LYRINEL XL 10MG PROLONGED RELEASE TABLET

Active substance: OXYBUTYNIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2012

5 mg prolonged release tablets
10 mg prolonged release tablets
Oxybutynin hydrochloride
Read all of this leaflet carefully
before you start taking this
medicine.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask your
doctor, nurse or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1 What Lyrinel is and what it is used for
2 Before you take Lyrinel
3 How to take Lyrinel
4 Possible side e ects
5 How to store Lyrinel
6 Further information

1 What Lyrinel is and what it is used for
What Lyrinel is

What Lyrinel is used for

The name of your medicine is Lyrinel XL
prolonged release tablets. It is called Lyrinel
in this leaflet. Lyrinel contains a medicine
called oxybutynin hydrochloride.
This belongs to a group of medicines called
‘anticholinergics’ or ‘antispasmodics’.

Lyrinel 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.

How Lyrinel works
Lyrinel 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.

2 Before you take Lyrinel
Do not take Lyrinel if:
• You are allergic (hypersensitive)
to oxybutynin hydrochloride or any
of the other ingredients of Lyrinel
(listed in Section 6 below)
• You have raised pressure in your eye
(glaucoma)
• You have a muscle weakness problem
called ‘myasthenia gravis’
• You have a feeling of incomplete emptying
of the bladder (urinary retention)
• 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
• You have a severe form of condition known
as ‘ulcerative colitis’. This is a disease that
causes frequent diarrhoea
• You have heart or kidney failure and need
to pass urine more often than usual,
especially at night
• You have a blood problem called ‘porphyria’.
Do not use Lyrinel if any of the above apply
to you. If you are not sure, talk to your doctor,
nurse or pharmacist before taking Lyrinel.

Take special care with Lyrinel
Check with your doctor, nurse or pharmacist
before taking Lyrinel if:
• You are elderly and frail (weak or in poor
health) as you may be more sensitive
to Lyrinel
• You have a problem with your gut
(stomach or intestine)
• You have kidney or liver problems
• You have a problem called ‘bladder outflow
obstruction’ which makes it difficult to pass
urine
• You have a urinary tract infection
• You have an overactive thyroid
• You have heart problems
• You have high blood pressure
• You have prostate problems
• 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
• The person taking the medicine is a child
(use is not recommended under 5 years
of age).
If you are not sure if any of the above apply
to you, talk to your doctor, nurse or pharmacist
before taking Lyrinel.

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

Taking other medicines

This includes medicines obtained without
a prescription and herbal therapies. This is
because Lyrinel can a ect the way some
other medicines work. Also, some other
medicines can a ect the way Lyrinel 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
• 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).
If you are not sure if any of the above apply
to you, talk to your doctor, nurse or
pharmacist before taking this medicine.

Pregnancy and breast-feeding
• Talk to your doctor, nurse or pharmacist
before taking Lyrinel if you are pregnant,
might become pregnant or think you may
be pregnant
• Do not breast-feed if you are taking Lyrinel.
This is because small amounts may pass
into your milk.
Ask your doctor, nurse or pharmacist for
advice before taking any medicine during
pregnancy or while breast-feeding.

Driving and using machines
You may feel drowsy or have blurred vision
while taking Lyrinel. If this happens, do not
drive or use any tools or machines.

Important information about some
of the ingredients of Lyrinel
Lyrinel 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.

Please tell your doctor, nurse or pharmacist
if you are taking or have recently taken any
other medicines.

3 How to take Lyrinel
Always take Lyrinel exactly as your doctor has
told you. You should check with your doctor,
nurse or pharmacist if you are not sure.

How to take Lyrinel
• Lyrinel 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.
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.
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.

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If you take more Lyrinel 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
• If you forget a dose, do not worry. Just skip
that dose and take your next dose at the
regular time.
• Do not take a double dose to make up for
a forgotten dose.
If you have any further questions on the
use of this product, ask your doctor,
nurse or pharmacist.

© J-C 2012

4 Possible side e ects
Like all medicines, Lyrinel can cause some
side effects, although not everybody gets
them.
Stop taking Lyrinel 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.
Common 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.
If any of the side effects gets serious,
or if you notice any side effects not listed
in this leaflet, please tell your doctor,
nurse or pharmacist. Seek medical attention
immediately if you have an allergic reaction
and difficulty breathing.

5 How to store Lyrinel
Keep out of the reach and sight of children.
Do not use Lyrinel 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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

6 Further information
What Lyrinel contains
The active substance is oxybutynin
hydrochloride. Each prolonged-release
tablet contains either 5 mg or 10 mg
of oxybutynin hydrochloride.
The other ingredients 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:
Name of the
member state

Name of the
medicinal product

Greece

LYRINEL

Ireland

LYRINEL XL

Italy

LYRINEL

Portugal

LYRINEL

United Kingdom

LYRINEL XL

For information in
large print, tape, CD or
Braille, phone
0800 731 8450 (UK) or
1800 709122 (IRE)
This leaflet was last revised in July 2012.
August 2012.

What Lyrinel looks like and
contents of the pack
Lyrinel XL 5 mg prolonged release tablet:
round, yellow coloured tablet printed “5 XL”
with black ink.
Lyrinel XL 10 mg prolonged release tablet:
round, pink coloured tablet printed “10 XL"
with black ink.
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
UK
Manufacturer:
Janssen-Cilag SpA
Via C. Janssen-Cilag Ltd
Borgo S. Michele
04010 Latina
Italy

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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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