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1. Lyrinel Xl 10mg Prolonged Release Tablet
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PACKAGE LEAFLET: INFORMATION FOR THE USER

5 mg prolonged release tablets 10 mg prolonged release tablets

Oxybutynin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it

•    If you have any further questions, ask your doctor, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaf I et. See section 4.

What is in this leaflet:

1    What Lyrinel XL is and what it is used for

2    What you need to know before you take Lyrinel XL

3    How to take Lyrinel XL

4    Possible side effects

5    How to store Lyrinel XL

6    Contents of the pack and other information

1 What Lyrinel XL is and what it is used for

Your tablets are made in a 'prolonged release' form. The tablets are coated with a 'special membrane', which slowly release the medicine. This membrane may pass through your body unchanged. This does not affect the way the medicine works.

•    To help adults control when and how often they pass urine

•    In children 5 years or older to treat:

-    Loss of control in passing urine (urinary

-    Increased need or urgency to pass urine

-    Night time bedwetting, when other treatments have not worked.

If your symptoms do not improve after 7 days talk to your doctor.

You must talk to a doctor if at any time your

2 What you need to know before you take Lyrinel XL

Do not take Lyrinel XL:

•    if you are allergic to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in section 6).

•    If you have raised pressure in your eye (glaucoma)

•    If you have a muscle weakness problem called 'myasthenia gravis'

•    If you have a feeling of incomplete emptying of the bladder (urinary retention)

•    If you have a problem with your gut (stomach or intestine) called 'toxic megacolon', 'paralytic ileus' or 'intestinal atony'. These are when your gut is blocked, perforated or not working properly

•    If you have a severe form of condition known as 'ulcerative colitis'. This is

a disease that causes frequent diarrhoea

•    If you have heart or kidney failure and need

especially atnight

•    If you have a blood problem called 'porphyria'.

Do not use Lyrinel XL if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before taking Lyrinel XL.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Lyrinel XL

•    if you are elderly and frail (weak or in poor health) as you may be more sensitive to

•    if you have a problem with your gut (stomach or intestine)

•    if you have hiatal hernia, reflux disease (GERD) or heart burn

•    if you at taking medicines to treat osteoporosis (drugs known as bisphosphonates)

•    if you have kidney or liver problems

•    if you have a problem called 'bladder outflow obstruction' which makes it difficult to pass urine

•    if you have a urinary tract infection

•    if you have an overactive thyroid

•    if you have heart problems

•    if you have high blood pressure

•    if you have prostate problems

•    if you have something called 'dementia' (memory loss and confusion) and are being treated for it with a certain type of medicine, such as donepezil, rivastigmine, galantamine or tacrine

•    if you have Parkinson's disease

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Lyrinel XL.

Hot weather or fever

Care must be taken when using Lyrinel XL in hot weather or in people with a fever. This is because Lyrinel XL reduces the amount a person sweats. This can lead to heat exhaustion and heat stroke.

Children

Lyrinel XL is not recommended in children under 5 years of age.

Other medicines and Lyrinel XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal therapies. This is because Lyrinel XL can affect the way some other medicines work. Also, some other medicines can affect the way Lyrinel XL works.

In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

•    For mental problems such as phenothiazines or butyrophenones and clozapine

•    For depression called 'tricyclic antidepressants' (such as amitriptyline or desipramine)

•    For Parkinson's disease such as amantadine or levodopa

•    For allergy called 'antihistamines' (such as chlorphenamine or diphenhydramine)

•    For heart problems such as quinidine or digitalis

•    For treating or preventing muscle spasms (antispasmodics such as diazepam)

•    Used to thin your blood called dipyridamole

•    Other anticholinergic medicines such as atropine for glaucoma or hyoscine for

•    For dementia such as donepezil, rivastigmine, galantamine or tacrine

•    Placed under the tongue to treat angina (sublingual nitrates)

•    For fungal infections such as ketoconazole, itraconazole and fluconazole

•    Antibiotics called 'macrolides' (such as erythromycin)

•    Domperidone and metoclopramide - used to stop you feeling sick (nausea) or being sick (vomiting).

•    Medicines used to help empty the stomach and move foods through the gut (such as domperidone).

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking this medicine.

Do not drink alcohol while taking this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There have been reports of dizziness and

You should therefore be careful when driving, using machinery or performing

attention.

Lyrinel XL contains lactose

Lyrinel XL tablets contain lactose (0.03 mg), a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

3 How to take Lyrinel XL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are

•    Lyrinel XL should be taken once daily

•    Take your medicine at the same time

•    Swallow the tablet whole with a glass

•    Do not chew, break or crush the tablet

•    You can take your medicine with food

How much to take

Your doctor will decide what dose of medicine is best for you.

Use in adults

•    The starting dose is normally one 5 mg

•    After at least one week, your doctor may increase your dose to 10 mg each day

•    Your doctor may increase this to a maximum of 20 mg each day

•    Your doctor will leave a gap of at least one week between changing the dose.

