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OXYBUTYNIN HYDROCHLORIDE 3 MG TABLETS

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Oxybutynin hydrochloride 3 mg tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 3 mg of oxybutynin hydrochloride.
Excipient: each tablet contains 71.40 mg lactose monohydrate.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Tablet.
White circular, flat, beveled edged tablet, scored on one side, diameter 6.5 mm,
thickness 2.3 -2.7 mm.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Oxybutynin hydrochloride is indicated for urinary incontinence, urgency and
frequency in unstable bladder, whether due to neurogenic bladder disorders (detrusor
hyperreflexia) in conditions such as multiple sclerosis and spina bifida, or to
idiopathic detrusor instability (motor urge incontinence).

Paediatric population
Oxybutynin hydrochloride in indicated in children over 5 years of age for:
-

Urinary incontinence, urgency and frequency in unstable bladder conditions due
to idiopathic overactive bladder or neurogenic bladder disorders (detrusor
overactivity).

4.2

Posology and method of administration
Adults:
The usual dose is 5mg two or three times a day. This may be increased to a
maximum of 5mg four times a day to obtain a clinical response provided that
the side effects are tolerated.
Elderly:
The elimination half-life may be increased in some elderly people. Therefore,
the dose must be set individually, starting with 2.5 mg twice a day. Afterwards
the lowest effective dose has to be chosen.
Children (under 5 years of age): not recommended

Children over 5 years:
Neurogenic bladder instability: the usual dose is 2.5mg twice a day. This dose
may be titrated upwards to 5mg two or three times a day to obtain a clinical
response provided the side effects are well tolerated. Nocturnal enuresis: the
usual dose is 2.5 mg twice a day. This dose may be titrated upwards to 5mg
two or three times a day to obtain a clinical response provided the side effects
are tolerated. The last dose should be given before bedtime.
The tablets have to be swallowed with plenty of fluid and may be taken on an
empty stomach. If gastric irritation occurs the tablets may also be taken during
meals or with some milk.
4.3

Contraindications
Hypersensitivity to oxybutynin or one of the other ingredients of the tablet
Narrow-angle glaucoma or shallow anterior chamber
Myasthenia gravis
Obstruction of the gastro-intestinal tract, paralytic ileus, intestinal atony
Micturition problems caused by either obstructive uropathy or prostate hypertrophy
Severe ulcerative colitis
Toxic megacolon

4.4

Special warnings and precautions for use
Care is essential with frail elderly patients and children who may be more
sensitive to the effects of oxybutynin and in patients with autonomic
neuropathy, hiatus hernia with reflux oesophagitis or other serious gastrointestinal diseases and decreased hepatic or renal function.

The symptoms of hyperthyroidism, congestive cardiac failure, coronary heart
disease, cardiac arrhythmias, tachycardias, hypertension and prostate
hypertrophy may be aggravated during the treatment with oxybutynin.
Oxybutynin can cause decreased sweating: in high environmental temperatures
this can lead to heat prostration.
Special care should be taken in patients with hiatus hernia associated with
reflux oesophagitis, as anticholinergic drugs can aggravate this condition.
Prolonged use may contribute in the development of caries, periodontal
disease, oral candidiasis and discomfort due to decrease of inhibition of the
salivary flow.
If a urinary tract infection is present an appropriate antibacterial therapy
should be started.
Oxybutynin hydrochloride should be used with caution in patients with
pollakisuria and nocturia due either to heart disease or renal disease.
Patients with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency, or glucose – galactose malabsorption should not take this
medicine.
Paediatric population
The use of oxybutynin in children under 5 years of age is not recommended; it
has not been established whether oxybutynin can be safety used in this age
group.
There is limited evidence supporting the use of oxybutynin in children with
monosymptomatic nocturnal enuresis (not related to detrusor overactivity). In
children over 5 years of age, oxybutynin hydrochloride should be used with
caution as they may be more sensitive to the effects of the product, particularly
the CNS and psychiatric adverse reactions.
4.5

Interaction with other medicinal products and other forms of interaction
Care should be taken if other anticholinergic agents are administered together with
Oxybutynin hydrochloride as potentiation of anticholinergic effects can occur.
Potentiation of the effects could occur during administration of atropine and other
parasympatholytic acting agents.
By the decrease of the gastro-intestinal motility oxybutynin can influence the
absorption of other medicines.
Occasional cases of interaction between anticholinergics and clozapine
phenothiazines, amantadine, butyrophenones, levodopa, digitalis, quinidine and

tricyclic antidepressants have been reported, and care should be taken if oxybutynin is
administered concurrently with such drugs.
Since oxybutynin is metabolised by cytochrome P450 isoenzyme 3A4, interactions
with drugs that inhibit this isoenzyme can not be excluded. This should be
considered when oxybutynin is used concomitantly with antimycotics of the azolegroup (e.g. ketoconazole) or macrolide antibiotics (e.g erythromycin). Itraconazole
has been demonstrated to inhibit oxybutynin metabolism. This led to doubling of the
oxybutynin plasma levels, but only to a 10 % increase for the active metabolite.
Because the metabolite is responsible for about 90 % of the antimuscarinic activity,
the changes appear to be of minor clinical importance.
Care should be taken if prokinetic agents are taken concurrently with Oxybutynin
hydrochloride as decrease of the effect may occur.

