Diclofenac- SodiumVDOFEN – 50 Each enteric coated tablet contains diclofenac sodium 50mg

DICLOFENAC SODIUM TABLETS

film coated tablet contains Diclofenac sodium 50mg  

PHARMACOLOGICAL CLASSIFICATION:   Anti-inflammatory 

MECHANISM OF ACTION Diclofenac competitively inhibits both cyclooxygenase (COX) isoenzymes, COX-1 and COX-2, by blocking arachidonate binding resulting in analgesic, antipyretic, and anti-inflammatory pharmacologic effects. The enzymes COX-1 and COX-2 catalyze the conversion of arachidonic acid to prostaglandin G2 (PGG2), the first step of the synthesis prostaglandins and thromboxanes that are involved in rapid physiological responses. COX isoenzymes are also responsible for a peroxidase reaction, which is not affected by NSAIDs. In addition, NSAIDs do not suppress leukotriene synthesis by lipoxygenase pathways. COX-1 is constitutively expressed in almost all tissues, while COX-2 appears to only be constitutively expressed in the brain, kidney, bones, reproductive organs, and some neoplasms (e.g., colon and prostate cancers). COX-1 is responsible for prostaglandin synthesis in response to stimulation by circulating hormones, as well as maintenance of normal renal function, gastric mucosal integrity, and hemostasis. However, COX-2 is inducible in many cells in response to certain mediators of inflammation (e.g., interleukin-1, tumor necrosis factor, lipopolysaccharide, mitogens, and reactive oxygen intermediates). 

PHARMACOKINETICS

Diclofenac is rapidly absorbed when given orally. It is absorbed more slowly when given as enteric-coated tablets, especially when this dosage form is given with food. Although diclofenac given orally is almost completely absorbed, it is subject to first-pass metabolism so that about 50% of the drug reaches the systemic circulation in the unchanged form. Diclofenac is also absorbed percutaneously. At therapeutic concentrations it is more than 99% bound to plasma proteins. Diclofenac penetrates synovial fluid where concentrations may persist even when plasma concentrations fall; small amounts are distributed into breast milk. The terminal plasma half-life is about 1 to 2 hours. Diclofenac is metabolised to 4´-hydroxydiclofenac, 5-hydroxydiclofenac, 3´-hydroxydiclofenac and 4´, 5-dihydroxydiclofenac. It is then excreted in the form of glucuronide and sulfate conjugates, mainly in the urine (about 60%) but also in the bile (about 35%); less than 1% is excreted as unchanged diclofenac. 

INDICATIONS

Diclofenac is used for musculoskeletal complaints, especially arthritis (rheumatoid arthritis, osteoarthritis, spondylarthritis, ankylosing spondylitis), gout attacks, and pain management in case of kidney stones and gallstones. An additional indication is the treatment of acute migraines. Diclofenac is used commonly to treat mild to moderate post-operative or post-traumatic pain, particular when inflammation is also present, and is effective against menstrual pain. 

Patient Information: 

BEFORE YOU TAKE VDOFENDo not take VDOFEN 50 if you Have, or have ever had, peptic ulceration (ulcers in the stomach or duodenum) or bleeding in your digestive tract. - are pregnant or breastfeeding.- are allergic to diclofenac sodium, aspirin, ibuprofen or any other medicines used to treat painful conditions affecting the joints and muscles or to any of the inactive ingredients in this medicine.                

- have asthma, have you ever had an asthmatic attack, a skin reaction or a runny nose after taking aspirin or any other anti-inflammatory medicine (e.g. aspirin, ibuprofen). suffer from heart, liver or kidney disease, porphyria, Crohn’s disease or ulcerative colitishave or have you ever had bloody diarrhea. are suffer from any blood disorders including abnormal bleeding or bruising.

• Follow your doctors instructions exactly on how much VDOFEN 50 to take and when. The usual dose is one tablet 2 or 3 times a day.
• Take your tablets with food.
• Swallow the tablets whole - dont chew them.

• If you forget to take a tablet, take it as soon as you remember. But if it is almost time for your next tablet, do not take the tablet you have missed. Dont take more than one tablet at a time.
• These tablets are for you. You must not give them to other people.

WHAT TO DO IF AN OVERDOSE IS TAKEN

SIDE EFFECTS:

The following side effects have been reported with NSAIDs

  • Effects on the digestive system:  Peptic ulcers, perforation or gastrointestinal bleeding, nausea, vomiting, diarrhoea, flatulence, constipation, mouth ulcers. Less frequently, gastritis (inflamed stomach). Stop taking VDOFEN 50 and tell your doctor if you experience indigestion (heart burn), pains in your stomach or other abnormal stomach symptoms.

 • Allergic effects:  Anaphylaxis (an extreme allergic reaction), asthma, wheeziness, difficulty with breathing. Skin disorders e.g. rash, itch, urticaria (nettle rash), purpura (purple spots), swelling of face and tongue, eczema. If you have trouble breathing, become wheezy, notice any unusual swelling or have a blistering rash you should stop taking this medicine and see your doctor at once. 

 • Effects on the heart and blood vessels: Oedema (water retention/swelling).  

 • Effects on the kidney: Kidney failure, inflammation of the kidney. 

 • Effects on the liver: Liver problems such as jaundice or hepatitis (if you notice a yellowing of your skin or the white of your eyes, your urine becomes darker or your stools lighter in colour, see your doctor). 

 • Effects on the nervous system/special senses: Headache, visual disturbance, depression, confusion, hallucinations, ringing in ears, paraesthesia (numbness, tingling, itch), vertigo, dizziness, tiredness, drowsiness and malaise. If you notice symptoms such as stiff neck, headache, nausea and vomiting, consult your doctor. 

 • Effects on the blood: A decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting). The first signs you might notice could be bruising, bleeding, fever, unusually pale complexion or sore throat. Please see your doctor if you notice small red or purple spots on your skin as this could be a sign that your blood is not clotting properly.

• Effects on the skin: Skin rashes made worse by sunlight.  If these side effects or any other side effects are troublesome you should tell your doctor.