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DITROPAN TABLETS 2.5MG

Active substance(s): OXYBUTYNIN HYDROCHLORIDE

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

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

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 you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. Section 4.

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

What Ditropan Tablets are used for
Ditropan Tablets 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 Ditropan Tablets
Do not take Ditropan tablets:
You are allergic (hypersensitive) to
oxybutynin hydrochloride or any of the
other ingredients of Ditropan Tablets
(listed in Section 6: Contents of the pack
and other information)
Signs of an allergic reaction include:
a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
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Warnings and precautions
Talk to your doctor or pharmacist
before taking Ditropan Tablets
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

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What Ditropan Tablets are

You have a rare muscle illness called
'Myasthenia gravis'
You have glaucoma (increased pressure
in the eye, sometimes sudden and painful
with blurred vision or loss of vision)
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
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Ditropan
Tablets.

Other medicines and Ditropan Tablets
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 Tablets
can affect the way some other medicines
work. Also some medicines can affect
the way Ditropan Tablets 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, breast-feeding and fertility
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.

2

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 Tablets
This medicine contains:
• Lactose: 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.

3. How to take Ditropan Tablets
Always take Ditropan Tablets exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

Taking this medicine
• Take this medicine by mouth
• Swallow the tablets with a glass of water
• Do not give this medicine to children
under 5 years old
• If you feel the effect of your medicine is
too weak or too strong, do not change
the dose yourself, but ask your doctor

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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 Tablets.

If you forget to take Ditropan Tablets

Your doctor will decide the dose appropriate
for you.

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.

Adults
• The usual dose is one 5mg tablet two or
three times each day
• Your doctor may decide to increase to
the maximum dose of 5mg four times
each day

Elderly
• The usual dose is 2.5mg twice each day
• Your doctor may decide to increase this
to 5mg twice each day

Children (over 5 years)
• The usual dose is one 2.5mg tablet
twice each day
• Your doctor may decide to increase this
to one 5mg 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 Ditropan Tablets than
you should
If you take more Ditropan Tablets 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 Ditropan Tablets 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 stop taking Ditropan Tablets
Keep taking Ditropan Tablets until your
doctor tells you to stop. Do not stop taking
Ditropan Tablets just because you feel better.

4. Possible side effects
Like all medicines Ditropan Tablets can cause
side effects, although not everybody gets them.
Children are at higher risk of the effects.

Stop taking Ditropan Tablets and see a
doctor or go to a hospital straight away if:
Frequency unknown
• You have an allergic reaction. The signs
may include: a rash, swallowing or
breathing problems, swelling of your, lips,
face, throat or tongue
• You may 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, rash or skin that is more sensitive
to the sun
• Headache
• Somnolence (feeling drowsy or sleepy)
• Dizziness
• Blurring of vision
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Common (affects 1 to 10 people in a 100 people)
• Dry eyes
• Diarrhoea
• Being sick (vomiting)
• Confusion
• Flushing especially in children
Uncommon (affects 1 to 10 people in a 1,000)
• 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 Ditropan
• Feeling excessive 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)

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How much to take

If you get any side effects, talk to your doctor,
pharmacist or nurse This includes any
possible side effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via
the Yellow card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
You can also report side effects directly via
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide
more information on the safety
of this medicine.

5. How to store Ditropan Tablets
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Ditropan Tablets after the expiry
date which is stated on the blister or carton
after EXP. The expiry date refers to the last
day of that month.
Store below 30'C.

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Medicines should not be disposed of 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 Ditropan Tablets contains
• Each tablet contains 2.5 mg or 5mg of the
active substance, oxybutynin hydrochloride.
• The other ingredients lactose, cellulose,
calcium stearate and indigo carmine (E132).

What Ditropan Tablets looks like and
contents of the pack
• Ditropan® 2.5mg Tablets are pale blue oval
bi-convex tablets with OXB2.5 on one side.
• Ditropan® 5mg Tablets are pale blue
circular tablets with OXB5 on one side and
a break-line on the other side
• Supplied in blisters packs of 6, 21 or 84
tablets. Not all pack sizes may be marketed

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Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi,
One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 0845372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie.
30-36 avenue Gustave Eiffel,
37000 Tours, France
This leaflet does not contain all the
information about your medicine. If you have
any questions or are not sure about anything,
ask your doctor or pharmacist.

This leaflet was last revised in April 2015
© Sanofi, 1992 - 2015

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Reporting of side effects

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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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