Package leaflet: Information for the user Rheumatoid arthritis • high levels of potassium in your blood, The recommended dose is 60 mg once a day, changes in blood or urine tests relating to increased to a maximum of 90 mg once a day if your kidney, serious kidney problems Etoricoxib 30 mg film-coated tablets needed. • chest pain Etoricoxib 60 mg film-coated tablets Ankylosing spondylitis Rare The recommended dose is 60 mg once a day, • angioedema (an allergic reaction with swelling Etoricoxib 90 mg film-coated tablets increased to a maximum of 90 mg once a day if of the face, lips, tongue and/or throat which Etoricoxib 120 mg film-coated tablets needed. may cause difficulty in breathing or Acute pain conditions swallowing, which may be serious enough to Etoricoxib Etoricoxib should be used only for the acute require immediate medical attention)/ painful period. anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction Read all of this leaflet carefully before you Gout that requires immediate medical attention) start taking this medicine because it contains The recommended dose is 120 mg once a day • confusion, restlessness important information for you. which should only be used for the acute painful • liver problems (hepatitis) • Keep this leaflet. You may need to read it period, limited to a maximum of 8 days treatment. again. • You are a woman trying to become pregnant. • low blood levels of sodium • If you have any further questions, ask your • You are over 65 years of age. Postoperative dental surgery pain • liver failure, yellowing of the skin and/or eyes (jaundice) doctor or pharmacist. If you are not sure if any of the above apply to The recommended dose is 90 mg once daily, • severe skin reactions • This medicine has been prescribed for you you, talk to your doctor before taking limited to a maximum of 3 days treatment. only. Do not pass it on to others. It may harm Etoricoxib to see if this medicine is suitable for People with liver problems Reporting of side effects them, even if their signs of illness are the you. • If you have mild liver disease, you should not If you get any side effects, talk to your doctor or same as yours. Etoricoxib works equally well in older and take more than 60 mg a day. pharmacist. This includes any possible side • If you get any side effects, talk to your doctor younger adult patients. If you are over 65 years of • If you have moderate liver disease, you effects not listed in this leaflet. You can also or pharmacist. This includes any possible side age, your doctor will want to appropriately keep a should not take more than 30 mg a day. report side effects directly via the national effects not listed in this leaflet. See section 4. check on you. No dosage adjustment is reporting system listed in Yellow Card Scheme, necessary for patients over 65 years of age. Use in children and adolescents Website: www.mhra.gov.uk/yellowcard or search What is in this leaflet Etoricoxib tablets should not be taken by children 1. What Etoricoxib is and what it is used for for MHRA Yellow Card in the Google Play or Children and adolescents or adolescents under 16 years of age. Apple App Store. By reporting side effects, you 2. What you need to know before you take Do not give this medicine to children and can help Etoricoxib adolescents under 16 years of age. Elderly No dose adjustment is necessary for elderly 3. How to take Etoricoxib provide more information on the safety of this 4. Possible side effects Other medicines and Etoricoxib patients. As with other medicines, caution should Tell your doctor or pharmacist if you are taking, medicine. 5. How to store Etoricoxib be exercised in elderly patients. have recently taken or might take any other 6. Contents of the pack and other information 5. How to store Etoricoxib medicines, including medicines obtained without Method of administration Etoricoxib is for oral use. Take the tablets once a 1. What Etoricoxib is and what it is used for a prescription. Keep this medicine out of the sight and reach of day. Etoricoxib can be taken with or without food. children. What is Etoricoxib? In particular if you are taking any of the following medicines, your doctor may want to monitor you If you take more Etoricoxib than you should Do not use this medicine after the expiry date • Etoricoxib contains the active substance You