OXYBUTYNIN HYDROCHLORIDE TABLETS 5MG

Active substance: OXYBUTYNIN HYDROCHLORIDE

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Oxybutynin Hydrochloride Tablets
2.5 mg and 5 mg
Oxybutynin Hydrochloride
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, pharmacist or
nurse.
• 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.
2 What you need to know
• If any of the side effects
before you take Oxybutynin
becomes serious, or if you
Tablets
notice any side effects not listed
Do not take Oxybutynin Tablets
if you
in this leaflet, please tell your
• are allergic (hypersensitive) to
doctor, pharmacist or nurse. This
oxybutynin hydrochloride or any of
includes any possible side effect
the ingredients of
not listed in the leaflet. See
Oxybutynin Tablets (see section
6, Contents of the pack and other
section 4.

wall, and helps to control the release
of urine.
It is used to treat the following
conditions:
Adults:
• Loss of control in passing water
(urinary incontinence), urgency
and frequency in patients unable to
control their bladder
• Neurogenic bladder disorders (lack of
bladder control caused by problems
with the nervous system or spinal
cord)
Children over 5 years:
Oxybutynin Hydrochloride Tablets can be
used 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

Your medicine is called Oxybutynin
Hydrochloride Tablets 2.5 mg and 5 mg
They will be referred to as Oxybutynin
Tablets throughout this leaflet for ease.

In this leaflet:
1 What Oxybutynin Tablets are
and what they are used for
2 What you need to know
before you take Oxybutynin
Tablets
3 How to take Oxybutynin
Tablets
4 Possible side effects
5 How to store Oxybutynin
Tablets
6 Contents of the pack and
other information.
1 What Oxybutynin Tablets are
and what they are used for
The active substance in Oxybutynin
Tablets is oxybutynin hydrochloride
This is one of a group of medicines
called anticholinergics or
antispasmodics.
It increases the volume of the bladder
by relaxing the muscle of the bladder
Continued top of next column

information., for a list of ingredients)
Signs of an allergic reaction include,
a rash, swallowing or breathing
problems, swelling of your lips, face
throat or tongue.
• have diseases or obstructions of
the intestine (gut), including bowel
obstruction or no bowel movement
• have a blocked urinary tract (causing a
poor flow of urine)
• have a condition called myasthenia
gravis (a muscle weakening disease)
• have untreated glaucoma (high
pressure and pain in the eyes)
• have problems with your blood
pressure
• have severe form of a condition
known as ulcerative colitis.
• if you are pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse
before taking Oxybutynin Tablets if any
of the following apply to you:
• an overactive thyroid gland (a gland
in your neck)
• heart disease, heart failure, fast or
irregular heartbeat
• high blood pressure
• an enlarged prostate gland (in men)
• hiatus hernia
Continued top of next column

• reflux oesophagitis (a condition
affecting the food pipe)
• raised body temperature
• taking this medicine in a hot climate
• have an illness affecting the nerves
called autonomic neuropathy
• have kidney or liver disease.
• are 65 years of age or older
• have dental caries, as long term use
can lead to an increase risk of tooth
decay, gum disease or fungal infection
Children
Check with your doctor pharmacist or
nurse before taking your medicine if:
The person taking this 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 or
pharmacist

Taking other medicines and
oxybutynin

Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines or might take any
other medicine. This includes medicines
you buy without prescription.
In particular, interaction with any of the
following may alter the effect of the
medicine:
• amantadine (used in Parkinson’s
disease or to treat and prevent some
viral infections)
• levodopa or biperiden (used to treat
Parkinson’s disease)
• digitalis, digoxin and quinidine (used
to treat heart problems)
• medicines to treat depression such as
amitriptyline,imipramine or dosulepin
(tricyclic antidepressants)
• 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)
• other medicines called 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
• antihistamines used to relieve allergy
symptoms
• medicines containing atropine or
related compounds like atropinic
antispasmodics and dipyridamole.

Continued over page

Oxybutynin Tablets with food,drink
and alcohol
Oxybutynin Tablets should be swallowed
with plenty of water, with or without food.
If you take alcohol while taking these
tablets, you may become very drowsy.

Pregnancy and breast-feeding

You should not take Oxybutynin Tablets if
you are pregnant or breast-feeding.
If you are planning to become pregnant
or suspect you might be pregnant, talk to
your doctor before taking your tablets.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines

Oxybutynin Tablets can sometimes cause
blurred vision, drowsiness or dizziness.
If you get any of these symptoms do not
drive or use any tools or machines until
they go away. If you are unsure, speak to
your doctor or pharmacist.

