Brand Name Choices
What Arcoxia is and what it is used for
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. 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. What is rheumatoid arthritis? Rheumatoid arthritis is a long term inflammatory disease of the joints. It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects. It may also cause inflammation in other areas of the body. What is gout? Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.
How to take Arcoxia
Always take this medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Do not take more than the recommended dose for your condition. 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.
There are different strengths available for this medicinal product and depending on your disease your
doctor will prescribe the tablet strength that is appropriate for you.
The recommended dose is:
The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.
The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.
The recommended dose is 120 mg once a day which should only be used for the acute painful
period, limited to a maximum of 8 days treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3 days treatment.
People with liver problems
• 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 30 mg a day. Use in children and adolescents ARCOXIA tablets should not be taken by children or adolescents under 16 years of age. Elderly No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients. Method of administration ARCOXIA is for oral use. Take the tablets once a day. ARCOXIA can be taken with or without food. If you take more ARCOXIA than you should You should never take more tablets than the doctor recommends. If you do take too many ARCOXIA tablets, you should seek medical attention immediately. If you forget to take ARCOXIA It is important to take ARCOXIA as your doctor has prescribed. If you miss a dose, just resume your usual schedule the following day. Do not take a double dose to make up for the forgotten tablet. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 problems
• 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
• stomach pain
• 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
• weakness and fatigue, flu-like illness
• 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, stomach 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
• 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
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine. Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: [email protected] United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
How to Store Arcoxia
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Bottles: Keep the container tightly closed in order to protect from moisture. Blisters: Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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