should never take more tablets than the etoricoxib. Etoricoxib is one of a group of to check that your medicines are working which is stated on the carton after EXP. The properly, once you start taking Etoricoxib: doctor recommends. If you do take too many expiry date refers to the last day of that month. medicines called selective COX-2 inhibitors. Etoricoxib tablets, you should seek medical These belong to a family of medicines called • medicines that thin your blood attention immediately. Store in the original package in order to protect non-steroidal anti-inflammatory drugs (anticoagulants), such as warfarin from moisture. If you forget to take Etoricoxib (NSAIDs). • rifampicin (an antibiotic) Do not throw away any medicines via wastewater What is Etoricoxib used for? • methotrexate (a drug used for suppressing It is important to take Etoricoxib as your doctor or household waste. Ask your pharmacist how to • Etoricoxib helps to reduce the pain and the immune system, and often used in has prescribed. If you miss a dose, just resume throw away medicines you no longer use. These swelling (inflammation) in the joints and rheumatoid arthritis) your usual schedule the following day. Do not measures will help protect the environment. muscles of people 16 years of age and older • ciclosporin or tacrolimus (drugs used for take a double dose to make up for the forgotten with osteoarthritis, rheumatoid arthritis, suppressing the immune system) tablet. 6. Contents of the pack and other ankylosing spondylitis and gout. • lithium (a medicine used to treat some types If you have any further questions on the use of information • Etoricoxib is also used for the short-term of depression) this medicine, ask your doctor or pharmacist. • medicines used to help control high blood What Etoricoxib contains treatment of moderate pain after dental • The active substance etoricoxib. surgery in people 16 years of age and older. pressure and heart failure called ACE 4. Possible side effects inhibitors and angiotensin receptor blockers, Each film-coated tablet contains 30 mg What is osteoarthritis? examples include enalapril and ramipril, and Like all medicines, this medicine can cause side etoricoxib. Osteoarthritis is a disease of the joints. It results losartan and valsartan effects, although not everybody gets them. Each film-coated tablet contains 60 mg from the gradual breakdown of cartilage that • diuretics (water tablets) If you develop any of these signs you should etoricoxib. cushions the ends of the bones. This causes • digoxin (a medicine for heart failure and stop Etoricoxib and talk to your doctor Each film-coated tablet contains 90 mg swelling (inflammation), pain, tenderness, irregular heart rhythm) immediately (see What you need to know etoricoxib. stiffness and disability. • minoxidil (a drug used to treat high blood before you take Etoricoxib section 2): Each film-coated tablet contains 120 mg pressure) • shortness of breath, chest pains, or ankle etoricoxib. What is rheumatoid arthritis? swelling appear or if they get worse Rheumatoid arthritis is a long term inflammatory • salbutamol tablets or oral solution (a medicine • The other ingredients are for asthma) • yellowing of the skin and eyes (jaundice) – Tablet Core: Microcrystalline Cellulose disease of the joints. It causes pain, stiffness, these are signs of liver problems swelling, and increasing loss of movement in the • birth control pills (the combination may (E460), Calcium Hydrogen Phosphate, increase your risk of side effects) • severe or continual stomach pain or your Croscarmellose Sodium, Magnesium Stearate joints it affects. It may also cause inflammation in stools become black other areas of the body. • hormone replacement therapy (the (E470b). combination may increase your risk of side • an allergic reaction- which can include skin Tablet coating: Polyvinyl Alcohol (E1203), What is gout? effects) problems such as ulcers or blistering, or Titanium Dioxide (E171), Glycerol Gout is a disease of sudden, recurring attacks of • aspirin, the risk of stomach ulcers is greater if swelling of the face, lips, tongue, or throat Monostearate (E471), Indigo Carmine very painful inflammation and redness in the you take Etoricoxib with aspirin. which may cause difficulty in breathing Aluminum Lake (E132) [only for 30 mg, 60 mg joints. It is caused by