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OXYBUTYNIN HYDROCHLORIDE 3 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 3 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 or
pharmacist.
! This medicine has been prescribed for you only. 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. See section 4.
In this leaflet:
1. What Oybutynin hydrochloride tablets are and what
they are used for
2. What you need to know before you take Oxybutynin
hydrochloride tablets
3. How to take Oxybutynin hydrochloride tablets
4. Possible side effects
5. How to store Oxybutynin hydrochloride tablets
6. Contents of the pack and other information
1. What Oybutynin hydrochloride tablets are and
what they are used for
Oxybutynin hydrochloride tablets belong to the group of
spasm-relieving agents (a so-called spasmolytic).
Oxybutynin hydrochloride tablets act by reducing the
muscle spasms of the bladder. It is these spasms that
cause the feeling of having to urinate frequently, which
in turn can lead to involuntary loss of urine. Oxybutynin
relaxes the bladder muscle, so that the bladder can hold
more urine and the frequent urge to urinate is reduced.
Oxybutynin hydrochloride tablets may be prescribed by
the doctor for the treatment of the involuntary loss of
urine as a result of an unstable or over-active bladder. In
other words, when it is not possible to keep the urge to
urinate and the frequent need to urinate normally under
control.
2. What you need to know before you take
Oxybutynin hydrochloride tablets
Do not take Oxybutynin hydrochloride tablets
if you are allergic to oxybutynin hydrochloride or any
of the other ingredients of this medicine (listed in
section 6).
! if you have an eye condition with raised eyeball
pressure (narrow angle glaucoma) or a shallow
anterior eye chamber.
! if you have a tendency to muscle weakness
(myasthenia gravis).
! if you have constriction in the gastrointestinal tract,
sluggish bowel movements or constipation as a
result of the complete absence of bowel peristalsis
(paralytic ileus) or as a result of weakness of the
bowel muscles (intestinal atony) or narrowing of the
outlet from your stomach which delays food passing
out of your stomach and may lead to vomiting
(pyloric stenosis).
! if you have difficulty in urinating as a result of
obstruction of the urinary tract or as a result of
enlargement of the prostate (prostatic hypertrophy).
! if you have a colostomy (opening of the colon by
surgery) or ileostomy (opening of the small intestine
by surgery).
! if you have a blockage that makes it difficult for you
to pass water (urine) (bladder outflow obstruction).
! if you have severe inflammation of the large bowel
that is accompanied by ulcers (severe ulcerative
colitis).
! if you have acute inflammation of the wall of the
large bowel with dilatation and ulcer formation in the
mucous membrane (toxic megacolon).
! if you suffer from frequent urination (pollakiuria), in
the daytime or at night (nocturia), caused by a 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 or pharmacist before taking
Oxybutynin hydrochloride tablets
! if you have kidney or liver problems
! if you are 65 years of age or older
! if the person taking the medicine is a child
! in debilitated, elderly persons because there may be
greater sensitivity to the effects of oxybutynin.
! if you suffer from certain nerve diseases
(autonomous neuropathy, Parkinson's disease),
reduced liver or kidney function, a rupture of the
diaphragm with regurgitating gastric acid (hiatus
hernia with reflux oesophagitis) or other severe
gastrointestinal disorders
! if you have the symptoms of an overactive thyroid
gland (hyperthyroidism), cardiovascular diseases,
heart failure, disturbances of heart rhythm, raised
blood pressure (hypertension) and enlarged
prostate (prostatic hypertrophy). These symptoms
may be intensified by the use of oxybutynin.
! if you have heart disease or high blood pressure
! if you have an irregular heart beat (palpitations)
and/or increased or rapid heart beat
! if you have an enlarged prostate gland
! if you have indigestion or heart burn caused by a “
hiatus hernia” (where part of your stomach pushes
through the diaphragm
! if you are taking medicines called bisphosphonates,
which are used to treat bone diseases
! in the case of treatment of patients subject to a high
environmental temperature or in cases of fever.
There is the risk of a greatly increased body
temperature (hyperpyrexia) due to a decrease in
sweat production as a result of the use of
oxybutynin
! because oxybutynin can cause a dry mouth. In
cases of long-term use this can lead to an increased
risk of the development of dental cavities (caries) or
to abnormalities of the tooth pockets, oral candida
(a fungal infection) in the oral cavity or general

!

