EXELON

Main information

  • Trade name:
  • EXELON PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EXELON PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222604
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222604

EXELON PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

7/04/2015

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. EXELON PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet

Product Type

Single Medicine Product

Effective date

4/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

EXELON / PROMETAX is indicated for the treatment of patients with mild, moderate and severe dementia of the Alzheimer's type.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Other composite

material

2 Years

Store below 25

degrees Celsius

Child resistant closure

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

30 transdermal drug delivery systems

(S4) Prescription Only Medicine

7 transdermal drug delivery systems

(S4) Prescription Only Medicine

Components

1. EXELON PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet

Dosage Form

Drug delivery system, transdermal

Route of Administration

Transdermal

Visual Identification

Circular 15 cm2 transdermal drug delivery system, backing layer (beige),

bi-layer adhesive matrix and an oversized rectangular overlapping release

liner with dimples. Patch backing is printed with "CNFU" and "Exelon Patch

15 (rivastigmine)"

Active Ingredients

Rivastigmine

27 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 26.11.2017 at 11:02:56 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

Exelon

®

Patch

Rivastigmine

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Exelon Patch.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

final page. More recent information

on the medicine may be available.

You should ensure that you speak

to your pharmacist or doctor to

obtain the most up to date

information on the medicine. You

can also download the most up to

date leaflet from

www.novartis.com.au

Those updates may contain important

information about the medicine and

its use of which you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking it against the

benefits they expect it will provide.

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 Exelon Patch is

used for

Exelon Patch contains rivastigmine

as the active substance. Rivastigmine

belongs to a class of substances

called cholinesterase inhibitors and is

used to treat a condition called

Alzheimer's disease.

In patients with Alzheimer's

dementia, certain nerve cells die in

the brain, resulting in low levels of

the neurotransmitter: acetylcholine (a

substance that allows nerve cells to

communicate with each other). This

causes changes in the brain and

problems with memory, thinking and

behaviour. These problems gradually

become worse with time.

Exelon Patch works by preventing

the breakdown of a chemical in the

brain called acetylcholine. This

chemical is needed to help keep the

brain working properly.

Rivastigmine helps to reduce the

symptoms of Alzheimer's disease, to

slow down the mental decline that

happens in people with this

condition, and helps to improve the

patient's ability to cope with

everyday activities. It does not cure

the condition.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

Exelon Patch is only available with a

doctor's prescription. It is not

addictive.

There is not enough information to

recommend this medicine for

children.

Before you apply

Exelon Patch

When you must not use it

Do not apply Exelon Patch if you

have had an allergic reaction to

any of the following:

rivastigmine, the active ingredient

in Exelon Patch

any of the other ingredients of

Exelon Patch listed at the end of

this leaflet.

other related "carbamate"

medicines (if you are unsure

about these, ask your doctor or

pharmacist)

Symptoms of an allergic reaction

may include wheezing or difficulty

breathing; swelling of the face, lips,

tongue or other parts of the body;

rash or hives on the skin.

Do not apply Exelon Patch if you

have a severe liver disorder.

There is no information on the use of

this medicine in people with severe

liver problems.

Do not apply Exelon Patch if you

have had a skin reaction which has

spread beyond the patch size, if

there was a more intense local

reaction (such as blisters,

increasing skin inflammation,

swelling) and if it did not improve

within 48 hours after removal of

the transdermal patch.

Do not apply Exelon Patch after

the expiry date printed on the pack

or if the packaging is torn or shows

signs of tampering.

In that case, return it to your

pharmacist.

Do not use Exelon Patch in

children.

It is not known how Exelon Patch

will affect children.

If you are not sure whether you

should start using Exelon Patch,

talk to your doctor or pharmacist.

EXELON

PATCH

Before you start to use it

Tell your doctor if you have any of

the following conditions:

a problem with your heart

a history of stomach ulcer

problems with your lungs such as

asthma or obstructive pulmonary

disease

emphysema

difficulty passing urine (water)

seizures (fits)

problems with your kidneys or

liver

problems with your stomach such

as nausea (feeling sick) and

vomiting (being sick)

if you have a low body weight

(less than 50 kg)

If you have any of the above

conditions your doctor may want to

take special precautions while you

are taking this medicine.

Tell your doctor if you are

pregnant or breast-feeding.

It is not known whether using Exelon

Patch during pregnancy or while

breast-feeding could affect your

baby.

