Do not take DICLOFENAC SODIUM 50MG if:

• you are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of DICLOFENAC SODIUM 50mg tablets (these are listed under section 6 “CONTENTS OF THE PACK AND OTHER INFORMATION” of the leaflet). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction.
• you have now, or have ever had, two or more distinct episodes of 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 heart, kidney or liver failure
• 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.
• you have or have had problems with your blood circulation (peripheral arterial disease).
• you are more than six months pregnant

Warnings and precautions

Talk to your doctor or pharmacist before taking Diclofenac if:

• you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn’s disease
• you have kidney or liver problems, or you are elderly
• you have a condition called porphyria
• 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.
• you ever had asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic pulmonary diseases or infections of the respiratory tract.
• you are breast feeding
• you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
• you 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 diabetes
• you smoke
• you have Systemic Lupus Erythematosus SLE (inflammatory, auto-immune disorder which causes symptoms such as joint pain, joint inflammation, skin rashes, fever) or any similar condition

Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking DICLOFENAC SODIUM 50mg, as DICLOFENAC can sometimes worsen wound healing in your gut after surgery.

Tell your doctor or pharmacist if you have any of these conditions because Diclofenac Sodium 50mg might not be the right medicine for you.

Children

These tablets are not suitable for children aged under 12.

Other medicines and Diclofenac Sodium 50mg

Some medicines can interfere with your treatment. Please 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 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 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/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 doctor.

Diclofenac Sodium 50mg with food and drink

Take this medicine with or after food.

• Pregnancy and breast-feeding Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take DICLOFENAC SODIUM 50mg tablets 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.
• Taking Diclofenac Sodium 50mg 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 pregnant.
• You should avoid taking Diclofenac Sodium whilst breast feeding.

Driving and using machines

Very 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 machinery.

Other special warnings

• You should take the lowest effective dose of Diclofenac Sodium 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 Diclofenac Sodium. 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.
• If at any time while taking Diclofenac Sodium you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness or slurring of speech, contact your doctor immediately.
• 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, 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 tablets.

These tablets are not suitable for children aged under 12.

Diclofenac Sodium 50mg tablets 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 product.

Diclofenac Sodium 50mg tablets contains a colouring agent, sunset yellow (E110). Sunset yellow (E110), may cause allergic reactions.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.