APO-DONEPEZIL

Main information

  • Trade name:
  • APO-DONEPEZIL donepezil hydrochloride (as monohydrate) 5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-DONEPEZIL donepezil hydrochloride (as monohydrate) 5 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213495
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213495

APO-DONEPEZIL donepezil hydrochloride (as monohydrate) 5 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

23/09/2013

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. APO-DONEPEZIL donepezil hydrochloride (as monohydrate) 5 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

7/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Donepezil is indicated for the treatment of mild, moderate and severe Alzheimer's disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-DONEPEZIL donepezil hydrochloride (as monohydrate) 5 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off white, circular biconvex, film-coated tablets, embossed with 'C'

on one side and '7' on the other side.

Active Ingredients

Donepezil hydrochloride

5 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 11:06:31 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

APO-Donepezil Tablets

Contains the active ingredient donepezil hydrochloride (as monohydrate)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about donepezil. 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

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Donepezil. It contains the active

ingredient donepezil hydrochloride

(as monohydrate).

It is used to treat mild, moderate and

severe Alzheimer's disease, also

called dementia of the Alzheimer's

type.

This medicine will not cure this

disease, but it should help your

memory and improve your ability to

think more clearly.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

How it works

This medicine belongs to a group of

medicines called acetylcholinesterase

inhibitors. They are thought to work

by increasing the level of a chemical

called acetylcholine in the brain.

Use in children

Do not give this medicine to

children.

There is not enough information to

recommend using this medicine in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have had an allergic

reaction to donepezil,

piperidine derivatives or any of

the ingredients listed at the end

of this leaflet.

Symptoms of an allergic reaction

may include: shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue,

throat or other parts of the body;

rash, itching or hives on the skin.

If you think you are having an

allergic reaction, contact your

doctor immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does

not look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

heart problems

stomach problems, particularly

gastric or duodenal ulcer

seizures or fits (epilepsy)

asthma or obstructive lung

(pulmonary) disease

APO-DONEPEZIL TABLETS

loss of memory or other mental

capacity due to a stroke or blood

vessel problems

a tendency towards aggressive

behaviour.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

You are planning to have surgery

or an anaesthetic.

Donepezil may interfere with

some of the medicines given

during an operation.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

If you have not told your doctor

about any of the above, tell them

before you take this medicine.

Taking other medicines

Some medicines and donepezil may

interfere with each other. These

include:

any other medicine for dementia

some medicines used to relieve

stomach cramps or spasms,

Parkinson's disease or travel

sickness

some medicines used to treat

difficulty in passing urine

non-steroidal anti-inflammatory

drugs (NSAIDs) - medicines used

to treat arthritis, pain or

inflammation

some medicines used to relax

muscles

some medicines used to treat high

blood pressure or fast heart beat

some medicines used to treat

irregular heart beat such as

quinidine

some medicines for treating

asthma, diarrhoea, depression,

schizophrenia and related mental

conditions or used in general

anaesthesia

carbamazepine, phenobarbitone

or phenytoin, medicines used to

treat epilepsy

ketoconazole, a medicine used to

treat fungal infections

rifampicin, an antibiotic used to

treat tuberculosis

dexamethasone, a corticosteroid

medicine.

These medicines may be affected by

donepezil or may affect the way

donepezil works. You may need

different amounts of your medicines,

or may need to take different

medicines.

Other medicines not listed above

may also interact with donepezil.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take this

medicine

Follow carefully all directions

given to you by your doctor

carefully.

Their instructions may be different to

the information in this leaflet.

If you are not sure how to take this

medicine, ask your doctor or

pharmacist for help.

How much to take

Your doctor or pharmacist will tell

you how much of this medicine you

should take. This will depend on

your condition and whether you are

taking any other medicines. The

usual starting dose is one 5 mg tablet

each day. After one month, your

doctor will assess your response and

may increase your dose to one 10 mg

tablet each day.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Always swallow the tablets whole

with a full glass of water.

Take the tablet every night just

before you go to bed.

Taking it at the same time each day

will have the best effect and will also

help you remember when to take it.

It does not matter if you take it

before, with or after food.

How long to take it

Continue taking this medicine for as

long as your doctor tells you.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

It may take several weeks for this

medicine to take effect, so do not be

discouraged if you do not see an

improvement straight away.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

Otherwise take it as soon as you

remember and then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of

unwanted side effects.