deposits of mineral crystals - aspirin for prevention of heart attacks or The frequency of possible side effects listed & 120 mg], Yellow Iron Oxide (E172) [only for in the joint. stroke: below is defined using the following convention: 30 mg, 60 mg & 120 mg], Talc (E553b), What is ankylosing spondylitis? Etoricoxib can be taken with low-dose Very common (affects more than 1 user in 10) Sodium Laurilsulfate. Ankylosing spondylitis is an inflammatory disease aspirin. If you are currently taking Common (affects 1 to 10 users in 100) What Etoricoxib looks like and contents of the of the spine and large joints low-dose aspirin to prevent heart attacks Uncommon (affects 1 to 10 users in 1,000) or stroke, you should not stop taking pack Rare (affects 1 to 10 users in 10,000) Film coated tablet. 2. What you need to know before you take aspirin until you talk to your doctor Very rare (affects less than 1 user in 10,000) Etoricoxib - aspirin and other non-steroidal The following side effects can occur during Etoricoxib 30 mg film-coated tablets Do not take Etoricoxib: anti-inflammatory drugs (NSAIDs): treatment with Etoricoxib: Blue-green, apple-shaped, biconvex film coated • if you are allergic (hypersensitive) to do not take high dose aspirin or other tablet, debossed with “30” on one side and plain anti-inflammatory medicines while taking Very Common on the other, with dimensions of 5.8 x 5.9 mm etoricoxib or any of the other ingredients of • stomach pain this medicine (listed in section 6) Etoricoxib ± 7.5%. • if you are allergic to non-steroidal Common Etoricoxib 60 mg film-coated tablets Etoricoxib with food and drink • dry socket (inflammation and pain after a anti-inflammatory drugs (NSAIDs), including The onset of the effect of Etoricoxib may be Dark green, apple-shaped, biconvex film coated tooth extraction) aspirin and COX-2 inhibitors (see Possible faster when taken without food. tablet, debossed with “60” on one side and plain Side Effects, section 4) • swelling of the legs and/or feet due to fluid on the other, with dimensions of 7.1 x 7.3 mm • if you have a current stomach ulcer or Pregnancy, breast-feeding, and fertility retention (oedema) ± 7.5%. Pregnancy • dizziness, headache bleeding in your stomach or intestines Etoricoxib 90 mg film-coated tablets Etoricoxib tablets must not be taken during • palpitations (fast or irregular heartbeat), • if you have serious liver disease White, apple-shaped, biconvex film coated tablet, pregnancy. If you are pregnant or think you could irregular heart rhythm (arrhythmia) • if you have serious kidney disease debossed with “90” on one side and plain on the be pregnant, or if you are planning to become • increased blood pressure • if you are or could be pregnant or are other, with dimensions of 8.1 x 8.3 mm ± 7.5%. breast-feeding (see ‘Pregnancy, breast pregnant, do not take the tablets. If you become • wheezing or shortness of breath feeding, and fertility’) pregnant, stop taking the tablets and consult your (bronchospasms) Etoricoxib 120 mg film-coated tablets • if you are under 16 years of age doctor. Consult your doctor if you are unsure or • constipation, wind (excessive gas), gastritis Pale green, apple-shaped, biconvex film coated • if you have inflammatory bowel disease, such need more advice. (inflammation of the lining of the stomach), tablet, debossed with “120” on one side and plain heartburn, diarrhoea, indigestion on the other, with dimensions of 8.9 x 9.2 mm as Crohn’s Disease, Ulcerative Colitis, or Breast-feeding (dyspepsia)/stomach discomfort, nausea, ± 7.5%. Colitis It is not known if Etoricoxib is excreted in human • if you have high blood pressure that has not being sick (vomiting), inflammation of the milk. If you are breast-feeding, or planning to oesophagus, mouth ulcers Etoricoxib film-coated tablets are supplied in been controlled by treatment (check with your breast-feed, consult your doctor before taking blister pack contains 7, 14, 20, 28, 30, 50, 98 and doctor or nurse if you are not sure whether • changes in blood tests related to your liver Etoricoxib. If you are using Etoricoxib, you must • bruising 100 film-coated tablets. your blood pressure is adequately controlled) not breast-feed. • if your doctor has diagnosed heart problems • weakness and fatigue, flu-like illness Not all pack sizes may be marketed. including