ALZIRAS rasagiline (as mesilate) 1 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rasagiline mesilate, Quantity: 1.56 mg (Equivalent: rasagiline, Qty 1 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: citric acid monohydrate; pregelatinised maize starch; purified talc; colloidal anhydrous silica; microcrystalline cellulose; stearic acid; maize starch

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rasagiline is indicated for the symptomatic treatment of idiopathic Parkinson?s disease (PD) as monotherapy and as adjunct therapy to dopamine agonists or to levodopa.

Product summary:

Visual Identification: White to off-white, circular, flat faced, beveled edge, uncoated tablets, "1" debossed on one face with the other face plain.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-09-13

Patient Information leaflet

1
ALZIRAS
Rasagiline mesilate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Alziras.
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 Alziras 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 ALZIRAS IS USED FOR
Alziras is used to treat the
symptoms of Parkinson’s
disease. It can be taken
with or without dopamine
agonist or levodopa
therapy.
Parkinson's disease is a
condition of the brain that
mainly affects body
movement. The three
main symptoms of
Parkinson's disease are:

Shaking (tremor)

Muscle stiffness

Slow and unsteady
movement
In Parkinson's disease,
there is a loss of cells
producing dopamine in
certain areas in the brain.
Alziras
works
by
increasing
and
maintaining
the
level
of
dopamine
in
your
brain
which
will
decrease
symptoms of Parkinson's
disease.
ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS
ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have
prescribed it for another
reason.
This medicine is available
only with a doctor’s
prescription. It is not
addictive.
Alziras should not be
given to children under 18
years of age as there is no
specific information about
such use. Always ask
your doctor before giving
medicines to children.
BEFORE YOU TAKE ALZIRAS
_ _
_WHEN YOU MUST NOT _
_TAKE IT. _
DO NOT TAKE ALZIRAS IF
YOU HAVE EVER HAD AN
ALLERGIC REACTION TO
RASAGILINE OR ANY OF THE
INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
If you have an allergic
reaction you may get a
skin rash, have difficulty
in breathing, get
symptoms of hay fever or
feel faint.
IF YOU ARE ALREADY
TAKING ALZIRAS, DO NOT
TAKE ANOTHER MEDICINE
CALLED:

MONOAMINE OXIDASE
INHIBITORS (MAOI),
WHETHER USED TO
TREAT DEPRESSION,
PAR

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - ALZIRAS (RASAGILINE)
1. NAME OF THE MEDICINE
Rasagiline mesilate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as mesilate)
Rasagiline mesilate is a white to off-white powder, freely soluble in
water or ethanol and
sparingly soluble in isopropanol
Dissociation Constant: pKa (R
2
NH
2
+
/R
2
NH) = 7.4
Partition Coefficient (Log P): Octanol/Water
pH
1.2
5.0
7.0
7.4
Log P
-1.10
0.09
1.56
1.84
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
White to off-white, circular, flat faced, beveled edge, uncoated
tablets, “1” debossed on one face
with the other face plain.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline is indicated for the symptomatic treatment of idiopathic
Parkinson’s disease (PD) as
monotherapy and as adjunct therapy to dopamine agonists or to
levodopa.
4.2 DOSE AND METHOD OF ADMINISTRATION
Rasagiline should be administered orally, at a dose of 1 mg once daily
in both monotherapy and
adjunct therapy. It may be taken with or without food. Clinical trials
have demonstrated no
efficacy advantage for higher doses of rasagiline.
Change of levodopa dose in adjunct therapy: When rasagiline is used in
combination with
levodopa, a reduction of the levodopa dosage may be considered based
upon individual response.
ELDERLY PATIENTS (>65 YEARS)
No change in dosage is required for elderly patients.
Rasagiline was shown to be well-tolerated in elderly PD patients in
both monotherapy and
adjunct therapy.
CHILDREN AND ADOLESCENTS (<18 YEARS)
Not recommended as the safety and efficacy have not been established
in this population.
PATIENTS WITH HEPATIC IMPAIRMENT
Rasagiline
should
not
be
used
in
patients
with
hepatic
insufficiency
(SEE
SECTION
4.3
CONTRAINDICATIONS).
PATIENTS WITH RENAL IMPAIRMENT
No change in dosage is required for moderate renal impairment.
4.3 CONTRAINDICATIONS:
Rasagiline is contraindicated for use in patients who have
demonstrated hypersensitivity to
rasagiline or tablet