Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
FESOTERODINE FUMARATE
PFIZER PHARMACEUTICALS ISRAEL LTD
G04BD11
TABLETS SUSTAINED RELEASE
FESOTERODINE FUMARATE 8 MG
PER OS
Required
PFIZER INC, USA
FESOTERODINE
FESOTERODINE
Treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome.
2023-09-30
Toviaz PIL WC 111223 2022-0082192, 2023-0088299 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only TOVIAZ ® 4 MG TOVIAZ ® 8 MG SUSTAINED-RELEASE TABLETS EACH TABLET CONTAINS: FESOTERODINE FUMARATE 4 MG, 8 MG Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is generally not indicated in children under the age of 18. 1. WHAT IS THIS MEDICINE INTENDED FOR? For the treatment of symptoms that may occur in patients with overactive bladder syndrome such as increased urinary frequency and/or urgency and/or urgency incontinence. THERAPEUTIC GROUP: Muscarinic receptor antagonist. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient, soya, peanuts or to any of the other ingredients in this medicine (listed in section 6) (see also section 2,’Important information about some of this medicine’s ingredients’). • You are unable to completely empty your bladder (urinary retention). • Your stomach empties slowly (gastric retention). • You have an eye disease called narrow angle glaucoma (high pressure in the eye), which is not under control. • You have excessive weakness of the muscles (myasthenia gravis). • You have severe ulcerative colitis. • You have an abnormally large or distended colon (toxic megacolon). • You have severe liver problems. • You have kidney problems or moderate to severe liver problems and are taking medicines containing any of the following activ Διαβάστε το πλήρες έγγραφο
Toviaz LPD CC 040124 2022-0082192, 2023-0088299, 2022-0083135 1 4 MG ® TOVIAZ 8 MG ® TOVIAZ 1. NAME OF THE MEDICINAL PRODUCT TOVIAZ 4 mg TOVIAZ 8 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TOVIAZ 4 mg Each sustained release tablet contains fesoterodine fumarate 4 mg. TOVIAZ 8 mg Each sustained release tablet contains fesoterodine fumarate 8 mg. Excipients with known effect _TOVIAZ 4 mg _ Each 4 mg sustained release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactosemonohydrate. _TOVIAZ 8 mg _ Each 8 mg sustained release tablet contains 0.525 mg of soya lecithin and 58.125 mg of lactosemonohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sustained release tablet. TOVIAZ 4 mg The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FS’. TOVIAZ 8 mg 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 Treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients 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. Toviaz LPD CC 040124 2022-0082192, 2023-0088299, 2022-0083135 2 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 table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of moder Διαβάστε το πλήρες έγγραφο