heart failure (moderate or severe Fertility Uncommon Marketing Authorisation Holder types), angina (chest pain) Etoricoxib is not recommended in women • gastroenteritis (inflammation of the Milpharm Limited • if you have had a heart attack, bypass attempting to become pregnant. gastrointestinal tract that involves both the Ares Block, Odyssey Business Park surgery, peripheral arterial disease (poor stomach and small intestine/stomach flu), Driving and using machines West End Road circulation in legs or feet due to narrow or upper respiratory infection, urinary tract Dizziness and sleepiness have been reported in Ruislip HA4 6QD blocked arteries) infection some patients taking Etoricoxib. United Kingdom • if you have had any kind of stroke (including Do not drive if you experience dizziness or • changes in laboratory values (decreased mini-stroke, transient ischaemic attack or sleepiness. number of red blood cells, decreased number Manufacturer TIA). Etoricoxib may slightly increase your risk Do not use any tools or machines if you of white blood cells, platelets decreased) Rontis Hellas Medical and Pharmaceutical of heart attack and stroke and this is why it experience dizziness or sleepiness. • hypersensitivity (an allergic reaction including Products S.A. should not be used in those who have already hives which may be serious enough to require P.O. Box 3012, had heart problems or stroke. Etoricoxib contains sodium immediate medical attention) This medicine contains less than 1 mmol sodium Larisa Industrial Area If you think any of these are relevant to you, do • appetite increases or decreases, weight gain Larisa, 41004, Greece (23 mg) per tablet, that is to say essentially • anxiety, depression, decreases in mental not take the tablets until you have consulted your ‘sodium-free’. This leaflet was last revised in 09/2020. doctor. sharpness; seeing, feeling or hearing things that are not there (hallucinations) 3. How to take Etoricoxib Warnings and precautions • taste alteration, inability to sleep, numbness Talk to your doctor or pharmacist before taking Always take this medicine exactly as your doctor or tingling, sleepiness Etoricoxib if: has told you. You should check with your doctor • blurred vision, eye irritation and redness • You have a history of stomach bleeding or or pharmacist if you are not sure. • ringing in the ears, vertigo (sensation of spinning while remaining still) ulcers. Do not take more than the recommended dose • abnormal heart rhythm (atrial fibrillation), fast • You are dehydrated, for example by a for your condition. Your doctor will want to heart rate, heart failure, feeling of tightness, prolonged bout of vomiting or diarrhoea. discuss your treatment from time to time. It is pressure or heaviness in the chest (angina • You have swelling due to fluid retention. important that you use the lowest dose that pectoris), heart attack • You have a history of heart failure, or any controls your pain and you should not take • flushing, stroke, mini-stroke (transient other form of heart disease. Etoricoxib for longer than necessary. This is ischaemic attack), severe increase in blood • You have a history of high blood pressure. because the risk of heart attacks and strokes pressure. inflammation of the blood vessels Etoricoxib can increase blood pressure in might increase after prolonged treatment, • cough, breathlessness, nose bleed some people, especially in high doses, and especially with high doses. your doctor will want to check your blood • stomach or bowel bloating, changes in your pressure from time to time. There are different strengths available for this bowel habits, dry mouth, stomach ulcer, • You have any history of liver or kidney medicinal product and depending on your inflammation of the stomach lining that can disease. disease your doctor will prescribe the tablet become serious and may lead to bleeding, • You are being treated for an infection. strength that is appropriate for you. irritable bowel syndrome, inflammation of the Etoricoxib can mask or hide a fever, which is The recommended dose is: pancreas a sign of infection. • swelling of the face, skin rash or itchy skin, • You have diabetes, high cholesterol, or are a Osteoarthritis redness of the skin smoker. These can increase your risk of heart The recommended dose is 30 mg once a day, • muscle cramp/spasm, muscle pain/stiffness disease. increase to a maximum of 60 mg once a day if needed.

