Chemmart Baclofen 25mg Tablets (Pack of 100)

Chem mart(R) BACLOFEN

Baclofen Tablets
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Chem mart Baclofen.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking baclofen 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 Chem mart Baclofen is used for

Baclofen belongs to a group of medicines called muscle relaxants. This medicine is used to reduce excess tension in your muscles which causes spasms. These spasms happen in various illnesses such as multiple sclerosis and diseases or injuries of the spinal cord.

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.

Your doctor may have prescribed baclofen for another reason. Ask your doctor if you have any questions about why baclofen has been prescribed for you.

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

Before you take Chem mart Baclofen

When you must not take it

Do not take baclofen if you have an allergy to baclofen or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction to baclofen 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 baclofen 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 as it should.

    Do not take baclofen if the packaging is torn or shows signs of tampering or if the tablets do not look quite right.

    If you are not sure whether you should start taking baclofen, talk to your doctor.

    Before you start to take it

    Tell your doctor or pharmacist if you have allergies to:

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

    • Tell your doctor if you are pregnant or intend to become pregnant.

    There is very little information on the use of this medicine in pregnancy. Your doctor can discuss with you the possible risks and benefits of using baclofen during pregnancy.

    Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.

    There is very little information on the use of this medicine while breast-feeding. Your doctor can discuss with you the possible risks and benefits of using baclofen during breast-feeding.

    Tell your doctor if you have or have had any medical conditions, especially the following:

  • a psychiatric illness
  • epilepsy (seizures)
  • stomach ulcers
  • stroke or other blood vessel disease
  • heart disease
  • kidney disease
  • liver disease
  • breathing problems or lung disease
  • problems with urination
  • diabetes
  • high blood pressure
  • porphyria, a rare disturbance in the production of porphyrin, a pigment important for liver function and blood formation
  • alcoholism

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

    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 and medicines for colds or allergies
  • medicines used to treat depression, including tricyclic antidepressants, lithium and monoamine oxidase inhibitors (MAOIs)
  • medicines for high blood pressure
  • medicines used to treat Parkinson`s disease
  • medicines used for psychiatric illness
  • medicines used to treat diabetes

    • You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

    Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking baclofen.

    How to take Chem mart Baclofen

    Carefully follow all directions given to you by your doctor.

  • These directions may differ from the information contained in this leaflet.

    • How much to take

    Your doctor will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

    Treatment is usually 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 unwanted side effects.

    If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

    How to take it

    Take the tablets during meals with a glass of water.

    When to take it

    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.

    If you forget to take it

    If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

    Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

    Do not take a double dose to make up for the one that you missed.

    If you double a dose, 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.

    How long to take it

    Continue taking baclofen for as long as your doctor recommends.

    Your doctor will check your progress to make sure the medicine is working and will discuss with you how long your treatment should continue.

    Make sure that you keep enough baclofen to last over weekends and holidays.

    If you take too much (overdose)

    Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your 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.

    Some of the symptoms of an overdose may include drowsiness, confusion, unusual muscle weakness, blurred vision, vomiting, diarrhoea, excessive saliva, breathing problems, slow heart beat, fainting or fits (seizures).

  • While you are taking Chem mart Baclofen

    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, tell your doctor, dentist or pharmacist that you are taking baclofen.

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

    Your doctor can discuss with you the risks of taking it while pregnant.

    To help prevent unwanted side effects from occurring, your doctor may want to do some tests from time to time during the course of your treatment. Be sure to keep all your doctors appointments so that your progress can be checked.

    If your muscle spasms come back, tell your doctor. Your doctor may be able to change the dose of baclofen to make it work better for you.

    Things you must not do

    Do not give baclofen to anyone else, even if their symptoms seem similar to yours or they have the same condition as you.

    Do not take baclofen to treat any other complaints unless your doctor tells you to.

    Do not stop taking baclofen suddenly.

    This medicine is not addictive, but stopping it suddenly may bring on unwanted side effects. When baclofen is stopped, your doctor will reduce the dose gradually so that unwanted side effects are avoided.

    Things to be careful of

    Be careful driving, operating machinery or doing jobs that require you to be alert while you are taking baclofen until you know how it affects you.

    This medicine may cause sleepiness 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 and less alert than usual.

    Side effects

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

    All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

    Side effects occur mainly at the start of treatment with baclofen or if the dose is too high or is increased too rapidly. 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.

    Do not be alarmed by this list of possible side effects.
    You may not experience any of them.

    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, feeling exhausted
  • dizziness or light-headedness
  • spinning sensation (vertigo)
  • mental confusion
  • 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
  • numbness or tingling in hands and feet
  • muscle weakness, spasms or pain
  • problems with coordination and balance
  • difficulty in speaking
  • swelling of ankles due to fluid build-up
  • blurred or double vision
  • ringing in the ears
  • frequent urination or bed wetting
  • excessive sweating
  • impotence or inability to ejaculate
  • weight gain

    • Tell your doctor immediately if you notice any of the following:

  • 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
  • seizures (fits)
  • chest pain
  • depression or other mood changes
  • hallucinations (imagined sensations)
  • being unable to urinate or pain when urinating; blood in the urine
  • uncontrollable eye movements

    • These may be serious side effects and may need urgent medical attention.

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

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

    After using Chem mart Baclofen

    Storage

    Keep your tablets in the bottle until it is time to take them.

    If you take the tablets out of the bottle they will not keep well.

    Keep your tablets in a cool dry place where the temperature stays below 25 degrees C.

    Do not store baclofen or any other medicine in the bathroom or near a sink.

    Do not leave it in the car or on windowsills.

    Light 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 baclofen or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

    Product description

    What it looks like

    Chem mart Baclofen 10 mg tablets are white, oval, flat-faced, bevel-edged tablets, scored and engraved “APOB10” on one side. 100 tablets per bottle.

    Chem mart Baclofen 25 mg tablets are white, round, flat-faced, bevel-edged tablets, scored on one side. 100 tablets per bottle.

    Ingredients

    Chem mart Baclofen tablets contain baclofen as the active ingredient. Chem mart Baclofen tablets are available in two strengths:

  • Chem mart 10mg Baclofen
  • Chem mart 25mg Baclofen

    • Other ingredients

  • lactose,
  • maize starch,
  • microcrystalline cellulose and
  • magnesium stearate.

    • Chem mart Baclofen does not contain sucrose, gluten, tartrazine or any other azo dyes.

    Sponsor

  • GenRx Pty Ltd
  • ABN: 52 096 916 148
  • Level 21, 390 St Kilda Road
  • Melbourne, Victoria 3004
  • Australia

    • Distributor

  • Chem mart Pty Limited
  • ABN: 92 001 235 374
  • 115 Sherriff Street
  • Underdale
  • South Australia 5032
  • Chem mart is a registered trade mark of FH Faulding & Co Limited

  • ARTG No:

  • Chem mart Baclofen 10 mg AUST R 77573
  • Chem mart Baclofen 25 mg AUST R 77572
  • Date of leaflet preparation: February 2004
    •

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