AKM RASAGILINE rasagiline (as mesilate) 1 mg tablet bottle 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:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

30, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AKM 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, uncoated round, flat, bevelled tablets debossed with "RAS" on one side and "1" on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-10-29

Patient Information leaflet

AKM RASAGILINE
®
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 AKM RASAGILINE?
AKM Rasagiline contains the active ingredient rasagiline (as
mesilate). AKM Rasagiline 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 AKM RASAGILINE? IN
THE FULL CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AKM RASAGILINE?
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
AKM Rasagiline? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AKM Rasagiline 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 AKM RASAGILINE?
• The usual dose for AKM Rasagiline is one tablet of 1 mg taken
orally once a day.
• Swallow the tablets whole with a full glass of water.
• AKM Rasagiline can be taken with or without food.
More instructions can be found in Section 4. How do I use AKM
Rasagiline? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AKM RASAGILINE?
THINGS
YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are using
AKM Rasagiline.

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 AKM Rasagiline 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

Summary of Product characteristics

Version 02
1
AUSTRALIAN PRODUCT INFORMATION
AKM RASAGILINE
(RASAGILINE MESILATE 1 MG TABLETS)
1 NAME OF THE MEDICINE
Rasagiline mesilate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Rasagiline mesilate is a white to off-white powder, freely soluble in
water or ethanol and
sparingly soluble in isopropanol.
Akm Rasagiline 1 mg tablets contain 1 mg Rasagiline (as mesilate)
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Tablets
Rasagiline (as mesilate) 1 mg tablets are white to off white, uncoated
round, flat bevelled
tablets debossed with "RAS" on one side and "1" on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Akm 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.
Version 02
2
_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 excipients.
Concomitant