Black Rheumatoid arthritis • high levels of potassium in your blood, The recommended dose is 60 mg once a day, changes in blood or urine tests relating to increased to a maximum of 90 mg once a day if your kidney, serious kidney problems needed. • chest pain Ankylosing spondylitis Rare The recommended dose is 60 mg once a day, • angioedema (an allergic reaction with swelling increased to a maximum of 90 mg once a day if of the face, lips, tongue and/or throat which needed. may cause difficulty in breathing or Acute pain conditions swallowing, which may be serious enough to Etoricoxib should be used only for the acute require immediate medical attention)/ painful period. anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction Read all of this leaflet carefully before you Gout that requires immediate medical attention) start taking this medicine because it contains The recommended dose is 120 mg once a day • confusion, restlessness important information for you. which should only be used for the acute painful • liver problems (hepatitis) • Keep this leaflet. You may need to read it period, limited to a maximum of 8 days treatment. again. • You are a woman trying to become pregnant. • low blood levels of sodium • If you have any further questions, ask your • You are over 65 years of age. Postoperative dental surgery pain • liver failure, yellowing of the skin and/or eyes (jaundice) doctor or pharmacist. If you are not sure if any of the above apply to The recommended dose is 90 mg once daily, • severe skin reactions • This medicine has been prescribed for you you, talk to your doctor before taking limited to a maximum of 3 days treatment. only. Do not pass it on to others. It may harm Etoricoxib to see if this medicine is suitable for People with liver problems Reporting of side effects them, even if their signs of illness are the you. • If you have mild liver disease, you should not If you get any side effects, talk to your doctor or same as yours. Etoricoxib works equally well in older and take more than 60 mg a day. pharmacist. This includes any possible side • If you get any side effects, talk to your doctor younger adult patients. If you are over 65 years of • If you have moderate liver disease, you effects not listed in this leaflet. You can also or pharmacist. This includes any possible side age, your doctor will want to appropriately keep a should not take more than 30 mg a day. report side effects directly via the national effects not listed in this leaflet. See section 4. check on you. No dosage adjustment is reporting system listed in Yellow Card Scheme, necessary for patients over 65 years of age. Use in children and adolescents Website: www.mhra.gov.uk/yellowcard or search What is in this leaflet Etoricoxib tablets should not be taken by children for MHRA Yellow Card in the Google Play or 1. What Etoricoxib is and what it is used for Children and adolescents or adolescents under 16 years of age. Apple App Store. By reporting side effects, you 2. What you need to know before you take Do not give this medicine to children and can help Etoricoxib adolescents under 16 years of age. Elderly No dose adjustment is necessary for elderly 3. How to take Etoricoxib provide more information on the safety of this 4. Possible side effects Other medicines and Etoricoxib patients. As with other medicines, caution should Tell your doctor or pharmacist if you are taking, medicine. 5. How to store Etoricoxib be exercised in elderly patients. have recently taken or might take any other 6. Contents of the pack and other information 5. How to store Etoricoxib medicines, including medicines obtained without Method of administration Etoricoxib is for oral use. Take the tablets once a 1. What Etoricoxib is and what it is used for a prescription. Keep this medicine out of the sight and reach of day. Etoricoxib can be taken with or without food. children. What is Etoricoxib? In particular if you are taking any of the following medicines, your doctor may want to monitor you If you take more Etoricoxib than you should Do not use this medicine after the expiry date • Etoricoxib contains the active substance You should never take more tablets than the etoricoxib. Etoricoxib is one of a group of to check that your