RASALECT 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:

Teva Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: stearic acid; purified talc; mannitol; colloidal anhydrous silica; maize starch; pregelatinised maize starch

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RASALECT 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 GIL + 1 on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-07-30

Patient Information leaflet

RASALECT™
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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 RASALECT?
RASALECT contains the active ingredient rasagiline (as mesilate).
RASALECT 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 RASALECT? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RASALECT?
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
RASALECT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with RASALECT 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 RASALECT?
•
The usual dose for RASALECT is one tablet of 1 mg taken orally once a
day.
•
Swallow the tablets whole with a full glass of water.
•
RASALECT can be taken with or without food.
More instructions can be found in Section 4. How do I use RASALECT? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RASALECT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
RASALECT.
•
Tell your doctor if you notice any unusual skin lumps or moles which
are new or have changed.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine without first checking with your
doctor.
•
Do not take RASALECT to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if their symptoms seem
similar to yours.
DRIVING
OR USING
M

Summary of Product characteristics

Rasalect PI V2
Based on CCSI_752_03_03_17
Page 1
AUSTRALIAN PRODUCT INFORMATION – RASALECT™ (RASAGILINE)
1
NAME OF THE MEDICINE
Rasagiline 1 mg tablets
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, round, flat, bevelled tablets, debossed with
“GIL” and “1” underneath on one side
and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
RASALECT 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.
Rasalect PI V2
Based on CCSI_752_03_03_17
Page 2
PATIENTS WITH HEPATIC IMPAIRMENT
Rasagiline should not be used in patients with hepatic insufficiency
(SEE SECTION 4.3).
PATIENTS WITH RENAL IMPAIRMENT
No change in dosage is required for moderate renal impairment.
4.3
C
ONTRAINDICATIONS
Rasagiline is contrai