Contains the active ingredient baclofen
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about baclofen. 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.
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 using 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- Baclofen Tablets. It contains the active ingredient baclofen.
It is used to treat:
multiple sclerosis
spinal cord damage resulting from disease or physical injury.
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.
How it works
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.
There is no evidence that this medicine is addictive.
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 are hypersensitive to, or have had an allergic reaction to, baclofen 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.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
1.You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
lactose intolerance. This medicine contains a small amount of lactose.
a psychiatric illness
Parkinson's disease
seizures (fits) from any cause
stiffness and restriction of movement in muscle groups
stomach or duodenal ulcers
stroke or other blood vessel disease
heart problems
kidney problems
liver problems
breathing problems or lung problems which make breathing difficult
problems with urination
diabetes
high blood pressure
porphyria, a disorder which can affect the liver and blood formation
alcohol dependence.
3. 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.
4. 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.
5. You are planning to have surgery or an anaesthetic.
6. You are currently receiving or are planning to receive dental treatment.
7. 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 baclofen. These include:
any medicine that tends to make you sleepy, such as medicines used to help you sleep, calm 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. Alcohol will also have this effect.
some medicines used for depression, 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.
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 baclofen.
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.
You would normally start by taking small doses of baclofen in hospital.
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.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
Swallow the tablets with some water.
When to take it
Take the tablets during meals.
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.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and 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.
Your doctor will check your progress to make sure the medicine is working and will discuss with you how long your treatment should continue.
Do not stop taking baclofen suddenly.
This medicine is not habit-forming, but stopping it suddenly may bring on severe spasms and other side effects.
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 you experiencing side effects.
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)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or 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.
If you take too much baclofen you may feel drowsy, have problems breathing or lose consciousness.
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).
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 condition unless your doctor tells you to.
Stop taking your medicine, or change the dosage, without first 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 or operating machinery until you know how this medicine affects you.
This medicine may cause sleepiness, dizziness, lightheadedness 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 than usual.
Possible side effects
Tell your doctor as soon as possible if you do not feel well while you are taking baclofen or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
daytime sleepiness or drowsiness
lack of energy, feeling exhausted
dizziness or light-headedness
spinning sensation (vertigo)
headache
difficulty sleeping or nightmares
nausea (feeling sick), retching or vomiting
constipation, stomach cramps or diarrhoea
loss of appetite
stuffy or blocked nose
dry mouth
change in sense of taste
mild rash or mildly itchy skin
ringing in the ears
frequent urination or bed wetting
excessive sweating
erection problems or inability to ejaculate
weight gain.
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
mental confusion
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.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects and you may need urgent medical attention or hospitalisation:
slow or difficult breathing
fast or irregular heart beat
fainting or loss of consciousness
seizures (fits)
chest pain
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 discontinuation of the medicine (such as spasms).
Other side effects not listed above may occur in some patients.
Allergic reactions
If you think you are having an allergic reaction to baclofen, 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.
Storage and disposal
Storage
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 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 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 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-Baclofen looks like
Baclofen 10 mg tablets:
White, oval, flat-faced, bevel-edged tablets scored and engraved "APOB10" on one side.
Baclofen 25 mg tablets:
White, round, flat-faced, bevel-edged tablets, scored on one side.
* Not all strengths, pack types and/or pack sizes may be available.
Ingredients
Each tablet contains 10 mg or 25 mg of baclofen as the active ingredient.
It also contains the following inactive ingredients:
lactose
maize starch
microcrystalline cellulose
magnesium stearate.
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
