Diclofenac free acid equivalent to 50mg diclofenac sodium, the active ingredient in Emifenac 50 DT, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

Emifenac 50 DT act quickly and so are used to treat short term painful conditions affecting the joints and muscles. They are especially useful for the treatment of sprains, strains and back pain. They should not be taken for more than three months.

· you think you may be allergic to diclofenac, aspirin, ibuprofen or any other NSAID, or any of the ingredients of Emifenac 50 DT listed at the end of this leaflet (see ‘Further information’). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction.

· you 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 NSAIDs

· you have severe heart, kidney or liver failure.

· 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)

· you are more than six months pregnant.

You should also ask yourself these questions before taking Emifenac 50 DT:

· Do you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease?       · Do you have kidney or liver problems, or are you elderly?

· Do you have a condition called porphyria?   · Do you 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 tablets.

· Have you ever had asthma?      

· Are you breast-feeding?

· Do you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides 

· Do you have heart problems, or have you had a stroke, or do 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)?  · Do you have diabetes?  

· Do you smoke?

· Do you have Lupus (SLE) or any similar condition?

· Do you have phenylketonuria (a rare, hereditary disorder of the metabolism)?

If the answer to any of these questions is YES, tell your doctor or pharmacist because Emifenac 50 DT might not be the right medicine for you.

Are you taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:

· Medicines to treat diabetes    

· Anticoagulants (blood thinning tablets like warfarin)

· Diuretics (water tablets)           

· Lithium (used to treat some mental problems)

· Methotrexate (for 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-oxgenase-2) inhibitor, for example aspirin or ibuprofen

· Mifepristone (a medicine used to terminate pregnancy)

· Cardiac glycosides (for example digoxin), used to treat heart problems

· Medicines 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 inhibitors.     

· Voriconazole (a medicine used to treat fungal infections).

· Phenytoin (a medicine used to treat seizures)

· Colestipol and cholestyramine (used to lower cholesterol)

Pregnancy and breast-feeding

· Are you pregnant or planning to become pregnant? Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take Emifenac 50 DT during the last 3 months of pregnancy as it may affect the baby's circulation.

· You should advise your doctor or pharmacist if you think you might be pregnant or are up to 6 months pregnant.

· Are you trying for a baby? Taking Emifenac 50 DT 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 pregnant.

· You should avoid taking Emifenac 50 DT whilst breast feeding.

Driving and using machines

Very occasionally people have reported that diclofenac 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 machinery.

Important information about some of the ingredients of Emifenac 50 DT

Emifenac 50 DT contains aspartame, a source of phenylalanine: patients with phenylketonuria (a rare, hereditary disorder of the metabolism)  should take into account that each  Emifenac 50 DT contains 3 mg aspartame, contact your doctor before taking this medicinal product.

Warnings:

· Do not take Emifenac 50 DT if you had prior gastrointestinal bleeding or perforation, related to the use of anti-inflammatory analgesics.

· Do not take Emifenac 50 DT for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

·  Do not take Emifenac 50 DT along with anticoagulants and antiplatelets.

· Close medical surveillance is required when taking Emifenac 50 DT in patients with impaired liver function, as their condition may be exacerbated. If abnormal liver function tests persist or worsen, if signs or symptoms consistent with liver disease develop Emifenac 50 DT should be discontinued. Discuss with your doctor.

· Use of Emifenac 50 DT, particularly at high dose (150mg/day) and in long-term treatment, increase the risk of arterial thromboembolic events slightly more than other NSAIDs, but similarly to selective COX-2 inhibitors.

· If you are a patient with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, you should only be treated with Emifenac 50 DT after careful consideration. Similar consideration should also be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (eg. hypertension, .hyperlipidaemia, diabetes mellitus, smoking)

· As with all types of analgesics long term use for relief of headache can develop or worsen. Headache caused by over usages of analgesics should not be treated with increased dose of analgesics. In such cases the treatment should be withdrawn. Headache due to over usage of medicines should be suspected patients with frequent or daily attack of headache despite (or because of) regular use of analgesics.

Other special warnings

· You should take the lowest dose of Emifenac 50 DT for the shortest possible time, particularly if you are underweight or elderly.

· There is a small increased risk of heart attack or stroke when you are taking any medicine like Emifenac 50 DT. The risk is higher if you are taking high doses for a long time. Always follow the doctor’s instructions on how much to take and how long to take it for.

· Whilst you are taking these medicines your doctor may want to give you a check-up from time to time. · If 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 symptoms.

· Because it is an anti-inflammatory medicine, Emifenac 50 DT 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 Emifenac 50 DT.

Emifenac 50 DT is not suitable for children

The doctor will tell you how many Emifenac 50 DT tablets to take and when to take them. Always take Emifenac 50 DT 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 tablets before or with food. Drop the tablets into a glass of water, and stir. Drink the liquid at once. To make sure you get all of the medicine, rinse the glass round with a small amount of water and drink this as well.

The usual dose is:

Adults: One tablet two or three time a day.

Elderly: 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 Emifenac 50 DT is not affecting your stomach.

Children: These tablets are not suitable for children.

The 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 well.

If you forget to take 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, though, just take the next dose and forget about the one you missed. Do not double up on the next dose to make up for the one missed. Do not take more than 150 mg (three tablets) in 24 hours.

 If you take too many tablets?

If you, or anyone else, accidentally takes too much, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.

Emifenac 50 DT is suitable for most people, but, like all medicines, they can sometimes cause side effects. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Some side effects can be serious

Stop taking Emifenac 50 DT and tell your doctor straight away if you notice:

· Stomach 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 faeces

· Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering

· Wheezing or shortness of breath (bronchospasm)

· Swollen face, lips, hands or fingers

· Yellowing of your skin or the whites of your eyes

· Persistent sore throat or high temperature

· An unexpected change in the amount of urine produced and/or its appearance

· Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Emifenac 50 DT and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain.

If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

The side effects listed below have also been reported.

Common side effects (These may affect between 1 and 10 in every 100 patients):

· Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite

· Headache, dizziness, vertigo

· Skin rash or spots

· Raised levels of liver enzymes in the blood.

Rare side effects (These may affect between 1 in every 1000 to 1 in every 10,000 patients):

· Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly)

· Gastritis (inflammation, irritation or swelling of the stomach lining)

· Vomiting blood   • Diarrhoea with blood in it or bleeding from the back passage

· Black, tarry faeces or stools       • Drowsiness, tiredness

· Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness)

· Skin rash and itching

· Fluid retention, symptoms of which include swollen ankles

· Liver function disorders, including hepatitis and jaundice.

Very rare side effects (These may affect less than 1 in every 10,000 patients):

Effects on the nervous system: Tingling or numbness in the fingers, tremor, visual disturbances such as 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 sensation.

Effects on the stomach and digestive system: Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn’s disease).

Effects on the heart, chest or blood: Palpitations (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), stroke.

Effects on the liver or kidneys: Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine.

Effects on skin or hair: Serious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.

Hair loss.

Other side effects that have also been reported include:

Inflammation 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 Emifenac 50 DT without any problems.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine

Keep all medicines out of the sight and reach of children. Do not store above 30°C. Store in a dry place. Protect from light. Do not use Emifenac 50 DT after the expiry date (EXP) which is stated on the carton and blister. 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.