discomfort caused by the reduced salivation.
Regular dental check-ups are therefore advisable
during longterm treatment. The ability of sublingual
tablets to melt under the tongue may deteriorate
due to dry mouth. You should moisten the mouth
with the tongue or with a little water before taking
sublingual tablets. Careful oral hygiene is necessary
in the case of a urinary tract infection during
treatment, an adequate therapy with antibiotics has
to be started

Please contact a physician immediately if you
experience a sudden loss of visual acuity or ocular pain.
If you are not sure if any of the above applies to you,
talk to your doctor or pharmacist before taking
Oxybutynin Tablets.
Children
Oxybutynin hydrochloride tablets should not be used in
children under the age of 5.
Other medicines and Oxybutynin hydrochloride
tablets
Please tell your doctor or pharmacist if you are taking or
have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Oxybutynin may slow the digestive tract and thereby
influence the effect of other medicines, or the use of this
medicine together with other medicines may increase
the effect of oxybutynin. In particular, tell your doctor if
you are taking any one of the following:
! The effect may be potentiated by administration of
other anticholinergic agents (a group of medicines
to which oxybutynin belongs) or atropine and other
parasympatholytic agents (medicines in eye drops
for dilating the pupils, among other things)
! By reducing the motility of the gastrointestinal tract,
oxybutynin can influence the uptake of other
medicines into the blood
! Prochlorperazine or chlorpromazine
(phenothiazines), Clozapine or other antipsychotics
(Medicines used to treat psychosis)
! Haloperidol or beneridol (butyrophenones)
(Medicines used to treat certain mental illness)
! Amitriptyline, imipramine or dosulepin or 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)
! Quinidine (used to treat heart problems)
! Dipyridamole (used to treat blood clotting problems)
! Certain anti-fungal agents (antimycotics) such as
e.g. ketoconazole or itraconazole or fluconazole,
and macrolide antibiotics, e.g. erythromycin. The
effect of oxybutynin may increase
! Agents for nausea (metoclopramide and
domperidone); the effect of oxybutynin may be
reduced by these agents
! Antihistamines
! Cholinesterase inhibitors
In this section, medicines are indicated with the name of
the active substance or the group to which the
substance belongs. Usually you know a medicine by its
trade name. Therefore, check the pack or the package
leaflet of the medicine that you are using in order to
establish which substances are present, or ask your
doctor or pharmacist for advice.
Oxybutynin Tablets with alcohol
Oxybutynin may cause drowsiness or blurred vision.
Drowsiness may be increased by consumption of
alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Pregnancy
If you are pregnant, 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.
Breast-feeding
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.
Driving and using machines
You may feel drowsy or have blurred vision while you
are taking this medicine, especially in combination with
alcohol. If this happens, do not drive or use any tools or
machines.
Oxybutynin hydrochloride tablets contain lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take Oxybutynin hydrochloride 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
You should follow your doctor's instructions closely. In
general the dosage will begin with one Oxybutynin
hydrochloride 2.5 mg tablet three times daily, later to be
increased to a dosage between 10 and 15 mg per day,
possibly to a maximum of 20 mg, to be taken in 2 to 3
(maximum 4) doses.

Elderly
The dose must be determined individually for each
patient by starting with an initial dosage of 2.5 mg twice
daily. Then the lowest possible effective dose should be
chosen.

Not known (frequency
cannot be estimated
from the available data)

Children aged 5 years and older
The initial dosage is 2.5 mg twice daily.
The maximum dosage adjusted to bodyweight (0.3-0.4
mg/kg per day) is given in the table below:
Age
Dosage
5-9 years
2.5 mg three times daily
9-12 years
5 mg twice daily
older than 12 years 5 mg three times daily

!
!
!

