Contains the active ingredient baclofen
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about this medicine. It does not contain
all the available information. It does not take the place of talking to your doctor
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.
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 this medicine is used for
The name of your medicine is APO- Baclofen Tablets. It contains the active ingredient
It is used to treat:
spinal cord damage resulting from disease or physical injury
Baclofen belongs to a group of medicines called muscle relaxants. It is used to reduce
excess tension in your muscles which causes spasms.
Because this medicine reduces spasms and the pain that goes with them, it helps to
make you more mobile. This helps you to manage your daily activities more easily.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed it for another reason.
There is no evidence that this medicine is addictive.
This medicine is available only with a doctor's prescription.
Use in children
Baclofen should be used with extreme caution in children under 16 years of age as
only limited information is available. Baclofen should not be used in children who
weigh less than 33 kg.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
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.
Do not take this medicine if you are currently pregnant or you plan to become pregnant.
Do not take this medicine until you and your doctor have discussed the risks and benefits
If you must take baclofen during pregnancy, your baby may have convulsions and other
symptoms related to sudden discontinuation of the medicine just after delivery.
Do not take this medicine if you are currently breastfeeding or you plan to breastfeed.
Baclofen may pass into breast milk and there is a possibility that your baby may be
Do not take this medicine until you and your doctor have discussed the risks and benefits
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
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.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
lactose intolerance – this medicine contains a small amount of lactose
any mental/psychiatric illness
seizures (fits) from any cause
stiffness and restriction of movement in a group of muscles
stomach or duodenal ulcers
stroke or other blood vessel diseases
lung problems which make breathing difficult
high blood pressure
porphyria, a disorder which can affect liver function and blood formation
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
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 get without a prescription from your pharmacy, supermarket or health food
Some medicines may interact with baclofen. These include:
any medicine that tends to make you sleepy, such as medicines used to help you sleep
or calm you down (e.g. diazepam), relax muscles (e.g. tizanidine), pain relievers
(e.g. morphine), travel sickness medicines and medicines for colds or allergies -
these may add to the sedative effect of baclofen
medicines used to treat mood disorders such as tricyclic antidepressants, lithium
and monoamine oxidase inhibitors (MAOIs)
medicines for high blood pressure
medicines used to treat Parkinson's disease, including levodopa and carbidopa
medicines used to treat diabetes
medicines which may affect the way your kidney works
These medicines may be affected by baclofen 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 have more information on medicines to be careful with or
avoid while taking this medicine.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist
How much to take
This will depend on your condition and whether you are taking any other medicines.
Treatment is normally started in hospital with small doses of baclofen.
The dose is then gradually increased to an amount that works best for you.
For example, baclofen may be started at a dose of 15 mg a day, then increased slowly
to anywhere from 30 to 75 mg a day. Sometimes, doses up to 100 mg a day may be needed.
If you are under the age of 16 or over 65, or you have kidney disease, your doctor
may start you on a lower dose and increase it more gradually to prevent side effects.
How to take it
Swallow the tablets during meals with some water.
This will lessen the chance of a stomach upset.
Baclofen is usually taken in at least three divided doses throughout the day. But
your doctor may tell you to take it more or less often, depending on your situation.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Your doctor will check your progress to make sure the medicine is working and will
discuss with you how long your treatment should continue.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your
next dose when you are meant to.
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 you experiencing side effects.
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 to help you remember.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice or go to Accident and Emergency 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 include feeling drowsy, having problems breathing or losing
You may also feel confused, hallucinate (imagine things that are not there), have
unusual muscle weakness, blurred vision, feel sick (nausea), be sick (vomit), faint,
have diarrhoea, increased saliva, slow or irregular heartbeat, or fits (seizures).
If you have kidney disease and have accidentally taken more tablets than your doctor
has prescribed, you may experience neurological symptoms of overdose (e.g. drowsiness,
feeling confused, hallucinations)
While you are taking this medicine
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
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
It may affect other medicines used during surgery.
If you become pregnant or start to breastfeed while taking this medicine, tell your
If you are about to have any blood tests, tell your doctor that you are taking this
It may interfere with the results of some tests.
Keep all your doctor's appointments so that your progress can be checked.
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.
Things you must not do
Do not take this medicine to treat any other complaints unless your doctor tells you
Do not give your medicine to anyone else, even if they have the same condition as
Do not stop taking your medicine or lower the dosage without checking with your doctor.
This medicine is not habit-forming but stopping it suddenly may bring on severe spasms
and other side effects.
Things to be careful of
Be careful when driving, operating machinery or doing jobs that require you to be
alert until you know how this medicine affects you.
Baclofen may cause sleepiness, dizziness, light-headedness and decreased alertness
in some people, especially at the start of treatment.
Be careful when drinking alcohol while you are taking baclofen.
The combination may make you feel more sleepy, dizzy or lightheaded and less alert
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking this medicine.
All medicines can have side effects. Sometimes they are serious but most of the time
they are not.
Do not be alarmed by the following lists of side effects. You may not experience any
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:
daytime sleepiness or drowsiness
lack of energy or feeling exhausted
dizziness or light-headedness
spinning sensation (vertigo)
difficulty sleeping or nightmares
nausea (feeling sick), retching or vomiting
constipation, stomach cramps or diarrhoea
loss of appetite
stuffy or blocked nose
change in sense of taste
mild rash or mildly itchy skin
ringing in the ears
frequent urination or bed wetting
erection problems or inability to ejaculate
Tell your doctor as soon as possible if you notice any of the following:
numbness or tingling in hands and feet
muscle weakness, spasms or pain
swelling of ankles due to fluid build-up
blurred or double vision
problems with coordination, balance and movement
difficulty in speaking
increased blood sugar
low body temperature.
These may be serious side effects and you may need medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
slow or difficult breathing
fast or irregular heart beat
fainting or loss of consciousness
uncontrollable muscle spasms affecting the eyes, head, neck or body
depression or other severe mood or mental changes
hallucinations (feeling, hearing or seeing things that are not there)
being unable to urinate or pain when urinating; blood in the urine
symptoms following sudden discontinuation of the medicine (such as spasms).
The above list includes very serious side effects. You may need urgent medical attention
Other side effects not listed above may occur in some patients.
Storage and disposal
Keep your medicine 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 medicine in a cool dry place where the temperature stays below 25°C.
Do not store this 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.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
What APO-Baclofen looks like
Baclofen 10 mg tablets:
White, oval, flat-faced, bevel-edged tablets scored and engraved "APOB10" on one side.
AUST R 77577.
Baclofen 25 mg tablets:
White, round, flat-faced, bevel-edged tablets, scored on one side. AUST R 77576.
Bottle packs of 100 tablets.
* Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 10 mg or 25 mg of baclofen as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was last updated in July 2019.