RUMAFEN 50MG 20 TAB

1. What this product is and what it is used forRISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:Cardiovascular Thrombotic EventsNonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke ,which can be fatal. This risk may occur early in treatment and may increase with duration of use.Diclofenac Sodium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.Gastrointestinal Bleeding, Ulceration and perforationNSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events Diclofenac sodium, the active ingredient in RUMAFEN, is one of a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. RUMAFEN tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons includingRheumatoid arthritis, osteoarthritis, acute gout (painful inflammation of the joints especially in the feet and hands), ankylosing spondylitis (form of spinal arthritis)Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fracturesConditions affecting the tendons for example, tendonitis, tenosynovitis, bursitisThey are also used to treat pain and inflammation associated with dental and minor surgery 2. What you need to know before you use this productDo not take Rumafen 50 mg Tablets ifyou are allergic (hypersensitive) to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or any of the other ingredients of RUMAFEN tablets (these are listed under section 6 "FURTHER INFORMATION" of the leaflet). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems , runny nose, skin rash or any other allergic type reactionyou have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces)you have had stomach or bowel problems after you have taken other NSAIDsyou have severe heart, kidney or liver failureyou 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 blockagesyou have or have had problems with your blood circulation (peripheral arterial disease)you are more than six months pregnantWarnings and precautionsTalk to your doctor or pharmacist before taking Rumafen 50 mg Tablets ifyou suffer from any stomach or bowel disorders including ulcerative colitis or Crohn’s diseaseyou have kidney or liver problems, or you are elderlyyou have a condition called porphyriayou suffer from any blood or bleeding disorder. If you do, your doctor may ask you to go for regular check-ups while you are taking these tabletsyou ever had asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic pulmonary diseases or infections of the respiratory tractyou are breast feedingyou have angina, blood clots, high blood pressure, raised cholesterol or raised triglyceridesyou have heart problems or if you had a stroke or you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker)you have diabetesyou smokeyou have Systemic Lupus Erythematosus SLE (inflammatory, auto-immune disorder which causes symptoms such as joint pain, joint inflammation, skin rashes, fever) or any similar conditionyou have an intolerance to some sugars such as lactose (these tablets contain lactoseTell your doctor or pharmacist if you have any of these conditions because Rumafen 50 mg tablets might not be the right medicine for youChildrenThese tablets are not suitable for children aged under 12Other medicines and Rumafen 50 mg TabletsSome medicines can interfere with your treatment. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially any of the followingMedicines to treat diabetesAnticoagulants (blood thinning tablets like warfarin)Diuretics (water tablets)Lithium (used to treat some mental problems)Methotrexate (for treatment of some inflammatory diseases and some cancers)Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)Trimethoprim (a medicine used to prevent or treat urinary tract infections)Quinolone antibiotics (for infections)Any other NSAID or COX-2 (cyclo-oxygenase-2) inhibitor, for example aspirin or ibuprofenMifepristone (a medicine used to terminate pregnancy)Cardiac glycosides (for example digoxin), used to treat heart problemsMedicines known as SSRIs (used to treat depression)Oral steroids (an anti-inflammatory drug)Medicines used to treat heart conditions or high blood pressure, for example beta blockers or ACE inhibitorsVoriconazole (a medicine used to treat fungal infections)Phenytoin (a medicine used to treat seizures)Colestipol/cholestyramine (used to lower cholesterol)Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctorTaking RUMAFEN 50 mg Tablets with food and drinkTake this medicine with or after foodPregnancy and breast-feedingAlthough not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take RUMAFEN tablets during the last 3 months of pregnancy as it may affect the baby"s circulationYou should advise your doctor or pharmacist if you think you might be pregnant or up to 6 months pregnantTaking RUMAFEN tablets may make it more difficult to become pregnant. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnantYou should avoid taking RUMAFEN whilst breast feedingDriving and using machinesVery occasionally people have reported that diclofenac sodium tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machineryOther special warningsYou should take the lowest effective dose of Diclofenac Sodium for the shortest possible time particularly if you are underweight or elderlyThere is a small increased risk of heart attack or stroke when you are taking any medicine like Diclofenac Sodium. The risk is higher if you are taking high doses for a long timeAlways follow the doctor’s instructions on how much to take and how long to take it forWhilst you are taking these medicines your doctor may want to give you a check-up from time to timeIf you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptomsBecause