NORSPAN

Main information

  • Trade name:
  • NORSPAN buprenorphine 25 micrograms/h transdermal drug delivery system sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NORSPAN buprenorphine 25 micrograms/h transdermal drug delivery system sachet
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217508
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217508

NORSPAN buprenorphine 25 micrograms/hour transdermal drug delivery system sachet

ARTG entry for

Medicine Registered

Sponsor

Mundipharma Pty Ltd

Postal Address

GPO Box 5214,SYDNEY, NSW, 2001

Australia

ARTG Start Date

28/11/2014

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. NORSPAN buprenorphine 25 micrograms/h transdermal drug delivery system sachet

Product Type

Single Medicine Product

Effective date

21/12/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

The management of moderate to severe pain.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Al laminated with

LDPE/paper

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

2 patches

(S8) Controlled Drug

Components

1. NORSPAN buprenorphine 25 micrograms/h transdermal drug delivery system sachet

Dosage Form

Drug delivery system, transdermal

Route of Administration

Transdermal

Visual Identification

Beige coloured rectangular patch with rounded corners on an aluminised

rigid removable protective layer. The trade name and the strength is printed

on the patch.

Active Ingredients

Buprenorphine

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 23.11.2017 at 10:57:36 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

NORSPAN

®

Transdermal Drug Delivery System

Buprenorphine (boo-pree-nor-feen)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about NORSPAN

Transdermal Drug Delivery System

("patches").

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 this medicine

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What NORSPAN

patches are used for

NORSPAN patches contain

buprenorphine. Buprenorphine

belongs to a group of medicines

called opioid analgesics.

NORSPAN patches are used to

relieve moderate to severe pain.

Opioid analgesics such as

buprenorphine have been used to

treat pain for many years. Your

doctor, however, may prescribe it for

another purpose.

Ask your doctor if you have any

questions about why it has been

prescribed for you.

NORSPAN patches act through the

skin. After application,

buprenorphine passes through the

skin into the blood. Each patch

should be worn for seven days.

As with all strong painkillers, your

body may become used to you using

buprenorphine patches. Using them

may result in physical dependence.

Physical dependence means that you

may experience withdrawal

symptoms if you stop using

buprenorphine suddenly, so it is

important to use it exactly as directed

by your doctor.

This medicine is only available with

a doctor's prescription. Selling or

giving away NORSPAN patch is

against the law.

Before you use

NORSPAN patches

When you must not use

them

Do not use NORSPAN patches if

you:

have any breathing problems or

have a condition where your lung

function is severely impaired

have confusion and shaking due

to stopping drinking alcohol

have just had an operation or are

about to have surgery on your

spine for pain relief in the next 24

hours

suffer from myasthenia gravis, a

condition in which the muscles

become weak and tire easily

are taking medicine for

depression called a 'monoamine

oxidase inhibitor' or have taken

any in the last two weeks

are dependent on opioids such as

morphine, oxycodone, pethidine,

fentanyl or methadone. Using

NORSPAN patches after using

these medicines can cause the

onset of withdrawal symptoms.

Do not use NORSPAN patches if

you are allergic to buprenorphine,

opioid analgesics or any of the

ingredients listed at the end of this

leaflet.

Do not use this medicine after the

expiry date (EXP) printed on the

pack.

If you use it after the expiry date has

passed, it may not work very well.

Do not use it if the packaging is

torn or shows signs of tampering.

Do not use this medicine if you are

pregnant or plan to become

pregnant whilst using this

medicine.

Like most medicines of this kind,

NORSPAN patches should not be

used during pregnancy. Your doctor

can discuss with you the risks of

using it if you are pregnant.

Do not give this medicine to a child

or adolescent younger than 18

years of age.

Safety and effectiveness in children

younger than 18 years have not been

established.

