Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 2020-03-18
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Pink, circular, coated, biconvex tablets, diameter 6mm
inflammatory diseases of the musculoskeletal system, post-traumatic pain syndromes accompanied by inflammation, postoperative pain (short — term-up to 7 days treatment of pain syndrome),
In the treatment of soft tissue injuries, the transdermal Diclof patch
In / m, slowly, 75 mg (3 ml) 1 time a day.
In primary dysmenorrhea®
Rapid should not be used in children and adolescents under 14 years of age, if it is necessary to treat this category of patients, the drug Voltaren
Hypersensitivity, including in the anamnesis, peptic ulcer disease, pregnancy (I-th trimester).
erosive and ulcerative changes of the gastric or duodenal mucosa, active gastrointestinal bleeding,
progressive kidney disease,
congestive heart failure,
dyslipidemia / hyperlipidemia,
Creatinine Cl <60 ml / min,
The use of Diclofenac potassium with concomitant 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. The elderly have increased frequency of adverse reactions to NSAIDs especially gastro intestinal bleeding and perforation which may be fatal. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.
Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders, with a history suggestive of gastric or intestinal ulceration, bleeding or perforation, with ulcerative colitis, or with Crohn's disease as these conditions may be exacerbated.
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
GI bleeding (haematemesis, melaena), ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.).
Caution should be advised in patients receiving concomitant medications which increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin.
When GI bleeding or ulceration occurs in patients receiving diclofenac potassium, the treatment should be withdrawn.
As with other non-steroidal anti-inflammatory drugs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur without earlier exposure to the drug.
Like other NSAIDs, Diclofenac Potassium tablets may mask the signs and symptoms of infection due to their pharmacodynamic properties.
SLE and mixed connective tissue disease
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
Cardiovascular, Renal and Hepatic Impairment
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. As fluid retention and oedema have been reported in association with NSAIDs therapy, including diclofenac, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery. Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation therapy is usually followed by recovery to the pre-treatment state.
Close medical surveillance is required when prescribing diclofenac to patients with impairment of hepatic function as their condition may be exacerbated.
As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged treatment with Diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Diclofenac Potassium tablets should be discontinued.
Hepatitis may occur without prodromal symptoms.
Use of Diclofenac Potassium tablets in patients with hepatic porphyria may trigger an attack.
Diclofenac Potassium tablets may reversibly inhibit platelet aggregation. Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.
Long term treatment
All patients who are receiving long term treatment with non-steroidal, anti-inflammatory agents should be monitored as a precautionary measure eg renal function, hepatic function (elevation of liver enzymes may occur) and blood counts. This is particularly important in the elderly.
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 on 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.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a previous history of bronchial asthma.
Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy including diclofenac.
Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high dose (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease and with significant risk factors for cardiovascular events (e.g. hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including Diclofenac Potassium. Patients appear to be at the 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. Diclofenac Potassium tablets should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Impaired female fertility
The use of Diclofenac Potassium tablets may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Diclofenac Potassium tablets should be considered.
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
Adverse reactions that develop often - >1/100, sometimes - <1/100–>1/1000, rarely - <1/1000.
often — NSAID-gastropathy (gastralgia and discomfort in the epigastric region, nausea, a feeling of overflow of the stomach, belching, heartburn, diarrhea, abdominal pain, flatulence), erosive and ulcerative lesions of the gastrointestinal tract, perforation of the intestinal wall, bleeding from the gastrointestinal tract, dry mouth, constipation, pancreatitis, toxic hepatitis, sometimes-vomiting, decreased appetite or anorexia, stomatitis, glossitis.
often-fluid retention, sometimes-dysmenorrhea, hematuria, cystitis, pollakiuria, proteinuria, interstitial nephritis, nephrotic syndrome, oliguria or anuria, acute renal failure, peripheral edema.
(gel for external use 1%). 99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%).
Relevant information on the safety of Diclofenac Potassium Tablets is included in previous sections of this Summary of Product Characteristics.
Silica colloidal anhydrous
Sodium starch glycollate
Calcium hydrogen phosphate anhydrous
Polyvinyl alcohol partially hydrolysed
Titanium dioxide E171
Lecithin Soya E322
Iron Oxide red E172
Iron Oxide yellow E172
Xanthan gum E415
Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Concomitant use with paracetamol increases the risk of developing the nephrotoxic effects of diclofenac.
Keep out of reach of children.5 лет.
Not applicable.Administrative data
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