it is an anti-inflammatory medicine, Diclofenac Sodium tablets may reduce the symptoms of infection, for example, headache, and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac Sodium tabletsThese tablets are not suitable for children aged under 12Rumafen tablets containsRumafen 50 mg contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product3. How to use this product.The doctor will tell you how many RUMAFEN tablets to take and when to take them. Always take RUMAFEN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Keep taking your tablets for as long as you have been told, unless you have any problems. In that case, check with your doctor. Take the tables with or after food. Swallow the tablets whole with a glass of water. DO NOT crush or chew the tabletsThe usual dose isAdults75 to 150 mg daily in two or three divided dosesThe number of tablets which you take will depend on the strength the doctor has given you.ElderlyThe lowest effective dose should be used. Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Your doctor may also want to check closely that the Diclofenac Sodium tablets are not affecting your stomachChildrenThese tablets are not suitable for children aged under 12The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as wellIf you take more RUMAFEN 50 mg Tablets than you shouldIf you, or anyone else, accidentally takes too much RUMAFEN, tell your doctor or go to your nearest hospital casualty department immediately. Take your medicine pack with you so that people can see what you have takenSymptoms of an overdose can include: headache, nausea (feeling sick), vomiting, abdominal pain, stomach or intestinal bleeding, rarely diarrhea, disorientation, excitation, coma, drowsiness, dizziness, ringing in the ears, fainting, or occasionally convulsions (seizures, uncontrolled fits)If you forget to take RUMAFEN 50 mg TabletsIt is important that you do not miss a dose. If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, just take the next dose and forget about the one you missed. Do NOT take a double dose to make up for a forgotten tablet. Do not take more than 150 mg in 24 hours. If you have trouble remembering to take the tablets, tell your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacistIf you have any further questions on the use of this medicine, ask your doctor or pharmacist4. Possible side effectsLike all medicines, RUMAFEN can cause side effects, although not everybody gets themSome side effects can be seriousSTOP TAKING RUMAFEN and seek immediate medical help if you noticeStomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faecesAllergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or BlisteringWheezing or shortness of breath (bronchospasm)Swollen face, lips, hands or fingersYellowing of your skin or the whites of your eyesPersistent sore throat or high temperatureAn unexpected change in the amount of urine produced and/or its appearanceMild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclofenac Sodium and followed by rectal bleeding or bloody diarrhea usually within 24 hours of the onset of abdominal painStevens Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitalsIf you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctorThe side effects listed below have also been reportedCommon (may affect up to 1 in 10 people)Stomach pain, heartburn, nausea, vomiting, diarrhea, indigestion, wind, loss of appetiteHeadache, dizziness, vertigoSkin rash or spotsRaised levels of liver enzymes in the bloodRare (may affect up to 1 in 1,000 people)Stomach ulcers or bleeding (there have been very rare reported cases resulting in deathparticularly in the elderlyGastritis (inflammation, irritation or swelling of the stomach lining)Vomiting bloodDiarrhoea with blood in it or bleeding from the back passageBlack, tarry faeces or stoolsDrowsiness, tirednessHypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headednessSkin rash and itchingFluid retention, symptoms of which include swollen anklesLiver function disorders, including hepatitis and jaundiceVery rare (may affect up to 1 in 10,000 people)Effects on the nervous systemTingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensationEffects on the stomach and digestive systemConstipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including of the colon or worsening of ulcerative colitis or Crohn’s disease)Effects on the heart, chest or bloodPalpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), heart disorders, including congestive heart failure or heart attack, blood disorders (including anaemia Effects on the liver or kidneysKidney or severe liver disorders including liver failure, presence of blood or protein in the urineEffects on skin or hairSerious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight. Hair lossOther side effects that have also been reported includeInflammation of the pancreas, impotence. Facial swelling, inflammation of the lining of the brain (meningitis), stroke, throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye Do not be alarmed by this list - most people take Diclofenac Sodium Tablets without any problems If any of the side effects becomes serious, or if you notice side effects not listed in this leaflet, please tell your doctor or the pharmacist 5. How to store this product- Keep out of the sight and reach of children- Store in original package in order to protect from light- Store below 30 °C- Do not use RUMAFEN 50 mg Tablets after the expiry date printed on the pack. The expiry date refers to the last day of that month- Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment