Oxybutynin hydrochloride 5mg/5ml Oral Solution

• 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.

The name of your medicine is Oxybutynin hydrochloride 5mg/5ml Oral Solution but it will be referred to as Oxybutynin throughout this leaflet.

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

• 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

You must talk to a doctor if you do not feel better or if you feel worse.

• 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.

• you have a rare muscle illness called ‘Myasthenia gravis’
• you have increased pressure in the eye (glaucoma)
• your gut (stomach or intestine) is blocked, perforated or not working properly
• you have a severe form of a condition known as ‘ulcerative colitis’
• you have a blockage that makes it difficult for you to pass water (urine).

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Oxybutynin.

Talk to your doctor or pharmacist before taking Oxybutynin if:

• you are 65 years of age or older
• you have certain heart conditions (deficiency congestive heart failure, coronary heart disease)
• the person taking the medicine is a child (use is not recommended under 5 years of age)
• you have brain problems (such as hallucinations, agitation, confusion, drowsiness)
• you have kidney or liver problems
• you have bowel problems (such as bowel obstruction, bowel laziness, inflammation of bowel)
• you have neurological disorders (such as Parkinson's disease)
• you have an illness affecting the nerves called ‘autonomic neuropathy’
• you have eye problem (such as glaucoma)
• you have an overactive thyroid gland (‘Hyperthyroidism’)
• you have dental caries or a fungal infection in the mouth
• 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

Do not give this medicine to children under the age of 5 years.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Oxybutynin.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

This is because Oxybutynin can affect the way some medicines work. Also some medicines can affect the way Oxybutynin work.

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) or if you are feeling sick (nausea) or have vertigo - such as prochlorperazine or chlorpromazine
• 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’) and lithium
• Amantadine, biperiden, levodopa - used in Parkinson’s disease or to treat and prevent some viral infections
• Aminopenicillins, tetracyclines, sulfamethoxazole, cotrimoxazole - drugs used for inhibition of bacterial infections
• Digoxin, quinidine, disopyramide, procainamide and lidocaine - used to treat heart problems
• Dipyridamole - used to treat blood problems
• Antihistamines - used to treat allergies
• Paracetamol - used to treat pain
• Phenylbutazone - used to treat inflammation
• Atropine and related compounds - drugs used for spasms of the digestive tract

Alcohol may increase drowsiness caused by oxybutynin.

Talk to your doctor before taking this medicine if:

• You are pregnant, think you may be pregnant or are planning to have a baby
• You are breast-feeding or planning to breast-feed. This is because small amounts may pass into mothers’ milk. Breast feeding while using Oxybutynin is therefore not recommended

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.

Sorbitol (E420): This medicine contains 896mg sorbitol in each 5ml dose which is equivalent to 179.2mg/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.

Methyl parahydroxybenzoate (E218): may cause allergic reactions (possibly delayed).

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5ml dose, that is to say essentially 'sodium-free'.

Propylene glycol (E1520): This medicine contains 15.5mg propylene glycol in each 5ml dose which is equivalent to 3.1mg/ml.

• The usual dose is 5mg (5ml) two or three times a day
• Your doctor may decide to increase to the maximum dose of 5mg (5ml) four times a day

• The usual dose is 2.5mg (2.5ml) twice a day
• Your doctor may decide to increase this to 5mg (5ml) twice a day

• The usual dose is 2.5mg (2.5ml) twice a day
• Your doctor may decide to increase this to 5mg (5ml) two or three times a day
• If you are giving it to a child to prevent bedwetting, give the last dose just before bedtime

• For oral use only
• Use the 2.5-5ml double-ended spoon supplied in the pack to measure the required dose (see figure below).
• Swallow the solution.
• Wash the spoon with clean water after taking every dose.

2.5-5ml double-ended Spoon

Contact your nearest hospital casualty department or tell your doctor immediately. 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 heart beat may become very fast, uneven or forceful. You may get breathing problems or numbness or go into a coma.

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.

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.

• 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

Very common: may affect more than 1 in 10 people

• Dry mouth, constipation, nausea
• Dizziness, headache, drowsiness
• Dry skin

Common: may affect up to 1 in 10 people

• Diarrhoea, vomiting
• Confusional state
• Dry eyes
• Inability or difficulty in passing water (urine)
• Flushing

Uncommon: may affect up to 1 in 100 people

• Stomach pain, loss of appetite (anorexia), decrease appetite, difficulty in swallowing (dysphagia)

Not known: cannot be estimated from the available data

• A bladder infection (Urinary tract infection)
• Indigestion or heartburn (acid reflux)
• Fits (convulsions)
• Agitation
• Seeing or hearing things that are not there (hallucinations)
• Nightmares
• A forceful heartbeat that may be rapid or irregular
• Blurring of vision, enlargement of the pupil of the eye, increased pressure in the eyes (glaucoma), dry eyes
• Rash or skin that is more sensitive to the sun
• Anxiety
• Feeling excessive suspicious and distrustful of others
• Mental Health disorders

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.

The active substance is oxybutynin hydrochloride.

Each 5ml oral solution contains 5mg oxybutynin hydrochloride.

The other ingredients are citric acid monohydrate (E330), sodium citrate (E331), liquid sorbitol (noncrystallising) (E420), glycerol (E422), methyl parahydroxybenzoate (E218), raspberry flavor (containing propylene glycol (E1520)) and purified water.

Oxybutynin is a clear, colourless oral solution with raspberry odour and supplied in amber glass bottles with tamper evident child resistant plastic cap and with a 2.5-5ml double ended spoon for measuring the dose.

Oxybutynin hydrochloride 5mg/5ml oral solution is supplied in bottles containing 100ml and 150ml solution.

Not all pack sizes may be marketed.