Skip to Content

UK Edition. Click here for US version.

OXYBUTYNIN HYDROCHLORIDE 3MG TABLETS

Active substance(s): OXYBUTYNIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
1. What oxybutynin is and
what it is used for

Oxybutynin Hydrochloride
3mg Tablets

What oxybutynin is
The name of your medicine is Oxybutynin
Hydrochloride 3mg Tablets (referred to as
oxybutynin throughout this leaflet).
It contains a medicine called oxybutynin
hydrochloride. This belongs to two groups
of medicines called ‘anticholinergics’ and
‘antispasmodics’.

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 oxybutynin is and what it is
used for
2. Before you take oxybutynin
3. How to take oxybutynin
4. Possible side effects
5. How to store oxybutynin
6. Further information

How oxybutynin works
It works by relaxing the muscles of the
bladder and stops sudden muscle
contractions (spasms). This helps control
the release of water (urine).
What oxybutynin is used for
Oxybutynin 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 oxybutynin
Do not take this medicine and tell
your doctor if:
✕ You are allergic (hypersensitive) to
oxybutynin hydrochloride or any of the
other ingredients in this medicine
(listed in Section 6 Further
Information)
1

Signs of an allergic reaction include:
a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
✕ 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 oxybutynin.
Take special care with oxybutynin.
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 this 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

632306_NT. OXYBUTININ 3 MG RL S1 GB.qxp_FORMAT 210x170mm-RL-DBL.qxd 08/04/16 16:58 Page1

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 oxybutynin can
affect the way some other medicines work.
Also, some other medicines can affect the
way oxybutynin works.

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
2

amounts may pass into mothers’ milk.
Breastfeeding while using oxybutynin is
therefore not recommended.
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 oxybutynin
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 oxybutynin
Always take oxybutynin 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.

632306_NT. OXYBUTININ 3 MG RL S1 GB.qxp_FORMAT 210x170mm-RL-DBL.qxd 08/04/16 16:58 Page2

▲ You have an irregular heart beat
(palpitations) and/or increased or rapid
heart beat
▲ 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
Oxybutynin 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.
Oxybutynin 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 oxybutynin.

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 oxybutynin
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 oxybutynin
Keep taking oxybutynin until your doctor
tells you to stop. Do not stop taking
oxybutynin just because you feel better.
4. Possible side effects
Like all medicines, oxybutynin can cause
side effects, although not everybody gets
them. Children are at higher risk of the
effects.
Stop taking oxybutynin and see a doctor
or go to a hospital straight 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
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
3

• 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)
• Agitation
• Anxiety
• Becoming dependent on Oxybutynin
• Feeling excessively suspicious and
distrustful of others (paranoia)
• Seeing or hearing things that are not
there (hallucinations)
• Drowsiness
• Nightmares

632306_NT. OXYBUTININ 3 MG RL S1 GB.qxp_FORMAT 210x170mm-RL-DBL.qxd 08/04/16 16:58 Page3

How much to take
Your doctor will decide the dose
appropriate for you.
Adults
• The usual starting dose is one 5mg
oxybutynin 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 oxybutynin than you
should
If you take more oxybutynin 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 much oxybutynin can be very
dangerous. You may become very restless
or excited, flush or get dizzy or lightheaded.

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

*632306*

632306_NT. OXYBUTININ 3 MG RL S1 GB.qxp_FORMAT 210x170mm-RL-DBL.qxd 08/04/16 16:58 Page4

• 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)

6. Further Information
What Oxybutynin 3mg Tablets contain
• Each tablet contains 3mg of the active
substance oxybutynin hydrochloride
• The other ingredients are lactose,
microcrystalline cellulose, calcium
stearate and indigo carmine aluminium
lake (E132)
What oxybutynin looks like and contents
of the pack
• Oxybutynin 3mg Tablets are pale blue
round tablets with OXB3 on one side.
Supplied in blisters of 56 tablets.
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
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.
This leaflet was last revised in
April 2016.
‘Zentiva’ is a registered trademark
© 2016 Zentiva.
4

632306

Expand view ⇕

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.

Hide