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CYSTRIN 5MG TABLETS

Active substance(s): OXYBUTYNIN HYDROCHLORIDE

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1. What Cystrin Tablets are and
what they are used for

Cystrin 5mg Tablets

What Cystrin Tablets are
Cystrin Tablets contain a medicine called
oxybutynin hydrochloride. This belongs
to two groups of medicines called
‘anticholinergics’ and ‘antispasmodics’.

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 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 get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Cystrin Tablets are and what they
are used for.
2. Before you take Cystrin Tablets.
3. How to take Cystrin Tablets.
4. Possible side effects.
5. How to store Cystrin Tablets.
6. Further information.

How Cystrin Tablets work
It works by relaxing the muscles of the
bladder and stops sudden muscle
contractions (spasms). This helps control
the release of water (urine)
What Cystrin Tablets are used for
Cystrin Tablets can be used in adults and
children 5 years or older to treat:
• Loss of control in passing water (urinary
incontinence)
• Increased need or urgency to pass water
(urine)
• Night time bedwetting, when other
treatments have not worked
2. Before you take Cystrin Tablets
Do not take this medicine and tell
your doctor if:
✕ You are allergic (hypersensitive) to
oxybutynin hydrochloride or any of the
other ingredients of Cystrin Tablets
(listed in Section 6 Further Information)
Signs of an allergic reaction include:
a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
1

✕ You have a rare muscle illness called
‘Myasthenia gravis’
✕ You have glaucoma (increased pressure
in the eye, sometimes sudden and
painful with blurred vision or loss of
vision)
✕ Your gut (stomach or intestine) is
blocked, perforated or not working
properly
✕ You have a severe form of a condition
known as ‘ulcerative colitis’
✕ You have a blockage that makes it
difficult for you to pass water (urine)
Do not take this medicine if any of the
above applies to you. If you are not sure,
talk to your doctor or pharmacist before
taking Cystrin Tablets.
Take special care with Cystrin Tablets.
Check with your doctor or pharmacist
before taking your medicine if:
▲ You have kidney or liver problems
▲ You are 65 years of age or older
▲ The person taking the medicine is a
child (use is not recommended under
5 years of age)
▲ You have an illness affecting the nerves
called ‘autonomic neuropathy’
▲ You have an overactive thyroid gland
(‘Hyperthyroidism’)
▲ You have heart disease or high blood
pressure
▲ You have an irregular heart beat
(palpitations) and/or increased or
rapid heart beat

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines. This includes medicines
you buy without a prescription, including
herbal medicines. This is because Cystrin
Tablets can affect the way some other
medicines work. Also, some other medicines
can affect the way Cystrin Tablets work.
In particular, tell your doctor if you are
taking any of the following:
• Other anticholinergic or antimuscarinic
medicines – such as some medicines

for irritable bowel syndrome, asthma
or incontinence, motion sickness or
movement disorders associated with
Parkinson’s disease
• Medicines used to make you feel sleepy
(sedatives) or if you are feeling sick
(nausea) or have vertigo – such as
prochlorperazine or chlorpromazine
• Medicines used to treat certain mental
illnesses such a clozapine, phenothiazines
haloperidol or benperidol (butyrophenones)
• Medicines for depression – such as
amitryptyline, imipramine or dosulepin
(“tricyclic antidepressants”)
• Amantadine – used in Parkinson’s
disease or to treat and prevent some
virus infections
• L-dopa – used to treat Parkinson’s disease
• Digoxin – used to treat heart problems.
• Medicines for stomach and bowel
related problems - such as
domperidone, metoclopromide or
bethanechol
Pregnancy and breastfeeding
Talk to your doctor before taking this
medicine if
• You are pregnant, might become pregnant
or think you may be pregnant
• You are breast-feeding or planning to
breast feed. This is because small
amounts may pass into mothers’ milk.
Breastfeeding while using oxybutynin is
therefore not recommended.
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Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breastfeeding.
Driving and using machines
You may feel drowsy or have blurred
vision while you are taking this medicine.
If this happens, do not drive or use any
tools or machines.
Important information about some of
the ingredients of Cystrin Tablets
This medicine contains:
• Lactose: If you have been told by your
doctor that you cannot tolerate or digest
some sugars (have an intolerance to
some sugars), talk to your doctor before
taking this medicine.
3. How to take Cystrin Tablets
Always take Cystrin Tablets exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets with a glass of
water
• Do not give this medicine to children
under 5 years old
• If you feel the effect of your medicine is
too weak or too strong, do not change
the dose yourself, but ask your doctor.

