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OXYBUTYNIN HYDROCHLORIDE 2.5 MG TABLETS

Active substance(s): OXYBUTYNIN HYDROCHLORIDE

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Package leaflet: Information for the user

Oxybutynin hydrochloride
2.5 mg tablets
Oxybutynin hydrochloride
5 mg tablets
Oxybutynin hydrochloride
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor, pharmacist or nurse.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs are the same as yours.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in the leaflet. See section 4.
What is in this leaflet
1. What Oxybutynin Tablets are and what they
are used for
2. What you need to know before you take
Oxybutynin Tablets
3. How to take Oxybutynin Tablets
4. Possible side effects
5. How to store Oxybutynin Tablets
6. Contents of the pack and other information

1. What Oxybutynin Tablets are
and what they are used for
Oxybutynin Tablets 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).

can affect the way some other medicines work.
Also some medicines can affect the way
Oxybutynin Tablets works.
In particular, tell your doctor if you are taking
any one of the following:
- Atropine, compounds related to atropine (used
for treatment of cramps) or other anticholinergic
medicines (used for treatment in stomach
disorders such as irritable bowel syndrome)
- Prochlorperazine, chlorpromazine or other
phenothiazines, Clozapine or other
antipsychotics (Medicines used to treat
psychosis).
- Haloperidol, beneridol or other butyrophenones
(Medicines used to treat certain mental illness)
- amitriptyline, imipramine,dosulepin or other
tricyclic anti depressants (Medicines used to
treat depression)
- Amantadine (used in Parkinson’s disease or to
treat and prevent some virus infections)
- Levodopa, biperiden (used to treat Parkinson’s
disease)
- Digoxin (used to treat heart problems)
- Dipyridamole (used to treat blood clotting
problems).
- Ketoconazole, itraconazole or fluconazole (used
for the treatment of fungal infections).
- Erythromycin or other macrolide antibiotics
(used to treat bacterial infections).
- Quinidine (used to treat heart problems)
- Anti-histamines (used to treat allergic reactions)
- Metoclopramide or domperidone (used to treat
nausea and vomiting)
- Cholinesterase inhibitors (used to treat
Alzheimer’s disease)
Oxybutynin Tablets with alcohol
Oxybutynin may cause drowsiness or blurred
vision. Drowsiness may be increased by
consumption of alcohol.
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 as oxybutynin should not be
used during pregnancy unless clearly necessary

Oxybutynin Tablets can be used to treat:
Adults:
Frequent and severe urinary urgency or Loss of
control in passing urine (urge incontinence).

When oxybutynin is used during breast-feeding, a
small amount is excreted in the mother’s milk.
Use of oxybutynin while breast-feeding is
therefore not recommended.

Children over 5 years:
- Loss of control in passing water (urinary
incontinence).
- Increased need or urgency to pass urine
(frequent and excessive urination).
- Night time bedwetting in children when other
treatments have not worked.

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.

2. What you need to know before
you take Oxybutynin Tablets
Do not take Oxybutynin Tablets and tell your
doctor if:
- You are allergic to Oxybutynin hydrochloride or
any of the other ingredients of this medicine
(listed in Section 6).
- You have a rare condition called “Myasthenia
gravis” that makes the muscles in the body
become weak and tire easily.
- 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 (inflammatory disease of the
large intestine)”.
- You have a blockage that makes it difficult for
you to pass water (urine).
- You have frequent urination at night caused by
heart or kidney disease
Do not take this medicine if any one of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Oxybutynin
Tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Oxybutynin Tablets if:
- You have kidney or liver problems
- You are 65 years of age or older
- The person taking the medicine is a child
- 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 gastro-intestinal disorders
- You have indigestion or heart burn caused by a
“ hiatus hernia” (where part of your stomach
pushes through the diaphragm and/or are
concurrently taking medicinal products (such as
bisphosphonates) that can cause or worsen
oesophagitis.
- 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. It is therefore important to take special
care in your oral hygiene while using this
medicine. Regular dental check-ups are
advisable during long-term treatment.
- If oxybutynin is used in hot climate there is a
risk for heat prostration due to decreased
sweating.
Children
Children below 5 years of age
Oxybutynin Tablet is not recommended for use in
children below 5 years
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking Oxybutynin Tablets.
Other medicines and Oxybutynin Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.This includes medicines you buy
without a prescription, including herbal
medicines. This is because Oxybutynin Tablets

Oxybutynin Tablets contains lactose
Oxybutynin Tablets contains lactose. If you have
intolerance to some sugars, consult your doctor
before taking this medicine.

