Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
solifenacin succinate, Quantity: 10 mg
Arrow Pharma Pty Ltd
Tablet, film coated
Excipient Ingredients: maize starch; lactose monohydrate; magnesium stearate; hypromellose; titanium dioxide; macrogol 6000; purified talc; iron oxide red
Oral
30 tablets
(S4) Prescription Only Medicine
SOLICARE is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
Visual Identification: Light pink colored, round, biconvex, film coated tablets, debossed with "EG" on one side and "2" on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-05-29
Solicare draft v0.2 Page 1 of 4 (solifenacin succinate) tablet, film coated SOLICARE 5 MG AND 10 MG FILM-COATED TABLETS _contains the active ingredient solifenacin succinate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet answers some common questions about Solicare. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Solicare against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT SOLICARE IS USED FOR Solicare is used to treat the symptoms of overactive bladder. These symptoms include needing to rush to the toilet to urinate without warning, needing to urinate frequently, or wetting yourself because you did not get to the toilet in time. Solicare belongs to a group of medicines called anticholinergic medicines. It works by acting on specialised cells to reduce the activity of your bladder and help you control your bladder. Your doctor may have prescribed Solicare for another reason. Ask your doctor if you have any questions about why Solicare has been prescribed for you. Solicare is available only with a doctor's prescription. There is no evidence that Solicare is addictive. BEFORE YOU TAKE SOLICARE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SOLICARE IF YOU ARE ALLERGIC TO MEDICINES CONTAINING SOLIFENACIN OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath. DO NOT TAKE SOLICARE IF YOU: • suffer from urinary retention (inability to urinate or empty your bladder completely) • are undergoing haemodial Läs hela dokumentet
Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION – SOLICARE (SOLIFENACIN SUCCINATE) TABLET 1 NAME OF THE MEDICINE Solifenacin succinate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Solicare 5 mg film-coated tablet: each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin. Solicare 10 mg film-coated tablet: each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin. List of excipients with known effect: sulfites and lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solicare 5 mg film-coated tablets: each 5 mg tablet is a light yellow coloured, round, biconvex, film coated tablet, debossed with “EG” on one side and “1” on other side. Solicare 10 mg film-coated tablets: each 10 mg tablet is a light pink coloured, round, biconvex, film coated tablet, debossed with “EG” on one side and “2” on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency. 4.2 DOSE AND METHOD OF ADMINISTRATION 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. CHILDREN AND ADOLESCENTS Safety and effectiveness in children have not yet been established. Therefore, Solicare should not be used in children. Page 2 of 15 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 Läs hela dokumentet