2. What should I know before I take Ebixa?
Do not use if you have ever had an allergic reaction to Ebixa or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions (such as epileptic seizures,
heart attack, heart failure, high blood pressure, kidney problems, severe bladder
infection, severe liver problems and if you smoke), take any other medicines, or are
pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Ebixa and affect how it works.
4. How do I take Ebixa?
Take Ebixa as a single dose either in the morning or in the evening.
Swallow the tablets with water, with or without food.
5. What should I know while taking Ebixa?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking Ebixa.
Tell your doctor if you become pregnant while taking Ebixa, are breastfeeding, or
are experiencing serious side effects such as feeling depressed or have any suicidal
thoughts.
|
|
Things you should not do
|
Do not stop taking Ebixa, or lower the dosage, without checking with your doctor.
|
|
Driving or using machines
|
If you drive a motor vehicle or operate machinery, ask your doctor whether you should
continue to do so.
|
|
Looking after your medicine
|
Store Ebixa below 30°C and keep the tablets in the blister pack until it is time to
take them.
|
6. Are there any side effects?
Common side effects include headache, drug hypersensitivity, increased blood pressure,
constipation, shortness of breath, tiredness, sleepiness, sleeplessness, or problems
sleeping, dizziness or feeling off balance, feeling anxious, diarrhoea, vomiting,
or nausea, loss of appetite, changes in liver function tests, conjunctivitis. Serious
side effects include serious allergic reaction; swelling of the 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. For epileptic patients,
Ebixa could increase the chance of a fit occurring.
Active ingredient(s): memantine hydrochloride (meh-MAN-teen high-dro-CLOR-ride)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking Ebixa. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Ebixa.
Where to find information in this leaflet:
1. Why am I taking Ebixa?
Ebixa contains the active ingredient memantine hydrochloride. Ebixa 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.
Ebixa 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.
Ebixa should improve your thinking capacity and your ability to remember.
Ask your doctor if you have any questions about why it has been prescribed for you.
Ebixa is not addictive.
2. What should I know before I take Ebixa?
Warnings
Do not use Ebixa if:
you are allergic or hypersensitive to memantine hydrochloride, or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing, swelling of the face, lips, tongue or other parts of the body, or rash,
itching or hives on the skin.
you have a seizure disorder or any history of seizures (fits or epilepsy).
Check with your doctor if you:
have allergies to any other substances such as foods, preservatives or dyes
have, or have had, any other medical conditions including the following:
a history of epileptic seizures or convulsions
kidney problems
severe bladder infection
severe liver problems
heart or blood vessel problems
high blood pressure
smoke
take any medicines for any other condition
Also tell your doctor if you have recently changed your diet, intend to change your
diet substantially or have had drastic changes in diet, or massive ingestions of gastric
buffers, for example if you wish to become a vegetarian.
Your doctor may need to adjust the dose.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Ebixa is not recommended to be used during pregnancy. Your doctor will discuss the
risks and benefits of using it if you are pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether Ebixa passes into breast milk. Due to the possibility that
their baby might be affected, women taking Ebixa should not breast-feed.
Children and adolescents
Do not give Ebixa to a child or adolescent under 18 years old.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Ebixa and affect how it works. 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 to treat smoking addiction
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
warfarin, used to prevent blood clots
hydrochlorothiazide (or any combination with hydrochlorothiazide) used to treat hypertension
and oedema
4. How do I take Ebixa?
How much to take
The standard dose for this medicine is 20 mg per day.
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 Ebixa works best for you.
Week 1 (5 mg per day)
Take half a 10 mg tablet (pale yellow to yellow).
Week 2 (10 mg per day)
Take one 10 mg tablet (pale yellow to yellow).
Week 3 (15 mg per day)
Take one and a half 10 mg tablets (pale yellow to yellow).
From week 4 onwards (20 mg per day)
Take two 10 mg tablets (pale yellow to yellow) or one 20 mg tablet (pink to grey-red).
Follow the instructions provided and take Ebixa until your doctor tells you to stop.
Dosage in patients with impaired kidney function
If you have impaired kidney function, your doctor will decide upon a dose that suits
your condition. In this case, monitoring of your kidney function should be performed
by your doctor at specified intervals.
When to take Ebixa
Take Ebixa as a single dose at the same time every day.
Take Ebixa with or without food.