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▲ You have an enlarged prostate gland
▲ You have indigestion or heart burn
caused by a ‘hiatus hernia’ (where part
of your stomach pushes through the
diaphragm)
▲ You have a raised body temperature or
fever
▲ You will be taking this medicine in a
hot climate
Cystrin tablets can cause glaucoma
(increased pressure in the eye) please
contact your doctor immediately if you
suffer any blurred vision, loss of vision or
have any pain in the eye.
Cystrin tablets may reduce the amount of
saliva resulting in tooth decay or fungal
infection of the mouth.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Cystrin Tablets.

Adults
• The usual starting dose is one 5mg
tablet two or three times each day
• Your doctor may decide to increase to
the maximum dose of 5mg four times
each day
Elderly
• The usual starting dose is one 3mg
tablet twice each day
• Your doctor may decide to increase
this until you respond to the medicine
Children (over 5 years)
• The starting dose is one 3mg tablet
twice each day
• The usual dose is then one 5mg tablet
twice each day
• Your doctor may decide to increase
this to one 5mg tablet two or three
times each day
• If you are giving it to a child to prevent
bedwetting, give the last dose just
before bedtime
If you take more Cystrin Tablets than
you should
If you take more Cystrin Tablets than you
should, tell a doctor or go to a hospital
casualty department straight away. Take
the medicine pack with you. This is so the
doctor knows what you have taken.

Taking too many Cystrin Tablets can be
very dangerous. You may become very
restless or excited, flush or get dizzy or
lightheaded. Your heart beat may
become very fast, uneven or forceful. You
may get breathing problems or numbness
or go into a coma.
If you forget to take Cystrin Tablets
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time
for the next dose, skip the missed dose.
Do not take a double dose to make up for
a forgotten dose.
If you stop taking Cystrin Tablets
Keep taking Cystrin Tablets until your
doctor tells you to stop. Do not stop
taking Cystrin Tablets just because you
feel better.
4. Possible side effects
Like all medicines, Cystrin Tablets can
cause side effects, although not
everybody gets them. Children are at
higher risk of the effects.
Stop taking Cystrin Tablets and see a
doctor or go to a hospital right away if:
Frequency unknown
• You have an allergic reaction. The signs
may include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue.
• You feel reduced sweating, leading to
overheating in hot environments
3

Tell your doctor or pharmacist if any of
the following side effects get serious or
lasts longer than a few days:
Very common (affects more than 1 in
10 people)
• Constipation
• Dry mouth
• Feeling sick, being sick
• Dry skin
• Headache
• Somnolence (feeling drowsy or sleepy)
• Dizziness
• Blurring of vision
Common (affects 1 to 10 people in a 100)
• Dry eyes
• Diarrhoea
• Vomiting
• Flushing especially in children
• Confusion
Uncommon (affects 1 to 10 people in a 1,000)
• Stomach pain
• Loss of appetite (anorexia)
• Difficulty in swallowing (dysphagia)
Frequency unknown
• Increased pressure in the eyes, sometimes
sudden and painful with blurred vision or
loss of vision (glaucoma), enlargement of
the pupil of the eye
• Indigestion or heartburn (acid reflux)
• Urinary tract infection
• Increased, rapid or irregular heartbeat
(palpitations)
• Heat stroke
• Difficulty passing water (urine)

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How much to take
Your doctor will decide the dose appropriate
for you.

after EXP. The expiry date refers to the last
day of that month.
Store below 30°C.
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.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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.

What Cystrin Tablets looks like and
contents of the pack
• Cystrin® 5mg Tablets are pale blue
round tablets with OXB5 on one side
and a break line on the other side.
Supplied in blisters of 84 tablets.

5. How to store Cystrin Tablets
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Cystrin Tablets after the expiry
date which is stated on the label or carton

This leaflet was last revised in
April 2016.
‘Zentiva’ is a registered trademark
© 2016 Zentiva

6. Further Information
What Cystrin Tablets contain
• Each tablet contains 5mg of the active
substance oxybutynin hydrochloride
• The other ingredients are lactose,
microcrystalline cellulose, calcium
stearate and indigo carmine aluminium
lake (E132)

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Zentiva,
One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Manufacturer
Sanofi Winthrop Industrie,
30-36 avenue Gustave Eiffel,
37000 Tours, France
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*632307*

This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.

632307

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• Agitation
• Anxiety
• Becoming dependent on Cystrin
• Feeling excessively suspicious and
distrustful of others (paranoia)
• Seeing or hearing things that are
not there (hallucinations)
• Drowsiness
• Nightmares
• Fits (convulsions)
• Depression
• Itchy, lumpy rash (Urticaria)
• Absence of sweating (hypohidrosis)
• Skin that is more sensitive to the sun
(photosensitivity)
• Abnormal bloating/swelling together
with pain and feeling or being sick
(pseudo-obstruction)

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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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