Product Details

WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACECLOFENAC TABLETS

Do not take Aceclofenac tablets: • if you are allergic (hypersensitive) to aceclofenac or any of the other ingredients of Aceclofenac tablets. • if you are allergic (hypersensitive) to aspirin or any other NSAIDs (such as ibuprofen, naproxen or diclofenac). • if you have taken aspirin or any other NSAIDs and experienced one of the following: – asthma attack – runny nose, itching and/or sneezing (irritation of the nose) – raised red circular patchy rash on the skin which may have been itchy, stung or had a burning sensation – severe allergic reaction (anaphylactic shock). Symptoms include difficulty breathing, wheezing, abnormal pain and vomiting • if you have a history of, suffer from, or suspect that you have a stomach ulcer or intestinal bleeding. • if you have severe kidney disease. • if you suffer from, or suspect that you have liver failure. • if you are pregnant or if you are breast-feeding (unless considered essential by your doctor). • if you have active bleeding or bleeding tendency. Aceclofenac 100 mg Film-coated Tablets Ver0116 2 • if you have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages • if you have or have had problems with your blood circulation (peripheral arterial disease) Aceclofenac tablets is not recommended for use in children. Take special care with Aceclofenac tablets: Before you start taking Aceclofenac tablets, tell your doctor: • if you suffer from any other form of kidney or liver disease. • if you have any of the following gastro-intestinal disorders including: – inflammatory bowel disease (ulcerative colitis) – chronic inflammatory bowel disease (Crohn’s disease) – ulceration, bleeding or perforation – blood disorders • if you suffer from asthma or any other breathing problems. • if you suffer from a blood disorder known as porphyria. • if chicken pox occurs, the use of this medicine should be avoided because of rare serious infections of the skin related to this use. • if you are recovering from major surgery. • if you are elderly (your doctor will prescribe you the lowest effective dose over the shortest duration). Hypersensitivity reactions can occur and very rarely, very serious allergic reactions are appearing (see section 4. Possible side effects). The risk is higher in the first month of treatment. Aceclofenac tablets should be discontinued at the first onset of a skin rash, injuries of mucous membrane or any signs of hypersensitivity. Medicines such as Aceclofenac tablets may be associated with an increased risk of heart attack (“myocardial infarction”) Make sure your doctor knows, before you are given aceclofenac: · If you smoke · If you have diabetes · If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. Taking other medicines Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Please tell your doctor if you are taking: • medicines used to treat depression (selective serotonin-reuptake inhibitors) or manic depression (lithium) • medicines used to treat heart failure and irregular heart beats (cardiac glycosides) • medicines used to treat high blood pressure (antihypertensives) • quinolone antibiotics Aceclofenac 100 mg Film-coated Tablets Ver0116 3 • drugs used to increase the rate of urine excretion (diuretics) • medicines that stop blood clotting (anticoagulants) such as warfarin, heparin • methotrexate which is used to treat cancer and autoimmune disorders • mifepristone which is used to induce abortions • any steroids (oestrogens, androgens, or glucocorticoids) • medicines used to supress the immune system (cyclosporin or tacrolimus) • medicines used to treat HIV (zidovudine) • medicines used to lower blood sugar levels (antidiabetics) • any other NSAID drugs (aspirin, ibuprofen, naproxen) including COX-2 inhibitors Taking Aceclofenac tablets with food and drink Aceclofenac tablets must be taken preferably with or after food. Fertiliy, pregnancy and lactation You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. NSAIDs may make it more difficult to become pregnant. Do not take Aceclofenac tablets if you are pregnant or think you are pregnant. The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Aceclofenac tablets should not be used if you are breast-feeding. It is not known if this medicine passes into breast milk. It is not recommended for use during breast-feeding unless considered essential by your doctor. Consult your doctor or pharmacist for advice before taking any medicine. Driving and using machines If you are taking Aceclofenac tablets and you experience dizziness, drowsiness, tiredness or any visual disturbances, you must not drive or use machinery.