País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fesoterodine fumarate
Pfizer Ltd
G04BD11
Fesoterodine fumarate
4mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5013457028065
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER TOVIAZ 4 MG PROLONGED-RELEASE TABLETS TOVIAZ 8 MG PROLONGED-RELEASE TABLETS fesoterodine fumarate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What TOVIAZ is and what it is used for 2. What you need to know before you take TOVIAZ 3. How to take TOVIAZ 4. Possible side effects 5. How to store TOVIAZ 6. Contents of the pack and other information 1. WHAT TOVIAZ IS AND WHAT IT IS USED FOR TOVIAZ contains an active substance called fesoterodine fumarate, and is a so called antimuscarinic treatment which reduces the activity of an overactive bladder and it is used in adults to treat the symptoms. TOVIAZ treats the symptoms of an overactive bladder such as not being able to control when you empty your bladder (called urgency incontinence) suddenly needing to empty your bladder (called urgency) having to empty your bladder more often than usual (called increased urinary frequency) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOVIAZ DO NOT TAKE TOVIAZ: - if you are allergic to fesoterodine or to peanut or soya or to any of the other ingredients of TOVIAZ (listed in section 6) (see section 2, “TOVIAZ contains lactose and soya oil”) - if you are not able to completely empty your bladder (urinary retention) - if your stomach empties slowly (gastric retention) - if you have an eye disease called narrow angle glaucoma (high pressure in the eye), which is not under control - if you have excessive weakness of the muscles (myasthenia gravis) - if you Leia o documento completo
OBJECT 1 TOVIAZ 4 MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 12-Oct-2017 | Pfizer Limited 1. Name of the medicinal product TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets 2. Qualitative and quantitative composition TOVIAZ 4 mg tablets Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine. TOVIAZ 8 mg tablets Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine. Excipients with known effect _TOVIAZ 4 mg tablets _ Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactose. _TOVIAZ 8 mg tablets _ Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 58.125 mg of lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet. TOVIAZ 4 mg tablets The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters 'FS'. TOVIAZ 8 mg tablets The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters 'FT'. 4. Clinical particulars 4.1 Therapeutic indications TOVIAZ is indicated in adults for treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur with overactive bladder syndrome. 4.2 Posology and method of administration Posology _Adults (including elderly) _ The recommended starting dose is 4 mg once daily. Based upon individual response, the dose may be increased to 8 mg once daily. The maximum daily dose is 8 mg. Full treatment effect was observed between 2 and 8 weeks. Hence, it is recommended to re-evaluate the efficacy for the individual patient after 8 weeks of treatment. In subjects with normal renal and hepatic function receiving concomitant administration of potent CYP3A4 inhibitors, the maximum daily dose of TOVIAZ should be 4 mg once daily (see section 4.5). Special population _Renal and hepatic impairment _ The following t Leia o documento completo