PHARMACOR TERIFLUNOMIDE 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:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

10 tablets, 14 tablets, 28 tablets, 84 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

Pharmacor Teriflunomide (V – 03)
1
PHARMACOR TERIFLUNOMIDE
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 PHARMACOR TERIFLUNOMIDE?
Pharmacor Teriflunomide contains the active ingredient teriflunomide.
Pharmacor Teriflunomide is used to treat relapsing
forms of multiple sclerosis (MS).
For more information, see Section 1. Why am I using Pharmacor
Teriflunomide? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PHARMACOR TERIFLUNOMIDE?
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
Pharmacor Teriflunomide? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pharmacor Teriflunomide 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 PHARMACOR TERIFLUNOMIDE?
•
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 Pharmacor
Teriflunomide? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PHARMACOR TERIFLUNOMIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Pharmacor Teriflunomide.
•
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 Pharmacor Teriflunomide, or lower the dose, without
checking with your doctor.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machin

Summary of Product characteristics

Pharmacor Teriflunomide (V 05)
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR TERIFLUNOMIDE (TERIFLUNOMIDE) FILM-COATED 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
PHARMACOR TERIFLUNOMIDE 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
PHARMACOR TERIFLUNOMIDE 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 PHARMACOR TERIFLUNOMIDE is 14 mg orally once
daily. PHARMACOR
TERIFLUNOMIDE 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.
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, USE IN 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).
Pharmacor Teriflunomide (V 05)
Page 2 of 23
Switching Patients from or to Other Disease Modifying Therapies
For
recommendations
related
to
switching
patients
from
other
disease
modifying
therapies
to
PHARMACOR TERIFLUNOMIDE (see Section 4.4 Special Warnings and
Precautions for Use – Switching to
or