LYRINEL XL 10MG PROLONGED RELEASE TABLET

Active substance: OXYBUTYNIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2014

5 mg prolonged release tablets
10 mg prolonged release tablets
Oxybutynin hydrochloride
Read all of this lea et carefully
before you start taking this
medicine because it contains
important information for you.

• Keep this lea et. 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 e ects, talk to your
doctor, pharmacist or nurse. This includes
any possible side e ects not listed in this
lea et. See section 4.

What is in this lea et:
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 e ects
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 lea et. 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 a ect 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, re ux 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
out ow obstruction’ which makes it di cult
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
a ect the way some other medicines work.
Also, some other medicines can a ect 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 uconazole
• 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 ushing or
drop in blood pressure, di culty 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.

© J-C 2014

4 Possible side e ects
Like all medicines, this medicine can cause
side e ects, 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), di culty
swallowing or breathing, swelling of your
lips, face, throat or tongue
• You have central nervous system (CNS)
e ects (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 rst 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 e ects get serious or
lasts longer than a few days:
Very common (a ects 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 (a ects 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 ( atulence) 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 (a ects less than 1 in 100
people)
• Seeing or hearing things that are not there
(hallucinations)
• Psychological problems, feeling agitated
or confused, di culty remembering
• Allergic reaction including hives or swelling
of the face, lips, tongue or throat
• Di culty 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 e ects:
• Di culty breathing due to a serious allergic
reaction
• Psychological problems
• Di culty getting or keeping an erection
• Anxiety
• Nightmares
• Paranoia
• Di culty thinking, remembering
information, or solving problems
• Dilated pupils
• High eye pressure
• Lack of sweating
• Heat stroke.
Additional side e ects in children
Constipation is a very common side e ect
in children. The following are common side
e ects in children: Loss of appetite, diarrhoea,
headache, problems sleeping, rash or itching,
ushing.

Reporting of side e ects

If you get any side e ects, talk to your doctor,
pharmacist or nurse. This includes any
possible side e ects not listed in this lea et.
In the UK, you can also report side e ects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
In Ireland, you can also report side e ects
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 e ects you can help
provide more information on the safety of
this medicine.

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.

What Lyrinel XL 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

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 lea et was last revised in April 2014.

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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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