Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Fesoterodine fumarate
Pinewood Laboratories Ltd
G04BD11
Fesoterodine fumarate
Prolonged-release tablet
fesoterodine
Marketed
2022-07-15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FESOTERODINE PINEWOOD 4 MG PROLONGED-RELEASE TABLETS FESOTERODINE PINEWOOD 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 Fesoterodine Pinewood is and what it is used for 2. What you need to know before you take Fesoterodine Pinewood 3. How to take Fesoterodine Pinewood 4. Possible side effects 5. How to store Fesoterodine Pinewood 6. Contents of the pack and other information 1. WHAT FESOTERODINE PINEWOOD IS AND WHAT IT IS USED FOR Fesoterodine Pinewood 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. Fesoterodine Pinewood 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 FESOTERODINE PINEWOOD DO NOT TAKE FESOTERODINE PINEWOOD - if you are allergic to fesoterodine or fructose or to any of the other ingredients of Fesoterodine Pinewood (listed in section 6) (see section 2, “Fesoterodine Pinewood contains lactose and fructose”) - if you are not able to completely empty your bladder (urinary retention) - if your stomach empties slowly (gastric retention) - if you have Baca dokumen lengkap
Health Products Regulatory Authority 29 January 2024 CRN00DVT7 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fesoterodine Pinewood 4 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 4 mg fesoterodine fumarate corresponding to 3.1 mg of fesoterodine. Excipients with known effect Each prolonged-release tablet contains 72.0 mg of fructose and 58.07 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Blue elliptical, biconvex and debossed with "F4" on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fesoterodine 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 Fesoterodine should be 4 mg once daily (see section 4.5). Special population _Renal and hepatic impairment_ The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of moderate and potent CYP3A4 inhibitors (see sections 4.3, 4.4, 4.5 and 5.2). Moderate (3) or potent (4) CYP3A4 inhibitors None Moderate Potent Renal impairment (1) Mild 4→8 mg (2) 4 mg Should be avoided Moderate 4→8 mg (2) 4 mg Contraindicated Severe 4 mg Should be avoided Contraindicated Hepatic impairment Mild 4→8 mg (2) 4 mg Should be avoided Moderate 4 Baca dokumen lengkap