Janssen-Cilag Ltd

Change to section 2 - Qualitative and quantitative composition

Each prolonged release tablet contains 5 mg of oxybutynin hydrochloride

Each prolonged release tablet contains 10 mg of oxybutynin hydrochloride

Excipient: Each Lyrinel XL prolonged release tablet contains 0.03 mg lactose.

For a full list of excipients, see Section 6.1.

Change to section 6.1 - List of Excipients

5 mg

Butylhydroxytoluene (E321), cellulose acetate 398-10,, hypromellose 5 cp, macrogol 3350, magnesium stearate, macrogol 200 000, macrogol 2 000 000, sodium chloride, black iron oxide (E172), ferric oxide yellow (E172) and lactose anhydrous.

Film coat: ferric oxide yellow (E172), hypromellose 3 cp and 6 cp, macrogol 400, polysorbate 80 and titanium dioxide (E171).

Printing Ink: black iron oxide (E172), hypromellose 6 cp, propylene glycol and purified water.

10 mg

Butylhydroxytoluene (E321), cellulose acetate 398-10, hypromellose 5 cp, macrogol 3350, magnesium stearate, macrogol 200 000, macrogol 2 000 000, sodium chloride, black iron oxide (E172), ferric oxide red (E172) and lactose anhydrous.

Film coat: ferric oxide red (E172), hypromellose 3 cp and 6 cp, macrogol 400, polysorbate 80 and titanium dioxide (E171).

Printing Ink: black iron oxide (E172), hypromellose 6 cp, propylene glycol and purified water

Change to section 6. 6 - Instructions for use, handling and disposal

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

Change to section 9 - Date of first Authorisation/renewal of the Authorisation

14 June 2010

Change to section 4.1 - Therapeutic indications

Change to indication for paediatric population

Change to section 4.2 - Posology and method of administration

Change to age for paediatric administration

Change to section 4.4 - Special warnings and precautions for Use

Additional information for paediatric population

Change to section 10 - Date of revision of the text

Change to 01 July 2011

Change to paediatric information

As detailed above.

X

Change to section 7 – Marketing Authorisation Holder

New Company address

X

Change to section 10 – Date of revision of the text

August 2008

Change to section 1 –Name of the medicinal product

Minor change

Change to section 2 – quantitative and qualitative composition

Minor change

Change to section 3 – pharmaceutical form

Minor change

Change to section 4.2 – Posology and |Method of Administration

Minor change

Change to section 4.3 – Contra-indications

Minor change

Change to section 4.4 – Special Warnings and Precautions for Use

Main change

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Minor change

Change to section 4.6 – Pregnancy and Lactation

Minor change

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Minor change

Change to section 4.9 - Overdose

Minor change

Change to section 5.2 - Pharmacokinetic properties

Minor change

Change to section 10 – Date of revision of the text

June 2008

4.1

Therapeutic Indications

New indication added

Children over the age of 6 years

The symptomatic treatment of detrusor hyperreflexia secondary to a neurogenic condition.

4.2

Posology and method of administration

Text deleted

The safety and efficacy of Lyrinel XL have not been established in patients under 18 years. The use of Lyrinel XL in children is not recommended.

Text inserted

Children over the age of 6 years

Initial dose of 5mg once a day increased in 5mg increments up to a maximum of 15mg once a day.

The safety and efficacy of Lyrinel XL has not been established in patients less than 6 years.

4.3

Contraindications

Text inserted

Porphyria

4.4

Special Warnings and Precautions for Use

Text inserted

Heat stroke added to following sentence

When oxybutynin is used in patients with fever or in high environmental temperatures, this can cause heat prostration, or heat stroke due to decreased sweating.

4.8

Undesirable effects

Text inserted

Night terror added to following sentence

Additional rare adverse events reported from worldwide post-marketing experience with oxybutynin chloride include hallucinations, convulsions, night terror and erectile dysfunction.

5.1

Pharmacodynamic properties

Text inserted

Children over the age of 6 years: in children with detrusor hyperreflexia secondary to a neurogenic condition, oxybutynin, in combination with clean intermittent urinary catheterisation, has been shown in open uncontrolled studies to increase mean urine volume per catherisation, increase maximum cystometric capacity and decrease mean detrusor pressure at maximum cystometric capacity.

5.2

Pharmacokinetic properties

Text inserted

Limited data suggest that the pharmacokinetics of Lyrinel XL is similar in adults and children aged 8 years and above.  The pharmacokinetics of Lyrinel XL have not been investigated in patients with renal or hepatic insufficiency.

Text deleted

The pharmacokinetics of Lyrinel XL tablets have not been investigated in children, nor in patients with renal or hepatic insufficiency.

10.

DATE OF REVISION OF THE TEXT

Changed to

30th June 2006