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OXYBUTYNIN HYDROCHLORIDE 2.5MG/5ML ORAL SOLUTION

Active substance(s): OXYBUTYNIN HYDROCHLORIDE

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Package Leaflet: Information for the user

Oxybutynin hydrochloride 2.5mg/5ml Oral Solution
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 or
pharmacist.
► 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See
section 4.
In this leaflet:
The name of your medicine is
Oxybutynin hydrochloride
2.5mg/5ml Oral Solution but it will
be referred to as Oxybutynin
throughout this leaflet.

► 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.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Oxybutynin if:
► you are 65 years of age or older
► you have certain heart conditions








What is in this leaflet
1. What Oxybutynin is and what



2. What you need to know



it is used for

3.
4.
5.
6.

before you take Oxybutynin
How to take Oxybutynin
Possible side effects
How to store Oxybutynin
Contents of the pack and
other information

1. What Oxybutynin is and what

it is used for

Oxybutynin contains a medicine
called oxybutynin hydrochloride.
This belongs to two groups of
medicines called ‘anticholinergics’
and ‘antispasmodics’.
It works by relaxing the muscles of
the bladder and stops sudden
muscle contractions (spasms). This
helps control the release of water
(urine).
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

You must talk to a doctor if you do
not feel better or if you feel worse
2. What you need to know
before you take Oxybutynin
Do not take Oxybutynin
if:
► you are allergic (hypersensitive)

to oxybutynin hydrochloride or
any of the other ingredients (see
section 6 ‘Contents of the pack
and other information’).

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 increased pressure in
the eye (glaucoma)
► your gut (stomach or intestine) is
blocked, perforated or not
working properly
PIL/UK/MFG030/04/v2













(deficiency congestive heart
failure, coronary heart disease)
the person taking the medicine is
a child (use is not recommended
under 5 years of age)
you have brain problems (such as
hallucinations, agitation,
confusion, drowsiness)
you have kidney or liver
problems
you have bowel problems (such
as bowel obstruction, bowel
laziness, inflammation of bowel)
you have neurological disorders
(such as Parkinson's disease)
you have an illness affecting the
nerves called ‘autonomic
neuropathy’
you have eye problem (such as
glaucoma)
you have an overactive thyroid
gland (‘Hyperthyroidism’)
you have dental caries or a
fungal infection in the mouth
you have heart disease or high
blood pressure
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

Children and adolescents:
Do not give this medicine to children
under the age of 5 years.
If you are not sure if any of the
above applies to you, talk to your
doctor or pharmacist before taking
Oxybutynin.
Other medicines and
Oxybutynin

► 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 as clozapine,
phenothiazines, haloperidol or
benperidol (butyrophenones)
Medicines for depression - such as
amitriptyline, imipramine or
dosulepin (‘tricyclic antidepressants’)
and lithium
Amantadine, biperiden, levodopa
- used in Parkinson’s disease or to
treat and prevent some viral
infections
Aminopenicillins, tetracyclines,
sulfamethoxazole, cotrimoxazoledrugs used for inhibition of bacterial
infections
Digoxin, quinidine, disopyramide,
procainamide and lidocaine - used to
treat heart problems
Dipyridamole – used to treat
blood problems
Antihistamines - used to treat
allergies
Paracetamol – use to treat pain
Phenylbutazone – use to treat
inflammation
Atropine and related compounds drugs used for spasms of the
digestive tract

Oxybutynin with food, beverages
and alcohol
Alcohol may increase drowsiness
caused by oxybutynin.
Pregnancy,
breast-feeding and
fertility
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. Breast
feeding while using Oxybutynin is
therefore not recommended
If you are pregnant or breastfeeding, think you may be pregnant
or planning to have a baby, ask your
doctor or pharmacist for advice
before taking this medicine.
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.
Oxybutynin contains:

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, including
herbal medicines.
This is because Oxybutynin can
affect the way some medicines
work. Also some medicines can
affect the way Oxybutynin 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

Liquid sorbitol (noncrystallising) (E420): if you have
been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking
this medicinal product.
Methyl parahydroxybenzoate
(E218): may cause allergic
reactions (possibly delayed).

