia Pty Ltd

DCI (Dénomination commune internationale):

Teriflunomide

forme pharmaceutique:

Tablet, film coated

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

14, 84, 28, 10, 5

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

AUBAGIO 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.

Descriptif du produit:

Visual Identification: pale blue to pastel blue pentagonal film-coated tablets with '14' imprint on one side and engraved with a logo on the other; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2012-11-14

Notice patient

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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 AUBAGIO?
Aubagio contains the active ingredient teriflunomide. Aubagio is used
to treat relapsing forms of multiple sclerosis (MS).
For more information, see Section 1. Why am I using Aubagio? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AUBAGIO?
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
Aubagio? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Aubagio 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 AUBAGIO?
•
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 Aubagio? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AUBAGIO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Aubagio.
•
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 Aubagio, 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 Aubagio affects you.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol. The effects of alcohol could be
made worse while taking Aubagio. It
is recommended that you minimise your alcohol

Résumé des caractéristiques du produit

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aubagio-ccdsv9-piv12-d2-27jan22
Page 1 of 27
DVCAUSTRALIAN PRODUCT INFORMATION – AUBAGIO
(TERIFLUNOMIDE)
1
NAME OF THE MEDICINE
Teriflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Aubagio 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.
Aubagio 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
Aubagio 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 Aubagio is 14mg orally once daily. Aubagio can
be taken with or
without food.
SPECIAL POPULATIONS
_Children _
The safety and efficacy of Aubagio in paediatric patients with MS
below the age of 18 years
has not yet been established.
_Elderly _
Clinical studies of Aubagio did not include patients over 65 years
old. Aubagio should be used
with caution in patients aged over 65 years.
.
aubagio-ccdsv9-piv12-d2-27jan22
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 other disease
modifying therapies to
Aubagio (see Section 4.4-Special Warnings and Precautions for use-
Switching to or from
Aubagio and Plasm