দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
solifenacin succinate, Quantity: 5 mg
Generic Health Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; lactose monohydrate; maize starch; hypromellose; titanium dioxide; purified talc; iron oxide yellow; macrogol 6000
Oral
30 tablets
(S4) Prescription Only Medicine
SOLIFENACIN LUPIN is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
Visual Identification: Light yellow colored, round, biconvex, film coated tablets, debossed with "EG" on one side and "1" 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
CONSUMER MEDICINE INFORMATION SOLIFENACIN LUPIN (SOLIFENACIN SUCCINATE) FILM-COATED TABLETS WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet answers some common questions about Solifenacin Lupin. 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 Solifenacin Lupin 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 SOLIFENACIN LUPIN IS USED FOR Solifenacin Lupin 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. Solifenacin Lupin 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 Solifenacin Lupin for another reason. Ask your doctor if you have any questions about why Solifenacin Lupin has been prescribed for you. Solifenacin Lupin is available only with a doctor's prescription. There is no evidence that Solifenacin Lupin is addictive. BEFORE YOU TAKE SOLIFENACIN LUPIN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SOLIFENACIN LUPIN 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 SOLIFENACIN LUPIN IF YOU: • suffer from urinary retention (inability to urinate or empty your bladder completely); • are undergoing haemodialysis সম্পূর্ণ নথি পড়ুন
AUSTRALIAN PRODUCT INFORMATION – SOLIFENACIN LUPIN (SOLIFENACIN SUCCINATE) FILM-COATED TABLET 1 NAME OF THE MEDICINE Solifenacin succinate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Solifenacin Lupin 5 mg film-coated tablet: Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin. Solifenacin Lupin 10 mg film-coated tablet: Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin. List of excipients with known effect in 5 mg tablets: sulfites and sugars as lactose. List of excipients with known effect in 10 mg tablets: sulfites and lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solifenacin Lupin 5 mg film-coated tablets: Light yellow coloured, round, biconvex, film-coated tablet, debossed with “EG” on one side and “1” on other side. Solifenacin Lupin 10 mg film-coated tablets: 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 Solifenacin Lupin 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, Solifenacin Lupin should not be used in children. Solifenacin Lupin v2 Page 2 of 15 (solifenacin succinate) film-coated tablet 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 সম্পূর্ণ নথি পড়ুন