|Information for patients
Aceclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs have anti-inflammatory and painkiller properties. The active ingredient of Aceclofenac is aceclofenac. Aceclofenac works by blocking the production of hormone-like substances called prostaglandins. Prostaglandins are released at the sites of injury, tissue damage and immune reactions. Prostaglandins play an important role in both the inflammatory response of the body and stimulating the re-absorption of bone in diseases. Aceclofenac is used to relieve pain and inflammation in patients suffering from:
•arthritis of the joints (osteoarthritis). This commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint.
•autoimmune disease that causes chronic inflammation of the joints (rheumatoid arthritis).
•arthritis of the spine which can lead to the fusion of the vertebrae (ankylosing spondylitis).
||•if you are allergic (hypersensitive) to aceclofenac.
•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:
-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
|Before Consuming the Medicine
||•if you have a history of, suffer from, or suspect that you have a stomach ulcer or intestinal bleeding.
•if you have moderate to severe kidney disease.
•if you have or have ever had a severe heart failure (heart attack).
•if you suffer from, or suspect that you have liver failure.
•if you are pregnant (unless considered essential by your doctor). Aceclofenac is not recommended for use in children
|Drug Special Care
||•if you suffer from any other form of liver disease.
•if you have any of the following gastro-intestinal disorders:
-inflammatory bowel disease (ulcerative colitis)
-chronic inflammatory bowel disease (Crohn’s disease)
-vomiting of blood
•if you have, or have ever had problems with the circulation of the blood to your brain.
•if you suffer from asthma or any other breathing problems.
•if you suffer from a blood disorder known as porphyria.
•if you have heart problems, previous stroke or think that you might be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
•If you are elderly (your doctor will prescribe you the lowest effective dose over the shortest duration). Medicines such as Aceclofenac may be associated with a small increased risk of heart attack (”myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
|Drug Drug Interactions
||•medicines used to treat depression or manic depression (lithium)
•medicines used to treat heart failure and irregular heart beats (cardiac glycosides)
•medicines used to treat high blood pressure (antihypertensives)
•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 as an emergency contraceptive or to induce abortions
•any steroids (oestrogens, androgens, or glucocorticoids)
•medicines used to supress the immune system (cyclosporine or tacrolimus)
•medicines used to treat HIV (zidovudine)
•medicines used to lower blood sugar levels (antidiabetics)
•any other NSAID drugs (aspirin, ibuprofen, naproxen)
|Drug Pregnancy Interaction
||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 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.
|Drug Breast feeding Interaction
||Aceclofenac 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.
|Drug Machinery Interaction
||If you are taking Aceclofenac and you experience dizziness, drowsiness, tiredness or any visual disturbances, you must not drive or use machinery.
|Drug More Information
||Aceclofenac must be taken preferably with or after food.
|How to take the Medicine
If you are elderly, you are more likely to experience serious sideeffects. If your doctor prescribes Aceclofenac for you, you will be given the lowest effective dose over the shortest duration.
||The recommended dose in adults is 200mg (two Aceclofenac tablets). One 100mg tablet should be taken in the morning and one in the evening.
||Tablets should be swallowed whole with plenty of water and should be taken with or after food. Do not crush or chew the tablets. Do not exceed the stated daily dose.
|Excess Drug Consumption
||If you accidentally take too many Aceclofenac tablets, contact your doctor immediately or go to your nearest hospital casualty department. Please take this leaflet or the box the Aceclofenac tablets came in, with you to the hospital so that they will know what you have taken.
|Forgot Drug Consumption
||If you miss a dose, do not worry, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.
|Stop Drug Consumption
||Do not stop taking Aceclofenac unless your doctor advises you.
|Possible Side Effects
||•low levels of iron in the blood
•hypersensitivity (allergic reaction)
•shortness of breath
|Common Drug Side Effects
•nausea (feeling sick)
•increased liver enzymes in the blood
|Rare Drug Side Effects
•inflammation or irritation of the lining of the stomach (gastritis)
•inflammation of the skin (dermatitis)
•raised circular red itchy, stinging or burning patches on the skin (hives)
•increase in blood urea levels
•increase in blood creatinine levels
|Very Rare Drug Side Effects
||•low white blood cells levels
•low platelets levels in the blood
•abnormal breakdown of red blood cells (anemia)
•high potassium levels in the blood
•inability to sleep
•tingling, pricking or numbness of skin
•uncontrollable shaking (tremor)
•abnormal taste in the mouth
•sensation of spinning when standing still
•heart pounding or racing (palpitations)
•high pitched noise when breathing
•inflammation of the mouth
•inflammation of the pancreas (pancreatitis)
•inflammation of the liver (hepatitis)
•yellowing of the skin (jaundice)
•spontaneous bleeding into the skin (appears as a rash)
•water retention and swelling
•increased blood alkaline phosphatase levels
|Drug Side Effects Symptoms
•blurred, partial or complete loss of vision
•painful movement of the eye
•ringing in the ears
•perforation of either the stomach, large intestine or bowel wall
•blistering and peeling of the top layer of skin
•mild, itchy pink/redness of the skin
•reddening or scaling of skin
•skin irritation (eczema)
•skin reaction to sunlight
•inflammation of the kidneys
•generally feeling unwell
•exacerbation of colitis and Crohn’s disease
•hypertension (high blood pressure)
•bone marrow depression
|How to Store the Medicine
|How to Store the Medicine
||Keep out of the reach and sight of children. Do not store above 30ºC. Do not use Aceclofenac after the expiry date which is stated on the outer carton. The expiry date refers to the last day of that month. It is recommended that you store Aceclofenac in the original box. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.