4.6

Fertility, pregnancy and lactation
Fertility: Studies in animals have shown impaired fertility in females (see
section 5.3).
Pregnancy: There are no data from the use of oxybutynin in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3). The
potential risk for humans is unknown.
Oxybutynin hydrochloride should not be used during pregnancy unless clearly
necessary.
Lactation: It is not known whether oxybutynin is excreted in human breast
milk. Oxybutynin is excreted in milk of rats. Use of oxybutynin is not
recommended during breast-feeding because there are no data with respect to
the effect of oxybutynin on the infant.

4.7

Effects on ability to drive and use machines
Oxybutynin hydrochloride has minor or moderate influence on the ability to drive and
use machines. As oxybutynin hydrochloride may cause dizziness, drowsiness or
blurred vision, especially in combination with alcohol, the patient should be
cautioned regarding activities requiring mental alertness such as driving, operating
machinery or performing hazardous work while taking this drug.

4.8

Undesirable effects

Oxybutynin hydrochloride tablets may produce all the side effects that may be
associated with anticholinergic drugs:
very
common
(≥1/10)

common
(≥1/100,
<1/10)

Psychiatric
disorders

very rare,
(<1/10000)

not known

restlessness,
disorientation,
confusion

impotence

agitation,
anxiety,
hallucination
s,
nightmares,
paranoia,
cognitive
disorders in
elderly,
symptoms of
depression,
dependence
(in patients
with history
of drug or
substance
abuse)

uncommon
(≥1/1000,
<1/100)

rare
(≥1/10000,
<1/1000)

Nervous system
disorders:

dizziness,
drowsiness

headache

convulsions
(children
may be more
liable to
such
effects).

Eye disorders:

blurred
vision,
widened
pupils

decreased
Lacrimation /
dry eyes

acute
glaucoma
(narrowangle
glaucoma)
tachycardi
a,
arrhythmia
s,
palpitation
s.

Cardiac
disorders:

Vascular
Disorders:

Gastrointestinal
disorders:

Facial
flushing

dry mouth

constipation,
nausea,
abdominal
discomfort/p
ain

anorexia,
diarrhoea,
vomiting

gastroesopha
geal reflux
disease,
pseudoobstruction
in patients at
risk (elderly
or patients
with
constipation

and treated
with other
medicinal
products that
decrease
intestinal
motility)
Skin and
subcutaneous
tissue disorders:

decreased
sweating/dry
skin,

skin
reactions
including
rash

Renal and
urinary
disorders:

micturition
problems

urinary
retention.

General
disorders and
administration
site conditions:

fatigue

angioedema,
photosensiti
vity

Heatstroke

Within each frequency grouping, undesirable effects are presented in order of
decreasing seriousness.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the national reporting system using the Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms:
An overdose of oxybutynin is characterised by an intensification of the
parasympatholytic adverse effects such as CNS disturbances (from restlessness and
excitement to psychotic behaviour), circulatory changes (flushing, fall in blood
pressure, circulatory failure, etc.), respiratory failure, paralysis and coma.
Treatment:
Measures to be taken are:
Immediate gastric lavage
Slow intravenous injection of physostigmine (only in severe cases):
Adults: 0.5 - 2 mg, repeat after 5 minutes when necessary, until max. 5 mg totally.
Children: 30 µg/kg body-weight, repeated when necessary until max. 2 mg totally

Fever should be treated symptomatically with tepid sponging or ice packs. In
pronounced restlessness or excitation, diazepam 10 mg may be given by intravenous
injection.
Tachycardia may be treated with intravenous propranolol, and urinary retention
managed by bladder catheterization.
In the event of progression of the muscle relaxant effect to paralysis of the respiratory
muscles, mechanical ventilation will be required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Urinary antispasmodics,
ATC code: G04BD04
Oxybutynin hydrochloride is a synthetic tertiary amine with a direct spasmolytic and
anticholinergic action on the smooth musculature of the detrusor muscle of the
bladder. It increases bladder capacity, reduces the frequency of uninhibited detrusor
contractions, and delays the first urge to urinate.

5.2

Pharmacokinetic properties
Absorption
Oxybutynin hydrochloride is rapidly absorbed from the gastro-intestinal tract
following oral administration.
Because of an extensive hepatic first pass effect, less than 10 % of the dose
administered reaches the general circulation unchanged. The maximum plasma level
occurs after 1 – 1.5 hours.
Metabolism
N-desethyloxybutynin is an active metabolite that reaches higher plasma levels than
the unchanged oxybutynin.
Oxybutynin is extensively metabolised by the liver, primarily by the cytochrome
P450 enzyme system, particularly CYP3A4.
Elimination
Elimination mainly takes place by metabolic changes in the liver, i. e. hydrolysis and
demethylation. The metabolites are excreted in the urine. Unchanged oxybutynin is

hardly found in the urine. The elimination half-life of oxybutynin is rapid, being
about 2 - 3 hours

5.3

Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of
general toxicity, genotoxicity and carcinogenicity beyond the information included in
other sections of the SmPC. Oxybutynin given to pregnant rats induced cardiac
malformations, consisting mainly of interventricular septal defects, an increased
incidence of supernumerary thoracolumbar ribs, and increased neonatal mortality in
the offspring, at maternally toxic dosages.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Crospovidone,
microcrystalline cellulose,
lactose monohydrate,
magnesium stearate.

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years

6.4

Special precautions for storage
Do not store above 25oC.
Store in the original package.
Keep out of the sight and reach of children

6.5

Nature and contents of container

Aluminium / PVC / PVdC strips
Pack with blisters of 7, 28, 56 and 84 tablets
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local
requirements.

7

MARKETING AUTHORISATION HOLDER
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 20117/0201

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/06/2013

10

DATE OF REVISION OF THE TEXT
20/05/2015

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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