Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
rasagiline mesilate, Quantity: 1.56 mg (Equivalent: rasagiline, Qty 1 mg)
Pharmacor Pty Ltd
Tablet, uncoated
Excipient Ingredients: colloidal anhydrous silica; stearic acid; citric acid monohydrate; purified talc; maize starch; microcrystalline cellulose; pregelatinised maize starch
Oral
30, 10
(S4) Prescription Only Medicine
PHARMACOR 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.
Visual Identification: White to off white, uncoated round, flat, bevelled tablets debossed with "RAS" on one side and "1" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-10-29
PHARMACOR 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 PHARMACOR RASAGILINE? Pharmacor Rasagiline contains the active ingredient rasagiline (as mesilate). Pharmacor 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 PHARMACOR RASAGILINE? IN THE FULL CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PHARMACOR 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 Pharmacor Rasagiline? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Pharmacor 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 PHARMACOR RASAGILINE? • The usual dose for Pharmacor Rasagiline is one tablet of 1 mg taken orally once a day. • Swallow the tablets whole with a full glass of water. • Pharmacor Rasagiline can be taken with or without food. More instructions can be found in Section 4. How do I use Pharmacor Rasagiline? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PHARMACOR RASAGILINE? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using Pharmacor 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 Pharmacor Rasagiline to treat any other complaints unless your doctor tells you to. Do not give yo Read the complete document
Version 02 1 AUSTRALIAN PRODUCT INFORMATION PHARMACOR 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. Pharmacor 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 Pharmacor 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 excip Read the complete document