Properties
What is it?
Edoloxi 60 mg film-coated tablets Etoricoxib Read the package leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine is for you only. Do not give it to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4. The leaflet contains: 1. What Edoloxi is and what it is used for 2. What you need to know before you take Edoloxi 3. How to take Edoloxi 4. Possible side effects 5. How to store Edoloxi 6. Contents of the pack and other information 1. What Edoloxi is and what it is used for What is Edoloxi? • Edoloxi contains the active substance etoricoxib. Edoloxi belongs to a group of medicines called selective COX-2 (cyclo-oxygenase-2) inhibitors, which are a type of non-steroidal anti-inflammatory drug (NSAID). What is Edoloxi used for? • Edoloxi reduces pain and swelling (inflammation) in the joints and muscles in patients aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout; • Edoloxi is also used for short-term treatment of moderate pain after dental surgery in patients aged 16 years and older. What is osteoarthritis? Osteoarthritis is a disease of the joints. It causes gradual breakdown of the cartilage that cushions the ends of bones, leading to swelling (inflammation), pain, stiffness, and reduced mobility. What is rheumatoid arthritis? Rheumatoid arthritis is a long-term inflammatory disease of the joints that causes pain, stiffness, swelling, and gradual loss of movement in the affected joints. It can also cause inflammation in other parts of the body. What is gout? Gout is a disease that causes sudden, recurrent attacks of joint inflammation with intense pain and redness. It is caused by the buildup of mineral crystals in the joints. What is ankylosing spondylitis? Ankylosing spondylitis is an inflammatory disease of the spine and large joints. 2. What you need to know before you take Edoloxi Do not take Edoloxi: • if you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6); • if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4); • if you have a recurrent stomach or duodenal ulcer or bleeding; • if you have severe liver disease; • if you have severe kidney disease; • if you are or may be pregnant, or are breastfeeding (see “Pregnancy, breast-feeding and fertility”); • if you are under 16 years of age; • if you have inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or colitis; • if you have high blood pressure that is not controlled by treatment (consult your doctor or nurse to check if your blood pressure is adequately controlled); • if you have been diagnosed with heart disease, including heart failure (moderate or severe), angina (chest pain); • if you have had a heart attack, have undergone bypass surgery, or have peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries); • if you have had any type of stroke (including transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack or stroke, and therefore it is not recommended if you have heart problems or a history of stroke. Consult your doctor before taking the medicine if you think any of the above applies to you. Warnings and precautions Talk to your doctor or pharmacist before taking Edoloxi: • if you have a history of stomach ulcers or bleeding; • if you are dehydrated, e.g. due to prolonged vomiting or diarrhoea; • if you have swelling due to fluid retention; • if you have a history of heart failure or other heart disease; • if you have a history of high blood pressure. Edoloxi can cause an increase in blood pressure in some patients, especially at high doses, and your doctor may check your blood pressure periodically; • if you have a history of liver or kidney disease; • if you are being treated for an infection, Edoloxi may mask a fever, which is a sign of infection; • if you have diabetes, high cholesterol, or are a smoker – these conditions may increase your risk of heart disease; • if you are trying to become pregnant; • if you are over 65 years of age. Consult your doctor before taking Edoloxi if you are unsure whether any of the above applies to you, as the medicine may not be recommended. Edoloxi is equally effective in elderly and younger patients. If you are over 65 years of age, your doctor may examine you. No dose adjustment is needed for patients over 65 years of age. Children and adolescents This medicine is not used in children and adolescents under 16 years of age. Taking Edoloxi with other medicines 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, tell your doctor if you are taking any of the following medicines. Your condition may need to be monitored when starting treatment with Edoloxi to check the effectiveness of your medicines: • Blood-thinning medicines (anticoagulants), such as warfarin; • Rifampicin (an antibiotic); • Methotrexate (a medicine that suppresses the immune system and is often used for rheumatoid arthritis); • Ciclosporin or tacrolimus (used to suppress the immune system); • Lithium (used to treat some types of depression); • ACE inhibitors and angiotensin receptor blockers, used to treat high blood pressure and heart failure, e.g. enalapril and ramipril, losartan and valsartan; • Diuretics; • Digoxin (used for heart failure and irregular heartbeat); • Minoxidil (used for high blood pressure); • Salbutamol tablets or oral solution (medicines for asthma); • Oral contraceptives (this combination may increase the risk of side effects); • Hormone replacement therapy (this combination may increase the risk of side effects); • Acetylsalicylic acid, the risk of stomach ulcers is higher if Edoloxi is taken with acetylsalicylic acid. - Acetylsalicylic acid is used to prevent heart attack or stroke: Edoloxi can be taken with low doses of acetylsalicylic acid. If you are taking low-dose acetylsalicylic acid to prevent heart attack or stroke, you should not stop taking it without consulting your doctor. - Acetylsalicylic acid and other NSAIDs: Do not take high doses of acetylsalicylic acid or other NSAIDs with this medicine. Taking Edoloxi with food and drink The effect of Edoloxi may occur more quickly if taken with food. Pregnancy, breast-feeding and fertility Pregnancy Do not take Edoloxi if you are pregnant. Do not take these tablets if you are pregnant, think you might be pregnant, or are planning to become pregnant. If you become pregnant, stop taking the tablets and consult your doctor. For more information, or if you are unsure, consult your doctor. Breast-feeding It is not known if Edoloxi passes into breast milk. Tell your doctor before taking Edoloxi if you are breastfeeding or plan to breastfeed. Do not breastfeed while being treated with Edoloxi. Fertility Edoloxi is not recommended for women who are trying to become pregnant. Driving and using machines Dizziness and drowsiness have been reported in some patients taking the medicine. Do not drive if you experience dizziness or drowsiness. Do not operate machinery if you experience dizziness or drowsiness. Edoloxi contains sodium This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is essentially ‘sodium-free’. 