Instructions for use Diclofenac Euro tablets 50 mg No. 100
Composition
active ingredient: diclofenac sodium;
1 tablet contains diclofenac sodium 50 mg;
Excipients: lactose monohydrate, corn starch, talc, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, methacrylate copolymer dispersion, sodium hydroxide, diethyl phthalate, polysorbate 80 (Tween 80), titanium dioxide (E 171), Sunset Yellow FCF dye (E 110).
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: round biconvex orange tablets in an enteric-coated shell.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs.
ATX code M01A B05.
Pharmacological properties
Pharmacodynamics.
Diclofenac sodium - the active substance of the drug, is a non-steroidal compound with pronounced antipyretic, analgesic and anti-inflammatory properties. Diclofenac sodium as a non-selective inhibitor of COX-1 and COX-2 disrupts the metabolism of arachidonic acid and inhibits the biosynthesis of prostaglandins by inhibiting the activity of the prostaglandin synthetase enzyme and thus significantly reduces the manifestation of symptoms of inflammation and increased sensitivity of nerve endings to mechanical irritation and the action of biologically active substances formed at the site of inflammation.
In rheumatic diseases, the anti-inflammatory and analgesic effect of Diclofenac Euro reduces the severity of pain (both at rest and during movement), morning stiffness, and joint swelling, thereby improving the patient's functional status.
In injuries and in the post-traumatic period, diclofenac reduces pain and inflammatory swelling.
In vitro, diclofenac sodium at concentrations equivalent to those achieved in the treatment of patients does not inhibit the biosynthesis of cartilage proteoglycans.
Pharmacokinetics.
Diclofenac is rapidly and completely absorbed from enteric-coated tablets. After a single oral dose of Diclofenac Euro at a dose of 50 mg, the maximum concentration (Cmax) is reached after approximately 2–3 hours and is 1.5 μg/ml. The concentration of the substance in the blood plasma is linearly proportional to the dose. No changes in the pharmacokinetics of diclofenac were observed with repeated administration; the drug does not accumulate if the patient adheres to the recommended interval between doses.
The bioavailability of diclofenac is 50%. Binding to blood proteins is 95–98% (mainly to albumin). Diclofenac Euro penetrates into the synovial fluid, where the maximum concentration is reached 2–4 hours later than in blood plasma. The half-life from the synovial fluid is 3–6 hours (the concentration of the active substance in the synovial fluid 4–6 hours after application of the drug is higher than in blood plasma and remains higher for the next 12 hours).
50% of the active substance is metabolized by the "first pass" through the liver. The area under the "concentration-time" curve (AUC) after oral administration is approximately half of the area in the case of parenteral administration of the same dose. The metabolism of diclofenac occurs mainly due to single hydroxylation and conjugation with glucuronic acid. The P450 CYP2C9 enzyme system is also involved in the metabolism of the drug. The pharmacological activity of the metabolites is lower than that of diclofenac.
The systemic clearance of diclofenac is 260 ml/min. The half-life from blood plasma is 1–2 hours. 60% of the dose is excreted in the form of metabolites by the kidneys with urine, in the form of a glucuronide conjugate of the intact molecule and in the form of metabolites, most of which are also converted to glucuronide conjugates; less than 1% is excreted unchanged; the rest of the dose is excreted in the form of metabolites with bile.
In patients with severe renal impairment (creatinine clearance less than 10 ml/min), the proportion of metabolites excreted in bile increases, and the estimated steady-state plasma concentrations of hydroxylated metabolites were approximately 4 times higher than in healthy volunteers. No significant changes in the pharmacokinetics of diclofenac were observed in the elderly and in patients with chronic hepatitis and compensated cirrhosis.
Indication
Inflammatory and degenerative forms of rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis);
pain syndromes in the spine;
rheumatic diseases of extra-articular soft tissues;
acute attacks of gout;
post-traumatic and postoperative pain syndromes accompanied by inflammation
and swelling, for example after dental and orthopedic interventions;
pain and/or inflammation accompanying inflammatory gynecological diseases, such as primary dysmenorrhea or adnexitis;
as an adjuvant for severe inflammatory diseases of the ENT organs, which are accompanied by pain, for example, with pharyngotonsillitis, otitis.
