Chemmart Gemfibrozil 600mg Tablets (Bottle of 60)

AUSCAP(R)

Fluoxetine capsules

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about AUSCAP. 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 AUSCAP 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 AUSCAP is used for

The name of your medicine is AUSCAP. It contains the active ingredient fluoxetine.

AUSCAP is used to treat depression. It belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).

Depression is longer lasting and/or more severe than the “low moods” everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing.

AUSCAP corrects this chemical imbalance and may help relieve the symptoms of depression.

It is also used to treat obsessive compulsive disorder (OCD). The symptoms of OCD vary from patient to patient. Check with your doctor if you need more information.

Your doctor, however, may prescribe AUSCAP for another purpose. Ask your doctor if you have any questions about why AUSCAP has been prescribed for you.

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

AUSCAP is not recommended for use in children and adolescents under 18 years of age.

Before you take AUSCAP

When you must not take it

Do not take AUSCAP if:

  • 1.you have an allergy to AUSCAP or any of the ingredients listed at the end of this leaflet
  • Some of the symptoms of an allergic reaction to AUSCAP may include asthma, shortness of breath, wheezing, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, hives, itching or skin rash or fainting.

  • 2.you are taking another anti-depressant medicine called a monoamine oxidase inhibitor (MAOI) or have been taking it within the last 14 days.
  • Taking AUSCAP with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.

    Ask your doctor or pharmacist if you are not sure if you have been taking one of these medicines.

  • 3.you are pregnant.
  • Medicines like AUSCAP may harm the developing baby.

  • 4.you are breast-feeding.
  • Like many other medicines, AUSCAP can pass into breastmilk and may harm your baby.

    Do not take AUSCAP if the packaging is torn or shows signs of tampering, or the capsules do not look quite right.

    Do not take AUSCAP if the expiry date (EXP) printed on the pack has passed.

    If you take this medicine after the expiry date has passed, it may not work as well.

    If you are not sure whether you should start taking AUSCAP, contact your doctor.

    Before you start to take it

    You must tell your doctor if:

  • 1.you are allergic to any other medicines, especially if they are in the same class as fluoxetine.
  • 2.you are allergic to any other medicines, foods, dyes or preservatives
  • 3.you have or have had any other health problems or medical conditions, including:
  • kidney problems
  • liver problems
  • diabetes
  • epileptic fits
  • a bleeding disorder or tendency to bleed more than usual
  • 4.you are pregnant or intend to become pregnant.
  • Your doctor will discuss the risks and benefits of using AUSCAP when pregnant.

  • 5.you are breastfeeding or wish to breastfeed.
  • Your doctor will discuss the risks and benefits of using AUSCAP when breastfeeding.

  • 6.you have a history of mania and/or bipolar disorder (manic/depressive illness).
  • Taking other medicines

    Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop, including alcohol.

    Some medicines may interfere with AUSCAP. These include:

  • Other medicines used to treat depression (eg. Monoamine oxidase inhibitors) or OCD
  • You should stop taking monoamine oxidase inhibitors or other medicines used to treat depression at least 2 weeks before starting AUSCAP.

    Do not take any monoamine oxidase inhibitors for at least 5 weeks after you have stopped AUSCAP.

    Do not start taking any other medicines for depression without first checking with your doctor. Do this even if you have already stopped taking AUSCAP.

  • Sleeping tablets or sedatives
  • Medicines for anxiety
  • Antipsychotics, medicines for certain mental or emotional conditions
  • Medicines used to prevent blot clots (eg. warfarin)
  • Anticonvulsants, medicines used to control fits
  • Lithium, a medicine used to treat certain mood disorders
  • Flecainide, a medicine used to treat irregular heart beat
  • Medicines used to relieve pain, such as tramadol
  • Sumatriptan, a medicine used to treat migraine
  • Tryptophan
  • St John`s Wort (Hypericum perforatum)
  • These medicines may be affected by AUSCAP 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.

    Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when taking AUSCAP with other medicines.

    Your doctor or pharmacist may have more information on medicines to avoid while taking AUSCAP.

    If you are 65 years or older, you should be especially careful while taking AUSCAP. Report any side effects promptly to your doctor.

    As people grow older, they are more likely to get side effects from medicines.

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

    How to take AUSCAP

    Follow all directions given to you by your doctor and pharmacist carefully.

    They may differ from the information contained in this leaflet.

    How much to take

    The recommended starting dose is one capsule (20 mg) each day, in the morning. The maximum daily dose should not exceed four capsules (80 mg). Your doctor will tell you how many capsules you will need to take each day. The dose will depend on how you respond to AUSCAP, your condition and whether you are taking any other medicines.

    How to take it

    Swallow AUSCAP with a glass of water.

    When to take it

    AUSCAP can be taken with or without food.

