DUTRAN 50 fentanyl 50 mcg/hr transdermal patch pouch

Main information

  • Trade name:
  • DUTRAN 50 fentanyl 50 mcg/hr transdermal patch pouch
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DUTRAN 50 fentanyl 50 mcg/hr transdermal patch pouch
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 190791
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

190791

DUTRAN 50 fentanyl 50 mcg/hr transdermal patch pouch

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

28/08/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. DUTRAN 50 fentanyl 50 mcg/hr transdermal patch pouch

Product Type

Single Medicine Product

Effective date

5/02/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Management of chronic pain requiring opioid analgesia.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Other plastic

laminate/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

5 patches

(S8) Controlled Drug

Components

1. DUTRAN 50 fentanyl 50 mcg/hr transdermal patch

Dosage Form

Drug delivery system, transdermal

Route of Administration

Transdermal

Visual Identification

Rectangular, round cornered, transparent and colourless patch with 15 cm2

active surface area contained in a protective pouch made from composite

foil.

Active Ingredients

Fentanyl

8.25 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 10:45:50 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

DUTRAN CMI 050315

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DUTRAN Transdermal Drug Delivery System

contains the active ingredient fentanyl

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about DUTRAN. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using DUTRAN

against the benefits this medicine

is expected to have for you.

If you have any concerns about

using DUTRAN, ask your doctor

or pharmacist.

Keep this leaflet with your

medicine. You may need to read it

again.

What DUTRAN is used

for

DUTRAN is used to relieve chronic

or long-lasting pain, which

requires strong painkillers.

DUTRAN contains a medicine

called fentanyl. This strong pain

reliever belongs to a group of

medicines known as

opioid

analgesics. Fentanyl

relieves pain

by blocking the nerves that

recognise pain messages from the

body.

Each patch is applied onto the skin

every 72 hours (3 days). The patch

releases a continuous amount of

fentanyl that is absorbed through

the skin in contact with the patch.

Your doctor may have prescribed

DUTRAN for another reason. Ask

your doctor if you have any

questions about why this medicine

has been prescribed for you.

Warning

DUTRAN patches may be

retrieved and abused by addicts.

Please ensure that used patches

are concealed and disposed of

carefully. Return unused patches

to the pharmacy (see Disposal at

the end of this leaflet).

Keep used and unused patches

where children cannot reach

them.

Before you use DUTRAN

When you must not use it

Do not use DUTRAN

if you have an allergy to

fentanyl or any of the

ingredients. See Product

Description at the end of this

leaflet for a list of ingredients.

for acute pain or pain following

surgery

for mild or intermittent pain

at a starting dose greater than

25 micrograms/hour if you

have never had opioid

analgesics for pain relief.

Do not use DUTRAN if the

packaging is torn or shows signs of

tampering. Do not use DUTRAN

beyond the expiry date (month and

year) printed on the pack.

Before you start to use it

You must tell your doctor if you

are pregnant or planning to

become pregnant

are breast feeding or wish to

breastfeed

have or have ever had liver or

kidney disease

have or have ever had lung

disease

have or have ever had heart

disorders

have or have ever had brain

lesions or head injuries

have medical conditions which

lower your resistance to

diseases.

You must tell your doctor if you

have not used any opioid

analgesics in the past, unless you

are being treated for cancer pain.

This is because you may be more

likely to experience some of the

side effects.

If you have not told your doctor or

pharmacist about any of the

above, tell them before you start

using or are given DUTRAN.

Tell your doctor if you (or a family

member) have ever abused or

DUTRAN CMI 050315

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been dependent on alcohol,

prescription medicines, or illegal

drugs.

Your doctor will advise you

whether or not to use DUTRAN or

if you need to adjust the dose or

adapt your treatment.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines you

certain medicines to treat

depression such as

nefazodone.

sedating antihistamines.

medicines used as sedatives,

hypnotics, sleeping tablets,

tranquillisers or muscle

relaxants.

