PACKAGE LEAFLET: INFORMATION FOR THE USER

Ditropan 2.5mg/5ml Elixir

Oxybutynin hydrochloride

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Read all of this leaflet carefully before you start taking this medicine

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ditropan Elixir is and what it is used for

2.    Before you take Ditropan Elixir

3.    How to take Ditropan Elixir

4.    Possible side effects

5.    How to store Ditropan Elixir

6.    Further information

1. What Ditropan Elixir is, How Ditropan Elixir works and What Ditropan Elixir is used for

What Ditropan Elixir is

Ditropan Elixir contains a medicine called oxybutynin hydrochloride. This belongs to two groups of medicines called 'anticholinergics’ and 'antispasmodics’.

How Ditropan Elixir works

It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps control the release of water (urine).

What Ditropan Elixir is used for

Ditropan Elixir 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. Before you take Ditropan Elixir

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to oxybutynin hydrochloride or any of the other ingredients of Ditropan Elixir (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

X You have a rare muscle illness called 'Myasthenia gravis’

X You have glaucoma (increased pressure in the eye, sometimes sudden and painful with blurred vision or loss of vision)

X Your gut (stomach or intestine) is blocked, perforated or not working properly

X You have a severe form of a condition known as 'ulcerative colitis’

X 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 Ditropan Elixir.

Take special care with Ditropan Elixir Check with your doctor or pharmacist before taking your medicine if:

▲    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 kidney or liver problems

▲    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

▲    Ditropan may reduce the amount of saliva resulting in tooth decay or fungal infection of the mouth

Ditropan 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 Ditropan Elixir.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Ditropan Elixir can affect the way some other medicines work. Also some medicines can affect the way Ditropan Elixir 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) 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’)

•    Amantadine - used in Parkinson’s disease or to treat and prevent some virus infections

•    L-dopa - used to treat Parkinson’s disease

•    Digoxin - used to treat heart problems

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if:

•    You are pregnant, might become pregnant or think you may be pregnant

•    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

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

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 Ditropan

Elixir

This medicine contains:

•    Sorbitol and sucrose: these are types of sugars. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

•    Sodium methyl-p-hydroxybenzoate: this may cause an allergic reaction (this might not happen straight away). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

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