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LYRINEL XL 10 MG PROLONGED RELEASE TABLETS

Active substance(s): OXYBUTYNIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lyrinel® XL 10 mg prolonged release tablets
(Oxybutynin hydrochloride)
This product will be referred to as Lyrinel XL in this leaflet.
Please note that this leaflet also contains information about
the other strength of this medicine, Lyrinel 5 mg.
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 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 harm them, even if their signs
of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. 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 you are not sure if any of the above apply to you, talk to
your doctor, nurse or pharmacist before taking Lyrinel XL.

Lyrinel XL may 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 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 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.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
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 movements
• 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 reaction
• 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
• Heat stroke.
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.

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 10 mg of oxybutynin
hydrochloride.
The other ingredients (excipients) are:
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) and lactose anhydrous.
Film coat: ferric oxide red (E172), hypromellose 3 cp and 6
cp, propylene glycol 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
Prolonged release tablet. Round, pink coloured tablet,
printed with “10 XL" in black ink.
Your medicine is available in a bottle containing 14 tablets.
Manufacturer:
Janssen-Cilag SpA
Via C. Janssen
04010 Borgo S. Michele (Latina)
Italy
Procured from within the EU and repackaged by the
Product Licence holder:
Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe
Business Park, Ashby de la Zouch, Leicestershire
LE65 2UY, UK.

POM

PL 33652/0063
Lyrinel® XL 10 mg prolonged release tablets

Leaflet edit date: 06.07.2016

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
By reporting side effects you can help provide more
information on the safety of this medicine.

P-PILLYRIXL10MGX14 (IT) V1

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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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