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OXYBUTYNIN HYDROCHLORIDE TABLETS 5MG

Active substance: OXYBUTYNIN HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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.
• If any of the side effects becomes serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor, pharmacist or nurse. This includes any possible
side effect not listed in the leaflet, see section 4.
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.







What is 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  to take Oxybutynin Tablets
How
4 
Possible side effects
5  to store Oxybutynin Tablets
How
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
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

2 
What you need to know before you take Oxybutynin
Tablets
Do not take Oxybutynin Tablets if you

• are allergic (hypersensitive) to oxybutynin hydrochloride or any of the
ingredients of Oxybutynin Tablets (see section 6, Contents of the pack and
other 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
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50853010 AAAH8783

• 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
• 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

Other medicines and Oxybutynin Tablets

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.

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.
Continued over page

Driving and using machines

Uncommon: (may affect up to 1 in 100 people)
Loss of appetite (anorexia)
Abdominal discomfort
Difficulty swallowing

Oxybutynin Tablets contain Lactose

Not known: (frequency cannot be estimated from the available data)
Urinary tract infection
Indigestion or heartburn (acid reflux)
Abdominal pain and bloating which may be accompanied by feeling or being sick,
difficulty with swallowing, diarrhoea or constipation, depending on the part of the gut
affected (pseudo-obstruction)
Agitation
Anxiety
Seeing things that are not there (hallucinations)
Nightmares
Feeling excessively suspicious and distrustful of others (paranoia)
Depression
Becoming dependent on Oxybutynin Tablets
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)
Heat stroke
Itchy, lumpy rash (urticaria)
Absence of sweating (hypohidrosis)
Allergic reaction, the signs may include a rash, swallowing or breathing problems,
swelling of the lips face throat or tongue

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.
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  to take Oxybutynin Tablets
How

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
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 than 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)
Dry eyes
Confusion
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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, 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  to store Oxybutynin Tablets
How

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 with a breakline on the reverse.
2.5 5

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 UK Limited, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in June 2015

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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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