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    Active Ingredient
    Diclofenac Sodium 50 mg, 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Suppositories

    10 X 50 mg

    full basket chart 7107 1009

    Sustained-Release Tablets

    10 X 100 mg

    full basket chart 7790 1805

    Sustained-Release Tablets

    20 X 100 mg

    full basket chart 7789 1804

    Related information


    Dosage

    As a general recommendation, the dose should be given for the shortest possible duration. Because of their dosage strength, it is not suitable for children and adolescents. Generally 2 suppositories daily are recommended, usually administered at night. In more severe cases, combined therapy with tablets is recommended. The daily dose should not exceed 150 mg of diclofenac.
    Elderly: Although the pharmacokinetics are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight and the patient should be monitored for GI bleeding during NSAID therapy.
    Renal impairment: Diclofenac is contraindicated in patients with severe renal impairment. No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate renal impairment.
    Hepatic impairment: Diclofenac is contraindicated in patients with severe hepatic impairment. No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment.     


    Indications

    Rheumatoid arthritis, osteoarthritis, low back pain and other acute musculoskeletal disorders such as periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains and dislocation, ankylosing spondylitis and acute gout. Control of pain and inflammation in orthopedic, dental, and other minor surgery.


    Contra-Indications

    Known hypersensitivity to the active substance or to any of the excipients. Active gastric or intestinal ulcer, bleeding or perforation. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy. Last trimester of pregnancy. Severe hepatic and renal failure. Established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease. Because of potential cross-sensitivity to other NSAIDs, diclofenac sodium should not be used in patients in whom aspirin or other NSAIDs have induced symptoms of asthma, acute rhinitis precipitated by ibuprofen, urticaria, nasal polyps, angioedema, bronchospasm and other symptoms of allergic reactions (anaphylactoid reactions have occurred in such patients). Patients with severe heart failure. The drug is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.      


    Special Precautions

    General: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. The concomitant use of diclofenac with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.Caution is indicated in the elderly on basic medical grounds.
    Arterial thrombotic events: Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg daily) and in long-term treatment. Patients with cardiovascular disease or with significant risk for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) may also be at greater risk and should only be treated with diclofenac after careful consideration. To minimise the potential risk of an adverse cardiovascular event in patients taking an NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically. There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.
    Hypertension: NSAIDs may lead to the onset of new hypertension or worsening of pre-existing hypertension and patients taking anti-hypertensives with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.
    Heart failure: Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure. Use of diclofenac suppositories may cause local reactions including itching, burning and increased frequency of bowel movement. Diclofenac Suppositories should be used with caution in patients with painful or irritable anorectal conditions.
    Pre-existing asthma: In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions or NSAIDs like asthma exacerbations (so-called intolerance to analgesics/analgesics-asthma), Quincke’s oedema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such patients (readiness for emergency). This is applicable as well for patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticaria.
    Gastrointestinal effects: Gastrointestinal bleeding (haematemesis, melaena), ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be withdrawn. As with all NSAIDs, close medical surveillance is imperative and particular caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation. The risk of GI bleeding is higher with increasing NSAIDs doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly. The elderly have increased frequency of adverse reactions to NSAIDs especially gastro intestinal bleeding and perforation which may be fatal.
    Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low-dose acetylsalicylic acid (ASA)/aspirin or other medicinal products likely to increase gastrointestinal risk. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors.
    Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn’s disease, as their condition may be exacerbated.
    Hepatic Effects: Close medical surveillance is required when prescribing diclofenac to patients with impairment of hepatic function as their condition may be exacerbated. Hepatitis may occur with diclofenac without prodromal symptoms. Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.
    Severe skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported very rarely in association with the use of NSAIDs, including diclofenac. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity, and this drug should be discontinued.
    Systemic lupus erythematosus and mixed connective tissue disease: In patients with systemic lupus erythematosus and mixed connective tissue disorders there may be an increased risk of aseptic meningitis. Aseptic meningitis with fever and coma has been observed on rare occasions in patients on NSAID therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. If signs or symptoms of meningitis develop in a patient on ibuprofen, the possibility of its being related to ibuprofen should be considered.
    Patients Who Require Surgery (Including Dental Surgery: Caution is recommended in patients who require surgery. Most of the nonsteroidal anti-inflammatory agents inhibit platelet aggregation and may prolong bleeding time, which may increase intra-and postoperative bleeding. Consideration should therefore be given to discontinuing NSAIAs treatment for an appropriate length of time prior to elective surgery, depending on the potency and duration of effect of the individual agent on platelet aggregability. In case of patients requiring dental surgery, nonsteroidal anti-inflammatory agents may cause soreness, irritation, or ulceration of the oral mucosa. Most of the nonsteroidal anti-inflammatory agents may rarely cause leukopenia and/or thrombocytopenia, which may result in an increased incidence of microbial infection, delayed healing, and gingival bleeding. If leukopenia or thrombocytopenia occurs, dental work should be deferred until blood counts return to normal, and patients should be instructed in proper oral hygiene.
    For full details see prescribing information.


