gastric lavage, administration of activated charcoal, symptomatic therapy.
36 months
stomach ulcer, inflammatory bowel disease in the acute stage (ulcerative colitis, Crohn's disease), ulcerative bleeding or perforation,
erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase),
Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Concomitant use with paracetamol increases the risk of developing the nephrotoxic effects of diclofenac.
Hypoglycemic agents-hypo-or hyperglycemia may occur. With this combination of drugs, it is necessary to control the level of sugar in the blood.
Silica colloidal anhydrous
Sodium starch glycollate
Povidone
Starch maize
Calcium hydrogen phosphate anhydrous
Magnesium stearate
Tablet Coating:
Polyvinyl alcohol partially hydrolysed
Titanium dioxide E171
Talc
Lecithin Soya E322
Iron Oxide red E172
Iron Oxide yellow E172
Xanthan gum E415
very rarely — palpitations, tachycardia, extrasystole, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction.
often-headache, dizziness, rarely-drowsiness, very rarely-paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, cerebrovascular disorders.
very rarely — palpitations, pain behind the sternum, heart failure, myocardial infarction, hypertension, vasculitis.
often-increased blood pressure, sometimes-arrhythmia, cardialgia, decreased blood pressure, rarely - pain behind the sternum, nosebleeds, aggravation of congestive heart failure.
Allergic reactions:
Relevant information on the safety of Diclofenac Potassium Tablets is included in previous sections of this Summary of Product Characteristics.
back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica),
joint pain (finger joints, knee joints, etc.) in rheumatoid arthritis, osteoarthritis,
Sugar-coated tablets, 12.5 mg
lumbago, sciatica, neuralgia, myalgia, tendovaginitis, bursitis,
®
The plasma concentration is 1-2 hours. Four metabolites, including two active ones, also have a short T - 1-3 h. One metabolite-3' - hydroxy-4 ' - methoxydiclofenac-has a longer half-life, but is inactive. Diclofenac and its metabolites are mainly excreted in the urine.
within 24 hours, similar to that when using an equivalent amount of the drug 3-A Ofteno
In patients with impaired renal function, accumulation of diclofenac and its metabolites does not occur. In patients with chronic hepatitis or non-compensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as in patients without liver disease. Preclinical studies have shown the safety of using the drug.
50% of the active substance is metabolized during the first passage through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation with glucuronic acid. The enzyme system P450CUR2C9 participates in the metabolism of the drug. The pharmacological activity of the metabolites is lower than that of diclofenac.
In patients with severe renal impairment (creatinine Cl <10 ml / min), the time of excretion of metabolites with bile increases, but no increase in blood concentration is observed.
23/10/2017
Diclofenac Potassium 25 mg Tablets
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Each package contains 5, 10, 20 tablets in a blister.
PL 20075/0682
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.
Elderly
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.
Gastrointestinal
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.
Hypersensitivity reactions
As with other non-steroidal anti-inflammatory drugs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur without earlier exposure to the drug.
Infection
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.
Hepatic
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.
Haematological
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.
Respiratory disorders
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.
Dermatological
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.
do not chew, wash down with a sufficient amount of liquid.
Adults are prescribed an initial daily dose of 100-150 mg. The daily dose is usually distributed in 2-3 doses.
Not applicable.
Administrative dataM01AB05 Diclofenac
January 2011
