Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
solifenacin succinate, Quantity: 10 mg
Astellas Pharma Australia Pty Ltd
Solifenacin succinate
Tablet, film coated
Excipient Ingredients: hypromellose; lactose monohydrate; maize starch; magnesium stearate; titanium dioxide; macrogol 8000; purified talc; iron oxide red
Oral
10 tablets (sample pack), 30 tablets
(S4) Prescription Only Medicine
Vesicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
Visual Identification: Round, light pink film coated tablet marked with the Yamanouchi logo and "151" on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2006-08-28
VESICARE ® V e s i c a r e ® 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 VESICARE? VESICARE contains the active ingredient solifenacin succinate. VESICARE is used to treat the symptoms of overactive bladder. For more information, see Section 1. Why am I using VESICARE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE VESICARE? Do not use if you have ever had an allergic reaction to VESICARE or any of the ingredients listed at the end of the CMI. There are a number of circumstances in which a person should not use this medicine or may need to use caution. It is important to understand if these apply to you before taking VESICARE (see Section 2. What should I know before I use VESICARE? in the full CMI for more details) 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with VESICARE 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 VESICARE? • The usual dose is 5 to 10 mg of VESICARE once a day. Your doctor will decide the most suitable dose for you. • Talk to your doctor or pharmacist if you feel that the effect of VESICARE is too strong or too weak. More instructions can be found in Section 4. How do I use VESICARE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VESICARE? THINGS YOU SHOULD DO • Before starting any new medicine, tell your doctor or pharmacist that you are taking VESICARE. • Tell all the doctors, dentists and pharmacists who are treating you that you are taking VESICARE. • If you become pregnant while taking VESICARE, tell your doctor. • Visit your doctor regularly so they can check on your progress. THINGS YOU SHOULD NOT DO • Do not stop taking VESICARE, or lower the dose, without checking with your doctor. • Do not use VESICARE to treat any other conditions unless your doctor tells you to. • Do not give VESICARE to anyo read_full_document
1 AUSTRALIAN PRODUCT INFORMATION VESICARE ® (SOLIFENACIN SUCCINATE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE solifenacin succinate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vesicare 5 mg film-coated tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin. Vesicare 10 mg film-coated tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin. List of excipients with known effect lactose monohydrate For the full list of excipients, see Section 6.1 - LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tablet, film-coated. Vesicare 5 mg film-coated tablet is a round, light-yellow tablet marked with the logo and “150” on the same side. Vesicare 10 mg film-coated tablet is a round, light-pink tablet marked with the logo and “151” on the same side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Vesicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Adults, including the elderly The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to a maximum of 10 mg solifenacin succinate once daily. 2 Children and adolescents Safety and effectiveness in children have not yet been established. Therefore, Vesicare should not be used in children. Special populations Patients with renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 mL/min). Patients with severe renal impairment (creatinine clearance ≤ 30 mL/min) should be treated with caution and receive no more than 5 mg once daily. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh B) should be treated with caution and receive no more than 5 mg once daily. Vesicare is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Co-medication The maximum do read_full_document