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.
• 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 becomes serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
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 Before you take Oxybutynin Tablets
3 How to take Oxybutynin Tablets
4 Possible side effects
5 How to store Oxybutynin Tablets
6 Further 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 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, Further
Information, for a list of ingredients)
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• 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 muscleweakening
disease)
• have untreated glaucoma (high pressure and pain in the eyes)
• have problems with your blood pressure
• have megacolon (greatly enlarged colon) or severe colitis
(inflammation of the colon)

Take special care and talk to your doctor or pharmacist
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
• an enlarged prostate gland (in men)
• hiatus hernia
• reflux oesophagitis (a condition affecting the food pipe)

The tablets should be used with caution in
• the elderly
• patients with diseases of the nervous system, liver or kidneys.
Check with your doctor or pharmacist before taking your medicine if:
• The person taking this medicine is a child (use is not recommended
under 5 years of age.
Avoid exposure to extreme heat, as oxybutynin may make it harder
for your body to cool down when it gets very hot.
You may suffer from fever and heat stroke due to decreased sweating.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription.
In particular, interaction with any of the following may alter the effect
of the medicine:
• phenothiazines or tranquilizers (e.g. chlorpromazine,
thioridazine and fluphenazine)
• amantadine (used in Parkinson’s disease or to treat and prevent
some viral infections)
• haloperidol (used to treat certain mental illnesses)
• levodopa (used in Parkinson’s disease)
• digitalis (a heart medicine)
• tricyclic antidepressants
• sedatives (e.g. diazepam and oxazepam)
• other anticholinergic medicines (similar to oxybutynin)

Taking Oxybutynin Tablets with food and drink

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.
Continued over page

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.

Important information about some of the
ingredients of Oxybutynin Tablets

This medicine contains a type of sugar called lactose monohydrate.
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 has told you.
You should 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 usual 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 usual 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.
Children over 5 years: The usual 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.

Side effects reported by patients taking Oxybutynin Tablets include:
• Flushing of the face
• Fast, irregular or pounding heartbeats
• Skin rash
• Decrease in sweating
• Dry mouth
• Constipation
• Feeling sick (nausea)
• Difficulty in passing water
• Dizziness
• Drowsiness
• Difficulty sleeping
• Hallucinations (seeing and hearing things that are not there)
• Restlessness
• General feeling of weakness and tiredness
• Blurred vision, dry eyes
• Unable to get an erection (men)
• Lack of milk production (breast-feeding women)
If any of the side effects becomes serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5 How to store Oxybutynin Tablets

Keep out of the reach and sight 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.
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.

6 Further information

What Oxybutynin Tablets contain

If you take more Oxybutynin Tablets than you should

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).

If you forget to take Oxybutynin Tablets

What Oxybutynin Tablets look like and contents of the
pack

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.
If you forget to take a dose, take it as soon as you remember and then
continue with the next dose as usual. Do not take an extra tablet to
make up for missed doses.

If you stop taking Oxybutynin Tablets

Keep taking your medicine until your doctor tells you to stop.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4 Possible side effects

Like all medicines, Oxybutynin Tablets can cause side effects,
although not everybody gets them.

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

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.
Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK
Date of last approval:06/2011

Tell your doctor if you suffer from diarrhoea during your
treatment with Oxybutynin Tablets (especially if you have
had an ileostomy or a colostomy), as this could be an early
sign of intestinal obstruction.
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Actavis, Barnstaple, EX32 8NS, UK

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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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