Patient leaflet - OXYBUTYNIN HYDROCHLORIDE 5 MG / 5ML ORAL SOLUTION
Oxybutynin hydrochloride 5mg/5ml oral solution
Oxybutynin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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– 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
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1. What Oxybutynin hydrochloride oral solution is and what it is used for
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2. What you need to know before you take Oxybutynin hydrochloride oral solution
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3. How to take Oxybutynin hydrochloride oral solution
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4. Possible side effects
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5. How to store Oxybutynin hydrochloride oral solution
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6. Contents of the pack and other information
1. WHAT OXYBUTYNIN HYDROCHLORIDE ORAL SOLUTION
IS AND WHAT IT IS USED FOR
What Oxybutynin hydrochloride oral solution is
Oxybutynin hydrochloride 5mg/5ml oral solution (called Oxybutynin hydrochloride oral solution in this leaflet) contains a medicine called oxybutynin hydrochloride. This belongs to two groups of medicines called ‚anticholinergics‘ and ‚antispasmodics‘. 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 hydrochloride oral solution is used for
Oxybutynin hydrochloride 5mg/5ml oral solution 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 HYDROCHLORIDE ORAL SOLUTION
Do not take Oxybutynin hydrochloride oral solution if you:
- are allergic (hypersensitive) to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in Section 6)
- have a rare muscle illness called ‚Myasthenia gravis‘
- have glaucoma (increased pressure in the eye, sometimes sudden and painful with blurred vision or loss of vision)
- have a blocked, perforated gut (stomach or intestine) or it is not working properly
- have a severe form of a condition known as ‚ulcerative colitis‘
- have a blockage that makes it difficult for you to pass water (urine)
Warnings and precautions
Talk to your doctor before taking Oxybutynin hydrochloride oral solution, if:
- you have kidney or liver problems
- you are 65 years of age or older
- the person taking the medicine is a child (use is not recommended under 5 years of age)
- you have an illness affecting the nerves called ‚autonomic neuropathy‘
- you have an overactive thyroid gland (Hyperthyroidism)
- you have heart disease or high blood pressure
- you have an irregular heart beat (palpitations) and/or increased or rapid heart beat
- you have an enlarged prostate gland
- you have indigestion or heart burn caused by a ‚hiatus hernia‘ (where part of your stomach pushes through the diaphragm)
- you have a raised body temperature or fever
- you will be taking this medicine in a hot climate
Oxybutynin hydrochloride may reduce the amount of saliva resulting in tooth decay or fungal infection of the mouth. Oxybutynin hydrochloride 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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Oxybutynin hydrochloride.
Children and adolescents
Do not give Oxybutynin hydrochloride oral solution to children younger than 5 years of age.
Other medicines and Oxybutynin hydrochloride oral solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 such as prochlorperazine or chlorpromazine) or if you are feeling sick (nausea) or have vertigo-
- Medicines used to treat certain mental illnesses-such as clozapine, phenothiazines, haloperidol or benperidol (butyrophenones)
- 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
- Levadopa used to treat Parkinson's disease
- Digoxin- used to treat heart problems
- Domperidone, metoclopromide, bethanechol, medicines for stomach and bowel related problems
Pregnancy, breast-feeding and fertility
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.
Small amounts of Oxybutynin hydrochloride may pass into mothers' milk. Breast feeding while using Oxybutynin hydrochloride 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.
Important information about some of the ingredients of Oxybutynin hydrochloride oral solution
This medicine contains:
- Sorbitol: Oxybutynin hydrochloride oral solution contains 125 mg sorbitol in each ml which is equivalent to 625 mg per dose of 5 ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
- Maltitol: Oxybutynin hydrochloride oral solution contains 125 mg maltitol in each ml which is equivalent to 625 mg per dose of 5 ml. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- Methyl parahydroxybenzoate: it may cause allergic reactions (this may not happen straightaway). Signs of an allergic reaction include: rash, problems swallowing or breathing, swelling of the lips, face or throat.
- Propylene glycol: Oxybutynin hydrochloride oral solution contains 1.47 mg propylene glycol in each ml which is equivalent to 7.35 mg per dose of 5 ml.
- Sodium: Each dose (5 ml) of the medicine contains less than 23 mg of sodium; it is therefore considered sodium free.
- Ethanol (alcohol): This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml.
Talk to your pharmacist or doctor if you need Oxybutynin hydrochloride oral solution on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.