3. How to take Oxybutynin
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
The recommended doses are given
below. These may be changed by
your doctor:

TURN OVER

Adults
► The usual dose is 5mg (10ml)

two or three times a day
► Your doctor may decide to
increase to the maximum dose of
5mg (10ml) four times a day

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

► The usual dose is 2.5mg (5ml)

Stop taking Oxybutynin
and contact your doctor
immediately if you develop
the following symptoms:
► 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

► Your doctor may decide to

Other side effects:

Elderly
► The usual dose is 2.5mg (5ml)

twice a day
► Your doctor may decide to
increase this to 5mg (10ml) twice
a day
Children (over 5 years)
twice a day

increase this to 5mg (10ml) two
or three times a day
► If you are giving it to a child to
prevent bedwetting, give the last
dose just before bedtime
Method of administration
► Use the 2.5-5ml double-ended

Very common (may affect more
than 1 in 10 people):




Dry mouth, constipation, nausea
Dizziness, headache, drowsiness
Dry skin

Common (may affect up to 1 in
10 people):

spoon supplied in the pack to
measure the required dose (see
figure below).
► Swallow the solution.
► Wash the spoon with clean water
after taking every dose.






2.5-5ml double-ended Spoon



Diarrhoea, vomiting
Confusional state
Dry eyes
Inability or difficulty in passing
water (urine)
Flushing

Uncommon (may affect up to 1
in 100 people)


If you take more Oxybutynin
than you should
Contact your nearest hospital
casualty department or tell your
doctor immediately.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, flushed or
get dizzy or light-headed. 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.If you have any further
questions on the use of this
medicine, ask your doctor or
pharmacist.

Stomach pain, loss of appetite
(anorexia), decrease appetite,
difficulty in swallowing
(dysphagia)

Not known: cannot be estimated
from the available data











A bladder infection (Urinary tract
infection)
Indigestion or heartburn (acid
reflux)
Fits (convulsions)
Agitation
Seeing or hearing things that are
not there (hallucinations)
Nightmares
Increased, rapid or irregular
heartbeats (palpitation)
Blurring of vision, enlargement of
the pupil of the eye, increased
pressure in the eyes (glaucoma),
dry eyes
Rash or skin that is more
sensitive to the sun.

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
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 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
‘Exp’. The expiry date refers to
the last day of that month.
► Do not store above 25°C.
► Discard after 30 days of first
opening. Store in the original
packaging after first opening.
► Do not use this medicine if you
notice that the solution becomes
discoloured or shows any signs of
deterioration. Seek the advice of
your pharmacist.

PIL/UK/MFG030/04/v2

► Do not throw away any medicines

via wastewater or household
waste. Ask your pharmacist how
to dispose of medicines you no
longer use. These measures will
help to protect the environment.

6. Contents of the pack and
other information
What Oxybutynin contains
Each 5ml oral solution contains
2.5mg oxybutynin hydrochloride.
The other ingredients are citric acid
monohydrate (E330), sodium citrate
(E331), liquid sorbitol (noncrystallising) (E420), glycerol
(E422), methyl
parahydroxybenzoate (E218),
raspberry flavor (containing
propylene glycol (E1520)) and
purified water.
What Oxybutynin looks like and
contents of the pack
Oxybutynin is a clear, colourless oral
solution with raspberry odour and
supplied in amber glass bottles with
tamper evident child resistant plastic
cap and with a 2.5-5ml double
ended spoon for measuring the
dose.
Oxybutynin hydrochloride
2.5mg/5ml oral solution is supplied
in bottles containing 100ml and
150ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer:
Syri Limited,
t/a Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK
POM
This leaflet was revised in 03/2015

The medicinal product is authorized
in the Member States of the EEA
under the following names:
Name of
member
state
United
Kingdom
Ireland

:

Name of medicinal
product
Oxybutynin
hydrochloride
2.5mg/5ml Oral
Solution
Oxybutynin
hydrochloride
2.5mg/5ml Oral
Solution

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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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