Ditropan 5mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Oxybutynin hydrochloride
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
G04BD04
INN (International Name):
Oxybutynin hydrochloride
Dosage:
5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 07040200

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 you get any side effects, talk to your

doctor or pharmacist. This includes any

possible side effects not listed in this

leaflet. Section 4.

What is in this leaflet:

1. What Ditropan Tablets is and what it is

used for

2. What you need to know before you take

Ditropan Tablets

3. How to take Ditropan Tablets

4. Possible side effects

5. How to store Ditropan Tablets

6. Contents of the pack and other information

What Ditropan Tablets are

Ditropan Tablets contains a medicine called

oxybutynin hydrochloride. This belongs to

two groups of medicines called

'anticholinergics' and 'antispasmodics'.

How Ditropan Tablets work

It works by relaxing the muscles of

the bladder and stops sudden muscle

contractions (spasms). This helps control the

release of water (urine).

What Ditropan Tablets are used for

Ditropan Tablets 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

You are allergic (hypersensitive) to

oxybutynin hydrochloride or any of the

other ingredients of Ditropan Tablets

(listed in Section 6: Contents of the pack

and other 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

apply to you. If you are not sure, talk to your

doctor or pharmacist before taking Ditropan

Tablets.

Talk to your doctor or pharmacist

before taking Ditropan Tablets

You have kidney or liver problems

You are 65 years of age or older

The person taking the 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

Warnings and precautions

2. What you need to know before you

take Ditropan Tablets

Do not take Ditropan tablets:

765806_NT. DITROPAN 2,5-5MG RL V1 GB.qxp_FORMAT 210x170mm-RL-DBL.qxd 09/04/2020 16:48 Page 1

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

Ditropan may reduce the amount of saliva

resulting in tooth decay or fungal infection

of the mouth

Ditropan 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.

If you are not sure if any of the above apply

to you, talk to your doctor or pharmacist

before taking Ditropan Tablets.

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 Ditropan Tablets

can affect the way some other medicines

work. Also some medicines can affect

the way Ditropan Tablets 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, Bethanechol.

Pregnancy, breast-feeding and fertility

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. Breast

feeding while using oxybutynin is therefore

not recommended.

Ask your doctor or pharmacist for advice

before taking any medicine if you are

pregnant or breast-feeding.

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 Ditropan Tablets

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 Ditropan Tablets

Always take Ditropan Tablets 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

Other medicines and Ditropan Tablets

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How much to take

Your doctor will decide the dose appropriate

for you.

Adults

The usual dose is one 5mg 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 dose is 2.5mg twice each day

Your doctor may decide to increase this

to 5mg twice each day

Children (over 5 years)

The usual dose is one 2.5mg tablet

twice each day

Your doctor may decide to increase this

to one 5mg 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 Ditropan Tablets than

you should

If you take more Ditropan Tablets 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 Ditropan 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 Ditropan 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 Ditropan Tablets

Keep taking Ditropan Tablets until your

doctor tells you to stop. Do not stop taking

Ditropan Tablets just because you feel better.

4. Possible side effects

Like all medicines Ditropan Tablets can cause

side effects, although not everybody gets them.

Children are at higher risk of the effects.

Stop taking Ditropan Tablets 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 may 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

Nausea

Dry mouth

Dry skin, rash or skin that is more sensitive

to the sun

Headache

Somnolence (feeling drowsy or sleepy)

Dizziness

Blurring of vision

Common (affects 1 to 10 people in a 100 people)

Dry eyes

Diarrhoea

Being sick (vomiting)

Confusion

Flushing especially in children

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)

Indigestion or heartburn (acid reflux)

Urinary tract infection

Heat stroke

Difficulty passing water (urine)

Agitation

Anxiety

Becoming dependent on Ditropan

Feeling excessive suspicious and distrustful

of others

Mental Health disorders

Seeing or hearing things that are not there

(hallucinations)

Drowsiness

Nightmares

Fits (convulsions)

Depression

Increased heart beat (tachycardia)

Irregular heart beat (arrhythmia)

Dilation of pupil (mydriasis)

Itchy, lumpy rash (urticaria)

Absence of sweating (hypohidrosis)

Skin that is more sensitive to the sun

(photosensitivity)

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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.

