Etozon 90mg 28 tablets

Form

tableti shemogarsuli

Dosage mg

90

ETOSON 90 MG 28 TABLETS (ETORICOXIB) Read all of this 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 has been prescribed for you only. Do not pass it on 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. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What ETOSON is and what it is used for 2. What you need to know before you take ETOSON 3. How to take ETOSON 4. Possible side effects 5. How to store ETOSON 6. Contents of the pack and other information 1. What ETOSON is and what it is used for ETOSON contains the active substance etoricoxib. • It is a selective COX-2 (cyclo-oxygenase-2) inhibitor. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). • Etoricoxib helps to reduce pain and swelling (inflammation) in the joints and muscles in people aged 16 years and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. • Etoricoxib is also used for the short-term treatment of moderate pain after dental surgery in people aged 16 years and over. What is osteoarthritis? Osteoarthritis is a joint disease in which the cartilage tissue on the surface of the bones gradually wears away, causing swelling (a sign of inflammation), pain, thickening of the joint surfaces of the bones, 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 can also cause inflammation in other parts of the body. What is gout? Gout is a sudden disease with recurrent attacks of very painful inflammation and redness in the joints. It is caused by the deposition of mineral crystals in the joint. What is ankylosing spondylitis? Ankylosing spondylitis is an inflammatory disease of the spine and large joints. See also: ARCOXIA - ARCOXIA 90MG 28 TABLETS 2. What you need to know before you take ETOSON Do not take ETOSON • 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, including aspirin and Cox-2 inhibitors (see Possible side effects, section 4). • If you have a stomach ulcer or bleeding from the stomach or intestines. • 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 has not been controlled by treatment (check with your doctor or nurse if you are not sure that your blood pressure is adequately controlled). • If your doctor has diagnosed heart problems, including heart failure (moderate or severe), angina (chest pain). • If you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in your legs or feet due to narrowed or blocked arteries). • If you have had any type of stroke (including mini-stroke or transient ischemic attack (TIA)). Etoricoxib may slightly increase the risk of heart attack and stroke, so it should not be used in people who have had heart problems or a stroke. If you think any of the above applies to you, do not take ETOSON without consulting your doctor. Warnings and precautions Talk to your doctor or pharmacist before taking ETOSON if: • You have a history of stomach bleeding or ulcer disease. • You are dehydrated, e.g. after prolonged vomiting or diarrhoea. • You have swelling due to fluid retention. • You have a history of heart failure or other heart disease. • You have a history of high blood pressure. Etoricoxib can increase blood pressure in some people, especially at high doses. Check your blood pressure from time to time. • You have a history of liver or kidney disease. • You are being treated for an infection. Etoricoxib can mask or hide a fever, which is a sign of infection. • You have diabetes, high cholesterol levels or are a smoker. All of these can increase your risk of heart disease. • You are a woman planning a pregnancy. • You are > 65 years old. If you are not sure if any of the above applies to you, talk to your doctor before taking etoricoxib to check if this medicine is suitable for you. Etoricoxib works equally well in elderly and young (adult) patients. If you are over 65 years of age, your condition should be properly monitored by your doctor and the dose adjusted. Dose adjustment is not necessary for patients over 65 years of age. Children and adolescents The product is not used in children and adolescents under 16 years of age. Other medicines and ETOSON 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, if you are taking any of the following medicines, your doctor may order monitoring to check if the listed medicines are working properly when you start taking ETOSON: • Medicines that thin your blood (anticoagulants), such as warfarin. • Rifampicin (an antibiotic). • Methotrexate (used to suppress the immune system and often used for rheumatoid arthritis). • Ciclosporin or tacrolimus (immunosuppressant drugs). • Lithium (used to treat some types of depression). • Medicines used to control high blood pressure and heart failure, ACE inhibitors and angiotensin receptor blockers, for example enalapril, ramipril, losartan and valsartan. • Diuretics. • Digoxin (medicine for heart failure and irregular heart rhythm). • Minoxidil (used to treat high blood pressure). • Salbutamol tablets or oral solution (medicine for asthma). • Birth control pills (the combination may increase the risk of side effects). • Hormone replacement therapy (the combination may increase the risk of side effects). • Aspirin (acetylsalicylic acid), the risk of developing stomach ulcers is greater if you take etoricoxib with aspirin. • Taking aspirin with etoricoxib for the prevention of heart attack or stroke is possible with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attack or stroke, do not stop taking aspirin without consulting your doctor. Do not take high-dose aspirin or other anti-inflammatory drugs while taking etoricoxib. ETOSON with food and drink The effect of etoricoxib may occur more quickly if taken without food. Pregnancy, breast-feeding and fertility Pregnancy You must not take etoricoxib tablets during pregnancy. If you are pregnant or breastfeeding, suspect you are pregnant or plan to become pregnant, do not take this medicine. If you become pregnant, stop taking this medicine and talk to your doctor. Consult your doctor or pharmacist if you are unsure or need further advice. Breast-feeding It is unknown whether etoricoxib is excreted in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking etoricoxib. If you take etoricoxib, you must not breastfeed. Fertility Etoricoxib tablets are not recommended for women trying to become pregnant. Driving and using machines Dizziness and drowsiness have been reported in some patients taking etoricoxib. Do not drive any type of vehicle if you experience dizziness or drowsiness. ETOSON contains lactose It contains the milk sugar lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. ETOSON contains sodium It contains less than 1 mmol/l of sodium (23 mg) per film-coated tablet, meaning it is essentially "sodium-free". 