In accordance with generally accepted approaches to the treatment of infectious and inflammatory diseases, it is also necessary to use etiotropic agents. Fever itself is not an indication for the use of the drug.
Contraindication
acute gastric ulcer and/or duodenal ulcers, gastrointestinal bleeding or perforation;
history of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs);
active ulcer/bleeding or history of recurrent ulcer/bleeding (two or more separate episodes of diagnosed ulcer or bleeding);
inflammatory bowel disease (Crohn's disease or ulcerative colitis);
the last trimester of pregnancy;
liver failure;
renal failure (glomerular filtration rate (GFR) < 15 ml/min/1.73 m2);
congestive heart failure (II–IV functional class according to the New York Heart Association NYHA criteria);
ischemic heart disease in patients with angina pectoris who have had a myocardial infarction;
cerebrovascular disease in patients who have had a stroke or have episodes of transient ischemic attacks;
peripheral artery disease;
treatment of perioperative pain during coronary artery bypass grafting (or the use of a cardiopulmonary bypass machine);
Like other NSAIDs, diclofenac is also contraindicated in patients in whom the use of ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs provokes attacks of bronchial asthma, angioedema, urticaria or acute rhinitis, nasal polyps and other allergic symptoms.
Interaction with other medicinal products and other types of interactions
The following types of interactions have been observed with the use of Diclofenac Euro and/or diclofenac in other dosage forms and doses.
Lithium: Diclofenac may increase the concentration of lithium in the blood plasma when used concomitantly. Monitoring of serum lithium levels is recommended.
Digoxin: Diclofenac may increase plasma digoxin concentrations when used concomitantly. Monitoring of serum digoxin levels is recommended.
Diuretics and antihypertensives. Concomitant use of NSAIDs, in particular diclofenac, and diuretics or antihypertensive drugs [e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors] may reduce the antihypertensive effect by inhibiting the synthesis of vasodilator prostaglandins. Therefore, the combination of these drugs should be used with caution, especially in elderly patients: blood pressure should be carefully monitored. Patients should receive adequate fluid intake and renal function should be monitored after initiation of combination therapy and regularly thereafter, especially when diuretics and ACE inhibitors are used, due to the increased risk of nephrotoxicity.
Drugs causing hyperkalemia: Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may cause an increase in serum potassium levels, therefore patients should be monitored more frequently.
Anticoagulants and antithrombotic agents should be administered with caution, as the risk of bleeding increases with concomitant use of diclofenac. Although clinical studies do not indicate that diclofenac affects the action of anticoagulants, there are isolated reports of an increased risk of bleeding in patients receiving diclofenac and anticoagulants simultaneously. Therefore, careful monitoring of these patients is recommended to ensure that no changes in the dosage of anticoagulants are necessary. Like other nonsteroidal anti-inflammatory drugs, diclofenac in high doses may temporarily inhibit platelet aggregation.
Other NSAIDs, including selective cyclooxygenase-2 inhibitors, and corticosteroids. Concomitant use of diclofenac with other systemic NSAIDs or corticosteroids may increase the incidence of gastrointestinal adverse reactions (gastrointestinal bleeding or ulceration). The simultaneous use of two or more NSAIDs should be avoided.
Selective serotonin reuptake inhibitors (SSRIs): Concomitant administration of systemic NSAIDs, including diclofenac, and SSRIs increases the risk of gastrointestinal bleeding.
Antidiabetic drugs. Clinical studies have shown that diclofenac can be administered concomitantly with oral antidiabetic drugs without affecting their clinical effect. However, there are some reports of the development of both hypoglycemia and hyperglycemia in such cases, which necessitated the need to change the dose of antidiabetic drugs during the use of diclofenac. For this reason, it is recommended to monitor blood glucose levels during combination therapy.
