APO-MEMANTINE

Main information

  • Trade name:
  • APO-MEMANTINE memantine hydrochloride 20mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-MEMANTINE memantine hydrochloride 20mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207782
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207782

APO-MEMANTINE memantine hydrochloride 20mg film-coated 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

24/04/2014

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. APO-MEMANTINE memantine hydrochloride 20mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

31/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of the symptoms of moderately severe to severe Alzheimer's disease (see PHARMACOLOGY, PRECAUTIONS).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Blister Pack

PVC/PCTFE (Aclar)/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-MEMANTINE memantine hydrochloride 20mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pale red, oval, biconvex coated tablet. Engraved 'MEM 20' on one side,

'APO' on the other side.

Active Ingredients

memantine hydrochloride

20 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 12:04:09 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-Memantine

Contains the active ingredient memantine hydrochloride (meh-MAN-teen high-dro-CLOR-ride)

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 memantine. It does

not contain all the available

information. It does not take the

place of talking to your doctor,

pharmacist or diabetes educator.

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.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking this medicine

against the benefits expected for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may need to read it again.

What this medicine is

used for

The name of your medicine is APO-

Memantine.

It contains the active ingredient,

memantine (as memantine

hydrochloride).

This medicine is used to treat

moderately severe to severe

Alzheimer's disease (AD). AD can be

described as a general decline in all

areas of mental ability.

Ask your doctor if you have any

questions about why it has been

prescribed for you. Your doctor may

have prescribed this medicine for

another reason.

This medicine is only available with

a doctor's prescription.

How it works

Memantine belongs to a group of

medicines called N-methyl-D-

aspartate (NMDA) receptor

antagonists. It is thought to work by

protecting NMDA receptors in the

brain against high levels of the

chemical glutamate, which could be

the cause of brain degeneration.

NMDA receptors are involved in the

transmission of nerve signals within

the brain, e.g. in learning and

memory.

This medicine should improve your

thinking capacity and your ability to

remember.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have a seizure disorder or

a history of seizures (fits or

epilepsy).

You are hypersensitive to, or

have had an allergic reaction to,

memantine or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, 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; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

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.

APO-MEMANTINE TABLETS

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:

a history of convulsions or are at

risk of epilepsy

kidney problems

severe bladder infection

liver problems

heart or blood vessel problems

high blood pressure.

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 until you and

your doctor have discussed the

risks and benefits involved.

You have recently changed your

diet or intend to change your diet

substantially, for example if you

wish to become a vegetarian.

If you are lactose intolerant,

contact your doctor before taking

this medicine. The 10mg strength

tablet contains lactose.

You are planning to have surgery

or an anaesthetic.

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.

Some medicines may interact with

memantine. These include:

medicines used to treat stomach

cramps or spasms, or travel

sickness (anticholinergics)

atropine, a medicine used in some

eye drops

levodopa, bromocriptine,

amantadine and other medicines

for the treatment of Parkinson's

disease

anticonvulsants and barbiturates,

used to treat epilepsy or fits

ketamine, an anaesthetic agent

medicines used to treat certain

mental and emotional conditions

(psychoses or schizophrenia)

dantrolene and baclofen, used to

treat leg cramps or to relax

muscles

dextromethorphan, contained in

cough, cold and flu medicines

quinidine and procainamide, used

to treat irregular heart beat

nicotine, contained in patches or

gums or if you smoke

cimetidine and ranitidine, used to

treat stomach ulcers or reflux

urinary alkalinisers, used to treat

urinary tract infection

quinine, a medicine used to treat

malaria

anticoagulant medications such as

warfarin, used to prevent blood

clots.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with memantine.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor 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.

Your doctor will decide what dose

you will receive. This depends on

your condition and other factors,

such as your weight and your

response to the medicine.

Your doctor will start you on smaller

doses which will be gradually

increased for three weeks until the

dose is reached where memantine

works best for you.

Week 1 (5 mg per day):

Take half a 10mg tablet (white).

