RASAGILINE SANDOZ 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:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; maize starch; silicon dioxide; citric acid; pregelatinised starch; purified talc; stearic acid

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RASAGILINE SANDOZ 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, round, flat bevelled tablets debossed with C13 on one side and plain on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-12-23

Patient Information leaflet

Rasagiline Sandoz® Tablets
1
RASAGILINE SANDOZ® TABLETS
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 RASAGILINE SANDOZ?
Rasagiline Sandoz contains the active ingredient rasagiline mesilate.
Rasagiline Sandoz is used to treat the symptoms of
Parkinson’s disease. It can be taken with or without dopamine
agonist or levodopa therapy. For more information, see Section
1. Why am I using Rasagiline Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RASAGILINE SANDOZ?
Do not use if you have ever had an allergic reaction to rasagiline 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 Rasagiline Sandoz? in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rasagiline 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 RASAGILINE SANDOZ?
•
Your doctor will tell you how much Rasagiline Sandoz to take each day.
The usual dose is one tablet of 1 mg taken orally
once a day.
•
Swallow the tablet whole by mouth, with or without food, with a full
glass of water and take Rasagiline Sandoz at about
the same time each day
More instructions can be found in Section 4. How do I use Rasagiline
Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RASAGILINE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Rasagiline Sandoz.
•
If you become pregnant while using Rasagiline Sandoz, tell your doctor
immediately.
•
If you are about to be started on any new medicine, tell your doctor
and pharmacist you are taking
Rasagiline Sandoz.
THINGS YOU
SHOULD NOT DO
•
Do not ta

Summary of Product characteristics

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Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
RASAGILINE SANDOZ
® (RASAGILINE) TABLET
1.
NAME OF THE MEDICINE
Rasagiline
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RASAGILINE SANDOZ tablet 1mg: Each tablet contains rasagiline 1 mg (as
mesilate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
White to off-white, round, flat, bevelled tablets, debossed with
“C13” on one side and plain on
the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
RASAGILINE SANDOZ 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.
D
OSE 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.
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Page 2 of 23
4.3.
C
ONTRAINDICATIONS
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