You can also report side effects directly via

the Yellow card Scheme Website:

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 Ditropan Tablets

Keep this medicine in a safe place where

children cannot see or reach it.

Do not use Ditropan Tablets after the expiry

date which is stated on the blister or carton

after EXP. The expiry date refers to the last

day of that month.

Store below 30`C.

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. Contents of the pack and other

information

What Ditropan Tablets contains

Each tablet contains 2.5 mg or 5mg of the

active substance, oxybutynin hydrochloride.

The other ingredients lactose, cellulose,

calcium stearate and indigo carmine (E132).

What Ditropan Tablets looks like and

contents of the pack

Ditropan® 2.5mg Tablets are pale blue oval

bi-convex tablets with OXB2.5 on one side.

Ditropan® 5mg Tablets are pale blue

circular tablets with OXB5 on one side and

a break-line on the other side

Supplied in blisters packs of 6, 21 or 84

tablets. Not all pack sizes may be marketed

Marketing Authorisation Holder and

Manufacturer

Marketing Authorisation Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald, Germany

Manufacturer

Sanofi Winthrop Industrie

30-36 avenue Gustave Eiffel,

37000 Tours, France

This leaflet does not contain all the

information about your medicine. If you

have any questions or are not sure about

anything, ask your doctor or pharmacist.

This leaflet was last revised in April 2020

*765806*

765806

90002968/10

765806_NT. DITROPAN 2,5-5MG RL V1 GB.qxp_FORMAT 210x170mm-RL-DBL.qxd 09/04/2020 16:48 Page 4

Plant PM code :

765806

Update :

V6 - 09/04/2020

Local code : 90002968/10

Old PM code :

CREATION

Name :

NT. DITROPAN 2,5/5MG RL

CHP

Country :

GB

Plant :

Tours TN

Supplier code :

N.A.

Format : 210 x 170 mm - Rouleau - DOUBLE

Sens de déroulement

Recto Intérieur_1A (Paysage) - Verso Ext. : 2B

Plant barcode

: *765806*

Colors

: 2

- Noir PMS BLACK U

- Bleu PMS 281

Fonts

: OceanSansPro SAN - L39HrP24Dh

Size mini : 9,5 Pts

Assembly Card

: N.A.

Layout of Cutting

: TN_LCG_NTRL_12c

Technical Constraint

: PLANTYPE-NTRL-2015_S-DB

Nature du changement/Reason for change:

C - Marketing Change

Marketing Authorisation Transfer from Sanofi to

CHEPLAPHARM

Technical Data

Approvals

For Sanofi use only

Colours may note reproduce accurately on this proof.

You should refer to Pantone references for accurate colour match.

765806_NT. DITROPAN 2,5-5MG RL V1 GB.qxp_FORMAT 210x170mm-RL-DBL.qxd 09/04/2020 16:48 Page 5

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Ditropan tablets 5mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5mg oxybutynin hydrochloride as the active ingredient.

3

PHARMACEUTICAL FORM

Ditropan tablets 5mg are pale blue circular tablets with a 8.0 mm nominal

diameter, with a centre breakline on one side, and marked OXB5 on the

reverse.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Urinary incontinence, urgency and frequency in the 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 is indicated in children over 5 years of age for:

Urinary

incontinence,

urgency

frequency

unstable

bladder

conditions due to idiopathic overactive bladder or neurogenic bladder

disorders (detrusor overactivity).

Nocturnal enuresis associated with detrusor overactivity, in conjunction

with non-drug therapy, when other treatment has failed.

4.2

Posology and method of administration

Dosage and administration

Adults: The usual dose is 5mg two or three times a day. This may be increased

to a maximum of 5 mg four times a day to obtain a clinical response provided

that the side effects are tolerated.

Elderly (including frail elderly): The elimination half-life is increased in the

elderly. Therefore, a dose of 2.5mg twice a day, particularly if the patient is

frail, is likely to be adequate. This dose may be titrated upwards to 5mg two

times a day to obtain a clinical response provided the side effects are well

tolerated.

Children (under 5 years of age): Not recommended

Children (over 5 years of age): 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 2.5mg 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 tolerated. The last dose should be given

before bedtime.