medicines are working which is stated on the carton after EXP. The properly, once you start taking Etoricoxib: doctor recommends. If you do take too many expiry date refers to the last day of that month. medicines called selective COX-2 inhibitors. Etoricoxib tablets, you should seek medical These belong to a family of medicines called • medicines that thin your blood attention immediately. Store in the original package in order to protect non-steroidal anti-inflammatory drugs (anticoagulants), such as warfarin from moisture. If you forget to take Etoricoxib (NSAIDs). • rifampicin (an antibiotic) Do not throw away any medicines via wastewater What is Etoricoxib used for? • methotrexate (a drug used for suppressing It is important to take Etoricoxib as your doctor or household waste. Ask your pharmacist how to • Etoricoxib helps to reduce the pain and the immune system, and often used in has prescribed. If you miss a dose, just resume throw away medicines you no longer use. These swelling (inflammation) in the joints and rheumatoid arthritis) your usual schedule the following day. Do not measures will help protect the environment. muscles of people 16 years of age and older • ciclosporin or tacrolimus (drugs used for take a double dose to make up for the forgotten with osteoarthritis, rheumatoid arthritis, suppressing the immune system) tablet. 6. Contents of the pack and other ankylosing spondylitis and gout. • lithium (a medicine used to treat some types If you have any further questions on the use of information • Etoricoxib is also used for the short-term of depression) this medicine, ask your doctor or pharmacist. • medicines used to help control high blood What Etoricoxib contains treatment of moderate pain after dental • The active substance etoricoxib. surgery in people 16 years of age and older. pressure and heart failure called ACE 4. Possible side effects inhibitors and angiotensin receptor blockers, Each film-coated tablet contains 30 mg What is osteoarthritis? examples include enalapril and ramipril, and Like all medicines, this medicine can cause side etoricoxib. Osteoarthritis is a disease of the joints. It results losartan and valsartan effects, although not everybody gets them. Each film-coated tablet contains 60 mg from the gradual breakdown of cartilage that • diuretics (water tablets) If you develop any of these signs you should etoricoxib. cushions the ends of the bones. This causes • digoxin (a medicine for heart failure and stop Etoricoxib and talk to your doctor Each film-coated tablet contains 90 mg swelling (inflammation), pain, tenderness, irregular heart rhythm) immediately (see What you need to know etoricoxib. stiffness and disability. • minoxidil (a drug used to treat high blood before you take Etoricoxib section 2): Each film-coated tablet contains 120 mg pressure) • shortness of breath, chest pains, or ankle etoricoxib. What is rheumatoid arthritis? swelling appear or if they get worse Rheumatoid arthritis is a long term inflammatory • salbutamol tablets or oral solution (a medicine • The other ingredients are for asthma) • yellowing of the skin and eyes (jaundice) – Tablet Core: Microcrystalline Cellulose disease of the joints. It causes pain, stiffness, these are signs of liver problems swelling, and increasing loss of movement in the • birth control pills (the combination may (E460), Calcium Hydrogen Phosphate, increase your risk of side effects) • severe or continual stomach pain or your Croscarmellose Sodium, Magnesium Stearate joints it affects. It may also cause inflammation in stools become black other areas of the body. • hormone replacement therapy (the (E470b). combination may increase your risk of side • an allergic reaction- which can include skin Tablet coating: Polyvinyl Alcohol (E1203), What is gout? effects) problems such as ulcers or blistering, or Titanium Dioxide (E171), Glycerol Gout is a disease of sudden, recurring attacks of • aspirin, the risk of stomach ulcers is greater if swelling of the face, lips, tongue, or throat Monostearate (E471), Indigo Carmine very painful inflammation and redness in the you take Etoricoxib with aspirin. which may cause difficulty in breathing Aluminum Lake (E132) [only for 30 mg, 60 mg joints. It is caused by deposits of mineral crystals - aspirin for prevention of heart attacks or The frequency of possible