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OZERO contains the active substance etoricoxib. OZERO 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). OZERO helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. OZERO is also used for the short term treatment of moderate pain after dental surgery in people 16 years of age and older. How to use The recommended dose is: Osteoarthritis The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed. Rheumatoid arthritis The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. Ankylosing spondylitis The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. People with liver problems If you have mild liver disease, you should not take more than 60 mg a day. If you have moderate liver disease, you should not take more than 30 mg a day. Use in children and adolescents OZERO tablets should not be taken by children or adolescents under 16 years of age. Elderly No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients. Warnings and precautions Do not take OZERO: If you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of this medicine If you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors If you have a current stomach ulcer or bleeding in your stomach or intestines If you have serious liver disease If you have serious kidney disease If you are or could be pregnant or are breast-feeding 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 If your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) Side Effects If you develop any of these signs you should stop OZERO and talk to your doctor immediately: Shortness of breath, chest pains, or ankle swelling appear or if they get worse Yellowing of the skin and eyes (jaundice) – these are signs of liver problems Severe or continual stomach pain or your stools become black An allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing The following side effects can occur during treatment with OZERO: Very common Stomach pain Storage Information Store below 30°C. Drug Interactions In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking OZERO: Medicines that thin your blood (anticoagulants), such as warfarin Rifampicin (an antibiotic) Methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis) Ciclosporin or tacrolimus (drugs used for suppressing the immune system) Lithium (a medicine used to treat some types of depression) Diuretics (water tablets) Digoxin (a medicine for heart failure and irregular heart rhythm) Minoxidil (a drug used to treat high blood pressure) Salbutamol tablets or oral solution (a medicine for asthma) Hormone replacement therapy (the combination may increase your risk of side effects) Ingredients The active substance is Etoricoxib
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