Medication Guide App

OXYBUTYNIN 5MG TABLETS

Active substance: OXYBUTYNIN HYDROCHLORIDE

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Patient Information Leaflet
Read this entire leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should NOT pass it on to others. It
may harm them, even if their symptoms are the same as yours..
In this leaflet:
1. What is in Oxybutynin 5 mg Tablets?
2. What is your medicine used for?
3. Before you take Oxybutynin 5 mg Tablets
4. How to take your Oxybutynin 5 mg Tablets
5. Possible side effects
6. Storing your Oxybutynin 5 mg Tablets

Oxybutynin 5 mg Tablets
1. What is in Oxybutynin 5 mg Tablets?
Each tablet contains 5 mg oxybutynin hydrochloride as the active ingredient. The tablets also contain
the following inactive ingredients: lactose monohydrate, powdered cellulose, talc, magnesium
stearate.
The tablets are white, round, marked "OBC5" on one side, and scored with a division mark on both
sides.
Your medicine is available in blisters containing 20, 30, 50, 60 or 100 tablets. Not all pack
sizes may be marketed.
Marketing authorisation holder:
ratiopharm GmbH, Graf-Arco-Str. 3, D-89079 Ulm, Germany
Manufacturer:
Rottendorf Pharma GmbH, Ostenfelder Str. 51-61, 59320 Ennigerloh, Germany
2. What is your medicine used for?
Oxybutynin belongs to a group of medicines called antispasmodics, which help relax spasms in
certain types of smooth muscle.
Oxybutynin also belongs to another group of medicines called anticholinergics, which reduce the
effect of acetylcholine, a substance involved transmitting signals between nerves.
You have been prescribed Oxybutynin 5 mg Tablets to treat one of the following bladder problems:
• Difficulty controlling when to pass water (urinary incontinence)
• Needing to pass water very suddenly (urinary urgency)
• Needing to pass water very often (urinary frequency)
These problems can be caused either by spasms of the smooth muscles that control the bladder, or
by signals sent by the nerves in the spine that control these muscles, caused by conditions such as
multiple sclerosis or spina bifida. Oxybutynin 5 mg Tablets can treat both these causes and help
reduce the feeling of urgency and the number of times you need to urinate.
Oxybutynin 5 mg 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
3. Before you take Oxybutynin 5 mg Tablets

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Do not take this medicine if:
• You have ever had an allergic reaction to oxybutynin or to any of the other ingredients listed above.
• You have obstruction of the gastrointestinal tract, or intestinal atony (highly reduced bowel
movements)
• You have serious difficulty passing water.
• You suffer from severe ulcerative colitis (inflammation of the colon) or toxic megacolon (a lifethreatening complication of ulcerative colitis)
• You suffer from myasthenia gravis (a muscle disease)
• You suffer from glaucoma (an eye disease)
Talk to your doctor before taking Oxybutynin 5 mg Tablets if:
• You have autonomic neuropathy (a nerve problem which sometimes occurs with diabetes)
• You suffer liver or kidney disease
• You have hyperthyroidism (an overactive thyroid gland)
• You suffer heart disease
• You have a fast or irregular heartbeat
• You have prostatic hypertrophy (an enlarged prostate gland)
• You have a hiatus hernia (part of the stomach passing through a hole in the diaphragm)
• The person taking the medicine is a child (use is not recommended under 5 years of
age)
This product contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
If you are elderly or frail, your doctor may want to monitor your condition whilst taking Oxybutynin 5
mg Tablets.

You should always tell your doctor about any medicines you are taking. This includes any
medicines you have bought for yourself, as well as those prescribed for you by a doctor. Some
medicines may interact with Oxytbutynin 5 mg Tablets. These include:


Other anticholinergic drugs e.g. flavoxate, tolterodine, trospium



Phenothiazines or butyrophenones (for schizophrenia and other mental conditions)



Amantadine or L-dopa (for Parkinson’s disease)



Digitalis (for heart conditions)



Tricyclic antidepressants (for depression)

Pregnancy and breast-feeding
If you are pregnant or breast-feeding do not take this medicine until you have talked to your
doctor. Consult your doctor immediately if you become pregnant while taking this medicine.
Driving and using machines
Oxybutynin 5 mg Tablets can sometimes cause drowsiness or blurred vision. If you experience these
symptoms you should not drive or operate machinery.
4. How to take your Oxybutynin 5 mg Tablets
The label on the carton will tell you how many tablets to take and when. Follow your doctor’s advice.
The tablets should be swallowed whole with a glass of water. It is important to keep taking Oxybutynin
5 mg Tablets for as long as your doctor prescribes them. Do not stop taking your medicine without
consulting your doctor first.
The dose you take will depend on your condition and age:

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Bladder problems
Adults
The usual dose is 5 mg two or three times a day. Your doctor may increase this up to a maximum of 5
mg four times a day.
Elderly or frail patients
The usual dose is 2.5 mg twice a day. Your doctor may increase this up to a maximum of 5 mg twice a
day.
Children over 5 years old
The usual dose is 2.5mg twice a day. Your doctor may increase this up to a maximum of 5 mg two or
three times a day.
Bed-wetting
Children over 5 years old
The usual dose is 2.5mg twice a day. Your doctor may increase this up to a maximum of 5 mg two or
three times a day.The last dose should be given before bedtime.
Oxybutynin 5 mg Tablets should not be given to children under 5 years old.
What if you miss a dose?
Do not worry if you miss a tablet: just take your next dose at the appropriate time. Do not take an
extra dose to compensate.
What if you have taken too many tablets?
Contact your doctor or nearest hospital casualty department immediately. Take this leaflet and any
remaining tablets with you, so that the doctor knows what you have taken.
5. Possible side effects
Like all medicines, Oxybutynin 5 mg Tablets can cause side effects in some patients.
Common side effects include: dry mouth, constipation, blurred vision, feeling sick, stomach pain, red
or fluched face (particularly in children), difficulty passing water.
Less common side effects include: headache, build up of urine in the bladder, dizziness, drowsiness,
dry skin, diarrhoea, irregular heartbeay and skin reactions including rash, swelling and sensitivity to
sunlight.
There have also been reports of a range of side effects including restlessness, seeing or hearing
things (hallucinations), disorientation and fits; these are most common in children.
If you experience any of these side effects or any others not mentioned in this leaflet, please talk to
your doctor.
6. Storing your Oxybutynin 5 mg Tablets
Do not store above 25°C. Store in the original package.
Do not use Oxybutynin 5 mg Tablets after the expiry date printed on the blister strip or carton.
If you notice any defects or signs of deterioration in the tablets (such as broken tablets), please inform
your pharmacist.
Keep Oxybutynin Tablets out of the reach and sight of children
Revision date: May 2011

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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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