3. HOW TO TAKE OXYBUTYNIN HYDROCHLORIDE ORAL SOLUTION
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- For oral use only. Take this medicine by mouth.
- Shake the bottle before use
- Use the measuring cup provided (marked in 2.5ml and 5ml graduations)
- Do not give this medicine to children under 5 years old.
How much to take
Your doctor will decide the dose appropriate for you.
Adults
- The usual dose is 5mg (5ml) two or three times each day
- Your doctor may decide to increase to the maximum dose of 5mg (5ml) four times each day.
Elderly
- The usual dose is 2.5mg (2.5ml) twice each day
- Your doctor may decide to increase to the maximum dose of 5mg (5ml) twice each day.
Children (over 5 years)
- The usual dose is one 2.5mg (2.5ml) twice each day
- Your doctor may decide to increase this to 5mg (5ml) two or three times each day
- If you are giving it to a child to prevent bedwetting, give the last dose just before bedtime.
If you take more Oxybutynin hydrochloride oral solution than you should
If you take more Oxybutynin hydrochloride oral solution than you should, or if you think a child has accidently swallowed any, tell a doctor or go to a hospital casualty department straight away. Take this leaflet with you. This is so the doctor knows what you have taken.
Taking too much Oxybutynin hydrochloride 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 oral solution
If you forget a dose, take the next dose as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Oxybutynin hydrochloride oral solution
Keep taking Oxybutynin hydrochloride oral solution until your doctor tells you to stop. Do not stop taking Oxybutynin hydrochloride oral solution just because you feel better.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Children are at higher risk of the effects.
Stop taking Oxybutynin hydrochloride oral solution and see a doctor or go to a hospital straight away if:
- You have an allergic reaction. The signs may include: a rash, problems swallowing or breathing, swelling of your lips, face, throat or tongue
- You may feel reduced sweating, which can lead 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 (may affect more than 1 in 10 people)
- Constipation
- Nausea
- Dry mouth
- Dry skin, rash or skin that is more sensitive to the sun
- Headache
- Somnolence (feeling drowsy or sleepy)
- Dizziness
- Blurring of vision.
Common (affects between 1 in 10 and 1 in 100 people)
- Dry eyes
- Diarrhoea
- Being sick (vomiting)
- Confusion
- Flushing especially in children.
Uncommon (affects between 1 in 100 and 1 in 1,000 people)
- Stomach pain
- Loss of appetite (anorexia)
- Difficulty in swallowing (dysphagia).
Frequency unknown
- 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 hydrochloride
- Feeling excessively suspicious and distrustful of others
- Mental health disorders
- Seeing or hearing things that are not there (hallucinations)
- Drowsiness
- Nightmares
- Fits (convulsions)
- Depression
- Increased heart beat (tachycardia)
- Irregular heart beat (arrhythmia)
- Dilation of pupil (mydriasis)
- Itchy, lumpy rash (urticaria)
- Absence of sweating (hypohidrosis)
- Skin that is more sensitive to the sun (photosensitivity).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 HYDROCHLORIDE ORAL
SOLUTION
Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Once opened use within one month. Store in the original packaging.
Do not use this medicine after the expiry date which is stated on the carton after „EXP“. The expiry date refers to the last day of that month.
Do not dispose of any medicines 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. CONTENTS OF THE PACK AND OTHER INFORMATION What Oxybutynin hydrochloride oral solution contains
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– Each 5ml of oral solution contains 5 mg of the active substance oxybutynin hydrochloride.
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– The other ingredients are: Sorbitol (E420), maltitol (E965), glycerol (E422), xanthan gum, methyl parahydroxybenzoate (E218), citric acid monohydrate, sodium citrate dihydrate, strawberry flavour (contains propylene glycol (E1520)), citric acid solution, ethanol and purified water.
What Oxybutynin hydrochloride looks like and contents of the pack
Oxybutynin hydrochloride oral solution is a strawberry flavoured clear, colourless solution.
Oxybutynin hydrochloride oral solution is packed in amber, type III 150ml glass bottles sealed with a child-resistant, tamper-evident screw cap. It comes with a 15ml measuring cup with 2.5 and 5ml graduations.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ROMA Pharmaceuticals Limited
Gibraltar House, Burton-upon-Trent
DE14 2WE
Email:
Manufacturer
LABOMED PHARMACEUTICAL COMPANY S.A.
84, Ioannou Metaxa Str.,
Koropi,
Attica, 19441,
Greece
This leaflet was last revised in December 2021