TOVEDESO Prolonged-release tablet (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Tovedeso 3.5 mg Prolonged-release Tablets.
Qualitative and quantitative composition
Each prolonged-release tablet contains desfesoterodine succinate 3.5 mg corresponding to 2.6 mg of desfesoterodine. Excipients with known effect: Each prolonged-release tablet contains 11.175 mg of lactose ...
Pharmaceutical form
Prolonged-release tablet. The 3.5 mg tablets are light blue, oval, biconvex, film-coated, with dimensions of 11.6 mm x 6.35 mm and embossed on one side with 3.5.
Therapeutic indications
Tovedeso 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.
Posology and method of administration
Posology Adults (including elderly) The recommended starting dose is 3.5 mg once daily. Based upon individual response, the dose may be increased to 7 mg once daily. The maximum daily dose is 7 mg. Full ...
Contraindications
Hypersensitivity to the active substance (desfesoterodine), fesoterodine or to any of the excipients listed in section 6.1 Urinary retention Gastric retention Uncontrolled narrow angle glaucoma Myasthenia ...
Special warnings and precautions for use
Tovedeso should be used with caution in patients with: Clinically significant bladder outflow obstruction at risk of urinary retention (e.g. clinically significant prostate enlargement due to benign prostatic ...
Interaction with other medicinal products and other forms of interaction
Pharmacological interactions Caution should be exercised in coadministration of desfesoterodine with other antimuscarinics and medicinal products with anticholinergic properties (e.g. amantadine, tri-cyclic ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of fesoterodine, prodrug of desfesoterodine in pregnant women. Reproductive toxicity studies with fesoterodine in animals show minor embryotoxicity (see ...
Effects on ability to drive and use machines
Tovedeso has minor influence on the ability to drive and use machines. Caution should be exercised when driving or using machines due to possible occurrence of side effects such as blurred vision, dizziness, ...
Undesirable effects
Summary of the safety profile The safety of fesoterodine, prodrug of desfesoterodine, was evaluated in placebo-controlled clinical studies in a total of 2859 patients with overactive bladder, of which ...
Overdose
Overdose with antimuscarinics, including desfesoterodine can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdose, ECG monitoring is recommended; ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, Urinary antispasmodics ATC code: G04BD13 Mechanism of action Desfesoterodine is a competitive, specific muscarinic receptor antagonist. It is the primary active ...
Pharmacokinetic properties
Desfesoterodine is the active metabolite of the pro-drug fesoterodine. Absorption After oral administration of fesoterodine, due to rapid and extensive hydrolysis by non-specific plasma esterases, the ...
Preclinical safety data
In non-clinical safety pharmacology, general toxicity, genotoxicity and carcinogenicity studies with fesoterodine prodrug of desfesoterodine, no clinically relevant effects have been observed, except those ...
List of excipients
Microcrystalline cellulose (Type 101) Povidone 25 Hypromellose 2208 Microcelac 100 (containing lactose monohydrate and microcrystalline cellulose) Magnesium stearate Hypromellose 2910 Glycerol 85% Titanium ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Aluminium-aluminium blisters containing 14, 28, 56, 84, 98, 100 or 112 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Marketing authorization number(s)
PL 00289/2063
Date of first authorization / renewal of the authorization
28/07/2017
Date of revision of the text
06/12/2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