4.3

Contraindications

Hypersensitivity to oxybutynin or any component.

Myasthenia gravis.

Narrow-angle glaucoma or shallow anterior chamber.

Gastrointestinal

obstructive

disorders

including

paralytic

ileus,

intestinal

atony.

Patients with toxic megacolon.

Patients with severe ulcerative colitis.

Patients with bladder outflow obstruction where urinary retention may be

precipitated.

4.4

Special warnings and precautions for use

Oxybutynin should be used with caution in the frail elderly, patients with

Parkinson’s disease and children who are at greater risk of occurrence of

adverse reactions to the product and in patients with autonomic neuropathy

(such as those with Parkinson’s disease), severe gastro-intestinal motility

disorders, hepatic or renal impairment.

Anticholinergics should be used with caution in elderly patients due to the

risk of cognitive impairment.

Gastrointestinal disorders: Anticholinergic medicinal products may decrease

gastrointestinal motility and should be used with caution in patients with

gastrointestinal obstructive disorders, intestinal atony and ulcerative colitis.

Oxybutynin may aggravate tachycardia (and thus be cautious in case of

hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart

disease,

hypertension),

cognitive

disorders

symptoms

prostatic

hypertrophy.

Anticholinergic

effects

(e.g.

hallucinations,

agitation,

confusion,

somnolence) have been reported; monitoring recommended especially in first

months

after

initiating

therapy

increasing

dose;

consider

discontinuing therapy or reducing the dose if anticholinergic CNS effects

develop.

Since oxybutynin can cause narrow-angle glaucoma, patients should be

advised to contact a physician immediately if they are aware of a sudden loss

of visual acuity or ocular pain.

Oxybutynin may reduce salivary secretions which could result in dental

caries, parodontosis or oral candidiasis.

Anticholinergic medicinal products should be used with caution in patients

who have hiatus hernia/gastro-oesophageal reflux and/or who are concurrently

taking

medicinal

products

(such

bisphosphonates)

that

cause

exacerbate oesophagitis.

When oxybutynin is used in high environmental temperatures, this can cause

heat prostration due to decreased sweating.

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 safely 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 Ditropan, as potentiation of anticholinergic effects could occur.

The anticholinergic activity of oxybutynin is increased by concurrent use of

other anticholinergics or medicinal products with anticholinergic activity, such

as amantadine and other anticholinergic antiparkinsonian medicinal products

(e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines,

butyrophenones,

clozapine),

quinidine,

digitalis,

tricyclic

antidepressants,

atropine

related

compounds

like

atropinic

antispasmodics

dipyridamole.

By reducing gastric motility, oxybutynin may affect the absorption of other

drugs. Oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4.

Concomitant administration with a CYP3A4 inhibitor can inhibit oxybutynin

metabolism and increase oxybutynin exposure.

Oxybutynin,

anticholinergic

agent,

antagonize

effect

prokinetic therapies.

Concomitant

with

cholinesterase

inhibitors

result

reduced

cholinesterase inhibitor efficacy.

Patients should be informed that alcohol may enhance the drowsiness caused

by anticholinergic agents such as oxybutynin (see section 4.7).

4.6

Pregnancy and lactation

Pregnancy: there are no adequate data from the use of oxybutynin in

pregnant women. Animal studies are insufficient with respect to effects on

pregnancy, embryonal/foetal development, parturition or postnatal

development (see section 5.3). The potential risk for humans is unknown.

Oxybutynin should not be used during pregnancy unless clearly necessary.

Lactation: when oxybutynin is used during lactation, a small amount is

excreted in mother's milk. Use of oxybutynin during breast feeding is

therefore not recommended.

4.7

Effects on ability to drive and use machines

Oxybutynin may cause drowsiness or blurred vision. Patients 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

Classification of expected frequencies:

Very common (

1/10); common (

1/100 to <1/10); uncommon (

1/1,000 to

<1/100); rare (

1/10,000 to <1/1,000); very rare (<1/10,000), not known

(cannot be estimated from the available data).