Combination of these

medicines with DUTRAN may

increase the sedative effect of

these drugs or slow your ability

to react. A change in dose may

be required if DUTRAN is

Effect of alcohol

Avoid alcohol when using

DUTRAN since their combined

effect may cause drowsiness.

Tolerance

As with all opioid analgesics,

DUTRAN may lead to tolerance

with continued use. Your doctor

may, therefore, prescribe a higher

dose of DUTRAN after some time

to continue to give you pain relief.

can buy without a prescription

used with these medicines.

from a pharmacy, supermarket or

health food shop.

In particular, tell your doctor or

pharmacist if you are taking any of

the following:

other strong analgesics used to

manage pain such as opioids

and general anaesthetics.

ritonavir and nelfinavir (used

to treat AIDS). Do not take

ritonavir or nelfinavir while

using DUTRAN, unless you

are closely monitored by your

doctor.

if taking rifampicin,

carbamazepine, phenobarbital,

phenytoin, careful monitoring

by your doctor and dose

adjustment may be required.

antidepressant medicines

belonging to the class

monoamine oxidase inhibitors

(MAOIs), selective serotonin

re-uptake inhibitors (SSRIs), or

serotonin norepinephrine re-

uptake inhibitors (SNRIs).

DUTRAN should not be used

concurrently with these

medicines and should be

initiated 14 days after

cessation of MAOIs.

Combination of these

medicines with DUTRAN may

increase the risk of serotonin

syndrome, a potentially life-

threatening condition.

medicines used to treat mental

illness or psychotic conditions

and to relieve severe nausea

and vomiting, such as

phenothiazines.

certain antibiotics used to treat

infections such as

clarithromycin and

troleandomycin.

certain medicines to treat

fungal infections such as

ketoconazole and itraconazole

certain medicines that act on

the heart and blood vessels

such as calcium-channel

blockers like verapamil and

dilitiazem.

certain medicines used to treat

arrhythmias such as

amiodarone.

Your doctor or pharmacist can tell

you what to do if you are taking

any of these medicines.

Effect on driving and operating

machinery

DUTRAN can affect your alertness

and ability to drive and operate

machinery. Do not drive or operate

machinery until your doctor says it

is safe.

Using DUTRAN

How to use the patch

Adults

DUTRAN is available in five

different sizes. Your doctor will

decide which patch, or

combination of patches, is suitable

to control your pain.

Each patch is applied onto the

skin and lasts for three days

(72 hours).

After three days, remove the

patch and apply a new patch to

the skin at a different place.

You should not use more than one

patch at a time, unless your

doctor authorises otherwise (for

example to obtain a dose that

cannot be achieved with a single

patch). The old patch should be

removed before the new patch is

applied.

Children

DUTRAN should not be used in

children under 12 years of age or in

adolescents under 18 years of age

who weigh less than 50 kg.

Using it for the first time

The first patch may take up to a

day to take effect after it is applied

DUTRAN CMI 050315

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onto the skin. This is because

fentanyl is slowly absorbed

through the skin into the blood.

Your doctor may prescribe

additional medicines to control the

pain for the first day.

Applying the patch

Find an intact and hairless

spot of skin on the upper part

of your body or on your upper

arm. The skin should be

healthy and undamaged. Do

not place the patch onto skin

that is red, burnt or damaged.

Trim any excess hair with

scissors. Do not shave the hair

off since this may affect the

skin. If you need to wash the

skin before applying the

patch, use clean water only.

Do not use soap, oils or

lotions. The skin should be

completely dry before

applying the patch.

DUTRAN should be applied

immediately upon removal

from the protective pouch.

After locating the tear mark at

the edge of the pouch, it

should be carefully torn open

and the patch removed.

Each DUTRAN has a clear

divided, cut or damaged in any

way.

You can now leave the patch on

the skin for three days (72 hours).

You may have a bath, shower or

swim.

