TERIMIDE teriflunomide 14 mg film-coated tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

teriflunomide, Quantity: 14 mg

Disponible depuis:

Alphapharm Pty Ltd

forme pharmaceutique:

Tablet, film coated

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

5,10,14,28,84

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

TERIMIDE 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 tablet debossed with "L" on one side and "598" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Registered

Date de l'autorisation:

2019-01-07

Notice patient

TERIMIDE
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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 TERIMIDE?
TERIMIDE contains the active ingredient teriflunomide. TERIMIDE is
used to treat relapsing forms of multiple sclerosis (MS).
For more information, see Section 1. Why am I using TERIMIDE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TERIMIDE?
Do not use if you have ever had an allergic reaction to teriflunomide
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
TERIMIDE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TERIMIDE 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 TERIMIDE?
•
The usual dose for this medicine is one 14 mg tablet per day. Your
doctor may have prescribed a different dose.
•
Swallow the tablets whole with a full glass of water.
More instructions can be found in Section 4. How do I use TERIMIDE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TERIMIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TERIMIDE.
•
If you become pregnant while taking this medicine, stop taking it and
tell your doctor or pharmacist
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how TERIMIDE affects you.
DRINKING
ALCOHOL
•
The effects of alcohol could be made worse while taking TERIMIDE. It
is recommended you minimise
your alcohol intake while taking this medicine.
LOOKING AFTER
YOUR MEDI

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION
TERIMIDE
®
_teriflunomide film coated tablets _
1
NAME OF THE MEDICINE
Teriflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 14 mg of teriflunomide as the active
ingredient.
Excipients with known effect: lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Film coated tablet. Pale blue to pastel blue, pentagonal film-coated
tablet debossed with “L” on one side and
“598” on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TERIMIDE is indicated for the treatment of patients with relapsing
forms of Multiple Sclerosis (MS) 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 TERIMIDE is 14 mg orally once daily. TERIMIDE
can be taken with or without
food.
SPECIAL POPULATIONS
_CHILDREN _
The safety and efficacy of TERIMIDE 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. TERIMIDE 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).
_SWITCHING PATIENTS FROM OR TO OTHER DISEASE MODIFYING THERAPIES _
For recommendations related to switching patients from other disease
modifying therapies to TERIMIDE (see
Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE - Switching to or
from teriflunomide
and Plasma Monitoring).
TERIMIDE – PRODUCT INFORMATION
2
4.3
CONTRAINDICATIONS
TERIMIDE must not be given to: