Durotram XR (Tramadol HCl) 100mg Tablets (Pack of 10)

PREXIGE(R)

lumiracoxib
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Prexige.

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 final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au. Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking this medicine 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 Prexige is used for

Prexige belongs to a group of medicines called Coxibs. It works by blocking the production of certain substances that cause pain and inflammation.

Prexige is used to treat:

  • osteoarthritis.
  • other painful conditions such as dental pain and pain following surgical operations.
  • period pain (dysmenorrhoea)

    • Although Prexige will relieve the symptoms of pain and inflammation, it will not cure your condition.

    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 purpose.

    There is not enough information to recommend the use of Prexige in children.

    This medicine is only available with a doctor`s prescription. It is not habit-forming.

    Before you take Prexige

    When you must not take it

    Do not take Prexige if you have ever had an allergic reaction after taking:

  • lumiracoxib (the active ingredient in Prexige) or any of the other ingredients listed at the end of this leaflet
  • aspirin
  • any other NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen, naproxen or diclofenac

    • Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are allergic to aspirin or NSAID medicines and you use Prexige, these symptoms may be severe.

    Symptoms of an allergic reaction 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.

    If you are not sure if you are taking any of the above medicines, ask your doctor or pharmacist.

    Do not take Prexige if you have narrowing or a clotting disorder of the blood vessels of the heart or brain, or elsewhere in the body.

    This would include patients with angina, or a history of heart attack or stroke. Prexige should not be used to treat pain in the period before or after bypass surgery of the blood vessels of the heart.

    Do not take Prexige if your doctor has told you that you have severe kidney or liver problems.

    Your doctor will decide if your medical condition is too severe for you to safely take this medicine.

    Do not take Prexige after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

    In that case, return it to your pharmacist.

    Before you start to take it

    Tell your doctor if you have any of the following health problems/medical conditions:

  • heart problems or a history of heart problems or stroke
  • diabetes
  • high cholesterol
  • kidney problems
  • liver problems
  • high blood pressure
  • asthma
  • a past history of gastric/stomach ulcers
  • you are a smoker (which is a risk factor for heart disease).

    • Your doctor may want to take special precautions if you have any of the above conditions.

    Tell your doctor if you are lactose intolerant.

    The 200 mg tablets contain lactose.

    Tell your doctor if you currently have an infection.

    If you use Prexige while you have an infection, some of the signs of the infection such as pain, fever, swelling and redness may be hidden. You may think, mistakenly, that you are better or that the infection is not serious.

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

    Prexige is not recommended for use during pregnancy. Your doctor can discuss with you the risks and benefits involved.

    Tell your doctor if you are breast-feeding a baby. Ask your doctor about the risks and benefits of taking Prexige in this case.

    It is not known if lumiracoxib, the active ingredient of Prexige, passes into the breast milk and could affect your baby.

    Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

    Your doctor will want to know if you are prone to allergies.

    If you have not told your doctor about any of these things, tell him/her before you take Prexige.

    Taking other medicines

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

    Some medicines that are important to mention include:

  • aspirin, salicylates or other NSAID medicines
  • warfarin, a medicine used to stop blood clots
  • medicines used to treat high blood pressure and heart failure e.g. ACE inhibitors
  • lithium, a medicine used to treat some types of depression
  • diuretics, also called fluid or water tablets
  • cyclosporin or tacrolimus

    • Prexige may affect other medicines or they may affect how well Prexige works. You may need to take different amounts of your medicines or you may need to take different medicines.

    Your doctor and pharmacist have a more complete list of medicines to be careful of while taking Prexige.

    How to take Prexige

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

    These instructions may differ from the information contained in this leaflet.

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

    How much to take

    The recommended dose for osteoarthritis is 200 mg once daily.

    The recommended dose for acute pain and period pain is 400 mg once daily.

    When to take it

    Prexige tablets can be taken once a day (morning or night) with or without food.

    How to take it

    Swallow the tablet with a glass of water.

    You can take this medicine with or without food.

    Do not chew or crush the tablets.

    How long to take it

    Your doctor will tell you how long to take this medicine for osteoarthritis.

    Do not take this medication for more than 5 days continuously if you are taking it for acute pain or period pain.

    Prexige helps relieve the symptoms of your condition. It does not cure your condition.

    If you forget to take it

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

    Otherwise, take the dose 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.

    This may increase the chance of side effects.

    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 the Poisons Information Centre (telephone number: 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 taken too much Prexige. Do this even if there are no signs of discomfort or poisoning.

    Keep the telephone numbers for these places handy.

    While you are taking Prexige

    Things you must do

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

    You should not take this medicine while you are pregnant.

