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OXYBUTYNIN HYDROCHLORIDE 3MG TABLETS

Active substance(s): OXYBUTYNIN HYDROCHLORIDE / OXYBUTYNIN HYDROCHLORIDE / OXYBUTYNIN HYDROCHLORIDE

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Package Leaflet: Information for the User

Oxybutynin Hydrochloride 3mg Tablets
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 get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
• The name of this medicine is Oxybutynin Hydrochloride 3mg Tablets
but will be referred to as Oxybutynin throughout the remainder of this
leaflet.
• Oxybutynin is also available in other strengths.
In this leaflet:
1. What Oxybutynin is and what it is used for
2. Before you take Oxybutynin
3. How to take Oxybutynin
4. Possible side effects
5. How to store Oxybutynin
6. Further information
1. What Oxybutynin is and what it is used for
What Oxybutynin is
It contains a medicine called oxybutynin hydrochloride. This belongs to
two groups of medicines called ‘anticholinergics’ and ‘antispasmodics’.
How Oxybutynin 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 Oxybutynin is 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. Before you take Oxybutynin
Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to oxybutynin hydrochloride or any of
the other ingredients in this medicine (listed in Section 6 Further
Information)
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 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 applies to you. If you are
not sure, talk to your doctor or pharmacist before taking Oxybutynin.
Take special care with Oxybutynin. Check with your doctor or
pharmacist before taking your medicine if:
• You have kidney or liver problems
• You are 65 years of age or older
• The person taking this 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 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 may reduce the amount of saliva resulting in tooth decay or
fungal infection of the mouth.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Oxybutynin.
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 Oxybutynin can
affect the way some other medicines work. Also, some other 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) 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
• Medicines for stomach and bowel related problems - such as
domperidone, metoclopromide or bethanechol
Pregnancy and breastfeeding
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. Breastfeeding while using
Oxybutynin is therefore not recommended.
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breastfeeding.
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
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 Oxybutynin
Always take Oxybutynin 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.
How much to take
Your doctor will decide the dose appropriate for you.
Adults
• The usual starting dose is one 5mg Oxybutynin 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 starting dose is one 3mg tablet twice each day
• Your doctor may decide to increase this until you respond to the
medicine
Children (over 5 years)
• The starting dose is one 3mg tablet twice each day
• The usual dose is then one 5mg tablet twice each day
• Your doctor may decide to increase this to one 5mg tablet 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 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, flush or get dizzy or lightheaded. 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
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.
4. Possible side effects
Like all medicines, Oxybutynin can cause side effects, although not
everybody gets them. Children are at higher risk of the effects.













Becoming dependent on Oxybutynin
Feeling excessively suspicious and distrustful of others (paranoia)
Seeing or hearing things that are not there (hallucinations)
Drowsiness
Nightmares
Fits (convulsions)
Depression
Itchy, lumpy rash (urticaria)
Absence of sweating (hypohidrosis)
Skin that is more sensitive to the sun (photosensitivity)
Abnormal bloating/swelling together with pain and feeling or being sick
(pseudo-obstruction)

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 at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Oxybutynin
• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• Do not store above 30oC.
• Store in the original package.
• If your medicine becomes discoloured or shows any signs of
deterioration, return it to your pharmacist.
• 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. Further information

Stop taking Oxybutynin 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 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
• Dry mouth
• Feeling sick, being sick
• Dry skin
• Headache
• Somnolence (feeling drowsy or sleepy)
• Dizziness
• Blurring of vision

What Oxybutynin contains
The active substance is oxybutynin hydrochloride.
Each tablet contains 3mg oxybutynin hydrochloride.
The other ingredients are lactose, microcrystalline cellulose, calcium
stearate and indigo carmine aluminium lake (E132).
What Oxybutynin looks like and contents of the pack
Oxybutynin 3mg are light blue, biconvex, round tablets engraved ‘OXB 3’
on one side and plain on the reverse.
Oxybutynin is available in cartons containing 56 tablets in PVC
aluminium blister strips (28 tablets per strip).
Manufactured by
Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel,
37000 Tours – France.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.

Common (affects 1 to 10 people in a 100)
• Dry eyes
• Diarrhoea
• Vomiting
• Flushing especially in children
• Confusion

Repackaged by MPT Pharma Ltd

Uncommon (affects 1 to 10 people in a 1,000)
• Stomach pain
• Loss of appetite (anorexia)
• Difficulty in swallowing (dysphagia)

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Frequency unknown
• Increased pressure in the eyes, sometimes sudden and painful with
blurred vision or loss of vision (glaucoma), enlargement of the pupil of
the eye
• Indigestion or heartburn (acid reflux)
• Urinary tract infection
• Increased, rapid or irregular heartbeat (palpitations)
• Heat stroke
• Difficulty passing water (urine)
• Agitation
• Anxiety

