TERIFLUNOMIDE DR.REDDY'S teriflunomide 14 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

teriflunomide, Quantity: 14 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: maize starch; magnesium stearate; hyprolose; silicon dioxide; lactose monohydrate; sodium starch glycollate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

5, 84, 28, 10, 14

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TERIFLUNOMIDE DR.REDDY'S 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.

Product summary:

Visual Identification: Blue coloured, pentagonal shaped, biconvex, film coated tablets, debossed with "14" on one side and "T" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-04-08

Patient Information leaflet

TERIFLUNOMIDE DR.REDDY
’
S
_Teriflunomide_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Teriflunomide
Dr.Reddy’s.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Teriflunomide Dr.Reddy’s against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TERIFLUNOMIDE
DR.REDDY’S IS USED FOR
Teriflunomide Dr.Reddy’s is used
to treat relapsing forms of multiple
sclerosis (MS).
The cause of MS is not yet known.
MS affects the central nervous
system (CNS) - the brain and spinal
cord. In MS, the body's immune
system reacts against its own myelin
(the 'insulation' or the protective
sheath surrounding nerve fibres).
With relapsing forms of MS, people
can have repeated attacks or relapses
of inflammation of the CNS from
time to time. Symptoms vary from
patient to patient and may include
blurred vision, weakness in the legs
or arms, or loss of control of bowel
or bladder function. These are
followed by periods of recovery.
Teriflunomide Dr.Reddy’s works by
selectively interfering with the
ability of white blood cells
(lymphocytes) to produce
the disease response and nerve
damage that ultimately leads to
relapses.
Teriflunomide Dr.Reddy’s has been
shown to reduce or decrease the
number of relapses and slow down
the progression of physical disability
in patients with relapsing forms of
MS. Although it is not a cure,
patients treated with Teriflunomide
Dr.Reddy’s generally find they will
have fewer relapses.
Your doctor, however, may have
prescribed Teriflunomide
Dr.Reddy’s for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU T

Summary of Product characteristics

PRODUCT INFORMATION
TERIFLUNOMIDE DR.REDDY’S (TERIFLUNOMIDE)
1
NAME OF THE MEDICINE
Teriflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Teriflunomide, is an oral
_de novo _
pyrimidine synthesis inhibitor of the dihydroorotate
dehydrogenase (DHO-DH) enzyme.
Teriflunomide is a white to almost white powder that is sparingly
soluble in acetone, slightly
soluble in polyethylene glycol and ethanol, very slightly soluble in
isopropanol and practically
insoluble in water. Teriflunomide has a pKa of 3.1 at room temperature
and its aqueous solubility
is pH dependent and decreases with lowering pH. Teriflunomide is Class
2 in the
Biopharmaceutics Classification System.
Teriflunomide is formulated as film-coated tablets for oral
administration. Each tablet contains
14
mg of teriflunomide.
Excipients with known effect: Each tablet contains 83.4 mg of lactose
monohydrate. For the full
list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TERIFLUNOMIDE DR.REDDY’S is available as a blue coloured, pentagonal
shaped, biconvex
film-coated tablet with “14”
debossed on one side and “T” on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TERIFLUNOMIDE DR.REDDY’S 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.
Page 1
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
The recommended dose of TERIFLUNOMIDE DR.REDDY’S is 14mg orally once
daily.
TERIFLUNOMIDE DR.REDDY’S 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
DR.REDDY’S 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.
Teriflun