Breast-feeding is not recommended

while you are using this medicine. It

is not known whether the active

ingredient passes into breast milk and

could affect your baby.

Tell your doctor if you smoke.

Nicotine can affect the amount of

Exelon Patch that is in your body. A

sudden change in your usual smoking

habit can also change the effects of

Exelon Patch.

Taking other medicines

Tell your doctor 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 Exelon Patch

may interfere with each other. These

include:

cholinergic medicines (e.g.

bethanechol, medicines used

during surgery)

anticholinergic medicines (e.g.

medicines for stomach cramps,

medicines for travel sickness,

many medicines used to treat

mental illness)

metoclopramide (a medicine used

to relieve or prevent nausea and

vomiting).There may be additive

effects such as stiff limbs and

trembling hands.

beta-blockers (medicines used to

treat hypertension, angina and

other heart conditions). There

may be additive effects such as a

slow heartbeat that may result in

fainting or loss of consciousness.

non-steroidal anti-inflammatory

drugs (NSAIDs), which are

medicines used to treat arthritis

and other painful conditions such

as muscle strains, back pain,

menstrual cramps and migraine

You may need to take different

amounts of your medicines or to take

different medicines while you are

using Exelon Patch. Your doctor and

pharmacist have more information.

If you have not told your doctor

about any of these things, tell him/

her before you start using this

medicine.

How to use Exelon

Patch

Follow all directions given to you

by your doctor and pharmacist

carefully.

These instructions may differ from

the information contained in this

leaflet.

If you do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

How to apply Exelon Patch

Every 24 hours, gently remove any

existing Exelon patch before

putting on a new one. See "How to

remove Exelon Patch".

Having multiple patches on your

body could expose you to an

excessive amount of this medicine

which could be potentially

dangerous.

Apply your new patch to a

different area of skin.

Before you apply Exelon Patch,

make sure that your skin is:

clean, dry and hairless

free of any powder, oil,

moisturiser, or lotion (that could

keep the patch from sticking to

your skin properly)

free of cuts, rashes and/or

irritations.

Apply ONE patch only per day to

ONLY ONE of the following

locations on your body:

upper arm, left or right side, or

chest, left or right side, or

upper back, left or right side, or

lower back, left or right side.

A leaflet in the carton contains

diagrams showing these locations.

When changing your patch, you must

remove the previous day's patch

before you apply your new patch to a

different area of skin (for example on

the right side of your body one day,

then on the left side the next day). Do

not apply a new patch to that same

area for at least one week.

How to remove Exelon Patch

Gently pull at one edge of the

Exelon Patch to remove it

completely from the skin.

If any adhesive residue is left on

your skin, gently soak the area

with warm water and mild soap, or

use baby oil to remove it. Do not

use alcohol or other dissolving

liquids (nail polish remover or

other solvents).

Wash your hands with soap and

water after removing the patch.

In case of contact with eyes or if

the eyes become red after handling

the patch, rinse them immediately

EXELON

PATCH

with plenty of water and seek

medical advice if symptoms do not

resolve.

How much to use

Your doctor will tell you which

Exelon Patch is more suitable for

you. Treatment usually starts with

one Exelon Patch 5 daily. After about

four weeks of treatment the usual

daily dose is Exelon Patch 10. If well

tolerated, your doctor may increase

the dose to Exelon Patch 15.

During the course of the treatment

your doctor may adjust the dose to

suit your individual needs.

Do not wear more than one Exelon

Patch at a time.

If for any reason you stop using

Exelon Patch for more than three

days, tell your doctor before you

start taking Exelon Patch again.

Your doctor will restart you at the

lowest dose to help prevent side

effects such as nausea and vomiting.

How to use it

Read the "How to use" leaflet

carefully.

A "How to use" leaflet is enclosed in

Exelon Patch cartons. This leaflet

contains pictures and instructions

showing how to apply the patch

properly.

How long to use it

Apply a new patch every day.

Exelon Patch should be replaced with

a new one after 24 hours.

Apply the new patch at about the

same time each day.

Change your patch at the same time

each day to obtain the best effect

from your medicine. It will also help

you remember when to take it.

Continue using Exelon Patch for as

long as your doctor tells you to.

This medicine helps to slow the

progression of Alzheimer's disease

but does not cure it. Your treatment

can be continued for as long as it

benefits your condition. Your doctor

can give you more information.

