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OXYBUTYNIN HYDROCHLORIDE 5MG TABLETS

Active substance(s): OXYBUTYNIN CHLORIDE / OXYBUTYNIN HYDROCHLORIDE

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Package leaflet: Information for the patient
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 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.
What is in this leaflet
1.
What Oxybutynin hydrochloride is and what it is used for
2.
What you need to know before you take Oxybutynin hydrochloride
3.
How to take Oxybutynin hydrochloride
4.
Possible side effects
5.
How to store Oxybutynin hydrochloride
6.
Contents of the pack and other information
1.

What Oxybutynin hydrochloride is and what it is used for

Oxybutynin hydrochloride belongs to two groups of medicines called “antispasmodics” and “anticholinergics”.
Oxybutynin hydrochloride works by helping to reduce the muscle spasms of the bladder. It is these spasms
which make you feel that you need to urinate often. Oxybutynin therefore has the effect of relaxing the bladder
muscle so the bladder can hold more urine and the frequent urge to urinate is reduced. Oxybutynin
hydrochloride Tablets may therefore be used to treat conditions whereby you are unable to control your bladder
normally. The reason for this happening may not be known or may be due to a disorder affecting the body's
nerves to the bladder.
Oxybutynin hydrochloride can be used in adults and 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 hydrochloride

Do not take Oxybutynin hydrochloride:
- if you are allergic to oxybutynin or any of the other ingredients of this medicine (listed in section 6)
- if you have difficulty passing urine
- if you suffer from a severe condition called ulcerative colitis, or have noticed blood and mucus in your
stools
- if you suffer from a sluggish bowel, are constipated or have a gut problem (your gut is blocked,
perforated or not working properly)
- if you suffer from a condition which causes weak muscles (Myasthenia gravis)
- if you suffer from glaucoma (raised pressure in the eye)
- if you have a heart condition causing a racing or irregular heart beat
- if you have been told that you have a condition where the tissue of the brain is hardening (cerebral
sclerosis)
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxybutynin hydrochloride:
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- if you are elderly (65 years of age or older), as you may be more sensitive to the effects of Oxybutynin
Hydrochloride Tablets
- if the person taking the medicine is a child (use is not recommended under 5 years of age)
- if you have a heart or blood vessel condition, or high blood pressure
- if you have irregular heart beat and/or increased or rapid heart beat
- if you have liver, kidney or a gut disease
- if you have a condition which affects your nervous system
- if you have an overactive thyroid gland (hyperthyroidism)
- if you have a fever or are in a hot environment as oxybutynin may increase your risk of over-heating
- if you have an enlarged prostate gland
- if you have indigestion or heart burn caused by a disease called “hiatus hernia”
- if you have an urinary tract infection, this should be treated before starting the treatment with
oxybutynin
Tell your doctor if any of the above applies to you.
Other medicines and Oxybutynin hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription, herbal medicines or any of the following:
 antihistamine medicines to relieve allergic symptoms
 other medicines called anticholinergic or antimuscarinic - such as some medicines for irritable bowel
syndrome, asthma or incontinence, motion sickness or movement disorders associated with
Parkinson’s disease
 medicines to treat depression eg. amitriptyline, imipramine or dosulepin (tricyclic antidepressants)
 medicines to treat mental illness eg. clozapine, phenothiazines, butyrophenones
 anti-sickness medicines eg. metoclopramide, domperidone
 medicines containing atropine
 disopyramide or quinidine, digitalis used to treat irregular heart rhythm
 dipyridamole, used to prevent blood clots and stroke
 medicines to prevent some virus infections or treat Parkinson’s disease eg. levodopa, biperiden,
procyclidine, amantadine
 medicines that dissolves on the tongue eg. glyceryl trinitrate (GTN) tablets for angina, as
Oxybutynin hydrochloride can cause a dry mouth so the tablets may not dissolve properly
 digoxin, used to treat heart problems
 medicines to treat myasthenia gravis eg. neostigmine or pyridostigmine
 medicines for HIV infection eg. ritonavir, indinavir or saquinavir
 ketoconazole or itraconazole, used to treat fungal infections
 clarithromycin or telithromycin, used to treat bacterial infections.
Oxybutynin hydrochloride with food, drink and alcohol
Oxybutynin hydrochloride can be taken on an empty stomach but take with food or some milk if this
medicine gives you stomach problems.
Drinking alcohol may enhance the drowsiness caused by oxybutynin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Oxybutynin should only be given to pregnant women when the benefits to the mother outweigh the risks to
the baby. Speak to your doctor first. Do not breast-feed while taking oxybutynin as small amounts of
oxybutynin hydrochloride can pass into breast milk.
Driving and using machines
Do not drive or use machines if you feel dizzy or suffer from blurred vision while taking Oxybutynin
hydrochloride Tablets.
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Oxybutynin hydrochloride Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
3.

