Short-term treatment in the following acute conditions:

• Post-traumatic pain, inflammation, and swelling, such as sprains
• Post-operative pain, inflammation, and swelling following dental or orthopaedic surgery
• Painful and inflammatory gynaecological conditions, such as primary dysmenorrhoea or adnexitis
• Migraine attacks
• Painful syndromes of the vertebral column
• Non-articular rheumatism
• As an adjunct in severe painful inflammatory infections of the ear, nose, or throat, such as pharyngotonsillitis and otitis

The mechanism of action of Diclofenac Potassium, like other non-steroidal anti-inflammatory drugs (NSAIDs), is not completely understood but is mainly related to inhibition of cyclooxygenase enzymes (COX-1 and COX-2).

Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Therapeutic concentrations of diclofenac produce similar effects in vivo. Prostaglandins sensitize afferent nerves and enhance the action of bradykinin in producing pain. Since prostaglandins are important mediators of inflammation, the anti-inflammatory and analgesic effects of diclofenac are mainly due to reduced prostaglandin synthesis in peripheral tissues.

Adults: Following an initial loading dose of 50 mg, 25–50 mg is to be taken every eight hours if necessary.

Migraine: An initial loading dose of 50 mg, then if necessary a further 25–50 mg after 2 hours. The maximum daily dose is 150 mg. The tablets should be swallowed whole with liquid, preferably before meals.

Children: Children over 14 years of age: up to 75 mg daily in divided doses.

Diclofenac may interact with the following medicines:

• Lithium and Digoxin: Diclofenac may increase the plasma concentrations of lithium and digoxin.
• Anticoagulants: Combined use with anticoagulant therapy may increase the risk of haemorrhage.
• Cyclosporin: Concomitant use with cyclosporin may increase the risk of nephrotoxicity.
• Methotrexate: Serious toxicity may occur if methotrexate and NSAIDs are administered within 24 hours of each other.
• Diuretics: Diclofenac may reduce the effectiveness of diuretics.
• Other NSAIDs and Steroids: Concurrent use with other systemic NSAIDs or steroids may increase the frequency of adverse effects.

Diclofenac Potassium tablets are contraindicated in patients with known hypersensitivity to diclofenac. It should not be administered to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe and occasionally fatal anaphylactic-like reactions have been reported in such patients. Diclofenac is also contraindicated for the treatment of perioperative pain in patients undergoing coronary artery bypass graft (CABG) surgery.

Side effects of Diclofenac are usually mild and temporary. However, if serious adverse effects occur, Diclofenac should be discontinued. Occasional: Epigastric pain; other gastrointestinal disturbances (e.g., nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence, anorexia). Rare: Gastrointestinal bleeding, peptic ulcer (with or without bleeding or perforation), bloody diarrhoea.

Diclofenac should not be used during pregnancy unless clearly necessary. If prescribed during pregnancy, the lowest effective dose should be used. Use of this type of medicine is not recommended during the last trimester of pregnancy. Very small amounts of diclofenac may pass into breast milk; however, harmful effects in breastfed infants are not expected.

Drugs for osteoarthritis, drugs used for rheumatoid arthritis, non-steroidal anti-inflammatory drugs (NSAIDs).

Store below 30°C, protected from light and moisture. Keep out of the reach of children.