Always write the date and time you

applied the patch on the pack. It

will help you to use DUTRAN

correctly and remember when the

next patch is due.

Your doctor may prescribe

additional pain relievers to control

occasional outbreaks of pain.

Changing the patch

After three days (72 hours),

remove the patch.

Fold the used patch in half so

that the adhesive side sticks to

itself. Wrap the folded patch

and carefully dispose of it in

the garbage.

Apply a new patch straight

away to a different area of the

skin, following the steps under

Applying the patch.

If you do not understand the

instructions provided with this

If you receive too much

(overdose)

The most important sign of

overdose is difficulty in breathing.

If a person using DUTRAN has

abnormally slow or weak

breathing, remove the patch. Keep

the person awake by talking to

them or gently shaking them every

now and then.

Immediately telephone your

doctor or the Poisons Information

Centre (telephone 13 11 26) for

advice, or go to the Emergency

Department at your nearest

hospital.

Do this even if there are no signs of

discomfort or poisoning. The

person may need urgent medical

attention.

Information for the doctor in case

of overdose: inject with naloxone

and transfer patient to hospital.

Please refer to full Product

Information for details on

appropriate management of

overdose.

plastic protective liner that

medicine, ask your doctor or

can be peeled off in two

pieces. After folding the patch

in the middle, peel off each

part of the protective liner

separately. Patients should

avoid touching the adhesive

side of the patch.

The patch must be applied to

the skin by applying light

pressure with the palm of the

hand for about 30 seconds,

making certain the edges are

adhering properly.

Patients should wash hands

afterwards with clean water.

Never cut or divide the patch. Do

not use a patch that has been

pharmacist for help.

If your pain continues, see your

doctor who may prescribe

additional medicines to help

control the pain or change the

dose of DUTRAN.

If you forget to use it

If you forget to apply a patch, and

are not sure what to do, check with

your doctor or pharmacist.

If you have trouble remembering

when to apply each patch, ask your

pharmacist for some hints.

While you are using DUTRAN

Things you must do

Always follow your doctor's

instructions carefully.

Tell your doctor if you become

pregnant while using

DUTRAN.

If your pain continues or

returns, see your doctor. You

may need additional medicines

to control the pain or a change

in the strength of the DUTRAN.

Tell your doctor if you develop

a fever. At high temperatures,

DUTRAN CMI 050315

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the amount of fentanyl

absorbed by the skin increases.

Your doctor may need to

adjust your DUTRAN dose.

If you are about to start taking

a new medicine, tell your

doctor and pharmacist that

you are using DUTRAN.

Things you must not do

DO NOT expose the patch to

direct heat from electric blankets,

heat pads, heated water beds,

heat or tanning lamps, intensive

sunbathing, hot water bottles,

long hot baths, saunas or hot spa

baths while you are using

DUTRAN. Direct exposure to such

heat may cause an increase in the

amount of fentanyl absorbed by

the skin, resulting in possible

overdose and death.

Do not use DUTRAN to treat

any other complaint unless

your doctor says so.

Do not give the patches to

anyone else, even if their

symptoms seem similar to

yours.

Do not stop using DUTRAN

unless your doctor advises you

to do so. If you have been

using DUTRAN for a long

period of time but stop using it

suddenly without your doctor's

advice, you may experience

withdrawal symptoms (such as

nausea, vomiting, diarrhoea,

anxiety and shivering). Seek

your doctor's advice if you

experience these symptoms.

Things to be careful of

If the patch accidentally

adheres to another person (for

example a family member

sharing the same bed), remove

the patch and contact your

doctor. Do this even if there

are no signs of discomfort or

drowsiness.

Different brands of fentanyl

patches may vary in size,

shape, colour or adhesiveness.

DO NOT switch brands of

fentanyl patches unless your

doctor and pharmacist

authorise it.

Side Effects

All medicines can have side effects.

Sometimes they are serious, most

of the time they are not. You may

need medical treatment if you get

some side effects. Do not be

alarmed by this list of possible side

effects. You may not experience

any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you experience

any of the following:

nausea, vomiting, constipation,

dry mouth, diarrhoea,

uncomfortable feeling in

stomach or belching after

eating, indigestion, blockage of

the bowel.

low blood pressure, headache,

weakness or dizziness, high

blood pressure, being less alert

or aware, or loss of

consciousness.

blurred vision.

sleepiness, confusion,

hallucinations, euphoria,

depression, loss of appetite,

anxiety, trouble sleeping,

agitation, loss of memory, pins

and needles.

sweating or trouble in

urinating.

sudden life-threatening allergic

reaction.

sudden signs of allergy such as

rash, itching or hives on the

skin, swelling of the face, lips,

tongue or other parts of the

body, shortness of breath,

wheezing or trouble breathing.

skin rash (local redness and

itch at the site of the patch is

usually mild and resolves when

the patch is removed).

unusual tiredness or weakness,

feeling of body temperature

change.

Tell your doctor immediately if

you notice any of the following as

you may need urgent medical

care:

slow heart beat.

fast heart beat.

REMOVE the DUTRAN patch and

tell your doctor immediately or go

to the Emergency Department at

your nearest hospital if the

following happens:

breathing slows or weakens.

temporarily stopped breathing;

difficulty in breathing.

Make sure that you are with

someone who can keep you awake

by talking to you or gently shaking

you every now and then.

Nausea, vomiting, diarrhoea,

anxiety and shivering may occur

initially when you are switched

from other opioid analgesics to

DUTRAN or if therapy is stopped

suddenly. Tell your doctor if you

experience any of these effects.

Medicines like DUTRAN can lead

to addiction. This is unlikely when

DUTRAN is used correctly.

Other side effects not listed above,

sexual dysfunction and withdrawal

symptoms, may also occur in some

people. Tell your doctor if you

notice any other effects.

DUTRAN CMI 050315

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After using DUTRAN

Storage

Keep

patches

sealed

pouch

until

time

apply

them.

Keep

patches

place

where

temperature

stays

below

Keep

your

medicines

where

children

cannot

reach

them.

locked cupboard at least one-and-

a-half

metres

(1.5

above

ground

good

place

store

medicines.

Do not store DUTRAN or any other

medicine, in the bathroom or near

a sink. Do not leave medicines in

the car or on window sills. Heat

dampness can

destroy

some

medicines.

Disposal

The contents of the patches may

be retrieved and abused by

addicts.

Fold used patches so that the

adhesive side of the patch sticks

to itself, wrap and dispose of

carefully in the garbage.

If your doctor tells you to stop

using DUTRAN, or the patches

'fentanyl 25µg/h' for the 25

microgram/hour strength

'fentanyl 50µg/h' for the 50

microgram/hour strength

'fentanyl 75µg/h' for the 75

microgram/hour strength

'fentanyl 100µg/h' for the 100

microgram/hour strength

Each pack contains 5 patches. Each

patch is in a sealed pouch.

They are available in five sizes. The

number after the name DUTRAN

refers to the amount of fentanyl in

micrograms (one thousandth of a

milligram) released by the patch

per hour.

Ingredients

The patches contain the active

ingredient fentanyl.

The patch is composed of

polyacrylate adhesive.

Australian Registration numbers

DUTRAN 12 (AUST R 192231)

DUTRAN 25 (AUST R 190790)

DUTRAN 50 (AUST R 190791)

DUTRAN 75 (AUST R 190792)

DUTRAN 100 (AUST R 190793)

have passed their expiry date,

return the patches to your

Supplier

pharmacist.

Amneal Pharma Australia Pty Ltd

Product description

What it looks like

DUTRAN patches are rectangular,

round-cornered, transparent

patches imprinted with:

'fentanyl 12µg/h' for the 12

micrograms/hour strength

12 River St

South Yarra VIC 3141

This leaflet was prepared in

October 2017