Each Sachet of Dicloban-K®  Effervescent Granules contains: 

• Diclofenac Potassium     50 mg  

Dicloban-K® is used in: 

• Postoperative inflammation and pain e.g. ( following dental or orthopedic surgery) .
• Painful post-traumatic pain, inflammatory states, e.g. sprains. 
• Painful and/or inflammatory gynaecological conditions, e.g., (primary dysmenorrhoea or adnexitis).  
• Migraine attacks. 
• An adjunct in severe painful inflammatory infections of the ear, nose, or throat, e.g. ( pharyngotonssillitis and otitis ).    
• Painful syndromes of the vertebral column. 
• Non-articular rheumatism. 

• Peptic and gastric ulcer, hypersensitivity to the components and other substances chemically strictly correlated to them and in particular hypersensitivity to aspirin .   
• Dicloban-K® is contraindicated in patients in whom attack of asthma,urticaria  or acute rhinitis are precipitated or worsened by aspirin or other NSAIDs.
• Dicloban-K® is also contraindicated in children less than 14 years age.

• When given concomitantly with preparations containing digoxin or lithium, Dicloban-K® may increase their plasma concentrations. 
• Many NSAIDs are capable of inhibiting the activity of diuretics, concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium level, thus these should necessarily be checked regularity.
• Although no data in clinical investigations suggested that Dicloban-K® could have anticoagulant  effect, there have been isolated reports of an increased risk of haemorrhage in patients receiving it.Dicloban-K® and an anticoagulant therapy concomitantly, close monitoring of such as patients is therefore  recommended.
• Like other NSAIDs, Dicloban-K® at high dosage (200mg) may temporarily inhibit platelet  aggregation.
• Clinical studies have shown that Diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both  hypoglycemic and hyperglycemic effect during treatment with Dicloban-K® necessitating changes in the antidiabetic drug dosage.
• Special caution is required when NSAIDs are administered less than 24hours before treatment with methotrexate, as blood concentrations of methotrexate can rise, increasing its toxicity.
• The effects of NSAIDs on renal prostaglandins may increase the nephrotoxicity of cyclosporine.

• During pregnancy, Dicloban-K®  may be administrated only after careful evaluation of risk/ benefit analysis and in any case, with the lowest effective dose. 
• Dicloban-K® may not be used during the third trimester of pregnancy owing to possibility of delaying delivery and slackening labour, it is necessary to underline the risk of hemorrhage that can arise from administration of NSAIDS during the terminal phase of pregnancy.
• After oral doses of 50mg every 8hours, Dicloban-K® excreted in breast milk is so small that adverse effects in the neonate are unlikely.

• Dicloban-K® is generally well tolerated.
• The most common side effects include disturbances like ( nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia, peptic ulcer) .

Overdose:

• The procedures of management to be adopted in case of acute poisoning with NSAIDs is essentially a procedure of supportive or symptomatic measures.
• In case of overdosage, it is necessary to prevent absorption as soon as possible by means of gastric lavage and activated charcoal.

* In post-traumatic pains, postoperative cases and in the treatment of severe acute osteoarticular rheumatic pain, the attack dose in adults is

• in the range of 100 - 150 mg per day divided into 2 - 3 divded doses .

* In milder cases as well as for adolescents over 14 years of age

• a dose ranging between 50 and 100 mg daily will generally suffice.

* In primary dysmenorrhea, the daily dosage, which should be individually adjusted is generally

• between 50 to 150 mg and, if necessary, it may be raised over the course of other menstrual cycles until it reaches a maximum of 200 mg daily.

* Migraine:

• An initial dose of 50 mg is recommended at the first sign of an impending attack, in cases where pain relief is inadequate approx. 2 hours after ingestion of the first dose a further dose of 50 mg may be taken. If necessary, further 50 mg dose may be taken at intervals of 4 - 6 hours, although a  total dose of 200 mg must not be exceeded within a 24 hours period .

* The content of the sachet is to be dissolved in a half glass of natural water preferably before meals.

As with other NSAIDs, Dicloban-K® should be used with caution:

• In patients with impaired hepatic or renal function.
• History of cardiovascular diseases and  peptic ulcer.

• Dicloban-K® 50 mg / sachet: Pack of 10 sachets .

• Store in a dry place at a temperature below  25ºC.
• Protect from moisture and light.