Do not stop using Exelon Patch or

change your dose without talking

with your doctor.

Switching from Exelon

Capsules to Exelon Patch

Your doctor will have advised you on

switching from Exelon Capsules.

NEVER take Exelon Capsules

when using Exelon Patch.

If you forget to use it

If it is almost time for you to apply

the next patch dose, skip the patch

you missed and apply the next

patch when you are meant to.

Otherwise, apply a new patch as

soon as you remember, and then go

back to your usual schedule.

Do not apply two Exelon Patches to

make up for the one you missed.

This may increase the chance of you

getting an unwanted side effect.

Tell your doctor if you have not

applied your Exelon Patch for

more than three days. Do not apply

the next patch before you have

talked to your doctor.

Your doctor will restart you at the

lowest dose to help prevent side

effects such as nausea and vomiting.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

If your Exelon Patch falls off

If your Exelon Patch falls off,

apply a new patch to the same site

for the rest of the 24hours. Replace

this patch the next day at the same

time as usual.

Do not re-apply the used patch.

Applying a new patch ensures that

your body keeps getting the medicine

it needs.

If you use too much

(overdose)

If you think that you or anyone

else may have accidentally applied

more than one Exelon Patch at a

time or swallowed a patch,

immediately telephone your doctor

or the Poisons Information Centre

(telephone number 13 11 26), or go

to Accident and Emergency at

your nearest hospital. Do this even

if there are no signs of discomfort

or poisoning.

Keep the telephone numbers for

these places handy.

Because of the way this medicine is

used, an intentional overdose is

unlikely.

Applying more than one patch or

swallowing a patch may cause

nausea (feeling sick)

vomiting

diarrhoea

high or low blood pressure

fainting

salivation

sweating

increasing muscle weakness

hallucinations (hearing or seeing

things that are not there)

unusually slow heart beat

breathing difficulties

convulsions.

While you are using

Exelon Patch

Things you must do

Be sure to keep all of your doctor's

appointments so your progress can

be checked.

You and your caregiver can help to

produce the maximum benefit from

your treatment by keeping in close

contact with your doctor.

Tell your doctor if you smoke.

Nicotine can affect the amount of

Exelon that is in your body. A

sudden change in your usual smoking

habit can also change the effects of

Exelon.

EXELON

PATCH

Make sure you or your caregiver

tells your doctor if you experience

considerable nausea, vomiting or

diarrhoea with loss of appetite and

weight loss.

You may become dehydrated (losing

too much fluid) if vomiting or

diarrhoea are prolonged.

Talk to your doctor right away if

you have skin inflammation,

blisters or swelling of the skin that

are increasing and spreading.

If you become pregnant while

taking Exelon Patch, tell your

doctor.

There is not enough information to

recommend the use of this medicine

during pregnancy. Your doctor can

discuss with you the risks and

benefits involved.

If you are going to have surgery,

tell your doctor and anaesthetist

that you are using Exelon Patch.

Exelon Patch may affect some

medicines you receive during

surgery.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are using Exelon Patch.

Tell any other doctor, dentist or

pharmacist who treats you that

you are using Exelon Patch.

Things you must not do

Avoid placing the patch where it

might be rubbed off by tight

clothing.

Do not give this medicine to anyone

else even if their condition seems

similar to yours.

Do not use Exelon Patch to treat

any other complaints unless your

doctor tells you to.

Do not expose the patch to any

external heat sources (excessive

sunlight, saunas, and solariums)

for long periods of time.

Your doctor will tell you whether

your illness allows you to drive

vehicles and use machines safely.

Exelon Patch may cause dizziness

and somnolence, mainly at the start

of treatment or when increasing the

dose. Therefore, you should wait to

know what effects the drug may

cause before engaging in such

activities. If you feel dizzy or

drowsy, do not drive, use machines

or perform any other tasks that

require your attention.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using Exelon

Patch, even if you do not think it is

connected with the medicine.

All medicines can have side effects.

Sometimes they are serious, but most

of the time they are not. You may

need medical treatment if you get

some of the side effects.

