Adco Etoricoxib 30 mg Film-Coated Tablets

The active substance is: Etoricoxib 30 mg/ 60mg/ 90 mg or 120 mg. ADCO ETORICOXIB 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). ADCO ETORICOXIB is used to help reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. It is also used for the short-term treatment of moderate pain including cramp-like pain or discomfort before or during a menstrual period, and pain associated with minor dental procedures.

Do not take ADCO ETORICOXIB • If you are hypersensitive (allergic) to etoricoxib or any of the other ingredients of ADCO ETORICOXIB (see section 6 ). • If you have taken aspirin or other anti-inflammatory medicine (commonly known as NSAIDs) before, which caused asthma, itchy swellings on the skin (hives), runny nose, or other allergic reactions. • If you have a current stomach ulcer or bleeding in your stomach or intestines. • If you have had gastro-intestinal ( stomach or duodenal) ulcers. • If you have had bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces) after you have taken other NSAIDs. • If you have serious liver disease. • If you have serious kidney disease or kidney failure. • If you are or could be pregnant or are breastfeeding (see section 2 ). • If you are under 16 years of age. • If you have inflammatory bowel disease. • If your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries), or any kind of stroke (including mini-stroke, transient ischaemic attack or TIA). Etoricoxib may slightly increase your risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke. • If you have had or are having major surgery on your heart or arteries. • If you have high blood pressure that has not been controlled by treatment (check with your doctor or nurse if you are not sure whether your blood pressure is adequately controlled). • If you are currently using digoxin (medicines used to treat heart failure) or lithium (medicines used to treat mental disorders). • If you are using medications containing sulphonamides (antibiotics used to treat bacterial infection).

Do not share medicines prescribed for you with any other person. Always take ADCO ETORICOXIB exactly as your doctor, or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is: Osteoarthritis : The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, the dose may be increased to 60 mg once daily. Rheumatoid arthritis : The recommended dose is 90 mg once daily. Ankylosing spondylitis : The recommended dose is 90 mg once daily. Gout : The recommended dose is 120 mg once daily limited to a maximum of 8 days treatment. Acute pain conditions : The recommended dose is 90 mg or 120 mg once daily limited to a maximum of 8 days treatment. Menstrual pain : The recommended dose is 120 mg once daily. Post-operative dental surgery pain : The recommended dose is 90 mg once daily. Take ADCO ETORICOXIB tablets by mouth once a day. ADCO ETORICOXIB can be taken with or without food. Your doctor will tell you how long your treatment with ADCO ETORICOXIB will last. If you have the impression that the effect of ADCO ETORICOXIB is too strong or too weak, tell your doctor or pharmacist. Your doctor will decide on your dosages depending on your condition. If you take more ADCO ETORICOXIB than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you forget to take a dose of ADCO ETORICOXIB Do not take a double dose to make up for forgotten individual doses. It is important to take ADCO ETORICOXIB as your doctor has prescribed. If you miss a dose, resume your usual schedule the following day.

ADCO ETORICOXIB can have side effects. Not all side effects reported for ADCO ETORICOXIB are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ADCO ETORICOXIB, please consult your healthcare provider for advice. If any of the following happens, stop taking ADCO ETORICOXIB and tell your doctor immediately or go to the casualty department at your nearest hospital: • An allergic reaction, including skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing or swallowing. • Shortness of breath, chest pains, or ankle swelling appear or if they get worse (which may be a symptom of heart failure). • Vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools), or bloody diarrhoea – these may be symptoms of bleeding stomach ulcers which may occur at any time during use and without warning. • Fast or irregular heartbeats, also called palpitations (dysrhythmia). • Rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome). • Fever, skin rash, swelling of the lymph nodes and/or swelling of the face (also known as DRESS). These are all very serious side effects. If you have them, you may have had a serious reaction to ADCO ETORICOXIB. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: • Skin rash or itchiness. • Pinkish, itchy swellings on the skin, also called hives or nettle rash. • Redness of the skin. • Severe stomach pain. • Passing little or no urine. • Yellowing of the skin and/or eyes, also called jaundice. • A feeling of pain, tightness, pressure or heaviness in the chest (angina), heart attack. • Increased tendency to bleed/bruise, or tendency to bleed for a longer period of time – these may be symptoms of reduced platelets in your body. • Severe pain and swelling following a dental extraction, “dry socket”. These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Frequent side effects: • Swelling of the legs and/or feet due to fluid retention (oedema). • Dizziness, headache. • 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. • Bleeding in the digestive tract ( melaena or haematemesis). • Mouth ulcers with sore breaks in the skin (ulcerative stomatitis). • Lower gut disorders (inflammatory bowel disease or Crohn’s disease) . • Weakness and fatigue, flu-like illness. Less frequent side effects: • Gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small intestine/ stomach flu), upper respiratory infection, urinary tract infection. • 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). • Flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of the blood vessels. • 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. • Muscle cramp/spasm, muscle pain/stiffness. • Confusion, restlessness. • Changes in certain components of your blood. • Formation of fluid-filled blisters or sacs. Side effects of an unknown frequency: • Cardiovascular effects such as high blood pressure and heart failure. • Low blood counts (thrombocytopenia). • Hypersensitivity reactions such as rapid swelling of the face (angioedema) or severe allergic reactions. • Confusion, hallucinations. • Mood changes (depression). • Restlessness, sleeplessness. • Loss of taste sensation, blurred vision. • Heart failure, changes in heart rhythm and blood pressure. • Difficulty breathing (bronchospasm). • Stomach pain, vomiting, diarrhoea. • Bleeding of the gastrointestinal tract. • Mouth ulcers. • Liver failure or yellowing of the skin (jaundice). • Kidney failure or dysfunction. • Skin reactions such as itching, rash, severe skin peeling and blistering. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA”s publications: https://www.sahpra.org.za/Publications/Index/8 . By reporting side effects, you can help provide more information on the safety of ADCO ETORICOXIB.

Store all medicines out of reach of children. Store at or below 25 ºC. Store in the original package. Do not use after the expiry date stated on the carton and blister. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).