Maracoxa Film-Coated Tablets

• The active ingredient etoricoxib belongs to a group of medicines called COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory medicines.

• Your doctor has prescribed MARACOXA for one of the following conditions:

• relief of symptoms of osteoarthritis,
• relief of symptoms of rheumatoid arthritis,
• treatment of ankylosing spondylitis,
• short term relief of acute pain, treatment limited to a maximum period of 8 days,
• treatment of moderate to severe acute pain after dental surgery,
• treatment of menstrual pain,
• treatment of acute gout attacks.

Do not take MARACOXA:

• If you are hypersensitive (allergic) to the active substance etoricoxib or any of the other ingredients of MARACOXA.
• If you are allergic to non-steroidal anti-inflammatory medicines, including aspirin and COX-2 inhibitors, such as MARACOXA.
• If you have a stomach ulcer or bleeding in your stomach or intestines.
• If you have a serious liver disease.
• If you have a serious kidney disease.
• If you are pregnant or breastfeeding (see ‘Pregnancy and breastfeeding and fertility’).
• Do not give to children or adolescents under 16 years of age as safety and efficacy have not been established.
• If you have an inflammatory bowel disease.
• If your doctor has diagnosed heart problems including heart failure (moderate or severe), 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 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 having heart bypass.
• If you are taking lithium (a medicine used to treat some types of depression).
• If you are taking digoxin (a medicine for heart failure and irregular heart rhythm).

Warnings and precautions

Take special care with MARACOXA:

MARACOXA may cause serious health conditions such as involving the heart, gastro-intestinal (stomach) or skin reactions which may be fatal.

• If you have a history of stomach bleeding or ulcers.
• If you are dehydrated due to loss of too much water from the body, for example by being sick, diarrhoea or sweating.
• If you have swelling due to fluid retention.
• If you have a history of heart failure or any other form of heart disease.
• If you have a history of high blood pressure. MARACOXA can increase blood pressure in some people, especially in high doses, and your doctor will want to check your blood pressure from time to time.
• If you have any history of liver or kidney disease.
• If you are being treated for an infection, MARACOXA can mask or hide a fever, which is a sign of infection.
• If you are a woman trying to become pregnant.
• If you are elderly (i.e. over 65 years of age).
• If you have diabetes, high cholesterol or are a smoker. These can increase your risk of heart disease.

If you are not sure if any of the above apply to you, talk to your doctor before taking MARACOXA to find out if this medicine is suitable for you.

Do not share medicines prescribed for you with any other person. Always take MARACOXA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

• 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 MARACOXA for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.
• MARACOXA tablets should not be taken by children or adolescents under 16 years of age.
• Take MARACOXA tablets once a daily by mouth.
• MARACOXA can be taken with or without food.
• Your doctor will decide what dose of MARACOXA you should take and how long you should take it.
• If you have the impression that the effect of MARACOXA is too strong or too weak, tell your doctor or pharmacist.

The usual dose is:

For relief of symptoms of osteoarthritis:

- The recommended dose is 60 mg once daily.

For relief of symptoms for rheumatoid arthritis:

- The recommended dose is 90 mg once a day

For the treatment of ankylosing spondylitis:

- The recommended dose is 90 mg once a day.

Acute pain conditions:

- The recommended dose is 90 or 120 mg once daily, limited to a maximum of 8 days treatment.

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, limited to a maximum of 8 days treatment.

For the treatment of menstrual pain:

- The recommended dose is 120 mg once a day which should only be used for the acute painful period.

For relief of pain after dental surgery:

- The recommended dose is 90 mg once daily.

If you take more MARACOXA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you forget to take MARACOXA: Do not take a double dose to make up for forgotten individual doses.

MARACOXA can have side effects: Not all side effects reported for MARACOXA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MARACOXA, please consult your doctor, pharmacist or healthcare professional for advice.

If any of the following happens, stop taking MARACOXA and call your doctor immediately or go to the casualty department at your nearest hospital:

• An allergic reaction - which can include skin problems such as ulcers or blistering, swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing.
• Shortness of breath, chest pains, or ankle swelling appear or if they get worse.
• Codeine/NSAIDs (as contained in MARCOXA) combinations, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MARACOXA. 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:

• Yellowing of the skin and eyes (jaundice) – these are signs of liver disorders.
• Severe or continual stomach pain or your stools become black. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Stomach pain;
• swelling of the legs and/or feet due to fluid retention (oedema);
• dizziness, headache;
• palpitations (fast or irregular heartbeat);
• wheezing or shortness of breath (bronchospasms);
• 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;
• weakness and fatigue, flu-like illness.

The following side effects have been reported less frequently:

• Gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small intestine/stomach flu), upper respiratory infection, urinary tract infection;
• 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);
• irregular heart rhythm (dysrhythmia);
• constipation, appetite increases or decreases, weight gain;
• anxiety, depression, decreases in mental sharpness; confusion; 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;
• cough, breathlessness, nose bleed;
• stomach or bowel bloating, vomiting, 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 disorders;
• 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.

The following side effects have been reported but the frequency is unknown:

• Increased blood pressure;
• irregular heart rhythm (dysrhythmia).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 30 °C. Blisters: Store in the original package in order to protect from moisture and keep in the carton until required for use. Bottles: Keep the container tightly closed in order to protect from moisture. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Do not store in a bathroom. Store all medicines out of reach of children.