LYRINEL XL Prolonged release tablet Ref.[7927] Active ingredients: Oxybutinin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Product name and form

Lyrinel XL 5 mg prolonged release tablet.

Lyrinel XL 10 mg prolonged release tablet.

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 release tablets: Round pink coloured tablet, approximately 7.5 mm in diameter, printed with “10 XL” on one side in black ink.

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) with known effect: Each LYRINEL XL prolonged release tablet contains 0.03 mg lactose.

Each LYRINEL XL prolonged release tablet contains less than 1 mmol sodium (23 mg), and is essentially ‘sodium-free’.

Active Ingredient	Description
Oxybutinin	Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.

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 (E172) Ferric oxide yellow (E172) Lactose anhydrous. Film coat: Ferric oxide yellow (E172) Hypromellose 3 cp and 6 cp Propylene glycol 400 Polysorbate 8 Titanium dioxide (E171). Printing Ink: Black iron oxide (E172) Hypromellose 6 cp Propylene glycol 10 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 (E172) Ferric oxide red (E172) Lactose anhydrous. Film coat: Ferric oxide red (E172) Hypromellose 3 cp and 6 cp Propylene glycol 400 Polysorbate 80 Titanium dioxide (E171) Printing Ink: Black iron oxide (E172) Hypromellose 6 cp Propylene glycol

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 0242/0385
PL 0242/0386

1 August 2002/14 June 2010

Drugs

Drug	Countries
LYRINEL	Ireland, United Kingdom, South Africa

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