TERIFLUNOMIDE SANDOZ teriflunomide 14 mg film-coated tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

teriflunomide, Quantity: 14 mg

Prieinama:

Sandoz Pty Ltd

Vaisto forma:

Tablet, film coated

Sudėtis:

Excipient Ingredients: colloidal anhydrous silica; allura red AC aluminium lake; purified water; magnesium stearate; sodium starch glycollate type A; hypromellose; purified talc; maize starch; titanium dioxide; microcrystalline cellulose; glycerol; lactose monohydrate; hyprolose; indigo carmine aluminium lake; brilliant blue FCF aluminium lake

Vartojimo būdas:

Oral

Vienetai pakuotėje:

28

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

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.

Produkto santrauka:

Visual Identification: Blue coloured, round, biconvex film-coated tablets debossed with 14 on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizacija statusas:

Registered

Leidimo data:

2019-02-26

Pakuotės lapelis

Teriflunomide Sandoz®
1
TERIFLUNOMIDE SANDOZ®
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 SANDOZ?
Teriflunomide Sandoz contains the active ingredient teriflunomide.
Teriflunomide Sandoz is used to treat relapsing forms of
multiple sclerosis (MS). For more information, see Section 1. Why am I
using Teriflunomide Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TERIFLUNOMIDE SANDOZ?
Do not use if you have ever had an allergic reaction to Teriflunomide
Sandoz 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 Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Teriflunomide Sandoz 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 SANDOZ?
•
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 tablet whole with a glass of water.
More instructions can be found in Section 4. How do I use
Teriflunomide Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TERIFLUNOMIDE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Teriflunomide Sandoz.
•
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 using this medicine, 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 Sandoz
affects you.
DR

Prekės savybės

220429-Teriflunomide Sandoz-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
TERIFLUNOMIDE SANDOZ (TERIFLUNOMIDE)
1
NAME OF THE MEDICINE
Teriflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Teriflunomide film-coated tablet contains 14 mg of teriflunomide.
_Excipient(s) with known effect: _
Each tablet contains lactose monohydrate.
_ _
For the 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 Sandoz is a blue coloured, round, biconvex film-coated
tablet debossed with
‘14’ on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Teriflunomide Sandoz 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 Teriflunomide Sandoz is 14 mg orally once
daily.
Teriflunomide Sandoz can be taken with or without food.
Dosage adjustment in:

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).

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).

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
Sandoz should be used with caution in patients aged over 65 years.
220429-Teriflunomide Sandoz-pi
Page 2 of 24
SWITCHING PATIENTS FROM OR TO OTHER DISEASE MODIFYING THERAPIES
For recommendations related to switching patients from other disease
modifying therapies to
Teriflunomide Sandoz (see Section 4.4 Sp