NORSPAN

PATCH

Before you start to use it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

are severely drowsy or have a

reduced level of consciousness

suffer from irregular or fast

heartbeats or changes in the way

the heart beats

illness with high fever

convulsions, fits or seizures

head injury, brain tumour or

increased pressure in your head

shock (rapid and shallow

breathing, cold and clammy skin,

a rapid and weak pulse, dizziness,

weakness and fainting)

severe or long-term problems

with your liver

long-term problems with your

kidneys

low blood pressure including

from having low blood volume

increased prostate size

problems with or recent surgery

of your bile duct or gall bladder

problems

recent surgery on your abdomen

inflammation of the pancreas

adrenal glands not working

properly

inflammatory bowel disease

underactive thyroid gland

have an addiction or history of

abuse of alcohol or drugs.

Tell your doctor whether you have

used an opioid before.

Tell your doctor if you are

breastfeeding or planning to

breastfeed.

NORSPAN patches should not be

used by breastfeeding women as

buprenorphine can pass into the

breastmilk and can affect the baby.

If you have not told your doctor

about any of the above, tell them

before you start using NORSPAN

patches.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from a

pharmacy, supermarket or health

food shop.

Some medicines and alcohol may

interfere with NORSPAN patches.

These include:

other pain relievers including

other opioids and particularly

other long-acting (extended-

release) opioid pain medicines

medicines to treat depression,

anxiety, psychiatric or mental

disorders. Medicines for

depression belonging to a group

called monoamine oxidase

inhibitors must be stopped 14

days before NORSPAN patches

are used

medicines to help you sleep

medicines to put you to sleep

during an operation or procedure

quinidine, calcium channel

blockers and other medicines to

treat abnormal heart rhythms

medicines to treat seizures

medicines to thin the blood e.g.

coumarin derivatives such as

warfarin

medicines to stop nausea or

vomiting e.g. metoclopramide or

prochlorperazine

medicines to treat fungal

infections e.g. fluconazole or

itraconazole

medicines to treat bacterial

infections e.g. rifampicin,

macrolide antibiotics

medicines to treat HIV infections

alcohol.

These medicines and alcohol may be

affected by NORSPAN patches, may

affect how well the patches work or

may increase side effects. You may

need to use different amounts of your

medicines, or take different

medicines.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while using this

medicine.

How to use NORSPAN

patches

How much to use

Different strengths of NORSPAN

patches are available. Your doctor

will decide which strength is suitable

to control your pain.

During treatment, your doctor may

change the patch you use to a

different strength if necessary, or tell

you to use a combination of up to

two patches. Do not cut or divide the

patch or use a higher dose than

recommended.

The maximum total dose must not

exceed 40 micrograms/hour and

you should not apply more than

two patches at the same time. If

one 40 micrograms/hour patch is

applied, no additional patches

should be applied. Follow the

instructions your doctor or

pharmacist gives you exactly.

How to use the patch

Each patch is applied onto the skin

and lasts for seven days.

After seven days, remove the patch

and apply a new patch to a different

site.

Using the patch for the first

time

The first NORSPAN patch you use

may take up to three days to reach its

full effect. This is because

buprenorphine needs to be absorbed

through the skin and then into the

blood before you start to feel the

effects. Your doctor may prescribe

additional medicines to control the

pain during this time.

NORSPAN

PATCH

Applying the patch

Find a clean skin site on the upper

outer arm, upper chest, upper

back or the side of the chest. Do

not place the patch onto skin that

is red, burnt or injured.

Make sure the site is nearly

hairless and has no large scars.

Remove any hair by cutting with

scissors if you have to, but do not

shave the chosen area as this may

injure the skin.

Apply the patch to an area of skin

that is clean and dry and has not

had a patch applied to it for three

to four weeks. If necessary, wash

the area with water only. Do not

use soap, alcohol or a coarse cloth

to clean. Dry the area completely

after washing with water. Do not

apply oils or lotions to the chosen

area as this may prevent your

patch from sticking properly.

Each patch is sealed in a pouch.

Just before use, open the pouch

by cutting as close to the edge as

you can. Take out the patch. Do

not use the patch if the pouch is

torn or looks like it has been

tampered with or the pouch seal

is broken.

The sticky side of the patch is

covered by a silver backing foil.

Carefully peel off the smaller

portion of the scored backing foil.