If you forget to take it for more

than one week, call your doctor

before taking any more.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

APO-DONEPEZIL TABLETS

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively go to the Accident

and Emergency Department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Symptoms of an overdose may

include feeling sick in the stomach,

vomiting, increased sweating or

saliva production. You may also have

a slow heartbeat, feel dizzy, have

trouble breathing, faint, have fits, feel

weak or not be able to control your

bowel motions or passing of urine.

While you are taking

this medicine

Things you must do

If you become pregnant while

you are using this medicine, tell

your doctor.

Tell all doctors, dentists and

pharmacists who are treating you

that you are using this medicine.

If you are about to be started on

any new medicine, tell your

doctor or pharmacist that you are

using this medicine.

If you are about to have any

blood tests.

If you are going to have surgery,

inform your doctor and tell the

surgeon or anaesthetist that you

are using this medicine.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours

Take your medicine to treat any

other condition unless your

doctor or pharmacist tells you to

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

This medicine may cause fatigue,

dizziness and muscle cramps

especially at the start of treatment or

when the dose is increased. If you

have any of these symptoms, do not

drive, operate machinery or do

anything else that could be

dangerous.

In addition, Alzheimer's disease

may affect your ability to drive or

operate machinery. Ask your

doctor whether it is safe for you to

continue to drive or operate

machinery.

Please talk to your doctor or

pharmacist about any concerns you

may have about the above.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking this

medicine.

It can be difficult to tell whether side

effects are the result of taking this

medicine, the effects of your

condition or side effects of other

medicines you may be taking. For

this reason it is important to tell your

doctor of any change in your

condition.

Your doctor will decide whether any

change in your treatment is needed.

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 of the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following:

heartburn, indigestion, or stomach

pain

headache, dizziness

difficulty in sleeping

unusual tiredness

feeling sick, diarrhoea, vomiting,

loss of appetite, weight loss

bruising

muscle cramps, joint pain

tingling or numbness of the hands

or feet

depression, unusual dreams

agitation, aggressive behaviour

passing urine more often.

These are all mild side effects of

donepezil.

Tell your doctor as soon as possible

if you notice any of the following:

seeing, feeling or hearing things

that are not there

trembling and shaking of the

hands and fingers, shuffling walk

and stiffness of the arms and legs

severe upper stomach pain, often

with nausea, vomiting and fever.

The above list includes serious side

effects that may require medical

attention.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital.

any breathing problems

fainting, especially if you have a

slow or irregular heart beat

vomiting blood or material that

looks like coffee grounds

black sticky bowel motions

(stools)

convulsions or fits

APO-DONEPEZIL TABLETS

weakness, shortness of breath,

yellowing of the skin, dark brown

urine and stomach pain

sudden increase in body

temperature, sweating, muscle

stiffness, or altered consciousness

(awareness of oneself and ones

surrounding).

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Other side effects not listed above

may above may occur in some

people. Tell your doctor if you notice

any other side effects.

Allergic reactions

If you think you are having an

allergic reaction to this medicine,

tell your doctor immediately or go

to the Accident and Emergency

department at your nearest

hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing.

swelling of the face, lips, tongue,

or other parts of the body

rash, itching or hives on the skin

fainting

hayfever-like symptoms

Storage and disposal

Storage

Keep your tablets in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your tablets in a cool dry place

where the temperature will stay

below 30°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this 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

If your doctor or pharmacist tells you

to stop taking this medicine or they

have passed their expiry date, your

pharmacist can dispose of the

remaining medicine safely.

Product description

What APO-Donepezil looks

like

APO-Donepezil 5 mg tablet - white

to off-white, film coated circular,

biconvex tablet with 'C' embossed on

one side and '7' on the other.

APO-Donepezil 10 mg tablet - light

yellow to yellow, film coated

circular, biconvex tablet with 'C'

embossed on one side and '6' on the

other.

Ingredients

Each tablet contains 5 mg or 10 mg

of donepezil hydrochloride as the

active ingredient.

It also contains the following inactive

ingredients:

lactose

maize starch

microcrystalline cellulose

hydroxypropyl cellulose

sodium stearylfumarate

purified talc

macrogol 6000

hypromellose

titanium dioxide

iron oxide yellow (10mg tablet)

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

APO-Donepezil is available in:

Blister packs of 28 tablets.

* Not all strengths may be available.

Australian Registration

Numbers

New formulation

APO-Donepezil 5 mg tablet (blister

pack): AUST R 213495.

APO-Donepezil 10 mg tablet (blister

pack): AUST R 213496.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was prepared in

December 2016

APO-DONEPEZIL TABLETS

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12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety