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What is ARCOXIA?

  • ARCOXIA contains the active substance etoricoxib. ARCOXIA is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).


What is ARCOXIA used for?

  • ARCOXIA helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.

  • ARCOXIA is also used for the short-term treatment of moderate pain after dental surgery in people 16 years of age and older.

How to take Arcoxia

Note: Arcoxia has not been approved by the FDA for the U.S. market.

Take Arcoxia only when prescribed by your doctor.

For osteoarthritis, the recommended dose is 60 mg once a day.

For rheumatoid arthritis the recommended dose is 90 mg once a day.

For ankylosing spondylitis the recommended dose is 90 mg once a day.

For the relief of gout attacks the recommended dose is 120 mg once a day, which should only be used for the acute painful period.

For the relief of chronic musculoskeletal pain the recommended dose is 60 mg once a day.

Doses greater than those recommended for each condition have either not demonstrated additional efficacy or have not been studied. Therefore, the daily doses stated above for each condition should not be exceeded.

If you have mild liver disease, you should not take more than 60 mg a day. If you have moderate liver disease, you should not take more than 60 mg every other day.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help. Arcoxia comes as tablets.

When taking the tablets, swallow them with a glass of water. Do not halve the tablet.

Take your Arcoxia at about the same time each day.

Taking Arcoxia at the same time each day will have the best effect. It will also help you remember when to take the dose.

It does not matter if you take Arcoxia before or after food.

Do not use Arcoxia for longer than your doctor says.

Your doctor will want to discuss your treatment from time to time. It is important that you use the lowest dose that controls your pain and you should not take Arcoxia for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.

Depending on your condition, you may need to take Arcoxia for a few days or for a longer period.

For osteoarthritis and rheumatoid arthritis Arcoxia helps relieve your symptoms but it does not cure it. Continue taking Arcoxia for as long as your doctor prescribes.

For the relief of gout attacks or other types of pain, Arcoxia is usually only needed for a few days.

If you are not sure how long to take Arcoxia, talk to your doctor.

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 tablet(s) as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

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

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

If you take too much Arcoxia (overdose) immediately telephone your doctor or Poison Control Center or go to the emergency department at your nearest hospital, if you think that you or anyone else may have taken too much Arcoxia. Do this even if there are no signs of discomfort or poisoning.

While you are using Arcoxia

Note: Arcoxia has not been approved by the FDA for the U.S. market.

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

If you get an infection while taking Arcoxia, tell your doctor. Arcoxia may hide fever and may make you think, mistakenly, that you are better or that your infection is less serious than it might be.

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

Do not give Arcoxia to anyone else, even if they have the same condition as you.

Some self help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.

  • Exercise - regular exercise can help reduce pain and disability from osteoarthritis by increasing muscle strength and reducing the load on joints, but it is important not to overdo it. Walking is good exercise, however, before starting any exercise, ask your doctor about the best kind of programme for you.

  • Weight - your doctor may suggest losing some weight to help reduce the strain on your joints. Some people may need a dietician's help to lose weight.

  • Hot and cold treatments.

  • Using support devices.

Adverse Effects

Note: Arcoxia has not been approved by the FDA for the U.S. market.

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

Arcoxia helps most people with osteoarthritis, rheumatoid arthritis, menstrual pain, gout or other types of pain, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

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

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

  • feeling sick (nausea), vomiting

  • heartburn, indigestion, uncomfortable feeling or pain in the stomach

  • diarrhoea

  • swelling of the legs, ankles or feet

  • high blood pressure

  • dizziness

  • headache

Additionally, the following have been reported:

  • allergic reactions including rash, itching and hives

  • severe skin reactions, which may occur without warning

  • taste alteration

  • wheezing

  • insomnia

  • anxiety

  • drowsiness

  • mouth ulcers

  • diarrhoea

  • severe increase in blood pressure

  • confusion

  • hallucinations

  • platelets decreased

These are usually the mild adverse effects of Arcoxia.

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

  • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing (hypersensitivity reactions, anaphylactic/anaphylactoid reactions including shock)

  • abnormal rhythm of the heart (atrial fibrillation)

  • heart failure

  • palpitations

  • serious kidney problems

  • serious liver problems

  • stomach pain

  • stomach ulcers that may become serious and may bleed, and may occur at any time during use and without warning

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

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

Arcoxia

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