Try not to touch the sticky part of

the patch. Press the sticky edge of

the patch, which had the backing

foil removed, to the edge of the

chosen skin site. Peel off the

remaining foil and press the patch

firmly onto the skin with the palm

of the hand and count slowly to

Make sure the whole patch is in

contact with the skin especially

around the edges. If the edges of

the patch begin to peel off, they

may be taped down with a

suitable skin tape.

Wash your hands with clean

water when you have finished

applying the patch.

Wearing the patch

You should wear the patch

continuously for seven days. Bathing,

showering or swimming should not

affect the patch. However, it is a

good idea to keep the patch dry

whenever possible.

Do not expose the patch to heat

sources such as heating pads, hot

water bottles, electric blankets,

heat lamps, saunas, hot tubs or

heated water beds etc. and avoid

intensive sunbathing.

Heat may cause more medicine than

normal to be absorbed and lead to an

increase in side effects. External heat

may also prevent the patch from

sticking properly.

In the event that your patch falls off

before it needs changing, do not use

the same patch again. Apply a new

patch to a different site straight away.

If you feel that the effect of the patch

is too weak or too strong, talk to your

doctor.

Changing the patch

Change your patch on the same

day at the same time each week.

For example, if you start using your

patch on Monday at 9 am, change

your patch the following Monday at

9 am.

After seven days, take the old

patch off.

Fold the used patch in half so that

the sticky side sticks to itself.

Dispose of the used patch in a

safe place, where children cannot

reach it.

Apply a new patch straight away

to a different area of the skin,

following the steps under

'Applying the patch'.

A new patch should not be

applied to the same skin site for

three to four weeks.

If you forget to change it

Remove the old patch and apply a

new patch as soon as you

remember. Also make a note of the

day as your usual day of changing

the patch may now be different. If

you are late changing your patch,

your pain may return. In this case,

contact your doctor.

Do not apply twice the number of

patches to make up for the patch

that you forgot to change on time.

Using extra patches will increase the

chance of unwanted side effects.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

the day and time to change your

patch, ask your pharmacist for

some hints.

How long to use the patches

Continue using the patches for as

long as your doctor tells you.

If you stop using NORSPAN patches

suddenly, your pain may worsen and

you may experience withdrawal

symptoms such as:

body aches

loss of appetite, nausea, stomach

cramps or diarrhoea

fast heart rate

sneezing or runny nose

chills, tremors, shivering or fever

trouble sleeping

increased sweating and yawning

weakness

nervousness or restlessness.

If you receive too much

(overdose)

If you have received an overdose,

remove all patches and

immediately telephone your doctor

or the Poisons Information Centre

(Australia: telephone 13 11 26) for

advice, or go to Accident and

Emergency at the nearest hospital.

This also applies if someone else

has accidentally used your patches.

Keep telephone numbers for these

places handy.

Do this even if there are no signs of

discomfort or poisoning.

NORSPAN

PATCH

You may need urgent medical

attention.

If someone has overdosed they may

experience difficulties in breathing,

become drowsy and tired, feel sick,

vomit, have constricted pupils, have

very low blood pressure or slow heart

rate, and possibly may even become

unconscious or die.

When seeking medical attention, take

this leaflet and the used patch or any

remaining patches with you to show

the doctor. Also tell them about any

other medicines or alcohol which

have been taken.

While you are using

NORSPAN patches

Things you must do

Use NORSPAN patches exactly as

your doctor has prescribed.

Before you start on a new

medicine, remind your doctor and

pharmacist that you are using

NORSPAN patches.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are using this medicine.

If you are going to have surgery,

tell the surgeon and anaesthetist

that you are using this medicine.

It may affect other medicines used

during surgery.

Tell your doctor if you develop a

high fever.

At high body temperatures, the

amount of buprenorphine absorbed

into the skin may increase which may

increase the chance of unwanted side

effects.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Keep all your doctor's

appointments so that your progress

can be checked.

Tell your doctor if your pain is

getting worse, or if you are having

frequent breakthrough pain.

Tolerance to buprenorphine may

develop which means that the effect

of the medicine may decrease with

continued use. If this happens, your

doctor may review your dose so that

you get adequate pain relief.