PL: 33532/0750

POM

Leaflet dated 13th February 2017
Leaflet coded XXXXXXXXXXX

Package Leaflet: Information for the User

Cystrin® 3mg Tablets
(oxybutynin hydrochloride)
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 get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
 The name of this medicine is Cystrin® 3mg Tablets but will be referred
to as Cystrin throughout the remainder of this leaflet.
 Cystrin is also available in other strengths.
In this leaflet:
1. What Cystrin is and what it is used for
2. Before you take Cystrin
3. How to take Cystrin
4. Possible side effects
5. How to store Cystrin
6. Further information
1. What Cystrin is and what it is used for
What Cystrin is
It contains a medicine called Oxybutynin hydrochloride. This belongs to
two groups of medicines called ‘anticholinergics’ and ‘antispasmodics’.
How Cystrin 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 Cystrin is used for
Cystrin 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 Cystrin
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to oxybutynin hydrochloride or any of
the other ingredients in this medicine (listed in Section 6 Further
Information)
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 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 applies to you. If you are
not sure, talk to your doctor or pharmacist before taking Cystrin.
Take special care with Cystrin. Check with your doctor or
pharmacist before taking your medicine if:
 You have kidney or liver problems
 You are 65 years of age or older
 The person taking this 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

Cystrin 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.
Cystrin may reduce the amount of saliva resulting in tooth decay or
fungal infection of the mouth.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Cystrin.
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 Cystrin can
affect the way some other medicines work. Also, some other medicines
can affect the way Cystrin 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
 Medicines for stomach and bowel related problems - such as
domperidone, metoclopromide or bethanechol
Pregnancy and breastfeeding
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. Breastfeeding while using
Cystrin is therefore not recommended.
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breastfeeding.
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 Cystrin
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 Cystrin
Always take Cystrin 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.
How much to take
Your doctor will decide the dose appropriate for you.
Adults
 The usual starting dose is one 5mg Cystrin 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 starting dose is one 3mg tablet twice each day
 Your doctor may decide to increase this until you respond to the
medicine
Children (over 5 years)
 The starting dose is one 3mg tablet twice each day
 The usual dose is then one 5mg tablet twice each day
 Your doctor may decide to increase this to one 5mg tablet 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 Cystrin than you should
If you take more Cystrin 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 Cystrin can be very dangerous. You may become very
restless or excited, flush or get dizzy or lightheaded. 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 Cystrin
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 Cystrin
Keep taking Cystrin until your doctor tells you to stop. Do not stop taking
Cystrin just because you feel better.
4. Possible side effects
Like all medicines, Cystrin can cause side effects, although not
everybody gets them. Children are at higher risk of the effects.













Becoming dependent on Cystrin
Feeling excessively suspicious and distrustful of others (paranoia)
Seeing or hearing things that are not there (hallucinations)
Drowsiness
Nightmares
Fits (convulsions)
Depression
Itchy, lumpy rash (urticaria)
Absence of sweating (hypohidrosis)
Skin that is more sensitive to the sun (photosensitivity)
Abnormal bloating/swelling together with pain and feeling or being sick
(pseudo-obstruction)

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 at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Cystrin
 Keep out of the sight and reach of children.
 Do not take this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
 Do not store above 30oC.
 Store in the original package.
 If your medicine becomes discoloured or shows any signs of
deterioration, return it to your pharmacist.
 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. Further information

Stop taking Cystrin 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 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
 Dry mouth
 Feeling sick, being sick
 Dry skin
 Headache
 Somnolence (feeling drowsy or sleepy)
 Dizziness
 Blurring of vision
Common (affects 1 to 10 people in a 100)
 Dry eyes
 Diarrhoea
 Vomiting
 Flushing especially in children
 Confusion
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), enlargement of the pupil of
the eye
 Indigestion or heartburn (acid reflux)
 Urinary tract infection
 Increased, rapid or irregular heartbeat (palpitations)
 Heat stroke
 Difficulty passing water (urine)
 Agitation
 Anxiety

What Cystrin contains
The active substance is oxybutynin hydrochloride.
Each tablet contains 3mg oxybutynin hydrochloride.
The other ingredients are lactose, microcrystalline cellulose, calcium
stearate and indigo carmine aluminium lake (E132).
What Cystrin looks like and contents of the pack
Cystrin 3mg are light blue, biconvex, round tablets engraved ‘OXB 3’ on
one side and plain on the reverse.
Cystrin is available in cartons containing 56 tablets in PVC aluminium
blister strips (28 tablets per strip).
Manufactured by
Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel,
37000 Tours – France.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd
PL: 33532/0750
POM
Leaflet dated 13th February 2017
Leaflet coded XXXXXXXXXXX
Cystrin® is a registered trademark of Sanofi.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Expand Transcript

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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