Week 2 (10 mg per day):

Take one 10mg tablet (white).

Week 3 (15 mg per day):

Take one and a half 10mg tablet

(white).

From week 4 onwards (20 mg per

day):

Take two 10mg tablets (white) or

one 20mg tablet (pale red).

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

When to take it

Swallow the tablets with a full glass

of water. Do not chew them.

It does not matter if you take it

before, with or after food.

How to take it

Taking your medicine at the same

time each day will have the best

effect. It will also help you remember

when to take it.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

APO-MEMANTINE TABLETS

If you are not sure what to do, ask

your doctor or pharmacist.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

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 for 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 dizzy, tired or having

a headache. You may feel confused

and see, feel or hear things that are

not there. You could also have a

seizure.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

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 complaints unless your

doctor or pharmacist tells you to.

Stop taking your medicine, or

lower the dosage, without

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Your doctor will discuss with you

whether your condition allows you to

drive or operate machinery safely.

Furthermore, memantine may change

your reactivity which may make

driving or using machinery

inappropriate.

Alzheimer's disease has been

associated with depression and

thoughts of suicide. All mentions of

suicide or violence by a patient must

be taken seriously.

If you or someone you know

demonstrates suicide-related

behaviour while taking memantine,

contact a health care provider

immediately, or go to the nearest

hospital for treatment.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking memantine or if you have any

concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines may have some unwanted

side effects. Sometimes they are

serious, but most of the time, they are

not.

Tell your doctor if you notice any

of the following:

tiredness, sleeplessness or

problems sleeping

dizziness

diarrhoea, vomiting, or nausea

loss of appetite

feeling anxious

conjunctivitis

inflammation of the liver and/or

changes in liver function tests.

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects.

You may need urgent medical

attention:

swelling of hands, ankles or feet

headache

feeling confused

seeing, feeling or hearing things

that are not there

having fixed, irrational ideas that

are not shared by others

depression or suicidal thoughts.

Other side effects not listed above

may occur in some people.

Allergic reactions

If you think you are having an

allergic reaction to memantine, do

not take any more of this medicine

and 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,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

APO-MEMANTINE TABLETS

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take

them.

If you take the tablets out of their

original packaging they may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°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 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 it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What APO-Memantine looks

like

10 mg tablets:

White, peanut shaped, biconvex film

coated tablet. Engraved "APO" bisect

"APO" on one side, "MEM" bisect

"10" on the other side.

They are packaged in a blister pack

of 56 tablets

Also packaged in blister packs of 14,

30, 50, 100 tablets (not marketed).

Also packaged in bottles of 14, 30,

50, 56 & 1000 tablets (not marketed).

20 mg tablets:

Pale red, oval, biconvex, coated

tablet. Engraved "MEM 20" on one

side, "APO" on the other side.

They are packaged in a blister pack

of 28 tablets

Ingredients

Each tablet contains 10 mg or 20mg

of Memantine Hydrochloride, as the

active ingredient.

The 10mg tablets also contain the

following inactive ingredients:

Lactose

Microcrystalline cellulose

Croscarmellose sodium

Magnesium stearate

Hypromellose

Hydroxypropylcellulose

Macrogol 8000

Titanium dioxide.

The 20mg tablets also contain the

following inactive ingredients:

Microcrystalline cellulose

Croscarmellose sodium

Methylcellulose

Magnesium stearate

Hypromellose

Hydroxypropylcellulose

Macrogol 8000

Titanium dioxide

Euroxide red

Ferric oxide yellow.

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

The 10mg tablets contains lactose.

Australian Registration

Numbers

APO-Memantine

10 mg tablets blister pack:

AUST R 159582.

APO-Memantine

10 mg tablets bottles:

AUST R 159576.

APO-Memantine

20 mg tablets blister pack:

AUST R 207782.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are the registered

trade marks of Apotex Inc.

This leaflet was last updated in:

September 2014

APO-MEMANTINE TABLETS

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EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

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