Patient leaflet - Oxybutynin Hydrochloride 2.5 mg / 5 ml oral solution
1. What Oxybutynin is and what they are used for
What Oxybutynin are
Oxybutynin contains a medicine called Oxybutynin hydrochloride.
This belongs to two groups of medicines called ‘anticholinergics’ and ‘antispasmodics’.
How Oxybutynin work
It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps control the release of water (urine).
What Oxybutynin are used for Oxybutynin can be used in adults and children 5 years or older to treat:
- loss of control in passing water (urinary incontinence),
- increased need or urgency to pass water (urine),
night time bedwetting, when other treatments have
not worked.
2. What you need to know before you take Oxybutynin
Do not take Oxybutynin:
if you are allergic to Oxybutynin hydrochloride or any
of the other ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include:
a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
if you have a rare muscle illness called ‘Myasthenia
gravis’
if you have glaucoma (increased pressure in the eye,
sometimes sudden and painful with blurred vision or loss of vision).
if your gut (stomach or intestine) is blocked,
perforated or not working properly
if you have a severe form of a condition known as
‘ulcerative colitis’
if you have sudden widening of the colon, which
causes abdominal pain, fever or shock known as ‘toxic megacolon’.
if you have a blockage that makes it difficult for you
to pass water (urine).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Oxybutynin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxybutynin Especially be careful if:
- you have kidney or liver problems
you have an illness affecting the nerves called
‘autonomic neuropathy’ (e.g. Parkinson’s disease).
- you have an overactive thyroid gland (‘Hyperthyroidism’)
- you have heart disease or high blood pressure
you have an irregular heart beat (palpitations
arrythmias) and/or increased or rapid heart beat
you have an enlarged prostate gland (prostatic
hypertrophy)
you have gastro-intestinal disorders or a disease
called ulcerative colitis.
you have indigestion or heart burn caused by a
‘hiatus hernia’ (where part of your stomach pushes through the diaphragm), gastro-oesophageal reflux and/or you are using medicinal products that can cause or worsen oesophagitis.
- you have a raised body temperature or fever
- you will be taking this medicine in a hot climate.
Oxybutynin may reduce the amount of saliva resulting in tooth decay or fungal infection of the mouth.
Oxybutynin can cause glaucoma (increased pressure in the eye). Please contact your doctor immediately if you suffer any blurred vision, loss of vision or have any pain in the eye.
Oxybutynin can cause hallucinations, agitation, confusion or somnolence so that your doctor might consider to monitor you.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Oxybutynin.
Elderly
People 65 years of age or older should take Oxybutynin with caution, because of the risk of cognitive impairment and being at a greater risk of occurrence of adverse reactions.
Children
Children under 5 years of age
The use of Oxybutynin is not recommended in children under 5 years of age.
Children 5 years of age or older
Oxybutynin should be taken with caution as they may be more sensitive to the effects of the product and at a greater risk of occurrence of adverse reactions.
Other medicines and Oxybutynin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Oxybutynin can affect the way some other medicines work. Also, some medicines can affect the way Oxybutynin works.
In particular, tell your doctor if you are taking any of the following:
Other 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
- Medicines used to make you feel sleepy (sedatives)
Medicines used to treat nausea and vomiting
(prochlorperazine or chlorpromazine).
Medicines used to treat certain mental illnesses -
such as clozapine, phenothiazines, haloperidol or benperidol (butyrophenones)
Medicines used to treat dementia e.g. donepezil,
rivastigmine, galantamine or tacrine (cholinesterase inhibitors).
Medicines for depression - such as amitriptyline,
imipramine or dosulepin (‘tricyclic antidepressants’)
Amantadine used in Parkinson’s disease or to treat
and prevent some virus infections.
- L-dopa or biperidin used to treat Parkinson’s disease.
- Digoxin, quinidine used to treat heart problems
Atropine which is used to treat certain types of
poisonings, a slow heart rate, some eye conditions or is given during surgery.
Medicines for stomach and bowel related problems -
such as domperidone, metoclopromide, bethanechol.
- Medicines to treat allergic symptoms (antihistamines).
CYP3A inhibitor e.g. ketoconazole, itraconazole or
fluconazole used to treat fungal infections or erythromycin or other macrolide antibiotics used to treat bacterial infections.
Oxybutynin with alcohol
If you drink alcohol while using Oxybutynin, you may become very drowsy.
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.
While breast-feeding, small amounts may pass into mothers’ milk. Breast-feeding while using this medicine is therefore not recommended.
Driving and using machines
You may feel drowsy or have blurred vision while you are taking this medicine. If this happens, do not drive or use any tools or machines.
Oxybutynin contains
Oxybutynin contains sorbitol (E420), propylene glycol (E1520), methyl parahydroxybenzoate (E218) and sodium.
This medicine contains 910 mg of sorbitol in each 5 ml dose which is equivalent to 182 mg per ml.
This medicine contains 4 mg of propylene glycol in each 5 ml dose which is equivalent to 0.8 mg per ml.
This medicine contains 5 mg of methyl
parahydroxybenzoate in each 5 ml dose whch is equivalent to 1 mg per ml.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
3. How to take Oxybutynin
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Posology
Your doctor will decide the dose appropriate for you.
Adults
The recommended dose is 5 mg (10 ml) two or three times each day. Your doctor may decide to increase to the maximum dose of 5 mg (10 ml) four times each day.
Elderly
The recommended dose is 2.5 mg (5 ml) twice a day. Your doctor may decide to increase this to 5 mg (10 ml) twice each day.
Use in children and adolescents Children 5 years of age or older
The recommended dose is 2.5 mg (5 ml) twice each day. Your doctor may decide to increase this to 5 mg (10 ml) two or three times each day.
If you are giving it to a child to prevent bedwetting, give the last dose just before bedtime.
Method of administration
For oral use.
Use the 2.5-5ml double-ended spoon supplied in the pack to measure the required dose.
Swallow the solution. Wash the spoon with clean water after taking every dose.
If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
If you take more Oxybutynin than you should
If you take more Oxybutynin than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
Taking too much Oxybutynin can be very dangerous. You may become very restless or excited, flushed or get dizzy or light-headed. Your heartbeat may become very fast, uneven, or forceful or your blood pressure drops. You may get breathing problems or numbness or go into a coma.
If you forget to take Oxybutynin
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
Keep taking Oxybutynin 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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Oxybutynin and see a doctor or go to a hospital straight away if:
Frequency not known (frequency cannot be estimated from the available data):
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 lasts longer than a few days.
Very common (affects more than 1 in 10 people):
- constipation
- nausea
- dry mouth
- dry skin
- headache
- somnolence (feeling drowsy or sleepy)
- dizziness
- blurring of vision
Common (affects 1 to 10 people in a 100 people):
- dry eyes
- diarrhoea
- being sick (vomiting)
- confusion
- flushing especially in children
inability to completely empty the bladder (urinary
retention)
- a forceful heartbeat that may be rapid or irregular
Uncommon (affects 1 to 10 people in a 1,000):
- stomach pain,
- loss of appetite (anorexia),
- difficulty in swallowing (dysphagia).
Frequency not known: frequency cannot be estimated from the available data
increased pressure in the eyes sometimes sudden and
painful with blurred vision or loss of vision (glaucoma)
- indigestion or heartburn (acid reflux)
urinary tract infection
- heat stroke
- difficulty passing water (urine)
- agitation
- anxiety
- becoming dependent on Oxybutynin if there is a history of drug or substance abuse
- feeling excessive suspicious and distrustful of others
- mental Health disorders (especially in the elderly)
seeing or hearing things that are not there
(hallucinations)
- drowsiness
- nightmares
- fits (convulsions)
- depression
- increased heartbeat (tachycardia)
- Irregular heartbeat (arrhythmia)
- dilation of pupil (mydriasis)
- itchy, lumpy rash (urticaria)
- absence of sweating (hypohidrosis)
- skin that is more sensitive to the sun (photosensitivity)
- disorientation
- cognitive disorders
- nosebleed
- angioedema
- muscle weakness, pain or cramps
Additional side effects in children
Children are at higher risk of the effects.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Oxybutynin
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. Do not store above 25°C.
Discard 30 days after first opening.
Store in the original packaging after first opening. Do not use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist. 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
What Oxybutynin contains
The active substance is Oxybutynin hydrochloride.
Each 5ml oral solution contains 2.5mg Oxybutynin hydrochloride.
The other ingredients are citric acid monohydrate, sodium citrate, liquid sorbitol (non-crystallising (E420), glycerol (E422), methyl parahydroxybenzoate (E218), raspberry flavour (contains water, propylene glycol (E1520) and natural aroma chemicals) and purified water.
What Oxybutynin looks like and contents of the pack
Oxybutynin is a clear, colourless oral solution with a raspberry odour, supplied in an amber glass bottle with a tamper evident child resistant plastic cap and with a 2.5-5 ml double ended spoon for measuring the dose. Oxybutynin hydrochloride 2.5 mg/5 ml oral solution is supplied in bottles containing 150 ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Relonchem Limited,
Cheshire House, Gorsey Lane,
Widnes, Cheshire, WA8 0RP, UK.
PL 20395/0345
C73-0039 Version A
This leaflet was last revised in May 2025.
Oxybutynin hydrochloride 2.5 mg/5 ml Oral Solution
Package leaflet: Information for the user
POM
Oxybutynin hydrochloride