3. How to take Oxybutynin
Tablets
Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is
Adults
- An initial dose of 2.5 mg three times daily.
- Your doctor may decide to increase to the
maximum dose of 5mg four times daily
Elderly
- An initial dose is 2.5 mg twice daily
- Your doctor may decide to increase this to 5 mg
twice daily
Children (over 5 years)
- An initial dose is 2.5 mg twice daily
- Your doctor may decide to increase this to 5
mg two or three times daily
- If you are giving it to a child to prevent
bedwetting, give the last dose just before
bedtime
Swallow the tablet whole with a glass of water.
Do not change the dose yourself, inform your
doctor if you feel the effect of your medicine too
weak or too strong.
If you take more Oxybutynin Tablets than you
should
If you take more Oxybutynin Tablets than you
should, tell a doctor or go to a hospital casualty
department immediately. Take the medicine pack
with you, to inform the doctor what you have
taken.
Taking too many Oxybutynin 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 forget to take Oxybutynin Tablets
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 Tablets
Keep taking Oxybutynin Tablets until your doctor
tells you to stop. Do not stop taking Oxybutynin
Tablets just because you feel better.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Oxybutynin Tablets and see a
doctor or go to a hospital immediately if:
- You have an allergic reaction, the signs may
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or
tongue

(676437) Date: 27-06-17, R-18_12_17
Note: PIL should be single folded with front side outer and in bible paper.

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days:

The medicinal product is authorized in the
Member States of the EEA under the following
names:

Very common (may affect more than 1 in 10
people)
▪ dizziness, headache, somnolence (feeling
drowsy or sleepy)
▪ decreased tear production/dry eyes
▪ facial flushing (especially in children)
constipation
▪ nausea
▪ dry mouth
▪ dry skin/decreased sweating
▪ urinary retention

Name of
member state
France

Common (may affect up to 1 in 10 people)
▪ indigestion, diarrhoea, being sick (vomiting)
▪ confusion
Uncommon (may affect up to 1 in 100 people)
▪ loss of appetite (anorexia)
▪ drowsiness,
▪ stomach pain
▪ difficulty in swallowing (dysphagia)
▪ light hypersensitivity.

Name of medicinal product

Oxybutynin hydrochloride
Accord 5 mg comprimé
pelliculé.
Ireland
Oxybutynin hydrochloride
2.5 mg/5 mg tablets
Lithuania
Oxybutynin Accord 5 mg
tablets
Latvia
Oxybutynin hydrochloride
Accord 5 mg tabletes
Poland
Uralex, 5 mg, tabletki
Sweden
Oxybutynin Accord
2.5 mg/5 mg tabletter
United Kingdom Oxybutynin hydrochloride
2.5 mg/5 mg tablets
This leaflet was last revised in 12/2017.

Rare (may affect up to 1 in 1,000 people)
▪ restlessness
▪ erectile dysfunction
▪ disorientation, difficulties in concentration
▪ phototoxicity.
Unknown (frequency cannot be estimated from
the available data)
▪ urinary tract infection,
▪ hypersensitivity
▪ excitation/agitation, anxiety, seeing or hearing
things that are not there (hallucinations),
nightmares, paranoia, cognitive disorders in
elderly, depression, becoming dependent on
Oxybutynin, fits (convulsions), cognitive
dysfunction
▪ narrow angle closure glaucoma, dilation of pupil
(mydriasis), ocular hypertension, blurred vision
▪ Increased heartbeat (tachycardia), irregular
heartbeat (arrhythmia
▪ Indigestion or heartburn (acid reflux),
pseudo-obstruction in patients at risk (elderly or
patients with constipation and treated with other
medicinal products that decrease intestinal
motality) urticarial and angioedema,
▪ allergic reactions such as rash, absence of
sweating (hypohidrosis)
▪ heat stroke
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. By reporting
side effects you can help provide more
information on the safety of this medicine.
For UK - You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App
Store
For Ireland - You can also report side effects
directly via HPRA Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.

5. How to store Oxybutynin
Tablets
Keep this medicine out of the sight and reach of
children.
- Do not use this medicine after the expiry date
which is stated on the blister or carton. The
expiry date refers to the last day of that month.
- Do not store above 30°C. Store in the original
package in order to protect from moisture.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.

6. Contents of the pack and
other information
What Oxybutynin Tablets contains
The Active substance is Oxybutynin
hydrochloride.
Each tablet contains either 2.5mg or 5mg of the
oxybutynin hydrochloride.
The other ingredients are powdered cellulose,
lactose monohydrate, talc and magnesium
stearate (E572).
What Oxybutynin Tablets looks like and
contents of the pack
Oxybutynin 2.5mg Tablets are white to off white,
odourless, 5mm round biconvex, uncoated
tablets with inscription “BS” on one side and plain
on the other side.
Oxybutynin 5mg Tablets are white to off white,
odourless, 7.9mm round biconvex, uncoated
tablets with inscription “B” and “R” on either side
of score line on one side and plain on the other
side.
The 5 mg tablets can be divided into equal
halves.
Oxybutynin 2.5 and 5mg Tablets are packed in
blisters and further packed in a carton.
The carton contains 6, 20, 21, 28, 30, 50, 56, 60,
84 and 100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow
Middlesex HA1 4 HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow,
HA1 4HF, Middlesex,
United Kingdom.

(676437) Date: 27-06-17, R-18_12_17
Note: PIL should be single folded with front side outer and in bible paper.

INP001 10 0605 1 676437

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