Aurorix Moclobemide 300mg Tablets (Pack of 60)

AURORIX(R)

Moclobemide
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about AURORIX tablets.

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 AURORIX tablets 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 AURORIX is used for

    The name of your medicine is AURORIX. It contains the active ingredient called moclobemide.

    AURORIX belongs to a group of medicines called antidepressants. Antidepressants are used to treat depression and work on the central nervous system. They are thought to work by their action on brain chemicals called amines, which are involved in controlling mood.

    There are many different types of medicines used to treat depression. AURORIX belongs to a group of medicines called reversible inhibitors of monoamine oxidase A (RIMA).

    Your doctor, however, may have prescribed AURORIX for another purpose.

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

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

  • Before you take AURORIX

    Do not take AURORIX if:

  • you have ever had an allergic reaction to AURORIX or any of the ingredients listed in the Ingredients section of this leaflet
  • you are suffering from severe confusion
  • you are taking clomipramine (Anafranil) or selegiline (Eldepryl)

    • Taking AURORIX with the above medicines may cause a serious reaction called serotonin syndrome. This can cause a sudden increase in body temperature, high blood pressure and convulsions.

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

    It may have no effect at all or, worse, an entirely unexpected effect if you take it after the expiry date.

    Do not take AURORIX if the packaging is torn or shows signs of tampering or if the tablets appear damaged in some way.

    If you are not sure if you should be taking AURORIX, talk to your doctor.

    You must tell your doctor if:

  • 1.you are allergic to any other medicines, foods, dyes or preservatives
  • 2.you have any other health problems including:
  • liver disease
  • high blood pressure
  • mental illness other than depression
  • thyrotoxicosis (a condition of excessive thyroid hormones)
  • phaeochromocytoma (a rare tumour of adrenal gland)
  • 3.you are pregnant or intend to become pregnant
  • 4.you are breastfeeding or wish to breastfeed

    • Your doctor will discuss the risks and benefits of using AURORIX when pregnant and while breastfeeding.

  • Taking other medicines

    Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood shop.

    Some commonly used medicines that may interfere with AURORIX are

  • cimetidine (Tagamet)
  • dextromethorphan
  • pethidine
  • serotonin agonists (eg buspirone, sumatriptan)

    • Other antidepressant medicines may interfere with AURORIX such as fluoxetine, paroxetine, sertraline, amitryptyline and nortriptyline.

    Moclobemide may cause an additional drop in blood pressure if you are taking metoprolol.

    Your doctor or pharmacist has a complete list of medicines to avoid while taking AURORIX.

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

    How to take AURORIX

    Use AURORIX exactly as your doctor has prescribed.

    How much to take

    Your doctor will tell you how many AURORIX tablets to take each day.

    The usual dose is between 300 mg and 600 mg per day. The tablets are taken twice daily after meals.

    How to take it

    Tablets should be swallowed whole with a glass of water.

    You should follow your doctor`s instructions carefully if changing from one antidepressant to another and report any unexpected effects if they occur.

    When to take it

    AURORIX should be taken morning and evening at the end of your meal.

    How long to take AURORIX

    For depression, the length of treatment will depend on how quickly your symptoms improve. Most antidepressants take time to work so don`t be discouraged if you don`t feel better right away. Some of your symptoms may improve in 1 or 2 weeks but it can take up to 4 or 6 weeks to feel any real improvement. Even when you feel well, you will usually have to take AURORIX for several months or even longer to make sure the benefits will last. Continue taking it until your doctor tells you to stop.

    If you forget to take AURORIX

    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 then go back to taking it as soon as you would normally.
    Do not double a dose to make up for one you have missed.

    In case of an overdose

    Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have too much AURORIX, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

    Keep telephone numbers for these places handy.

    Some signs and symptoms of overdose include nausea, vomiting, drowsiness, slurred speech, reduced reflexes and agitation.

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

    While you are taking AURORIX

    Things you must do

    Tell all doctors, dentists and pharmacists who are treating you that you are taking AURORIX.

    Do not take any other medicines whether they require a prescription or not without first telling your doctor.

    Tell your doctor if you become pregnant while taking AURORIX.

    Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

    Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

    Tell your doctor if you feel the tablets are not helping your condition.

    If you are being treated for depression, tell your doctor immediately if you feel your condition has worsened or if you are experiencing suicidal thoughts.

    Be sure to discuss with your doctor any problems you may have and how you feel. This will help your doctor to determine the best treatment for you.

    Be sure to keep all of your appointments with your doctor so that your progress can be checked.

    Things you must not do

    Do not stop taking AURORIX or lower the dose without first checking with your doctor.

    Do not let yourself run out of medicine over the weekend or on holidays.

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

    Do not use AURORIX to treat other complaints unless your doctor says to.

    Things to be careful of

    Be careful driving or operating machinery until you know how AURORIX affects you.

    AURORIX causes dizziness in some people at first.

    Although drinking alcohol is unlikely to affect your response to AURORIX, your doctor may suggest avoiding alcohol while you are being treated for depression.

    Side Effects

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

    AURORIX helps most people with depression but it may have unwanted side effects in a few people. 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.

    Ask your doctor or pharmacist to answer any questions you may have.

    In the first week or two you may experience:

  • Sleep disturbances, dizziness, nausea, headache.

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

  • Insomnia, disturbed sleep, restlessness, dizziness, nausea, headache, anxiety, feeling of confusion, diarrhoea, constipation, feeling of fullness, upset stomach, dry mouth, blurred vision, skin rash, flushing

    • This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

    Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

    Ask your doctor or pharmacist if you don`t understand anything in this list.

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

    After taking AURORIX

    Storage

    Keep AURORIX where young children cannot reach it.

    A locked cupboard at least one-and-half metres above the ground is a good place to store medicines.

    Keep AURORIX in a cool dry place where it stays below 30 degrees C. Do not store it, or any other medicine, in a bathroom or near a sink.
    Do not leave it in the car or on window sills.

    Heat and dampness can destroy some medicines.

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

    If you take the tablets out of the blister, they may not keep well.

    Disposal

    If your doctor tells you to stop taking AURORIX, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

  • Product Description

    What AURORIX looks like

    AURORIX comes in two strengths of tablets.

    AURORIX 150 mg are light yellow scored tablets

    AURORIX 300 mg tablets are white scored tablets.

    Ingredients

    Active ingredient – moclobemide

  • each 150 mg AURORIX tablet contains 150 mg of the active ingredient moclobemide
  • each 300 mg AURORIX tablet contains 300 mg of the active ingredient moclobemide

    • Inactive ingredients –

  • both 150 mg and 300 mg tablets contain lactose, corn starch, povidone (1201), sodium starch glycollate, magnesium stearate (470), ethyl cellulose, macrogol 6000, hypromellose (464), talc (553), and are coloured with titanium dioxide (171). 150 mg tablets also contain yellow iron oxide CI 77492 (172).

    • AURORIX tablets are gluten free.

    Both strengths of AURORIX come in boxes of 10 and 60 tablets.

    Manufacturer

    AURORIX is distributed by:

  • Roche Australia Pty Limited
  • ACN 000 132 865
  • 4 – 10 Inman Road
  • Dee Why NSW 2099
  • Customer enquiries: 1 800 233 950
  • Please check with your pharmacist for the latest Consumer Medicine Information.
  • Australian Registration Number:
  • AURORIX 150 mg – AUST R 9987
  • AURORIX 300 mg – AUST R 51626
  • This leaflet was prepared 23 December 2004
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