RASAGILINE LUPIN 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:

Generic Health Pty Ltd

Pharmaceutical form:

Tablet

Composition:

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

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

CONSUMER MEDICINE INFORMATION
RASAZIL
(RASAGILINE MESILATE) TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Rasazil. 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
Rasazil 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 RASAZIL IS USED FOR
Rasazil 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; and
•
slow and unsteady
movement.
In Parkinson’s disease, there is
a loss of cells producing
dopamine in certain areas in the
brain.
Rasazil 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.
Rasazil 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 RASAZIL
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE RASAZIL 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
RASAZIL, DO NOT TAKE ANOTHER
MEDICINE CALLED:
•
MONOAMINE OXIDASE
INHIBITORS (MAOI), WHETHER
USED TO TREAT

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – RASAZIL
(RASAGILINE MESILATE) TABLETS
1
NAME OF THE MEDICINE
Rasagiline mesilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as mesilate).
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).
Rasazil v3.0
Page 2 of 23
(rasagiline mesilate) tablets
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 excipients.
Concomitant treatment with monoamine oxidase inhibitors (MAOIs) should
be avoided (see SECTION 4.5
INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). At
least 14 days