Methotrexate. Diclofenac may inhibit the renal tubular clearance of methotrexate, leading to increased methotrexate levels. NSAIDs should be used with caution at least 24 hours before or after treatment with methotrexate, as methotrexate blood concentrations may increase and increase toxicity. Serious toxicity has been reported when the interval between administration of methotrexate and NSAIDs, including diclofenac, was within 24 hours. This interaction is mediated by accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs.
Cyclosporine. Diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine due to its effects on renal prostaglandins, therefore diclofenac should be used in doses lower than for patients not taking cyclosporine.
Tacrolimus: The use of NSAIDs with tacrolimus increases the risk of nephrotoxicity, which may be mediated through the renal antiprostaglandin effects of the NSAID and the calcineurin inhibitor.
Quinolone antibiotics. There have been isolated reports of convulsions, which may be associated with the concomitant use of quinolones and NSAIDs. Convulsions may occur in patients with or without a history of epilepsy and seizures. Therefore, caution should be exercised when considering the use of a quinolone in patients already receiving NSAIDs.
Phenytoin: When using phenytoin concomitantly with diclofenac, it is recommended to monitor phenytoin plasma concentrations due to a possible increase in phenytoin exposure.
Colestipol and cholestyramine. These drugs may delay or reduce the absorption of diclofenac. Therefore, it is recommended that diclofenac be administered at least 1 hour before or 4–6 hours after colestipol/cholestyramine.
Cardiac glycosides. Concomitant use of cardiac glycosides and NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma glycoside levels.
Mifepristone: NSAIDs should not be used for 8–12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.
Potent CYP2C9 inhibitors: Diclofenac and CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole) should be co-administered with caution, as there may be a significant increase in peak plasma concentrations and effects of diclofenac due to inhibition of diclofenac metabolism.
CYP2C9 inducers: Caution is required when administering diclofenac concomitantly with CYP2C9 inducers (e.g. rifampicin). This may lead to a significant reduction in plasma concentrations and efficacy of diclofenac.
Application features
To minimize undesirable effects, treatment should be initiated at the lowest effective dose and continued for the shortest period necessary to control symptoms.
The concomitant use of Diclofenac and other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the lack of any evidence of a synergistic effect and due to potential additive side effects.
Placebo-controlled studies have shown an increased risk of thrombotic cardiovascular and cerebrovascular complications with the use of certain selective COX-2 inhibitors. A direct correlation of this risk with the selectivity of individual NSAIDs for COX-1/COX-2 has not yet been established. In the absence of comparable clinical trial data on long-term treatment with maximum doses of diclofenac, such an increased risk cannot be excluded. Before prescribing diclofenac, a careful risk-benefit assessment should be carried out in patients with clinically proven ischemic heart disease, cerebrovascular disorders, occlusive peripheral arterial disease or significant risk factors (such as arterial hypertension, hyperlipidemia, diabetes mellitus, smoking). The lowest effective dose should be used for the shortest possible duration of treatment.
The renal effects of NSAIDs include fluid retention with oedema and/or hypertension. Therefore, diclofenac should be used with caution in patients with impaired cardiac function and other conditions predisposing to fluid retention. Caution is also required if the patient is taking diuretics or ACE inhibitors concomitantly or is prone to hypovolaemia.
The effects are generally more severe in elderly patients. Caution should be exercised when prescribing the drug to elderly patients (over 65 years of age). In particular, it is recommended to use the lowest effective dose in frail elderly patients and patients with low body weight.
If gastrointestinal bleeding or ulceration occurs in patients receiving Diclofenac, its use should be discontinued.
When using diclofenac, as with other NSAIDs, allergic reactions (including anaphylactic/anaphylactoid reactions) may rarely develop, even without prior exposure to diclofenac.
Like other NSAIDs, Diclofenac Euro, due to its pharmacodynamic properties, may mask the signs and symptoms of infection.
Diclofenac Euro enteric-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Diclofenac Euro.
Effects on the digestive tract (GT).