Do not be alarmed by these lists 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 notice any

of the following and they worry

you:

nausea (feeling sick) or vomiting

diarrhoea

dehydration (losing too much

fluid)

loss of appetite

anorexia

anxiety

indigestion, abdominal pain or

discomfort

weight loss

dizziness or a spinning feeling

headache

unusual fatigue/tiredness,

weakness or sleepiness, feeling

generally unwell

inability to adequately retain

urine (urinary incontinence)

redness, itching, irritation,

swelling at the application site

increased sweating

difficulty sleeping

confusion

mood changes such as feeling

aggression, anxious, nervousness,

depressed (sad mood)

unusual high level of activity

(hyperactivity)

hallucinations (hearing or seeing

things that are not there)

loss of control of your bladder or

bowels (incontinence).

The above side effects usually

happen at the start of treatment when

the dose is being increased. They are

not usually serious and may

gradually disappear as your body

gets used to the medicine.

Women are more likely than men to

get some side effects (e.g. nausea,

vomiting, loss of appetite, weight

loss).

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

signs of allergy such as rash or

hives on the skin; swelling of the

face, lips, tongue or other parts of

the body; wheezing or difficulty

breathing

chest pain

stroke (loss of coordination,

difficulty in speaking and signs of

brain disorder)

unusually fast, slow or irregular

heart beat

raised blood pressure

unusual thinking (e.g. feeling a

fixed, irrational idea not shared

by others, or feeling strong

suspiciousness)

severe dizziness, fainting or fits

(seizures)

severe confusion

blood in the stools or when

vomiting gastric ulcer and

gastrointestinal haemorrhage)

severe pain in the abdomen, often

with nausea and vomiting

(inflammation of the pancreas)

EXELON

PATCH

signs of a urinary tract infection

such as frequent urge to urinate or

pain on urination

fits or convulsions

signs of a liver disorder (yellow

skin, yellowing of the whites of

eyes, abnormal darkening of the

urine or unexplained nausea,

vomiting, tiredness and loss of

appetite)

skin inflammation, blisters or

swelling of the skin that are

increasing and spreading

stiff limbs, trembling hands

(extrapyramidal symptoms)

Tell your doctor if you notice

anything else that is making you

feel unwell.

Some people may have other side

effects not yet known or mentioned

in this leaflet. Some of the side

effects can only be found when your

doctor does tests from time to time to

check your progress.

After using Exelon

Patch

Storage

Keep your medicine in the

original container (sachet) until it

is time to use it.

Store it in a cool, dry place at

room temperature (below 25°C).

Do not store Exelon patch or any

other medicine in the bathroom or

near a sink

Do not leave it in the car or on

window sills.

Heat and dampness can destroy some

medicines. Exelon Patch will keep

well if it is kept cool and dry.

Keep the medicine 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

After the patch has been removed,

fold the patch in half with the

adhesive sides on the inside and

press them together. Place the

folded used patch in its original

sachet. Discard safely out of reach

and sight of children. Wash your

hands with soap and water after

removing the patch.

If your doctor tells you to stop

using Exelon Patch or if they have

passed their expiry date, ask your

pharmacist what to do with any

medicine you have left over.

Product description

What it looks like

Exelon Patch is available in two

strengths, in packs of 30 sachets.

Patch 5: the outside of the

backing layer is beige and

labelled with "AMCX" and

"Exelon

Patch 5 (rivastigmine)"

Patch 10: the outside of the

backing layer is beige and

labelled with "BHDI" and

"Exelon

Patch 10

(rivastigmine)"

Patch 15: the outside of the

backing layer is beige and

labelled with "CNFU" and

"Exelon

Patch 15

(rivastigmine)"

Ingredients

Each Exelon Patch 5, Patch 10 or

Patch 15 contains respectively 9 mg,

18 mg or 27mg of the active

ingredient (rivastigmine). They also

contain:

Alpha-tocopherol

Acrylates copolymer

Silicone oil (dimethicone 12500)

Adhesive matrix (Durotak

387-2353 and Bio PSA Q7-4302)

Sponsor

Exelon is supplied in Australia by:

NOVARTIS Pharmaceuticals

Australia Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone 1 800 671 203

Web site: www.novartis.com.au

= Registered Trademark

This leaflet was prepared in

June 2016.

Australian Registration Numbers:

Exelon Patch 5: AUST R 133422

Exelon Patch 10: AUST R 133428

Exelon Patch 15: AUST R 222604

(exp080616c) based on PI

(exp080616i)

EXELON

PATCH

15-5-2018

Prometax (Novartis Europharm Limited)

Prometax (Novartis Europharm Limited)

Prometax (Active substance: Rivastigmine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2996 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/255/T/118

Europe -DG Health and Food Safety