3. How to take Edoloxi Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Do not take more than the recommended dose for your condition. Your doctor will discuss your treatment plan with you from time to time. It is important to take the lowest dose that controls your pain and not to take Edoloxi for longer than necessary, as prolonged treatment, especially at high doses, may increase the risk of heart attack and stroke. Different strengths of the medicinal product are available, and your doctor will prescribe the tablet strength appropriate for your condition. Recommended doses are: Osteoarthritis The recommended dose is 30 mg once a day, which can be increased to a maximum of 60 mg once a day if needed. Rheumatoid arthritis The recommended dose is 60 mg once a day, which can be increased to a maximum of 90 mg once a day if needed. Ankylosing spondylitis The recommended dose is 60 mg once a day, which can be increased to a maximum of 90 mg once a day if needed. Treatment of acute pain Etoricoxib should only be used for acute pain. Gout The recommended dose is 120 mg once a day, which should only be used for acute pain. The maximum duration of treatment is 8 days. Post-dental surgery pain The recommended dose is 90 mg once a day. The maximum duration of treatment is 3 days. Patients with liver problems • If you have mild liver impairment, do not take more than 60 mg per day; • If you have moderate liver disease, do not take more than 30 mg per day. Use in children and adolescents Edoloxi tablets are not used in children and adolescents under 16 years of age. Elderly No dose adjustment is needed for elderly patients. As with other medicines, caution is advised when used in elderly patients. How to take it Edoloxi is for oral use. The tablets are taken once a day. Edoloxi can be taken with or without food. If you take more Edoloxi than you should Do not take more tablets than prescribed by your doctor. If you take more Edoloxi than you should, seek medical attention immediately. If you miss a dose of Edoloxi It is important to take Edoloxi as prescribed by your doctor. If you miss a dose, take it the next day as usual. Do not double the dose to make up for a missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you develop any of the following symptoms, stop taking Edoloxi and seek medical attention immediately (see section 2. What you need to know before you take Edoloxi): • Shortness of breath, chest pain, or ankle swelling, or their worsening; • Yellowing of the skin and eyes (jaundice) – signs of liver problems; • Severe or prolonged stomach pain or black, tarry stools; • An allergic reaction – including skin problems such as the development of sores or blisters on the face, lips, tongue or throat, which may make breathing difficult. Side effects are classified by their frequency: Very common: affects more than 1 in 10 patients Common: affects up to 1 in 10 patients Uncommon: affects up to 1 in 100 patients Rare: affects up to 1 in 1,000 patients Very rare: affects up to 1 in 10,000 patients The following side effects have been reported during treatment with Edoloxi: Very common: • Stomach pain Common: • Alveolitis (inflammation and pain after tooth extraction) • Swelling of the legs and/or ankles due to fluid retention (oedema) • Dizziness, headache • Palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia) • High blood pressure • Wheezing or shortness of breath (bronchospasm) • Constipation, flatulence (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, dyspepsia and/or abdominal discomfort, nausea, vomiting, inflammation of the oesophagus, stomach ulcers • Changes in liver function in blood tests • Bruising • Weakness and fatigue, flu-like illness. Uncommon: • Gastroenteritis (inflammation of the stomach and intestines), upper respiratory tract infections, urinary tract infections • Changes in laboratory parameters (decrease in red blood cell count, decrease in white blood cell count, decrease in platelet count) • Hypersensitivity (allergic reaction including hives, which may require emergency medical attention) • Increased or decreased appetite, weight gain • Anxiety, depression, decreased sharpness of thinking; visual, auditory hallucinations • Change in taste, insomnia, tingling or numbness sensation, drowsiness • Blurred vision, eye irritation and redness • Ringing in the ears, vertigo (feeling of spinning even when still) • Arrhythmia (atrial fibrillation), tachycardia, heart failure, feeling of tightness, pressure or heaviness in the chest (angina), myocardial infarction • Blood clots, stroke, mini-stroke (transient ischemic attack), sudden increase in blood pressure, inflammation of blood vessels • Cough, shortness of breath, nosebleeds • Belching, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining which may be severe and cause bleeding, irritable bowel syndrome, pancreatitis • Swelling of the face, rash or itching, redness of the skin • Muscle cramps, muscle pain or stiffness • High potassium levels in the blood, changes in blood or urine tests of kidney function, severe kidney problems • Chest pain Rare: • Angioneurotic oedema (allergic reaction with swelling of the face, lips, tongue and/or throat, difficulty breathing or swallowing, which may require emergency medical attention); anaphylactic/anaphylactoid reactions, including shock (severe allergic reaction requiring emergency medical attention) • Disorientation, restlessness • Inflammation of the liver (hepatitis) • Low sodium levels in the blood • 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, even if they are not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Edoloxi Keep out of reach and sight 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. "EXP" on the packaging indicates the expiry date, and "LOT" indicates the batch number. The medicinal product does not require any special storage temperature conditions. Store in the original packaging to protect from moisture. Do not dispose of medicines down the drain or into household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Edoloxi contains • The active substance is etoricoxib. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of etoricoxib; The other ingredients are: • Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate. • Tablet coating: Edoloxi 30 mg, 60 mg: polyvinyl alcohol, titanium dioxide (E171), glycerol monostearate, indigo carmine aluminium lake (E132), iron yellow oxide E172, talc, sodium lauryl sulfate. Edoloxi 90 mg: polyvinyl alcohol, titanium dioxide (E171), glycerol monostearate, talc, sodium lauryl sulfate.
