Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Solifenacin succinate 10mg;
Viatris Limited
Solifenacin succinate 10 mg
10 mg
Film coated tablet
Active: Solifenacin succinate 10mg Excipient: Hypromellose Iron oxide red Iron oxide yellow Lactose Magnesium stearate Maize starch Propylene glycol Purified talc Titanium dioxide
Prescription
Megafine Pharma (P) Limited
Solifenacin Viatris is indicated for the treatment of unstable bladder with symptoms of increased urinary urgency, frequent microurination, and/or urge incontinence.
Package - Contents - Shelf Life: Blister pack, PVC-Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, HDPE - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
2014-08-27
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION SOLIFENACIN VIATRIS _SOLIFENACIN SUCCINATE, 5 MG AND 10 MG, FILM COATED TABLET_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Solifenacin Viatris. This leaflet answers some common questions about Solifenacin Viatris. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Solifenacin Viatris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SOLIFENACIN VIATRIS IS USED FOR Solifenacin Viatris is used to treat 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 Viatris contains the active ingredient solifenacin succinate. It belongs to a group of medicines called anticholinergic medicines. It works on specialised cells to reduce the activity of your bladder and help you control your bladder. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE SOLIFENACIN VIATRIS _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SOLIFENACIN VIATRIS IF YOU HAVE AN ALLERGY TO: any medicine containing solifenacin succinate. any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT GIVE THIS MEDICINE TO CHILDREN. Safety and effectiveness in children h Soma hati kamili
Page 1 of 14 NEW ZEALAND DATA SHEET SOLIFENACIN VIATRIS 1. PRODUCT NAME Solifenacin Viatris 5 mg and 10 mg, film coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 5 mg or 10 mg of solifenacin succinate. Excipients of known effect: Contains sugars as lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solifenacin Viatris 5 mg tablets: yellow film-coated, round, biconvex tablet debossed with M on one side of the tablet and SF over 5 on the other side. Solifenacin Viatris 10 mg tablets: pink film-coated, round, biconvex tablet debossed with M on one side of the tablet and SF over 10 on the other side. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Solifenacin Viatris is indicated for the treatment of unstable bladder with symptoms of increased urinary urgency, frequent micturition, and/or urge incontinence. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE _ADULTS_ 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. _SPECIAL POPULATIONS_ CHILDREN Safety and effectiveness in children has not yet been established. Solifenacin Viatris is not recommended for use in children. 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) Page 2 of 14 should be treated with caution and receive not more than 5 mg once daily. Pharmacokinetics in patients undergoing haemodialysis has not been studied. 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 not more than 5 mg once daily. Solifenacin Viatris is contraindicated in patients with severe hepatic impairment (Child- Pugh C). STRONG INHIBITORS OF CYTOCHROME P450 3A4 The maximum do Soma hati kamili