    Side Effects

    Headache, dizziness, Transaminases increased, Rash, Vertigo, Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
    For full details see prescribing information.


    Drug interactions

    Potent CYP2C9 inhibitors: Caution is recommended when co-prescribing diclofenac with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of diclofenac metabolism.
    Lithium: If used concomitantly, diclofenac may raise plasma concentrations of lithium. Monitoring of the serum lithium level is recommended.
    Digoxin: If used concomitantly, diclofenac may raise plasma concentrations of digoxin. Monitoring of the serum digoxin level is recommended.
    Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing drugs may be associated with increased serum potassium levels, which should therefore be monitored frequently.
    Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids: Concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of gastrointestinal undesirable effects. Avoid concomitant use of 2o or more NSAIDs.
    Anticoagulants and anti-platelet agents: Caution is recommended since concomitant administration could increase the risk of bleeding. Although clinical investigations do not appear to indicate that diclofenac affects the action of anticoagulants, there are isolated reports of an increased risk of haemorrhage in patients receiving diclofenac and anticoagulants concomitantly. Close monitoring of such patients is therefore recommended.
    Selective serotonin reuptake inhibitors (SSRIs): Concomitant administration of systemic NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding.
    Antidiabetics: 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 hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. For this reason, monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.
    Methotrexate: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.
    Ciclosporin and Tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin. There is also a possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
    Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.
    Drugs known to cause hyperkalemia: Concomitant treatment with potassium-sparing diuretics, ciclosporin, tacrolimus or trimethoprim may be associated with increased serum potassium levels, which should therefore be monitored frequently.
    Phenytoin: When using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.
    Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. This might be mediated through renal antiprostagladin effects of both NSAID and calcineurin inhibitor.
    Colestipol and cholestyramine: These agents can induce a delay or decrease in absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before or 4 to 6 hours after administration of colestipol/ cholestyramine.
    Probenecid: Probenecid may increase the plasma levels of some NSAIDs. The possibility of a drug interaction with diclofenac exists.
    Antacids: Concomitant administration of diclofenac and an aluminium and magnesium hydroxide antacid may result in delayed diclofenac absorption; however, extent of absorption is not affected.
    Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: The use of diclofenac in pregnant women has not been studied. Therefore, it should not be used during the first two trimesters of pregnancy unless the potential benefit to the mother outweights the risk to the foetus. As with other NSAIDs, use during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus. Animal studies have not shown any directly or indirectly harmful effects on pregnancy, embryonal/fetal development, parturition or postnatal development. See prescribing information for full details.
    Lactation: Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, diclofenac should not be administered during breast feeding in order to avoid undesirable effects in the infant. See prescribing information for full details.
    Fertility: As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.
    For full details see prescribing information.


    Overdose

    Symptoms: There is no typical clinical picture resulting from diclofenac overdose. Overdose can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
    Therapeutic Measures: Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Special measures such as forced diuresis, dialysis, or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism. Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
    Licence holder
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