Infections and infestations

Not known: urinary tract infection

Gastro-intestinal disorders

Very common: constipation, nausea, dry mouth

Common: diarrhoea, vomiting

Uncommon: abdominal discomfort, anorexia, decreased appetite, dysphagia

Not known: gastroesophageal reflux disease,

pseudo-obstruction in patients at

risk (elderly or patients with constipation and treated with other drugs that decrease

intestinal motility)

Psychiatric disorders

Common: confusional state

Not known: agitation, anxiety, hallucinations, nightmares, paranoia, cognitive

disorders in elderly, symptoms of depression,

dependence to oxybutynin (in

patients with history of drug or substance abuse)

Nervous system disorders

Very common: dizziness, headache, somnolence

Not known: cognitive disorders, convulsions, drowsiness, disorientation

Cardiac disorders

Not known: tachycardia, arrhythmia

Injury, poisoning and procedural complications

Not known: heat stroke

Eye disorders

Very common: vision blurred

Common: dry eyes

Not known: Angle closure glaucoma, mydriasis, ocular hypertension

Renal and urinary disorders

Common: urinary retention

Not known: difficulty in micturition

Vascular disorders

Common: flushing which may be more marked in children

Skin and subcutaneous tissue disorders

Very common: dry skin

Not known: angioedema, rash, urticaria, hypohidrosis, photosensitivity

Immune system disorders

Not known: hypersensitivity.

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 Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the

Google Play or Apple App Store.

4.9

Overdose

The symptoms of overdosage with oxybutynin progress from an intensification

of the usual side effects of CNS disturbances (from restlessness and

excitement to psychotic behaviour), circulatory changes (flushing, fall in

blood pressure, circulatory failure etc), respiratory failure, paralysis and coma.

Measures to be taken are:

immediate gastric lavage

physostigmine by slow intravenous injection

Adults: 0.5 to 2.0 mg of physostigmine by slow intravenous administration.

Repeat after 5 minutes, if necessary up to a maximum total dose of 5mg.

Children:

microgramsg/kg

physostigmine

slow

intravenous

administration. Repeat after 5 minutes, if necessary up to a maximum total

dose of 2mg.

Fever should be treated symptomatically with tepid sponging or ice packs.

In pronounced restlessness or excitation, diazepam 10mg may be given by

intravenous injection, tachycardia may be treated by intravenous injection of

propranolol and urinary retention can be managed by bladder catheterisation.

In the event of progression of the curare- like effect to the paralysis of the

respiratory muscles, mechanical ventilation will be required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Oxybutynin has both direct antispasmodic action on the smooth muscle of the

bladder detrusor muscle as well as an anticholinergic action in blocking the

muscarinic effects of acetylcholine on smooth muscle. These properties cause

relaxation of the detrusor muscle of the bladder in patients with an unstable

bladder. Ditropan increases bladder capacity and reduces the incidence of

spontaneous contractions of the detrusor muscle.

5.2

Pharmacokinetic properties

Oxybutynin is poorly absorbed from the gastrointestinal tract. It is highly

bound to plasma proteins, the peak plasma level is reached between 0.5 to 1

hour after administration. The half life is biexponential, the first phase being

about 40 minutes and the second about 2-3 hours. The elimination half life

may be increased in the elderly, particularly if they are frail.

Oxybutynin and its metabolites are excreted in the faeces and urine. There is

no evidence of accumulation.

5.3

Preclinical safety data

No data of therapeutic relevance.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Ditropan tablets contain lactose, cellulose, calcium stearate and indigo carmine

(E132).

6.2

Incompatibilities

None known.

6.3

Shelf life

3 years

6.4

Special precautions for storage

Store below 30°C.

6.5

Nature and contents of container

Polypropylene container* of 100 or 500 tablets and cartons containing 6*, 21

84 tablets in blister strips.

* Not marketed

6.6

Special precautions for disposal

No special requirements.

7

MARKETING AUTHORISATION HOLDER

Aventis Pharma Limited

410 Thames Valley Park Drive

Reading

Berkshire

RG6 1PT

Trading as:

Sanofi

410 Thames Valley Park Drive

Reading

Berkshire

RG6 1PT

8

MARKETING AUTHORISATION NUMBER(S)

PL 04425/0290

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

December 2000

10

DATE OF REVISION OF THE TEXT

14/08/2019

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