APO-Memantine

What APO-Memantine 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.

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.

Your doctor, however, may prescribe this medicine for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

This medicine is only available with a doctor's prescription.

Memantine is not addictive.

Use in children

This medicine is not recommended for use in children.

Before you take APO-Memantine

When you must not take it

Do not take this medicine if you 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 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.

Do not take this medicine if you have a seizure disorder or any history of seizures (fits or epilepsy).

Do not take this medicine after the expiry date (EXP) printed on the pack.

If you take this medicine after the expiry date has passed, it may not work as well.

Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor:

1. if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

2. if you are pregnant or intend to become pregnant.

Memantine is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of using it if you are pregnant.

3. if you are breast-feeding or planning to breast-feed.

It is not known whether Memantine passes into breast milk. Due to the possibility that their baby might be affected, women taking Memantine should not breast-feed.

4. if you have, or have had, the following medical conditions:

  • a history of epileptic seizures
  • or convulsions
  • kidney problems
  • severe bladder infection
  • liver problems
  • heart or blood vessel problems
  • high blood pressure.

5. if you smoke.

Also tell your doctor if you have recently changed your diet or intend to change your diet substantially, for example if you wish to become a vegetarian.

Your doctor may need to adjust the dose.

If you are lactose intolerant, contact your doctor before taking this medicine.

This medicine contains lactose.

Do not give Memantine to a child or adolescent under 18 years old.

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Memantine may interfere with each other. 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.

These medicines may be affected by Memantine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking this medicine.

Other interactions not listed above may also occur.

How to take APO-Memantine

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 Memantine works best for you.

  • Week 1 (5 mg per day):

Take half a tablet once a day.

  • Week 2 (10 mg per day):

Take half a tablet twice a day.

  • Week 3 (15 mg per day):

Take one tablet in the morning and half a tablet in the evening.

  • From week 4 onwards (20 mg per day):

Take one tablet in the morning and one tablet in the evening.

Your doctor may have prescribed a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, this medicine may not work as well and your condition may not improve.

How to take it

Take this medicine with or without food.

Swallow the tablets whole with a full glass of water.

Do not chew them.

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.

This medicine helps control your condition but does not cure it. Your doctor will assess your treatment on a regular basis.

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.

Do not take a double dose to make up for the dose that you 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 your medicine as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much of this medicine.

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 APO-Memantine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking Memantine, tell your doctor immediately.

Tell your doctor immediately if you 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 Memantine, contact a health care provider immediately, or even go to the nearest hospital for treatment.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not take your medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop taking your medicine, or lower the dosage, without checking with your doctor.

Things to be careful of

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, Memantine may change your reactivity which may make driving or using machinery inappropriate.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are not.

Your doctor has weighed the risks of using this medicine against the benefits he/she expects it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Memantine.

It helps most people with moderately severe to severe Alzheimer's disease, but it may have unwanted side effects in a few people.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • tiredness, sleepiness, sleeplessness, or problems sleeping
  • dizziness
  • diarrhoea, vomiting, or nausea
  • loss of appetite
  • feeling anxious
  • conjunctivitis.

These are mild side effects of the medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • 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.

These may be serious side effects of Memantine. You may need urgent medical attention.

If you are an epileptic, Memantine could increase the chance of a fit occurring.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following:

  • serious allergic reaction (symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, or hives).

This is a very serious side effect. You may need urgent medical attention or hospitalisation.

This side effect is very rare.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some people.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking APO-Memantine

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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Return any unused medicine to your pharmacist.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

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).

Ingredients

Each tablet contains 10 mg of Memantine Hydrochloride, as the active ingredient.

The tablets also contain the following inactive ingredients:

  • Lactose
  • Microcrystalline Cellulose
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Hypromellose
  • Hydroxypropylcellulose
  • Macrogol 8000
  • Titanium Dioxide.

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

This medicine contains lactose.

Australian Registration Numbers

APO-Memantine

10 mg tablets blister pack:

AUST R 159582.

APO-Memantine

10 mg tablets bottles:

AUST R 159576.