    How long to take it

    Most antidepressants take time to work, so do not be discouraged if you do not feel better straight away. It may take up to 4 weeks to feel the full benefit of AUSCAP. You may need to take AUSCAP for several months or longer. Continue taking it until your doctor tells you to stop.

    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, then go back to taking it as you would normally.

    Do not double a dose to make up for the dose you have missed.

    If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

    If you take too much (overdose)

    Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital if you think you or anyone else may have taken too much AUSCAP, even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy.

    If you take too much AUSCAP, you may feel sick, agitated, restless or excited or may vomit.

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

  • While you are taking AUSCAP

    Things you must do

    Tell your doctor immediately if you become pregnant while taking AUSCAP.

    If you are about to be started on any new medicines, tell your doctor or pharmacist that you are taking AUSCAP.

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

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

    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 capsules are not helping your condition.

    If you are being treated for depression, be sure to discuss with your doctor any problems you may have and how you feel, especially any feelings of severe sadness or bursts of unusual energy or anger.

    This will help your doctor to determine the best treatment for you.

    Tell your doctor immediately if you have any suicidal thoughts or other mental or mood changes.

    All thoughts or talk of suicide must be taken seriously. If you, or someone you know, has any of the following warning signs of suicide related behaviour while taking AUSCAP, then it is important to contact a health care provided right away or go to the nearest hospital for treatment

  • thoughts or talk of death or suicide
  • thoughts or talk of self-harm or harm to others
  • any recent attempts of self harm
  • increase in aggressive behaviour, irritability or agitation.
  • Be sure to keep all of your appointments with your doctor so that your progress can be checked.

    Your doctor may want to take some blood tests and check your heart and blood pressure from time to time. This helps prevent unwanted side effects.

    Things you must not do

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

    Your doctor may want you to gradually reduce the dose of AUSCAP you are using before stopping completely. This may help reduce the possibility of any withdrawal symptoms occurring.

    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 or if they have the same condition as you.

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

    Things to be careful of

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

    AUSCAP may cause drowsiness, dizziness or sleepiness in some people and affect alertness.

    Make sure you know how you react to AUSCAP before you drive or operate machinery.

    Although drinking moderate amounts of alcohol is unlikely to affect your response to AUSCAP, 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 AUSCAP.

    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 any questions you may have.

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

  • anxiety, nervousness and difficulty in sleeping
  • drowsiness and fatigue
  • tremor and sweating
  • loss of appetite and change in sense of taste
  • weight loss
  • nausea, vomiting or diarrhoea vomiting
  • dry mouth
  • chills
  • excessive sweating
  • irregular heart beat
  • dizziness and light-headedness
  • impaired sexual function
  • more frequent urination
  • changes in vision
  • These are the more common side effects of AUSCAP. Mostly, these are mild and short-lived.

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

  • muscle spasms
  • tremors
  • twitches
  • fits and seizures
  • rash
  • fast, irregular heart beat
  • abnormal bleeding or bruising
  • sudden switches of mood to one of overactivity and uninhibited behaviour.
  • These may be serious side effects of AUSCAP. You may need urgent medical attention. Serious side effects are rare.

    These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

    If any of the following happen, stop taking AUSCAP and tell your doctor immediately or go to casualty at your nearest hospital:

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • These are very serious side effects. You may need urgent medical attention or hospitalisation. This side effect is very rare.

    Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

    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 AUSCAP

    Do not take a monoamine oxidase inhibitor within 5 weeks of stopping AUSCAP.

    Storage

    Keep your capsules in their container until it is time to take them.

    If you take the capsules out of their container they may not keep well.

    Keep AUSCAP in a cool, dry place where it stays below 25 degrees Celcius. 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 this medicine where young 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 AUSCAP, or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules left over.

    Product description

    What it looks like

    AUSCAP 20 mg capsules are light green and ivory capsules. They are available in blisters of 28 capsules.

    Ingredients

    Active ingredient:

    Each AUSCAP capsule contains 20 mg fluoxetine (as fluoxetine hydrochloride).

    Inactive ingredients:

  • lactose
  • cellulose – microcrystalline
  • magnesium stearate
  • silica – colloidal anhydrous
  • gelatin
  • titanium dioxide CI77891
  • iron oxide yellow CI77492
  • quinoline yellow CI47005
  • indigo carmine CI73015
  • AUSCAP does not contain sucrose, gluten, tartrazine or any other azo dyes.

    Sponsor

  • Sigma Pharmaceuticals Pty Ltd
  • (A.C.N. 004 118 594)
  • 1408 Centre Road
  • Clayton VIC 3136 Australia
  • Tel: 03 – 9839 2800
  • Australian Registration Number :
  • AUST R 106775
  • This leaflet was prepared in January 1999 and updated in June 2000, June 2002, May 2004, October 2004, January 2005 and May 2005
  • ENQUIRE

    1800 200 736