Gastrointestinal bleeding (hemorrhage, melena), ulceration or perforation, which can be fatal, have been reported with all NSAIDs, whether COX-2 selective or not, including diclofenac, and can occur at any time during treatment with or without warning symptoms or a previous history of serious gastrointestinal events. These events are usually more severe in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be discontinued.
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
As with other NSAIDs, close medical supervision and special caution are necessary when prescribing Diclofenac Euro to patients with symptoms suggestive of gastrointestinal disorders, or with a history of ulceration, bleeding or perforation of the stomach or intestines. The risk of gastrointestinal bleeding increases with increasing NSAID doses, as well as in patients with a history of ulceration, especially if complicated (bleeding or perforation), and in elderly patients. To reduce the risk of gastrointestinal toxicity in such patients, treatment should be initiated and maintained at the lowest effective dose. For such patients, as well as for patients who require concomitant use of acetylsalicylic acid (ASA/aspirin) or other drugs that increase the risk of gastrointestinal adverse effects, combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered.
Patients with a history of TT toxicity, especially the elderly, should report any unusual abdominal symptoms (especially TT bleeding) to their physician. Caution should be exercised in prescribing the drug to patients who are concomitantly taking medications that increase the risk of ulceration or bleeding (systemic corticosteroids, anticoagulants (e.g. warfarin), antithrombotic agents (e.g. ASA), or selective serotonin reuptake inhibitors).
The use of NSAIDs, including diclofenac, may be associated with an increased risk of gastrointestinal anastomotic leakage. Close supervision and caution are recommended when using diclofenac after gastrointestinal surgery.
Effect on the liver.
Patients with liver impairment should be monitored closely as their condition may worsen.
NSAIDs, including diclofenac, may cause elevations in liver enzymes. The elevations were generally reversible upon discontinuation of the drug.
This phenomenon was observed very frequently with diclofenac in clinical trials (approximately 15% of patients), but was very rarely accompanied by clinical symptoms. In most cases, increases to borderline levels occurred. Moderate increases (≥ 3 to < 8 times the upper limit of normal) were common (2.5% of cases), while the frequency of severe increases (≥ 8 times the upper limit of normal) remained at approximately 1%. Elevated liver enzymes were accompanied by clinically significant liver damage in 0.5% of cases in the above-mentioned clinical trials.
It should be noted that Diclofenac Euro is recommended for short-term treatment only (no more than 2 weeks). In the case of long-term use of diclofenac, regular monitoring of liver function and liver enzyme levels is a precautionary measure. The use of this drug should be discontinued if liver function is impaired or worsened, if clinical signs or symptoms suggestive of liver disease develop, or if other symptoms occur, such as eosinophilia or rash.
In addition to elevated liver enzymes, rare cases of severe liver reactions have been reported, including jaundice, fulminant hepatitis, hepatic necrosis and hepatic failure, which in some cases have resulted in fatalities.
Diseases such as hepatitis may present without prodromal symptoms. Diclofenac should be used with caution in patients with hepatic porphyria due to the possibility of provoking an attack.
Effect on the kidneys.
NSAIDs, including diclofenac, reduce levels of prostaglandins, which are important for maintaining renal blood flow.
impaired cardiac or renal function, a history of arterial hypertension, elderly patients, patients who are simultaneously using diuretics or drugs that significantly affect renal function, as well as patients with a significant decrease in extracellular fluid volume for any reason, for example, before/after surgery. When prescribing Diclofenac Euro in such cases, renal function should be monitored. Discontinuation of therapy usually leads to a return to the state that preceded treatment.
Effects on the skin
Serious skin reactions (some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported very rarely with the use of NSAIDs, including Diclofenac. Patients are at highest risk of developing these reactions at the beginning of therapy: the onset of the reaction is noted in most cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
SLE and mixed connective tissue diseases: Patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases are at increased risk of developing aseptic meningitis.
Cardiovascular and cerebrovascular effects.
Treatment with Diclofenac Euro is generally not recommended for patients with diagnosed cardiovascular diseases (heart failure, ischemic heart disease, peripheral artery disease) or uncontrolled arterial hypertension.
