Arcoxia

What is Arcoxia?

  • Arcoxia contains the active substance etoricoxib. Arcoxia is one of a groupof medicines called selective COX-2 inhibitors. These belong to a family ofmedicines 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.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It results from the gradual breakdown

of cartilage that cushions the ends of the bones. This causes swelling

(inflammation), pain, tenderness, stiffness and disability.

Arcoxia works equally well in older and younger adult patients. If you are

over 65 years of age, your doctor will want to appropriately keep a check on

you. No dosage adjustment is necessary for patients over 65 years of age.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age.

Other medicines and Arcoxia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking Arcoxia:

  • medicines that thin your blood (anticoagulants), such as warfarin
  • rifampicin (an antibiotic)
  • methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis)
  • ciclosporin or tacrolimus (drugs used for suppressing the immune

system)

  • lithium (a medicine used to treat some types of depression)
  • medicines used to help control high blood pressure and heart failure called

Possible side effects

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

If you develop any of these signs you should stop Arcoxia and talk to your doctor immediately (see What you need to know before you take Arcoxia section 2):

  • shortness of breath, chest pains, or ankle swelling appear or if they get worse;
  • yellowing of the skin and eyes (jaundice) – these are signs of liver;
  • severe or continual stomach pain or your stools become black;
  • an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing.

The frequency of possible side effects listed below is defined using the

following convention:

  • Very common (affects more than 1 user in 10);
  • Common (affects 1 to 10 users in 100);
  • Uncommon (affects 1 to 10 users in 1,000);
  • Rare (affects 1 to 10 users in 10,000);
  • Very rare (affects less than 1 user in 10,000).

The following side effects can occur during treatment with Arcoxia:

Very Common:
  • stomach pain

Common:

  • dry socket (inflammation and pain after a tooth extraction)
  • swelling of the legs and/or feet due to fluid retention (oedema)
  • dizziness, headache
  • palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
  • increased blood pressure
  • wheezing or shortness of breath (bronchospasms)
  • constipation, wind (excessive gas), gastritis (inflammation of the lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, being sick (vomiting), inflammation of the oesophagus, mouth ulcers
  • changes in blood tests related to your liver
  • bruising
  • weakness and fatigue, flu-like illness
Uncommon:
  • gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small intestine/stomach flu), upper respiratory infection, urinary tract infection
  • changes in laboratory values (decreased number of red blood cells, decreased number of white blood cells, platelets decreased)
  • hypersensitivity (an allergic reaction including hives which may be serious enough to require immediate medical attention)
  • appetite increases or decreases, weight gain
  • anxiety, depression, decreases in mental sharpness; seeing, feeling or hearing things that are not there (hallucinations)
  • taste alteration, inability to sleep, numbness or tingling, sleepiness
  • blurred vision, eye irritation and redness
  • ringing in the ears, vertigo (sensation of spinning while remaining still)
  • abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
  • flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of the blood vessels
  • cough, breathlessness, nose bleed
  • stomach or bowel bloating, changes in your bowel habits, dry mouth, tomach ulcer, inflammation of the stomach lining that can become serious and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
  • swelling of the face, skin rash or itchy skin, redness of the skin
  • muscle cramp/spasm, muscle pain/stiffness
  • high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, serious kidney problems
  • chest pain
Rare:
  • angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing, which may be serious enough to require immediate medical attention)/ anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction that requires immediate medical attention)
  • confusion, restlessness
  • liver problems (hepatitis)
  • low blood levels of sodium
  • liver failure, yellowing of the skin and/or eyes (jaundice)
  • severe skin reactions