Oxybutynin Tablets contains
Lactose

If you have been told by your doctor that
you are intolerant to some sugars and have
to avoid them, contact your doctor before
taking this medicine.

3 How to take Oxybutynin
Tablets

Always take Oxybutynin Tablets exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.
The tablets should be swallowed with
plenty of water or other fluid, with or
without food.
Adults: The recommended dose is 2.5
to 5 mg swallowed two or three times a
day. Occasionally, 5 mg four times a day is
required.
Elderly (over 80 years): The
recommended dose is 2.5 to 5 mg
swallowed two or three times a day,
however, as the drug can remain in the
body for longer in elderly patients, 2.5 to
5 mg twice a day is usually sufficient.
Use in Children
Children over 5 years: The recommended
dose is 2.5 to 5 mg swallowed twice a day
Your doctor might decide to increase the
dose to three times a day if needed.
Nocturnal enuresis (nighttime
bedwetting): The usual dose is 5 mg
swallowed two or three times a day. The
last dose should be given just before
bedtime.
Children under 5 years: Not
recommended.
Sometimes your doctor may reduce your
dose, especially when you have been
taking your tablets for some time.

If you take more Oxybutynin
Tablets than you should
If you accidentally take more than your
prescribed dose, contact a doctor or your
nearest hospital casualty department
immediately. Take this leaflet and the pack
with you. This is so the doctor knows what
you have taken.
Taking too many Oxybutynin tablets can
be very dangerous. You may become very
restless or excited, flushed or get dizzy or
light headed.Your heart beat may become
Continued top of next column

very fast, uneven or forceful. You may get
breathing problems or numbness or go
into a coma.

If you forget to take Oxybutynin
Tablets

If you forget to take 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 tablet.

If you stop taking Oxybutynin
Tablets

Keep taking your medicine 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,
pharmacist or nurse.

4 Possible side effects

Like all medicines, Oxybutynin Tablets can
cause side effects, although not everybody
gets them. Children are at higher risk of
the effects.

Stop taking Oxybutynin Tablets
and see a doctor or go to a hospital
straight away if:
• 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 last longer that a
few days
Very common: (may affect more that 1 in
10 people)
Headache
Dizziness, drowsiness or confusion
Dry mouth which can lead to tooth decay,
gum disease or oral thrush.
Constipation
Feeling sick
Dry skin, rash or skin that is more sensitive
to the sun.
Common: (may affect up to 1 in 10 people)
Facial flushing especially in children
Diarrhoea
Vomiting
Difficulty passing water (urine)
Uncommon: (may affect up to 1 in 100
people)
Loss of appetite (anorexia)
Abdominal discomfort
Difficulty swallowing
Not known: (frequency cannot be
estimated from the data)
Agitation
Seeing things that are not there
(hallucinations)
Nightmares
Fits (convulsions)
Blurring of vision or sudden loss of vision,
increased pressure in the eyes (glaucoma),
pain the eyes, enlargement of the pupil of
the eye, or dry eyes
Increased, rapid or irregular heartbeat
(palpitations)

pharmacist or nurse. This includes any
possible side effect 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
Tablets

Keep out of the sight and reach of children.
Do not use Oxybutynin Tablets after the
expiry date which is stated on the carton
and blister strip. The expiry date refers to
the last day of that month.
Store below 25°C. Store in the original
package. Do not use Oxybutynin Tablets
if the tablets show visible signs of
deterioration.
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 to protect the
environment.

6 Contents of the pack and other
information
What Oxybutynin Tablets contain

The active substance is oxybutynin
hydrochloride. Each 2.5 mg tablet contains
2.5 mg oxybutynin hydrochloride.
Each 5 mg tablet contains 5 mg oxybutynin
hydrochloride.
The other ingredients are crospovidone,
cellulose, microcrystalline, lactose
monohydrate,
magnesium stearate and indigo carmine
aluminium lake (E132).
What Oxybutynin Tablets look like and
contents of the pack
Oxybutynin Hydrochloride Tablets are light
blue tablets, marked OXB or OXB

2.5 5
with a breakline on the reverse.
They are packed in blister strips
and supplied in cartons of
20, 28, 30, 56, 60, 84 and 120
tablets. Not all pack sizes may
be marketed.
Marketing Authorisation
Holder
Niche Generics Limited, 1 The
Cam Centre, Wilbury Way,
Hitchin, Herts SG4 0TW, United
Kingdom.
Manufacturers:
Actavis, Barnstaple,
EX32 8NS, UK
This leaflet was last revised in
September 2014

Reporting of side effects

If any of the side effects becomes serious,
or if you notice any side effects not listed
in this leaflet, please tell your doctor,
Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK
AAAG7929 50801746

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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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