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SPC: TOVIAZ Prolonged-release tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

TOVIAZ 4 mg prolonged-release tablets. TOVIAZ 8 mg prolonged-release tablets.

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 ...

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, ...

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.

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 ...

Contraindications

Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1 Urinary retention Gastric retention Uncontrolled narrow angle glaucoma Myasthenia gravis ...

Special warnings and precautions for use

TOVIAZ 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 fesoterodine 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 in pregnant women. Reproductive toxicity studies with fesoterodine in animals show minor embryotoxicity. In animal reproduction studies, ...

Effects on ability to drive and use machines

TOVIAZ 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 was evaluated in placebo-controlled clinical studies in a total of 2859 patients with overactive bladder, of which 780 received placebo. Due to ...

Overdose

Overdose with antimuscarinics, including fesoterodine 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: G04BD11 Mechanism of action Fesoterodine is a competitive, specific muscarinic receptor antagonist. It is rapidly and extensively ...

Pharmacokinetic properties

Absorption After oral administration, due to rapid and extensive hydrolysis by non-specific plasma esterases, fesoterodine was not detected in plasma. Bioavailability of the active metabolite is 52%. After ...

Preclinical safety data

In non-clinical safety pharmacology, general toxicity, genotoxicity and carcinogenicity studies no clinically relevant effects have been observed, except those related to the pharmacological effect of ...

List of excipients

Tablet core: Xylitol Lactose monohydrate Microcrystalline cellulose Hypromellose Glycerol dibehenate Talc Film-coating: Poly(vinyl alcohol) Titanium dioxide (E171) Macrogol (3350) Talc Soya lecithin Indigo ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

Nature and contents of container

TOVIAZ 4 mg and 8 mg tablets are packed in aluminium-aluminium blisters in cartons containing 7, 14, 28, 30, 56, 84, 98 or 100 tablets. In addition, TOVIAZ 4 mg and 8 mg tablets are also packed in HDPE ...

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

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization number(s)

TOVIAZ 4 mg tablets: EU/1/07/386/001-005 EU/1/07/386/011 EU/1/07/386/013-014 EU/1/07/386/017 EU/1/07/386/019 TOVIAZ 8 mg tablets: EU/1/07/386/006-010 EU/1/07/386/012 EU/1/07/386/015-016 EU/1/07/386/018 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 April 2007 Date of latest renewal: 15 March 2012

Πηγαίο έγγραφο

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