contains the active ingredient, baclofen
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about . It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
What Terry White Chemists Baclofen is used for
The name of your medicine is Terry White Chemists Baclofen. It contains the active ingredient, baclofen.
It is used to control muscle spasms in conditions such as:
multiple sclerosis
spinal cord damage resulting from disease or physical injury
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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
There is no known evidence to show that this medicine is addictive.
Use in children
These tablets should not be given to children under 33 kg in weight. Information about baclofen use in children under 16
years is very limited.
Before you take Terry White Chemists Baclofen
When you must not take it
Do not take this medicine if you 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: shortness of breath, wheezing or difficulty breathing; swelling of the face,
lips, tongue, throat or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the
skin.
Do not take this medicine after the expiry date (EXP) printed on the pack.
If you take it after the expiry date has passed, it may not work as well.
Do not take this medicine if the packaging is torn or 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 if:
1.
You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.
You have lactose intolerance.
This medicine contains a small amount of lactose.
3.
You are pregnant or plan to become pregnant or are breast feeding, or wish to breast feed.
There is very little information on the use of this medicine in pregnancy or during breastfeeding. Your doctor can discuss
with you the possible risks and benefits of taking baclofen during pregnancy or breastfeeding.
4.
You have or have had any medical conditions, especially the following:
a psychiatric illness
seizures (fits) from any cause
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.
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 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 baclofen may interfere with each other. These include:
any medicine that tends to make you sleepy, such as medicines used to help you sleep or calm you down, pain relievers, 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 selegiline and levodopa +carbidopa
medicines used to treat diabetes
diazepam, used for sedation and muscle relaxation
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 to take different amounts of your medicine, 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 baclofen.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions from your doctor or pharmacist carefully.
They may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how many tablets you will need to take. This depends on your condition and whether or not 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 unwanted side effects.
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 it at about the same times each day.
Taking your medicine at the same times each day will have the best effect. It will also help you remember when to take it.
How long to take it for
Keep 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 unwanted side effects. If
your doctor wants you to stop using it, they will reduce the dose gradually over 1 to 2 weeks to avoid unwanted effects.
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.
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 the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
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 some hints.
If you take too much (overdose)
Immediately telephone your doctor or pharmacist 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 baclofen.
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 any other doctors, dentists, and pharmacists who are treating you that you are taking baclofen.
If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking baclofen.
Tell your doctor immediately if you become pregnant.
Your doctor can discuss with you the benefits and risks of taking baclofen while pregnant.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Tell your doctor if your muscle spasms come back.
Your doctor may be able to change the dose of baclofen to make it work better for you.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take this medicine to treat any other complaints unless your doctor tells you to.
Do not stop taking baclofen suddenly, or change the dosage, without checking with your doctor.
This medicine is not habit-forming, but stopping it suddenly may bring on severe spasms and other unwanted side effects. If
your doctor wants you to stop using it, they will reduce the dose gradually over 1 to 2 weeks so that unwanted effects are
avoided.
Things to be careful of
Be careful driving, operating machinery or doing things that need you to be alert while you are taking baclofen until you
know how it 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.
Side effects
All medicines can have side effects. Sometimes they are serious, most of the time they are not. Your doctor has weighed the
risks of using this medicine against the benefits they expect it will have for you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking baclofen.
Side effects such as sleepiness or drowsiness are usually short-lived and occur mainly at the start of treatment with baclofen
or if the dose is too high or is increased too quickly. They can often be relieved by lowering the dose.
As people grow older, they are more likely to get side effects from medicines. If you are over 65 years of age, you should
be especially careful while taking this medicine. Report any side effects promptly to your doctor.
Ask your doctor or pharmacist to answer any questions you may have.
Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
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:
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
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happens:
signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body;
shortness of breath or wheezing
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
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are usually
very rare.
Other side effects not listed above may occur in some patients.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After taking this medicine
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 stays 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.
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 Terry White Chemists Baclofen looks like
Terry White Chemists Baclofen 10 mg tablets:
White, oval, flat-faced, bevel-edged tablets, scored and engraved "APOB10" on one side.
100 tablets per bottle.
Terry White Chemists Baclofen 25 mg tablets:
White, round, flat-faced, bevel-edged tablets, scored on one side.
100 tablets per bottle.
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.
Australian Registration Numbers
Terry White Chemists Baclofen 10 mg tablets:
AUST R 77571
Terry White Chemists Baclofen 25 mg tablets:
AUST R 77570
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Terry White Chemists is a registered trade mark of Symbion Pty Ltd.
This leaflet was prepared in:
June 2012.