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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

LYRINEL XL Prolonged release tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lyrinel XL 5 mg prolonged release tablet. Lyrinel XL 10 mg prolonged release tablet.

Qualitative and quantitative composition

Each prolonged release tablet contains 5 mg of oxybutynin hydrochloride. Each prolonged release tablet contains 10 mg of oxybutynin hydrochloride. For the full list of excipients, see Section 6.1. Excipient(s) ...

Pharmaceutical form

Prolonged release tablet. Lyrinel XL 5 mg prolonged release tablets: Round yellow coloured tablet, approximately 7.5 mm in diameter, printed with 5 XL on one side in black ink. Lyrinel XL 10 mg prolonged ...

Therapeutic indications

Adults Lyrinel XL is indicated in adults for the symptomatic treatment of urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with unstable bladder. Paediatric ...

Posology and method of administration

Posology Lyrinel XL may be administered with or without food (see section 5.2). Adults Starting dose: the recommended starting dose is one 5 mg tablet once daily. Maintenance dose/dose adjustment: In order ...

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 Narrow-angle glaucoma or shallow anterior chamber Myasthenia gravis Urinary retention Gastrointestinal obstructive ...

Special warnings and precautions for use

Oxybutynin is associated with anticholinergic central nervous system (CNS) effects (see section 4.8). Anticholinergic CNS effects (e g , hallucinations, agitation, confusion, somnolence) have been reported; ...

Interaction with other medicinal products and other forms of interaction

The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or medicinal products with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data on the use of oxybutynin in pregnant women. Studies in animals have shown minor reproductive toxicity (see section 5.3). Lyrinel XL is not recommended during pregnancy. ...

Effects on ability to drive and use machines

Oxybutynin has minor influence on the ability to drive and use machines. Oxybutynin may produce drowsiness or blurred vision; therefore, patients should be cautioned regarding activities requiring mental ...

Undesirable effects

Summary of the safety profile The most common adverse reactions reported during clinical trials by >5% of patients were dry mouth, constipation, diarrhoea, headache, somnolence and dizziness. Serious adverse ...

Overdose

The symptoms of overdose with oxybutynin progress from an intensification of the usual CNS disturbances (from restlessness and excitement to psychotic behaviour), circulatory changes (flushing, fall in ...

Pharmacodynamic properties

Pharmacotherapeutic group: urinary antispasmodic ATC code: G04BD04 Mechanism of action Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in ...

Pharmacokinetic properties

Absorption Following the first dose of Lyrinel XL, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter, concentrations are maintained for up to 24 hours, thus reducing the fluctuations between ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of acute toxicity, repeat dose toxicity, genotoxicity, carcinogenic potential and local toxicity. In a fertility study of subcutaneous ...

List of excipients

5 mg Butylhydroxytoluene (E321) Cellulose acetate 398-10 Hypromellose 5 cp Polyethylene glycol 3350 Magnesium stearate Polyethylene oxide 200K Polyethylene oxide 2000K Sodium chloride Black iron oxide ...

Incompatibilities

Not applicable.

Shelf life

<u>Lyrinel XL 5mg:</u> 2 years. <u>Lyrinel XL 10mg:</u> 18 months.

Special precautions for storage

Keep the container tightly closed in order to protect from moisture. Do not store above 25°C.

Nature and contents of container

High density polyethylene bottles with child resistant closure (polypropylene) and desiccant. Pack sizes 3, 7, 10, 14, 30, 50, 60, 90 or 100 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Do not remove or swallow the sachet of granules in the bottle. This contains desiccant, which keeps the tablets dry.

Marketing authorization holder

Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Marketing authorization number(s)

PL 0242/0385 PL 0242/0386

Date of first authorization / renewal of the authorization

1 August 2002/14 June 2010

Date of revision of the text

29 January 2019

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