Keep enough NORSPAN patches

with you to last over weekends and

holidays.

Store NORSPAN patch away from

children and in a safe place to

prevent theft and abuse.

Things you must not do

The maximum total dose must not

exceed 40 micrograms/hour and

you should not apply more than

two patches at the same time. If

one 40 micrograms/hour patch is

applied, no additional patches

should be applied.

Do not use NORSPAN patches to

treat any other complaint unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if you think they

may have the same condition as

you. They may experience side

effects and require medical

attention.

Do not expose the patch to direct

heat sources, or wear it in saunas

or hot tubs and avoid intensive

sunbathing.

Do not stop using your medicine or

change the dosage without

checking with your doctor.

Over time your body may become

used to you having buprenorphine so

if you stop using it suddenly, your

pain may worsen and you may have

unwanted withdrawal symptoms.

This is called physical dependence.

If you need to stop using this

medicine, your doctor will gradually

reduce the amount you use each day,

if possible, before stopping the

medicine completely.

The pain-relieving effect of the

NORSPAN patch is maintained for

some time after removal of the patch.

You should not start another opioid

analgesic (strong pain medicine)

within 24 hours after removal of the

patch.

Things to be careful of

Tell your doctor if you find that

you cannot concentrate or that you

feel more sleepy than normal when

you start having this medicine or

when the dose is increased.

This feeling should wear off after a

few days.

Do not drive or operate machinery

until you know how NORSPAN

patches affect you.

NORSPAN patches may cause

drowsiness, dizziness or may affect

alertness whilst being worn or for at

least 24 hours after the patch is

removed. Discuss these aspects and

any impact on your driving or

operating machinery with your

doctor.

Be careful when drinking alcohol

while you are taking this medicine.

Drinking alcohol whilst using

NORSPAN patch may make you feel

more sleepy and increase the risk of

serious side effects, such as shallow

breathing with the risk of stopping

breathing and loss of consciousness.

What to do if the patch

accidentally adheres to another

person:

If the patch accidentally adheres to

another person (e.g. a family member

sharing the same bed), remove the

patch immediately, wash the area

thoroughly and contact your doctor.

Do this even if there are no signs of

discomfort or drowsiness.

Be careful if you are elderly,

unwell or taking other medicines.

Some people may experience side

effects such as unsteadiness,

dizziness, drowsiness or confusion

which may increase the risk of a fall.

Tell your doctor if you suffer from

nausea or vomiting when using

NORSPAN patches.

Your doctor may prescribe some

medicine to help.

NORSPAN

PATCH

Tell your doctor if using

NORSPAN patches causes

constipation.

Your doctor can advise you about

your diet, the proper use of laxatives

and suitable exercise you can do to

help manage this.

There is potential for abuse of

buprenorphine and the

development of addiction to

buprenorphine. It is important to

discuss this issue with your doctor.

Side effects

All medicines may have some

unwanted side effects. Sometimes

they are serious, most of the time

they are not. Side effects from using

NORSPAN patches tend to reduce

over time except for constipation.

Your doctor has weighed the risks of

using this medicine against the

benefits they expect it will have for

you.

Do not be alarmed by this list of

possible side effects.

Not everybody experiences them.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using

NORSPAN patches.

This medicine helps most people

with pain, but it may have unwanted

side effects in some people. Other

side effects not listed here may also

occur.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

mild abdominal problems such as

feeling sick (nausea), loss of

appetite, constipation or diarrhoea

weight loss

dry mouth or changes in taste

sweating

feeling anxious or nervous or

having trouble sleeping

shaking or tremors

fatigue, feeling of tiredness,

drowsiness, or lack of energy

trouble with your balance

new problems with your eyesight

itching at the patch site or other

areas of your body

redness or rash at the patch site

dry skin

swelling, including but not only,

of the legs or ankles.

Tell your doctor as soon as possible

if you notice any of the following

and they worry you:

stomach discomfort or pain,

vomiting or indigestion

feeling deep sadness

fainting or dizziness especially

when standing up

noticeable heartbeats

headache or confusion

unusual weakness or loss of

strength or unusual sensations in

your limbs.