How to take Oxybutynin hydrochloride

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Taking this medicine
Swallow the tablets with a glass of water on an empty stomach. If the tablets upset your stomach take them
during meals or with some milk.
Visit your dentist regularly as oxybutynin can cause a dry mouth that can increase the risk of tooth decay.
Adults: The starting dose is one Oxybutynin hydrochloride 2.5 mg Tablets two or three times a day. The
recommended dose is one Oxybutynin hydrochloride 5 mg Tablets two or three times a day. The doctor may
increase this dose to a maximum dose of 5 mg four times a day.
Elderly patients: A lower starting dose of one Oxybutynin hydrochloride 2.5 mg Tablets twice a day, as
elderly or frail patients may be more sensitive to the effects of this medicine. The doctor may increase this
dose to a maximum dose of one Oxybutynin hydrochloride 5 mg Tablet twice a day.
Use in children and adolescents: Do not give this medicine to children under 5 years of age.
For children over 5 years, the recommended starting dose is one Oxybutynin hydrochloride 2.5 mg Tablets
twice daily. The doctor may increase this dose to one Oxybutynin hydrochloride 5 mg Tablet two or three
times a day. Give your child the last dose just before bedtime.
If you take more Oxybutynin hydrochloride than you should
If you take more Oxybutynin Hydrochloride Tablets than you should, contact your doctor or go to a hospital
casualty department straight away. Take the medicine pack with you.
Taking too many Oxybutynin hydrochloride 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 hydrochloride
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 hydrochloride
Keep taking Oxybutynin hydrochloride Tablets until your doctor tells you to stop. Don’t stop taking your
medicine just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In some cases, these effects may go away if your doctor reduces your dose.
If you get any of these serious side effects stop taking this medicine straight away and seek medical advice
immediately:
Common (may affect up to 1 in 10 people):
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-

You have problems or difficulty passing urine.

Not known (frequency cannot be estimated from the available data):
- You have a severe allergic reaction with swelling of the face, lips, mouth, tongue or throat which
may cause difficulty in swallowing or breathing (angioedema)
- You sweat less which leads to overheating in hot environments and can cause heat stroke
- You have raised pressure in the eye (glaucoma). If you notice a sudden change in your eyesight go to
an optician straight away.
You have urinary tract infection (signs may include pain or burning sensation while passing urine).
- Fits
- A part blockage of the bowel - you pass stools with difficulty or may not be able to pass stools, or
have a bloated, painful stomach.
Other side effects
Very common (may affect more than 1 in 10 people):
Headache, dizziness, drowsiness, dry mouth, dry skin, constipation, feeling sick.
Common (may affect up to 1 in 10 people):
Feeling confused, dry eyes, facial flushing (more common in children than adults), diarrhoea, being sick.
Uncommon (may affect up to 1 in 100 people):
Decreased appetite, loss of appetite, difficulty in swallowing, stomach discomfort.
Not known (frequency cannot be estimated from the available data):
Feeling restless, agitated, depressed, bad dreams, feeling anxious, paranoid or suffer from hallucinations
(seeing, feeling or hearing things that are not there), difficulty in learning, perception and problem solving,
dependence on taking this medicine. Elderly patients may be more sensitive to these side effects.
Other possible side effects include eyesight changes, blurred vision, a racing or irregular heartbeat, stomach
discomfort and heartburn, which usually occurs after eating or at night and which worsens when bending
over (gastroesophageal reflux), impotence, allergic skin reactions like rash, itching or increased sensitivity
of the skin to sun (photosensitivity).
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 internet 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 hydrochloride

Keep this medicine out of the sight and reach of children.
Do not store above 25ºC.
Blisters: Store in the original package in order to protect from light.
Bottles: Keep the container tightly closed in order to protect from light.
Do not use this medicine 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.
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 protect the environment.
6.

Contents of the pack and other information

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What Oxybutynin hydrochloride contains
The active substance is 2.5 mg or 5 mg of oxybutynin hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, calcium stearate and indigo
carmine E132.
What Oxybutynin hydrochloride looks like and contents of the pack
The 2.5 mg tablets are blue, capsule-shaped tablets marked ‘OB/2.5’ on one side and ‘G’ on the other. The
score line is only there to help you break the tablet if you have difficulty swallowing it whole.
The 5 mg tablets are blue, round, and marked ‘OB/5’ on one side and ‘G’ on the other. The 5 mg tablets can
be divided into equal doses.
Oxybutynin hydrochloride Tablets is available in plastic bottles or blister packs of 20, 30, 50, 56, 60, 84, 90,
100, 250 (bottles only) and 500 (bottles only) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,
Station Close,
Potters Bar,
Hertfordshire,
EN6 1TL,
United kingdom
Manufacturer
Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13
Ireland
Mylan Hungary Kft,
H-2900 Komárom,
Mylan utca 1,
Hungary
This leaflet was last revised in 04/2015.

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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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