    If you get an infection while taking Prexige, tell your doctor.

    This medicine may hide some of the signs of an infection (pain, fever, swelling, redness). You may think, mistakenly, that you are better or that the infection is not serious.

    As your doctor will want to reassess your condition from time to time please make sure to see your doctor at regular intervals.

    If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Prexige.

    Tell any other doctor, dentist or pharmacist who treats you that you are taking Prexige.

    Things you must not do

    Do not take any of the following medicines while you are taking Prexige without first telling your doctor:

  • aspirin
  • other salicylates
  • any other NSAID medicine

    • If you take these medicines together with Prexige, they may cause unwanted side effects.

    If you need to take something for headache or fever, it is usually okay to take paracetamol. If you are not sure, your doctor or pharmacist can advise you.

    Do not stop any other forms of treatment for arthritis that your doctor has told you to follow.

    This medicine does not replace exercise or rest programs or the use of heat/cold treatments.

    Do not use Prexige to treat any other complaints unless your doctor says you can.

    Do not give this medicine to anyone else, even if their condition seems to be similar to yours.

    Things to be careful of

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

    This medicine may cause tiredness, sleepiness or dizziness in some people. If you have these symptoms, do not drive or do anything else that could be dangerous.

    Side effects

    Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Prexige, even if you do not think it is connected with the medicine.

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

    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 these side effects and they worry you:

  • nausea (feeling sick), vomiting
  • diarrhoea, flatulence (wind)
  • stomach pains or indigestion
  • constipation
  • headache
  • dizziness, light headedness
  • depression or feelings of sadness, anxiety
  • trouble sleeping
  • chest or throat infections
  • swelling of hands, ankles or feet
  • drowsiness
  • tingling or numbness of the hands or feet
  • blurry vision and/or difficulty in seeing
  • bloating
  • flu-like symptoms, including fever, aches and pains
  • nosebleeds
  • inflammation of the gums, toothache
  • swollen joints, muscle pain
  • sinus congestion
  • thrush (a yeast infection).

    • Tell your doctor immediately if you get any of the following side effects:

  • signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or troubled breathing
  • palpitations (fast or irregular heart beat)
  • chest pain
  • signs of a possible stomach problem, such as severe pain or tenderness in the stomach, vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea.
  • yellowing of the skin and/or eyes (jaundice) and darkening of urine or pale bowel motions.
  • bruising more than usual
  • signs of anaemia such as tiredness being short of breath and looking pale
  • a change in the colour or amount of urine passed, frequent need to urinate, burning feeling when passing urine, blood in the urine
  • sudden or severe headache, nausea, dizziness, numbness, inability or difficulty in speaking, paralysis of one side of the body which can be signs of a stroke.

    • The above side effects may be serious. You may need urgent medical attention.

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

    Some people may get other side effects of Prexige.

    After using Prexige

    Storage

  • Keep your tablets in the original container until it is time to take them.
  • Store them in a cool dry place (room temperature).
  • Do not store Prexige or any other medicine in the bathroom or near a sink.
  • Do not leave the tablets in the car or on windowsills.

    • Heat and dampness can destroy some medicines. Prexige will keep well if it is cool and dry.

    Keep the tablets where children cannot reach them.

    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 Prexige, 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

    Prexige 200 mg tablets are oval shaped, red in colour with “NVR” inscribed on one side of the tablet and “OC” on the other side, in packs of 30 tablets.

    Prexige 400 mg tablets are oval shaped, red in colour with “NVR” inscribed on one side of the tablet and “OD” on the other side, in packs of 5 tablets.

    Ingredients

    Prexige tablets contain 200 mg or 400 mg of lumiracoxib as the active ingredient.

    The tablets contain the following non active ingredients:

  • microcrystalline cellulose
  • croscarmellose sodium
  • magnesium stearate
  • hypromellose
  • macrogol 4000
  • povidone
  • talc
  • red iron oxide CI 77491
  • black iron oxide CI 77499
  • titanium dioxide

    • The 200 mg tablets also contain the inactive ingredient lactose.

    Sponsor

  • Prexige is supplied in Australia by:
  • NOVARTIS Pharmaceuticals Australia Pty Limited
  • ABN 18 004 244 160
  • 54 Waterloo Road
  • North Ryde NSW 2113
  • Telephone: 1 800 671 203
  • (R) = Registered Trademark
  • This leaflet was prepared in April 2007.
  • Australian Registration Number.
  • Prexige 200 mg tabs AUST R 104279
  • Prexige 400 mg tabs AUST R 104280
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    ENQUIRE

    1800 200 736