All medicines have risks and benefits. Your doctor has weighed the risks of you taking ARCOXIA against the benefits they expect it will have for you.

ARCOXIA is used for the following:

• acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA)

• relief of chronic musculoskeletal pain
• relief of acute pain
• to treat acute gouty arthritis

ARCOXIA reduces pain and inflammation by blocking COX-2, an enzyme in the body.

ARCOXIA does not block COX-1, the enzyme involved in protecting the stomach from ulcers.

ARCOXIA relieves pain and inflammation with less risk of stomach ulcers compared to NSAIDS.

In clinical studies, the risk of developing ulcers on ARCOXIA was lower than with NSAIDs. Some people developed ulcers whether they were taking ARCOXIA or placebo in these studies; however the rate was higher on ARCOXIA.

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

ARCOXIA is not addictive.

Special precautions

Do not take ARCOXIA if:

• you have an allergy to ARCOXIA or any of the ingredients listed at the end of this leaflet

• the packaging is torn or shows signs of tampering
• The expiry date on the pack has passed.
• If you take this medicine after the expiry date has passed, it may not work.
• you are pregnant or intend to become pregnant

ARCOXIA is not recommended for use during late pregnancy. If there is a need to consider using ARCOXIA during your pregnancy, your doctor will discuss with you the benefits and risks of using it.

• you are breast-feeding or plan to breast-feed

It is not known if ARCOXIA passes into breast milk. You and your doctor should discuss whether you should stop breast-feeding or not take ARCOXIA.

• you have or have had any medical conditions, especially the following: history of angina, heart attack or a blocked artery in your heart, kidney disease, liver disease, heart failure, high blood pressure

• you have had an allergic reaction to aspirin or other anti-inflammatory medicines (commonly known as NSAIDs)
• Symptoms of an allergic reaction may include asthma, pinkish itchy swellings on the skin (hives), runny or blocked nose.
• you have an infection
• If you take ARCOXIA while you have an infection, it may hide fever and may make you think, mistakenly, that you are better or that your infection is less serious than it might be.
• You have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
• Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Side effects

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

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,
• diarrhea
• 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
• taste alteration
• wheezing
• insomnia
• anxiety
• drowsiness
• mouth ulcers

These are usually the mild adverse effects of ARCOXIA.

• swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing

• heart failure
• serious kidney problems
• serious liver problems
• stomach pain
• stomach ulcers that may become serious and may bleed

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

Keep all appointments with your doctor.

Don’t let anyone else take your medicines.