Use in children (over 5 years)

•    The starting dose is normally one 5 mg

•    Your child's doctor may increase the dose to a maximum of 15 mg each day.

If you take more Lyrinel XL than you should

If you think that you have taken too many tablets, tell a doctor or go to the nearest hospital casualty department straight away Take the medicine pack with you. This is so the doctor knows what you have taken.

You may experience symptoms starting as restlessness and excitement, and worsening to circulation changes such as f I ushing or drop in blood pressure, difficulty breathing, being unable to move your body and losing consciousness.

If you forget to take Lyrinel XL

•    Do not take a double dose to make up for a forgotten dose.

•    If you forget a dose, do not worry. Just skip that dose and take your next dose at the regular time.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist

4 Possible side effects

side effects, although not everybody gets

Stop taking Lyrinel XL and see a doctor or go to a hospital straight away if:

•    You have an allergic reaction. The signs may include: a rash, hives (also known as nettle rash or urticaria), difficulty swallowing or breathing, swelling of your lips, face, throat or tongue

•    You have central nervous system (CNS) effects (changes in thinking or emotions) such as anxiety, nervousness, seeing or hearing things that are not actually there, and trouble thinking clearly or making decisions. Watch for these signs, particularly in the first few months after you start taking your medicine or after an increase in dose.

•    You have a sudden change in the clearness of your eyesight.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Very common (affects 1 in 10 people or more)

•    Dry mouth

This is more common at doses of more than 10 mg once a day and may lead to tooth decay, gum disease or fungal infection. This may also prevent medicines you put under your tongue dissolving properly (such as angina medicines).

Common (affects less than 1 in 10 people)

•    Abnormal awareness of your heartbeat (palpitations)

•    Blurred eyesight, dry eyes

•    Constipation, diarrhoea, nausea, indigestion, stomach pain, change in the way things taste, feeling bloated (flatulence) or heartburn

•    Feeling tired

•    Dry skin or itching

•    Feeling dizzy or sleepy, having a headache, problems sleeping

•    Pain passing urine, delay when starting to pass urine, feeling of incomplete emptying of your bladder, urinary tract infection

•    Dry nose, dry or sore throat, cough. Uncommon (affects less than 1 in 100 people)

•    Seeing or hearing things that are not there (hallucinations)

•    Psychological problems, feeling agitated or confused, difficulty remembering

•    Allergic reaction including hives or swelling of the face, lips, tongue or throat

•    Difficulty swallowing

•    Thirst

•    Loss of appetite, vomiting, frequent bowel

•    High pressure and pain in the eyes (glaucoma), unable to tolerate light

•    Nasal congestion, impairment of the voice, such as hoarseness

•    Irregular heartbeat, racing heart

•    High blood pressure

•    Chest discomfort

•    Retaining water

•    Convulsions

•    Flushing

•    Falling

•    Rash.

Other side effects:

•    Difficulty breathing due to a serious allergic

•    Psychological problems

•    Difficulty getting or keeping an erection

•    Anxiety

•    Nightmares

•    Paranoia

•    Difficulty thinking, remembering information, or solving problems

•    Dilated pupils

•    High eye pressure

•    Lack of sweating

Additional side effects in children

Constipation is a very common side effect in children. The following are common side effects in children: Loss of appetite, diarrhoea, headache, problems sleeping, rash or itching, flushing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. In the UK, you can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard In Ireland, you can also report side effects directly via:

IMB Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

By reporting side effects you can help

provide more information on the safety of

5 How to store Lyrinel XL

Keep this medicine out of the sight and reach of children.Do not use this medicine after the expiry date which is stated on the carton and bottle label after "Expiry". The expiry date refers to the last day of that month.

Store your medicine in the original package. Do not store above 25°C. Keep the container tightly closed in order to protect from moisture.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What Lyrinel XL contains

The active substance is oxybutynin hydrochloride. Each prolonged-release tablet contains either 5 mg or 10 mg of oxybutynin hydrochloride.

The other ingredients (excipients) are:

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 and propylene glycol.

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 and propylene glycol.

This medicinal product is authorised in the Member States of the EEA under the following names:

For information in large print, tape,

CD or Braille, phone 0800 731 8450 (UK) or 1800 709122 (IRE)

This leaflet was last revised in April 2014.

What Lyrinel XL looks like and contents of the pack

Lyrinel XL 5 mg prolonged release tablet: round, yellow coloured tablet printed "5 XL"

Lyrinel XL 10 mg prolonged release tablet: round, pink coloured tablet printed "10 XL"

Your medicine is available in bottles containing 3, 7, 10, 14, 30, 50, 60, 90 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

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

Manufacturer:

Janssen-Cilag SpA Via C. Janssen-Cilag Ltd Borgo S. Michele 04010 Latina Italy

janssen