side effects listed & 120 mg], Yellow Iron Oxide (E172) [only for in the joint. stroke: below is defined using the following convention: 30 mg, 60 mg & 120 mg], Talc (E553b), What is ankylosing spondylitis? Etoricoxib can be taken with low-dose Very common (affects more than 1 user in 10) Sodium Laurilsulfate. aspirin. If you are currently taking Ankylosing spondylitis is an inflammatory disease Common (affects 1 to 10 users in 100) What Etoricoxib looks like and contents of the low-dose aspirin to prevent heart attacks of the spine and large joints Uncommon (affects 1 to 10 users in 1,000) pack or stroke, you should not stop taking Rare (affects 1 to 10 users in 10,000) Film coated tablet. 2. What you need to know before you take aspirin until you talk to your doctor Very rare (affects less than 1 user in 10,000) Etoricoxib - aspirin and other non-steroidal The following side effects can occur during Etoricoxib 30 mg film-coated tablets Blue-green, apple-shaped, biconvex film coated Do not take Etoricoxib: anti-inflammatory drugs (NSAIDs): treatment with Etoricoxib: • if you are allergic (hypersensitive) to do not take high dose aspirin or other tablet, debossed with “30” on one side and plain anti-inflammatory medicines while taking Very Common on the other, with dimensions of 5.8 x 5.9 mm etoricoxib or any of the other ingredients of • stomach pain this medicine (listed in section 6) Etoricoxib ± 7.5%. • if you are allergic to non-steroidal Common Etoricoxib 60 mg film-coated tablets Etoricoxib with food and drink • dry socket (inflammation and pain after a anti-inflammatory drugs (NSAIDs), including The onset of the effect of Etoricoxib may be Dark green, apple-shaped, biconvex film coated tooth extraction) aspirin and COX-2 inhibitors (see Possible faster when taken without food. tablet, debossed with “60” on one side and plain Side Effects, section 4) • swelling of the legs and/or feet due to fluid on the other, with dimensions of 7.1 x 7.3 mm • if you have a current stomach ulcer or Pregnancy, breast-feeding, and fertility retention (oedema) ± 7.5%. bleeding in your stomach or intestines Pregnancy • dizziness, headache • palpitations (fast or irregular heartbeat), Etoricoxib 90 mg film-coated tablets • if you have serious liver disease Etoricoxib tablets must not be taken during White, apple-shaped, biconvex film coated tablet, • if you have serious kidney disease pregnancy. If you are pregnant or think you could irregular heart rhythm (arrhythmia) • increased blood pressure debossed with “90” on one side and plain on the • if you are or could be pregnant or are be pregnant, or if you are planning to become other, with dimensions of 8.1 x 8.3 mm ± 7.5%. breast-feeding (see ‘Pregnancy, breast pregnant, do not take the tablets. If you become • wheezing or shortness of breath feeding, and fertility’) pregnant, stop taking the tablets and consult your (bronchospasms) Etoricoxib 120 mg film-coated tablets • if you are under 16 years of age doctor. Consult your doctor if you are unsure or • constipation, wind (excessive gas), gastritis Pale green, apple-shaped, biconvex film coated • if you have inflammatory bowel disease, such need more advice. (inflammation of the lining of the stomach), tablet, debossed with “120” on one side and plain as Crohn’s Disease, Ulcerative Colitis, or heartburn, diarrhoea, indigestion on the other, with dimensions of 8.9 x 9.2 mm Breast-feeding (dyspepsia)/stomach discomfort, nausea, ± 7.5%. Colitis It is not known if Etoricoxib is excreted in human • if you have high blood pressure that has not being sick (vomiting), inflammation of the milk. If you are breast-feeding, or planning to oesophagus, mouth ulcers Etoricoxib film-coated tablets are supplied in been controlled by treatment (check with your breast-feed, consult your doctor before taking blister pack contains 7, 14, 20, 28, 30, 50, 98 and doctor or nurse if you are not sure whether • changes in blood tests related to your liver Etoricoxib. If you are using Etoricoxib, you must • bruising 100 film-coated tablets. your blood pressure is adequately controlled) not breast-feed. • if your doctor has diagnosed heart problems • weakness and fatigue, flu-like illness Not all pack sizes may be marketed. including heart failure (moderate or severe Fertility Uncommon Marketing Authorisation Holder types), angina (chest pain) Etoricoxib is not recommended in women • gastroenteritis (inflammation of the Milpharm Limited • if you have had a heart attack, bypass attempting to become pregnant. gastrointestinal tract that involves both the Ares Block, Odyssey Business Park surgery, peripheral arterial disease (poor Driving and using machines stomach and small intestine/stomach flu), West End Road circulation in legs or feet due to narrow or Dizziness and sleepiness have been reported in upper respiratory infection, urinary tract Ruislip HA4 6QD blocked arteries) some patients taking Etoricoxib. infection United Kingdom • if you have had any kind of stroke (including Do not drive if you experience dizziness or • changes in laboratory values (decreased mini-stroke, transient ischaemic attack or sleepiness. number of red blood cells, decreased number Manufacturer TIA). Etoricoxib may slightly increase your risk Do not use any tools or machines if you of white blood cells, platelets decreased) Rontis Hellas Medical and Pharmaceutical of heart attack and stroke and this is why it experience dizziness or sleepiness. • hypersensitivity (an allergic reaction including Products S.A. should not be used in those who have already hives which may be serious enough to require P.O. Box 3012, had heart problems or stroke. Etoricoxib contains sodium immediate medical attention) Larisa Industrial Area This medicine contains less than 1 mmol sodium If you think any of these are relevant to you, do • appetite increases or decreases, weight gain Larisa, 41004, Greece (23 mg) per tablet, that is to say essentially • anxiety, depression, decreases in mental not take the tablets until you have consulted your ‘sodium-free’. This leaflet was last revised in 09/2020. doctor. sharpness; seeing, feeling or hearing things that are not there (hallucinations) 3. How to take Etoricoxib Warnings and precautions • taste alteration, inability to sleep, numbness Talk to your doctor or pharmacist before taking Always take this medicine exactly as your doctor or tingling, sleepiness Etoricoxib if: has told you. You should check with your doctor • blurred vision, eye irritation and redness • You have a history of stomach bleeding or or pharmacist if you are not sure. • ringing in the ears, vertigo (sensation of spinning while remaining still) ulcers. Do not take more than the recommended dose • abnormal heart rhythm (atrial fibrillation), fast • You are dehydrated, for example by a for your condition. Your doctor will want to heart rate, heart failure, feeling of tightness, prolonged bout of vomiting or diarrhoea. discuss your treatment from time to time. It is pressure or heaviness in the chest (angina • You have swelling due to fluid retention. important that you use the lowest dose that pectoris), heart attack • You have a history of heart failure, or any controls your pain and you should not take • flushing, stroke, mini-stroke (transient other form of heart disease. Etoricoxib for longer than necessary. This is ischaemic attack), severe increase in blood • You have a history of high blood pressure. because the risk of heart attacks and strokes pressure. inflammation of the blood vessels Etoricoxib can increase blood pressure in might increase after prolonged treatment, • cough, breathlessness, nose bleed some people, especially in high doses, and especially with high doses. your doctor will want to check your blood • stomach or bowel bloating, changes in your pressure from time to time. There are different strengths available for this bowel habits, dry mouth, stomach ulcer, • You have any history of liver or kidney medicinal product and depending on your inflammation of the stomach lining that can disease. disease your doctor will prescribe the tablet become serious and may lead to bleeding, • You are being treated for an infection. strength that is appropriate for you. irritable bowel syndrome, inflammation of the Etoricoxib can mask or hide a fever, which is The recommended dose is: pancreas a sign of infection. • swelling of the face, skin rash or itchy skin, • You have diabetes, high cholesterol, or are a Osteoarthritis redness of the skin smoker. These can increase your risk of heart The recommended dose is 30 mg once a day, • muscle cramp/spasm, muscle pain/stiffness disease. increase to a maximum of 60 mg once a day if needed. S05843