If you feel that the effects of Oxybutynin hydrochloride
tablets are too strong or too weak, ask your doctor or
pharmacist for advice. Oxybutynin hydrochloride tablets
should not be used in children under the age of 5.
Taking Oxybutynin hydrochloride tablets
Your doctor will tell you for how long Oxybutynin
hydrochloride tablets must be used. It is recommended
that the effect should be re-assessed after 4 to 6 weeks,
because normal bladder function may have returned.
Taking Oxybutynin hydrochloride tablets with food
or drink
The tablets should be taken on an empty stomach with
plenty of water. If irritation of the stomach occurs, the
tablets may be taken during a meal or with some milk.
If you take more Oxybutynin hydrochloride 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.
In cases of overdose the side effects occur to an
increased degree.
Symptoms include:
! Restlessness, agitation,
! Flushing, dizziness, light-headedness
! Very fast, uneven or forceful heart beats
! Mental disturbances,
! Redness of the (facial) skin,
! Fall in blood pressure,
! Disturbances in the blood circulation and the
airways,
! Paralysis,
! Breathing problems or numbness or go into a coma
! Loss of consciousness.
You must consult your doctor immediately.
The treatment consists of immediate stomach washout
and, depending on the severity of the clinical picture,
further treatment in hospital.
If you forget to take Oxybutynin hydrochloride
tablets
If you accidentally forget a dose, take it as soon as you
remember unless it is almost time for the next dose
according to the instructions. In that case take the next
dose as normal in accordance with the instructions.
Do not take a double dose of Oxybutynin hydrochloride
tablets to make up for a forgotten dose.
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 everyone 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.
Tell your doctor or pharmacist if any of the following
side effects get serious or lasts longer than a few
days:
Very common (may
! dizziness, headache,
somnolence (feeling
affect more than 1 in 10
drowsy or sleepy)
people)
! decreased tear
production/dry eyes
! facial flushing (especially
in children), constipation
! nausea
! dry mouth
! dry skin/decreased
sweating
! urinary retention
Common (may affect up ! indigestion, diarrhoea,
to 1 in 10 people)
being sick (vomiting)
! confusion
! blurred vision, dilation of
pupil (mydriasis)
! drowsiness, abdominal
discomfort/pain
Uncommon (may affect ! restlessness
! disorientation
up to 1 in 100 people)
! loss of appetite
(anorexia)
! difficulty in swallowing
(dysphagia)
! light hypersensitivity
! fatigue
! urination problems
Rare (may affect up to 1 ! difficulties in
in 1,000 people)
concentration
! Increased heartbeat
(tachycardia), irregular
heartbeat(arrhythmia)
! allergic reactions such
as rash, absence of
sweating (hypohidrosis)
Very Rare (may affect up ! impotence
! fits (convulsions)
to 1 in 10,000 people)
! narrow angle closure
glaucoma,
! allergic reactions such
as raised, itchy skin and
swelling (hives)
! photosensitivity
! heat stroke

!
!
!

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, cognitive
dysfunction
ocular hypertension
erectile dysfunction
Indigestion or heartburn
(acid reflux), pseudoobstruction in patients at
risk (elderly or patients
with constipation and
treated with other
medicinal products that
decrease intestinal
motility)

The experience of the above side effects may be
reduced by administering a lower dose of Oxybutynin
hydrochloride tablets.
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 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.
5. How to store Oxybutynin hydrochloride tablets

!
!
!

!

Do not store above 25°C. Store in the original pack.
Keep this medicine out of the sight and reach of
children.
Do not use Oxybutynin hydrochloride tablets after
the expiry date which is stated on the outer
packaging after “do not use after” and on the blister
strips after the term “Exp.” (month and year). The
expiry date refers to the last day of that month.
Always hand over any left-over medicine to the
pharmacist for safe disposal.

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 hydrochloride 2.5 mg / 3 mg / 5 mg
tablets contain
! Each Oxybutynin hydrochloride 2.5 mg Tablet
contains 2.5 mg oxybutynin hydrochloride.
! Each Oxybutynin hydrochloride 3 mg Tablet
contains 3 mg oxybutynin hydrochloride.
! Each Oxybutynin hydrochloride 5 mg Tablet
contains 5 mg oxybutynin hydrochloride.
The other ingredients are:
Crospovidone, microcrystalline cellulose, lactose
monohydrate and magnesium stearate.
What Oxybutynin hydrochloride 2.5 mg / 3 mg / 5 mg
tablets look like and contents of the pack
Oxybutynin hydrochloride is supplied as white circular
flat bevelled edge tablets.
Oxybutynin hydrochloride 2.5 mg tablet is marked '2.5'
on one side and plain on the other side.
Oxybutynin hydrochloride 3 mg tablet is scored on one
side and blank on the other side.
Oxybutynin hydrochloride 5mg tablet is marked '5' on
one side and marked with a scoreline on the other side.
The tablets are supplied in blister packs of 7, 28, 56 or
84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road,
Leicester, LE3 0PA,
UK
Manufacturer
FAL Duiven
Dijkgraaf, 6921,
RK Duiven,
The Netherlands
This leaflet was last revised in January 2018.

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