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LYRINEL XL 10MG PROLONGED RELEASE TABLETS

Active substance(s): OXYBUTYNIN HYDROCHLORIDE / OXYBUTYNIN HYDROCHLORIDE

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Lyrinel® XL 10mg prolonged release tablets
(oxybutynin hydrochloride)

Your medicine is known by the above name, but will be referred to as
Lyrinel XL throughout this leaflet. Lyrinel XL is also available as the 5mg
strength.

Patient Information Leaflet
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 again.
• If y ou hav e any f urther ques tions, a sk y our doc tor, phar macist or
nurse.
• This medicine has been pr escribed f or you onl y. Do not pas s i t on t o
others. It may harm them, even if their signs of illness are the same as
yours.
• If y ou get any s ide ef fects, t alk t o y our doc tor, phar macist or nur se.
This includes any po ssible side effects not l isted i n this l eaflet. 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

The name of your medicine is Lyrinel XL prolonged release tablets. It is
called Lyrinel XL in this leaflet. Lyrinel XL contains a medicine called
oxybutynin hydrochloride. This belongs to a group of medicines called
‘anticholinergics’ or ‘antispasmodics’.
Lyrinel XL works by relaxing your bladder muscles. It also stops bladder
contractions and delays the desire to pass urine (water).
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.
Lyrinel XL can be used:
• 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 incontinence)
− 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 symptoms worsen.

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 to pass urine more often
than usual, especially at night
• 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 Lyrinel XL
• if you have a problem with your gut (stomach or intestine)
• if you have hiatal hernia, reflux disease (GERD) or heart burn
• if you are 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 y ou ar e not s ure i f any of t he above appl y t o y ou, t alk t o y our doctor,
nurse or pharmacist before taking Lyrinel XL.
Lyrinel XL m ay reduce the amount of saliva resulting in tooth decay, gum
disease, or fungal infection of the mouth (oral thrush).
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 nausea
• 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 blurred vision with the use of
Lyrinel XL. You should therefore be careful when driving, using machinery
or performing other tasks that need full 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 not sure.
• Lyrinel XL should be taken once daily
• Take your medicine at the same time each day
• Swallow the tablet whole with a glass of water
• Do not chew, break or crush the tablet
• You can take your medicine with food or in between meals.
How much to take
Your doctor will decide what dose of medicine is best for you.
Use in adults
• The recommended starting dose is normally one 5 mg tablet each day
• 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 recommended starting dose is normally one 5 mg tablet each day
• 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 flushing 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 or nurse.

Medicines should not be disposed of via wastewater or household
waste. A sk y our phar macist how t o di spose of medicines no l onger
required. These measures will help protect the environment.

4) Possible side effects



Stop taking Lyrinel XL and see a doctor or go to a hospital straight
away if:
Not known (frequency cannot be estimated from the available data)
• You have a severe 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.

6) Contents of the pack and other information

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)
• You have a sudden decrease in vision, eye pain and/or high pressure
in the eye, which may cause blindness (glaucoma)
• You experience seizures (fits).
Tell your doctor or pharmacist if any of the following side effects get
serious or lasts longer than a few days:
Very common side effects (may affect more than 1 in 10 people)
• 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 side effects (may affect up to 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 side effects (may affect up to 1 in 100 people)
• Seeing or hearing things that are not there (hallucinations)
• Psychological problems, feeling agitated or confused, difficulty
remembering
• Allergic reaction
• Difficulty swallowing
• Thirst
• Loss of appetite, vomiting, frequent bowel movements
• Nasal congestion, impairment of the voice, such as hoarseness
• Irregular heartbeat, racing heart
• High blood pressure
• Chest discomfort
• Retaining water
• Flushing
• Falling
• Rash.
Not known (frequency cannot be estimated from the available data)
• Psychological problems
• Difficulty getting or keeping an erection
• Anxiety
• Becoming dependent on Lyrinel XL
• Nightmares
• Depression
• Paranoia
• Difficulty thinking, remembering information, or solving problems
• Dilated pupils
• Lack of sweating
• Heat stroke
• Abdominal pain and bloating which may be accompanied by feeling or
being sick, difficulty with swallowing, diarrhoea or constipation,
depending on the part of the gut affected (pseudo-obstruction).
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.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Lyrinel XL





Keep out of the sight and reach of children.
Do not store above 25°C. Keep the container tightly closed in order to
protect from moisture.
Do not use Lyrinel XL after the expiry date that is stated on the carton
and container. The expiry date refers to the last day of that month.
Do not r emove or s wallow t he s achet of gr anules i n t he bot tle. T his
contains desiccant, which keeps the tablets dry.

What Lyrinel XL contains
• The active substance is oxybutynin hydrochloride. Each prolongedrelease tablet contains 10 mg of oxybutynin hydrochloride.
• The other ingredients are butylhydroxytoluene (E321), cellulose
acetate 398-10, hypromellose 5 cps, macrogol 3350, magnesium
stearate, polyethylene oxide 200 000, polyethylene oxide 2 000 000,
sodium chloride, black iron oxide (E172), red ferric oxide (E172) and
lactose anhydrous.
Film coat: red ferric oxide (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.
What Lyrinel XL looks like and contents of the pack
Lyrinel XL 10 mg prolonged release tablet are round, pink coloured tablet
printed “10 XL" with black ink and plain on the reverse.
Lyrinel XL is available in a bottle of 30 tablets.
PL 10383/2129

Lyrinel XL 10 mg prolonged release tablets POM

Who makes and repackages your medicine?
Your medicine is manufactured by Janssen-Cilag SpA, Via C. Janssen, IT04010 Borgo San Michele, Latina, Italy. Procured from within the EU and
repackaged by the Product Licence Holder Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt UB5 5QS
Leaflet date: 25.04.2017
Lyrinel is a registered trademark of Johnson & Johnson, USA.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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