How to take Ebixa
Swallow the tablets with water..
How long should you take Ebixa
Continue taking your medicine for as long as your doctor tells you to.
Ebixa helps control your condition. Your doctor will assess your treatment on a regular
basis.
If you forget to take Ebixa
Ebixa should be taken regularly at the same time each day.
If you miss your dose at the usual time, and it is almost time for your next dose,
skip the dose you missed and take the next dose when you are meant to.
Do not take a double dose to make up for the dose you have missed.
If there is still a long time to go before your next dose, take it as soon as you
remember, and then go back to taking it as you would normally.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
hints.
If you take too much Ebixa
If you think that you have taken too much Ebixa, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre in Australia
(by calling
13 11 26, or the National Poisons Centre in New Zealand (by calling 0800 POISON or 0800 764 766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
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.
5. What should I know while taking Ebixa?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are taking Ebixa.
Call your doctor straight away if you:
become pregnant while taking Ebixa
are feeling depressed or have any suicidal thoughts.
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 Ebixa,
contact a health care provider immediately, or even go to the nearest hospital for
treatment.
Things you should not do
Do not stop taking Ebixa, or lower the dosage, without checking with your doctor.
Do not give the tablets to anyone else, even if they have the same condition as you.
Do not take Ebixa to treat any other complaints unless your doctor tells you to.
Driving or using machines
If you drive a motor vehicle or operate machinery, ask your doctor whether you should
continue to do so.
Your doctor will discuss with you whether your condition allows you to drive or operate
machinery safely. Furthermore, Ebixa may change your reactivity which may make driving
or using machinery inappropriate.
Looking after your medicine
Store Ebixa below 30°C and keep the tablets in the blister pack until it is time to
take them.
If you take the tablets out of the box or the blister pack they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date or if the packaging is torn or shows
signs of tampering.
If you take it after the expiry date has passed, it may not work as well. The expiry
date refers to the last day of the month.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Ebixa.
It helps most people with moderately severe to severe Alzheimer's disease, but it
may have unwanted side effects in a few people.
Less serious side effects
Serious side effects
Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems for Australia, and to consumer reporting at
https://pophealth.my.site.com/carmreportnz/s/ for New Zealand. By reporting side effects, you can help provide more information
on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Ebixa contains
|
Active ingredient
(main ingredient)
|
Ebixa 10 mg tablets
10 mg memantine hydrochloride (equivalent to 8.31 mg memantine) per tablet
Ebixa 20 mg tablets
20 mg memantine hydrochloride (equivalent to 16.62 mg memantine) per tablet
|
|
Other ingredients
(inactive ingredients)
|
Ebixa 10 mg tablets
microcrystalline cellulose
croscarmellose sodium
hypromellose
iron oxide yellow
macrogol 400
magnesium stearate
colloidal anhydrous silica
titanium dioxide
Ebixa 20 mg tablets
microcrystalline cellulose
croscarmellose sodium
hypromellose
iron oxide red
iron oxide yellow
macrogol 400
magnesium stearate
colloidal anhydrous silica
titanium dioxide
|
|
Potential allergens
|
Ebixa 10 mg and 20mg tablets do not contain gluten, lactose, sucrose, tartrazine or
any other azo dyes.
|
Do not take this medicine if you are allergic to any of these ingredients.
What Ebixa looks like
Ebixa 10 mg film-coated tablets - oval, pale yellow to yellow, embossed with 'M' on
both sides of the break line; on the other side, '1' and '0' left and right of the
break line (AUST R 180400).
Ebixa 20 mg film-coated tablets - oval, pink to grey-red, embossed with '20' on one
side and 'MEM' on the other side (AUST R 156299).
A box contains 56 tablets (Ebixa 10 mg) or 28 tablets (Ebixa 20 mg), respectively.
Note: Ebixa 20 mg tablets are not registered for supply in NZ.
Who distributes Ebixa
Distributed in Australia by:
Lundbeck Australia Pty Ltd
1 Innovation Road
North Ryde NSW 2113
Ph: +61 2 8669 1000
Distributed in New Zealand by:
Healthcare Logistics
PO Box 62027
Mt Wellington, Auckland
Ph: +64 9 918 5100
This leaflet was prepared in November 2025
"Ebixa" is the registered trademark of H. Lundbeck A/S.