3. How to take ETOSON Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not take more than the dose recommended for your condition. Your doctor will review your treatment from time to time. It is important to use the lowest dose that controls your pain and not to take ETORICOXIB for longer than necessary. This is because the risk of heart attack and stroke may increase after prolonged treatment, especially at high doses. This medicinal product can overcome different strengths of pain. Depending on your condition, your doctor will prescribe the appropriate form for you. The recommended dose is: Osteoarthritis The recommended dose is 30 mg once a day, increased if necessary to a maximum of 60 mg once a day. Rheumatoid arthritis The recommended dose is 60 mg once a day, increased if necessary to a maximum of 90 mg once a day. Ankylosing spondylitis The recommended dose is 60 mg once a day, increased if necessary to a maximum of 90 mg once a day. Acute pain episodes 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, for a maximum of 8 days. Pain after dental surgery The recommended dose is 90 mg once a day, for a maximum of 3 days. People with impaired liver function • If you have mild liver disease, 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 Etoricoxib is not used in children and adolescents under 16 years of age. Elderly Dose adjustment is not necessary for elderly patients. As with other medicines, caution is required. How to take Etoricoxib is intended for oral use. Take the tablets once a day. Etoricoxib can be taken with or without food. If you take more ETOSON than you should Never take more tablets than your doctor advises. If you take too many etoricoxib tablets, you should seek medical attention immediately. If you forget to take ETOSON It is important to take etoricoxib as prescribed by your doctor. If you miss a dose, simply resume your usual dosage the next day. Do not take a double dose to make up for a missed tablet. 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 any of the following signs develop, stop taking ETOSON and contact your doctor immediately: • Shortness of breath, chest pain or ankle swelling, or worsening of these signs. • Yellowing of the skin and eyes (jaundice is a sign of liver damage). • Severe or persistent stomach pain or black stools. • An allergic reaction - which may include skin problems such as sores or blisters, swelling of the face, lips, tongue or throat, which may make breathing difficult. The following side effects may develop during treatment with etoricoxib: Very common side effects (may affect more than 1 in 10 people). Stomach pain Common side effects (may affect up to 1 in 10 people). • Inflammation and pain after tooth extraction. • Swelling of the leg or legs due to fluid retention (oedema). • Dizziness, headache. • Palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia). • Increased blood pressure. • Wheezing or shortness of breath (bronchospasm). • Constipation, bloating (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, indigestion (dyspepsia), discomfort in the stomach area, nausea, vomiting, inflammation of the oesophagus, mouth ulcers. • Changes in blood tests related to the liver. • Bruising. • Weakness and fatigue, flu-like symptoms. Uncommon side effects (may affect up to 1 in 100 people) • Gastroenteritis (inflammation of the gastrointestinal tract, including both the stomach and the small intestine/stomach flu), upper respiratory tract infection, urinary tract infection. • Changes in laboratory indicators: Reduction in the number of red blood cells (erythrocytes), reduction in the number of white blood cells (platelets). • Hypersensitivity (allergic reaction including hives, which may be severe enough to require urgent medical attention). • Increased or decreased appetite, weight gain. • Anxiety, depression, decreased mental clarity; seeing, feeling or hearing things that are not there (hallucinations). • Change in taste, inability to sleep, numbness or tingling, drowsiness. • Blurred vision, eye irritation and redness. • Ringing in the ears, dizziness (feeling of spinning when not moving). • Abnormal heart rhythm (atrial fibrillation), fast heartbeat, heart failure, tightness, pressure or heaviness in the chest (angina), heart attack. • Flushing, stroke, mini-stroke (transient ischemic attack), sudden increase in blood pressure, inflammation of blood vessels. • Cough, shortness of breath, nosebleeds. • Stomach or intestinal bloating, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining, which can become serious and cause bleeding, irritable bowel syndrome, inflammation of the pancreas. • Swelling of the face, skin rash or itching, redness of the skin. • Muscle cramps/spasms, muscle pain/stiffness. • High levels of potassium in the blood, changes in blood or urine tests related to the kidneys, serious kidney problems. • Chest pain. Rare side effects (may affect up to 1 in 1000 people) • Angioedema (allergic reaction with swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing, which may be severe enough to require urgent medical attention)/anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction requiring urgent medical attention). • Cognitive impairment, restlessness. • Liver problems (hepatitis). • Low levels of sodium in the blood. • Liver failure, yellowing of the skin 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 via the national reporting system, as set out in Appendix V. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store ETOSON Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away medicines down the drain or into household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What ETOSON contains • The active substance is etoricoxib. Each film-coated tablet contains <60 mg> <90 mg> etoricoxib. • The other ingredients are: microcrystalline cellulose (E460), magnesium stearate (E572), croscarmellose sodium (E468), calcium hydrogen phosphate (E341) tablet core: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518). ETOSON and packaging Etoricoxib tablets are available in 2 strengths: 60 mg white, round, biconvex, film-coated tablets (approx. 8 mm) engraved with "E9OX" on one side and "60" on the other. 90 mg white, round, biconvex, film-coated tablets (approx. 9 mm) engraved with "E9OX" on one side and "90" on the other. [For information on specific contents of the packaging procedure, please refer to the procedure-specific annexes of this leaflet.] Not all pack sizes may be marketed. Dispensing category: Pharmaceutical product group II, dispensed with form №3 prescription.