If any of the following happen,

remove the NORSPAN patch and

go to Accident and Emergency at

your nearest hospital:

your breathing slows or weakens

you have an allergic reaction:

shortness of breath, wheezing,

shallow or difficult breathing;

swelling of the tongue, throat,

face, lips or other parts of the

body; rash, itching or hives on the

skin

fast or irregular heartbeats

chest pain.

The previous list includes very

serious side effects. You may need

urgent medical attention or

hospitalisation.

When seeking medical attention,

take this leaflet and the used patch

or any remaining patches with you

to show the doctor.

After using NORSPAN

patches

Storage

Keep your patches in the pouch

until it is time to use them.

If you take the patch out of the pouch

they may not keep as well.

Keep your patches in a cool dry

place where the temperature stays

below 25°C.

Do not store it or any other

medicine in the bathroom, near a

sink or on a window sill.

Do not leave it in the car.

Heat and damp can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist how to dispose of

medicines no longer required.

After removing the used patch, fold it

over on itself so that the adhesive

side of the patch sticks to itself, and

dispose of it safely where children

cannot reach it.

Product description

What it looks like

NORSPAN

patches are either

rectangular or square with rounded

corners. They are beige in colour.

Each NORSPAN

patch is printed

with the trade name and the strength

in blue ink. Each strength is a

different size. The higher the

strength, the larger the size.

NORSPAN

patches are supplied in

cartons containing two individually

packaged patches.

NORSPAN

PATCH

Ingredients

NORSPAN

patches contain

buprenorphine base as the active

ingredient and are available in seven

different strengths:

NORSPAN

5 patches are square,

beige-coloured patches which

contain a total of 5 mg buprenorphine

and release buprenorphine at a rate of

5 micrograms/hour.

NORSPAN

10 patches are

rectangular, beige-coloured patches

which contain a total of 10 mg

buprenorphine and release

buprenorphine at a rate of 10

micrograms/hour.

NORSPAN® 15 patches are

rectangular, beige-coloured patches

which contain a total of 15 mg

buprenorphine and release

buprenorphine at a rate of 15

micrograms/hour.

NORSPAN

20 patches are square,

beige-coloured patches which

contain a total of 20 mg

buprenorphine and release

buprenorphine at a rate of 20

micrograms/hour.

NORSPAN® 25 patches are

rectangular, beige-coloured patches

which contain a total of 25 mg

buprenorphine and release

buprenorphine at a rate of 25

micrograms/hour.

NORSPAN® 30 patches are

rectangular, beige-coloured patches

which contain a total of 30 mg

buprenorphine and release

buprenorphine at a rate of 30

micrograms/hour.

NORSPAN® 40 patches are

rectangular, beige-coloured patches

which contain a total of 40 mg

buprenorphine and release

buprenorphine at a rate of 40

micrograms/hour.

Inactive ingredients:

The patches also contain:

levulinic acid

oleyl oleate

povidone

Duro Tak 387-2051

Duro Tak 387-2054

polyethylene terephthalate.

Supplier

NORSPAN

patches are supplied in

Australia by:

Mundipharma Pty Limited

ABN 87 081 322 509

88 Phillip Street

Sydney NSW 2000

Phone: 1800 188 009

® NORSPAN is a registered trade

mark

This leaflet was prepared in March

2016.

Australian Registration numbers for

NORSPAN

patches are:

5 micrograms/hr AUST R 116647

10 micrograms/hr AUST R 116648

15 micrograms/hr AUST R 217507

20 micrograms/hr AUST R 116650

25 micrograms/hr AUST R 217508

30 micrograms/hr AUST R 217509

40 micrograms/hr AUST R 217510.

Orbis AU-3172

NORSPAN

PATCH

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

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FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

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FDA - U.S. Food and Drug Administration

15-5-2018

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

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FDA - U.S. Food and Drug Administration

13-6-2018

Suboxone (Indivior Europe Limited)

Suboxone (Indivior Europe Limited)

Suboxone (Active substance: buprenorphine / naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3632 of Wed, 13 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/697/T/38

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