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TOLTERODINE ACCORD Film-coated tablet (2022)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tolterodine Tartrate 1 mg Film-coated Tablet.

Qualitative and quantitative composition

Each film-coated tablet contains tolterodine tartrate 1 mg corresponding to 0.68 mg tolterodine. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated Tablet. White to off white, round, approximately 6.35 mm in diameter, biconvex, film-coated tablet, debossed S16 on one side and plain on other side.

Therapeutic indications

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

Posology and method of administration

Posology Adults (including elderly) The recommended dose is 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR≤30 ml/min) for whom the recommended ...

Contraindications

Tolterodine is contraindicated in patients with: Urinary retention Uncontrolled narrow angle glaucoma Myasthenia gravis Hypersensitivity to the active substance or to any of the excipients listed in section ...

Special warnings and precautions for use

Tolterodine shall be used with caution in patients with: Significant bladder outlet obstruction at risk of urinary retention Gastrointestinal obstructive disorders, e.g. pyloric stenosis Renal impairement ...

Interaction with other medicinal products and other forms of interaction

Concomitant systemic medication with potent CYP3A4 inhibitors such as macrolide antibiotics (e.g. erythromycin and claritromycin), antifungal agents (e.g. ketoconazole and itraconazole) and antiproteases ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of tolterodine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Consequently, ...

Effects on ability to drive and use machines

Since this medicinal product may cause accommodation disturbances and influence reaction time, the ability to drive and use machines may be negatively affected.

Undesirable effects

Summary of safety profile Due to the pharmacological effect of tolterodine it may cause mild to moderate antimuscarinic effects, like dryness of the mouth, dyspepsia and dry eyes. The table below reflects ...

Overdose

The highest dose given to human volunteers of tolterodine L-tartrate is 12.8 mg as single dose. The most severe adverse events observed were accommodation disturbances and micturition difficulties. In ...

Pharmacodynamic properties

Pharmacotherapeutic group: Urinary antispasmodics ATC code: G04BD07 Mechanism of action Tolterodine is a competitive, specific muscarinic receptor antagonist with selectivity for the urinary bladder over ...

Pharmacokinetic properties

Pharmacokinetic characteristics specific for this formulation Tolterodine is rapidly absorbed. Both tolterodine and the 5-hydroxymethyl metabolite reach maximal serum concentrations 1-3 hours after dose. ...

Preclinical safety data

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

List of excipients

Core: Cellulose, microcrystalline pH 102 Sodium starch glycolate (Type A) Magnesium stearate Colloidal anhydrous silica Film coating: Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000 Talc (E553b) ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/PVDC– Alu blister. <u>Pack sizes:</u> Tolterodine 1 mg Film-coated Tablets are available in the following pack sizes: Tolterodine 2 mg Film-coated Tablets are available in the following pack sizes: ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Accord Healthcare Limited, Sage house, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Marketing authorization number(s)

PL 20075/0357

Date of first authorization / renewal of the authorization

05/04/2014

Date of revision of the text

10/02/2022

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