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Package leaflet: Information for the user

3. How to take Oxybutynin hydrochloride tablets

Oxybutynin hydrochloride 2.5 mg tablets
Oxybutynin hydrochloride 3 mg tablets
Oxybutynin hydrochloride 5 mg tablets

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.

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
! 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
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).
! 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 severe inflammation of the large bowel
that is accompanied by ulcers (severe ulcerative
! if you have acute inflammation of the wall of the
large bowel with dilatation and ulcer formation in the
mucous membrane (toxic megacolon).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Oxybutynin hydrochloride tablets
! in debilitated, elderly persons because there may
be greater sensitivity to the effects of oxybutynin.
! if you suffer from certain nerve diseases
(autonomous neuropathy), reduced liver or kidney
function, a rupture of the diaphragm with
regurgitating gastric acid (hiatus hernia with reflux
oesophagitis) or other severe gastrointestinal
! 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.
! 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




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. Careful oral hygiene is necessary.
in the case of a urinary tract infection during
treatment an adequate therapy with antibiotics has
to be started.
if you suffer from frequent urination (pollakiuria), in
the daytime or at night (nocturia), caused by a heart
or kidney disease.

If any of the above warnings applies to you, or has done
in the past, please ask your doctor for advice.
Oxybutynin hydrochloride tablets should not be used in
children under the age of 5.
Other medicines and Oxybutynin hydrochloride
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
An interaction with other medicines can occur when
oxybutynin is used with the following medicines:
! 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.
! Anticholinergics and phenothiazines (medicines for
mental disorders), amantadine (medicine for
Parkinson's disease), butyrophenones (medicines
for mental disorders), levodopa (medicine for
Parkinson's disease), digitalis (medicine for heart
failure), quinidine (medicine for disturbances of
heart rhythm), and tricyclic antidepressants
(medicines for severe depression). Caution should
be exercised in cases of concomitant use of these
agents with oxybutynin.
! Certain anti-fungal agents (antimycotics) such as
e.g. ketoconazole or itraconazole, 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.
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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
During pregnancy, only take the product after consulting
your doctor. Oxybutynin may only be used during
pregnancy if the expected positive effect outweighs the
risks of treatment.
Oxybutynin is excreted into the breast-milk in animals
(rats). It is not known if the active substance is excreted
into the breast-milk in humans. Oxybutynin
hydrochloride tablets may only be used during lactation
under the supervision of your doctor, if the expected
positive effect outweighs the risks of treatment.
Driving and using machines
Oxybutynin hydrochloride tablets can cause drowsiness,
dizziness and blurred vision, especially in combination
with alcohol. You should take account of this when
driving vehicles or operating 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.

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
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:
5 - 9 years
9 - 12 years
older than 12 years

2.5 mg three times daily
5 mg twice daily
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 have used or taken more Oxybutynin
hydrochloride tablets than you should, contact your
doctor or pharmacist immediately.
In cases of overdose the side effects occur to an
increased degree.
Symptoms include:
! Restlessness, agitation,
! Mental disturbances,
! Redness of the (facial) skin,
! Fall in blood pressure,
! Disturbances in the blood circulation and the
! Paralysis,
! 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
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.
Never 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
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everyone gets them. A list of side effects is
given below.
The following side effects may occur during use of
Oxybutynin hydrochloride tablets:
Very Common side effects (≥1/10)
Dry mouth.
Common side effects (≥1/100, <1/10)
Blurred vision, dilatation of the pupils (mydriasis), facial
flushing, constipation, nausea, abdominal
discomfort/pain, dizziness, drowsiness.
Uncommon side effects (≥1/1000, <1/100)
Restlessness, disorientation, confusion, headache,
reduced tear secretion /dry eyes, lack of appetite
(anorexia), diarrhoea, vomiting, reduced sweating/dry
skin, problems with urination, fatigue.

Rare side effects (≥1/10000, <1/1000)
Accelerated heartbeat (tachycardia), disturbances of
heart rhythm (palpitations, arrhythmias), skin reactions
including rash, problems with urine remaining in the
bladder on account of disturbed bladder emptying.
Very rare side effects (<1/10000)
Impotence, convulsions (children can be more
susceptible to this type of side effect), increased eyeball
pressure (narrow angle glaucoma), repeated episodes
of transient itchy oedema of the skin and/or mucous
membranes (angioedema), photosensitivity, heatstroke.
Frequency unknown
Agitation, anxiety, seeing or hearing things that are not
there (hallucinations), nightmares, feeling excessively
suspicious and distrustful of others (paranoia), elderly
patients may feel confused, depression, becoming
dependent on Oxybutynin hydrochloride tablets,
indigestion or heartburn (acid reflux) and abdominal
discomfort in elderly patients.
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: 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
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 through 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 breakline line on the other
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,
FAL Duiven
Dijkgraaf, 6921,
RK Duiven,
The Netherlands
This leaflet was last revised in April 2015.

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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.