Diclofenac should be prescribed to patients with significant risk factors for cardiovascular events (such as hypertension, hyperlipidemia, diabetes mellitus, smoking) only after careful clinical evaluation and only at doses up to 100 mg per day for a course of treatment of more than 4 weeks. Since the cardiovascular risks increase with increasing dose and duration of treatment with diclofenac, it should be used for the shortest possible period and at the lowest effective dose. The patient's need for diclofenac to relieve symptoms and the response to therapy should be periodically reviewed, especially when treatment lasts more than 4 weeks.
For patients with a history of hypertension and/or mild to moderate congestive heart failure, appropriate monitoring and advice is necessary, as fluid retention and oedema have been reported in association with the use of NSAIDs, including diclofenac.
Diclofenac should be used with caution in patients taking concomitant diuretics or ACE inhibitors and in patients at increased risk of hypovolemia.
Clinical trial data and epidemiological data suggest that the use of diclofenac, especially at high doses (150 mg/day) and for long periods, slightly increases the risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
It is not recommended to prescribe diclofenac to patients with uncontrolled arterial hypertension, congestive heart failure, stable ischemic heart disease, peripheral artery disease and/or cerebrovascular disease; if necessary, use is possible only after a careful risk-benefit assessment, only at a dosage of no more than 100 mg per day for no more than 4 weeks.
Patients should be informed of the possibility of serious thrombotic events (chest pain, shortness of breath, weakness, speech disorders) occurring at any time during treatment. In this case, a doctor should be consulted immediately.
Effect on hematological parameters.
The drug Diclofenac Euro is recommended for short-term treatment only. If this drug is prescribed for a longer period, it is recommended (as with other NSAIDs) to regularly monitor the blood count.
Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation, therefore, patients with impaired hemostasis, hemorrhagic diathesis or hematological disorders should be carefully monitored.
History of asthma.
Patients with bronchial asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps), chronic obstructive pulmonary disease (COPD) or chronic respiratory tract infections (especially those associated with allergic rhinitis-like symptoms) are more likely than other patients to experience side effects such as exacerbation of bronchial asthma (so-called analgesic intolerance or analgesic asthma), angioedema, urticaria when taking NSAIDs. In this regard, special precautions are required (readiness to provide emergency care). The above also applies to patients with allergic manifestations when using other drugs, e.g.: rash, itching, urticaria.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other NSAIDs can provoke the development of bronchospasm when used in patients suffering from bronchial asthma or in patients with a history of bronchial asthma.
The drug contains the dye sunset yellow FCF (E 110), which may cause allergic reactions.
Use during pregnancy or breastfeeding
Pregnancy. From the 20th week of pregnancy, the use of Diclofenac Euro may cause oligohydramnios due to fetal renal dysfunction. This may occur soon after the start of treatment and is usually reversible after discontinuation of treatment. Diclofenac Euro should not be used during the first and second trimesters of pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. For a woman attempting to conceive, or during the first or second trimester of pregnancy, the dose should be kept as low and the duration of treatment as short as possible. Antenatal monitoring for oligohydramnios should be considered after exposure to Diclofenac Euro for several days, starting from the 20th week of pregnancy. Diclofenac Euro should be discontinued if oligohydramnios is detected.
Like other NSAIDs, the drug is contraindicated in the third trimester of pregnancy (possible suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus) (see section "Contraindications").
Inhibition of prostaglandin synthesis may adversely affect the course of pregnancy and/or embryo/foetal development. Epidemiological data suggest an increased risk of miscarriage and/or cardiac malformations and gastroschisis following exposure to a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations has been increased from less than 1% to approximately 1.5%.
It is possible that the risk increases with increasing dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo/fetal lethality.
In addition, an increased incidence of various malformations, including those of the cardiovascular system, was recorded in animals treated with a prostaglandin synthesis inhibitor during organogenesis.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may affect the fetus in the following ways:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
renal impairment (see above).
Effects of prostaglandin synthesis inhibitors on the mother and newborn, as well as at the end of pregnancy:
possible prolongation of bleeding time, antiplatelet effect, which can be observed even at very low doses;
inhibition of uterine contractions, leading to delayed or prolonged labor.
Therefore, Diclofenac Euro is contraindicated during the third trimester of pregnancy.
Breastfeeding. Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be used by women during breastfeeding to avoid undesirable effects on the infant.
If treatment is necessary, breastfeeding should be discontinued.
Female fertility. Like other NSAIDs, Diclofenac may impair female fertility and is therefore not recommended for use in women attempting to conceive. In women who have difficulty conceiving or are undergoing investigation of infertility, discontinuation of Diclofenac should be considered.
Based on animal studies, impaired male reproductive function cannot be excluded. The relevance of these data to humans has not been established.
Ability to influence reaction speed when driving vehicles or other mechanisms
Usually, when taking the drug in recommended doses and with a short course of treatment, there is no effect on the reaction speed. However, patients who experience visual disturbances, dizziness, vertigo, drowsiness or other central nervous system disorders, lethargy or fatigue when using the drug Diclofenac Euro should not drive or operate other mechanisms.
Method of administration and doses
According to general recommendations, the drug should be used in the lowest effective doses that are sufficient to relieve symptoms of the disease for the shortest period of time.
The tablets should be taken whole, without chewing, with a small amount of water, during or after meals.
For adults: the recommended dose of the drug is 100–150 mg per day. The daily dose should be divided into 2–3 doses. After achieving the optimal therapeutic effect, the dose can be gradually reduced to a maintenance level of 75–100 mg per day. The daily dose of the drug should not exceed 150 mg.
In primary dysmenorrhea, the daily dose of Diclofenac Euro should be selected individually. The daily dose is usually 50–150 mg. The initial dose may be 50–100 mg, but if necessary, the dose may be increased to a maximum of 200 mg per day during the next few menstrual cycles. The use of Diclofenac Euro tablets should be started at the first symptoms and continued for several days depending on the response and symptoms.
Elderly patients: Although the pharmacokinetics of Diclofenac Euro are not altered to a clinically significant extent in elderly patients, special caution is required, as these patients are more prone to developing adverse reactions. In particular, the lowest effective dose is recommended for debilitated elderly patients and for patients with low body weight; patients should also be monitored for gastrointestinal bleeding during treatment with NSAIDs.
Presence of cardiovascular disease or significant risk factors
Diclofenac is contraindicated in patients with congestive heart failure, ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Diclofenac should only be prescribed to patients with significant risk factors for cardiovascular events (such as hypertension, hyperlipidemia, diabetes mellitus, smoking) after careful clinical evaluation. Since the cardiovascular risks increase with increasing dose and duration of treatment with diclofenac, it should be used for the shortest possible period and at the lowest effective dose. The patient's need for diclofenac to relieve symptoms and the response to therapy should be periodically reviewed.
Kidney dysfunction
Diclofenac is contraindicated in patients with renal insufficiency (GFR < 15 mL/min/1.73 m2).
No specific studies have been conducted in patients with renal impairment and no dose adjustment recommendations are available. Diclofenac should be used with caution in patients with moderate or severe renal impairment.
Liver dysfunction
Diclofenac is contraindicated in patients with hepatic insufficiency.
No specific studies have been conducted in patients with hepatic impairment and no dose adjustment recommendations are available. Diclofenac should be used with caution in patients with moderate or severe hepatic impairment.
Children.
The drug in this dosage is not used in children due to the high content of the active substance.
Overdose
Symptoms. There is no typical clinical picture characteristic of diclofenac overdose. Overdose can cause symptoms such as dizziness, disorientation, headache, drowsiness, coma, nausea, vomiting, diarrhea, abdominal pain, epigastric pain, gastrointestinal bleeding, psychomotor agitation, tinnitus, convulsions, loss of consciousness; in case of severe poisoning, acute renal failure and liver damage may develop.
Treatment of acute poisoning with NSAIDs, including diclofenac, consists of supportive and symptomatic therapy. This includes treatment of manifestations such as hypotension, renal failure, convulsions, gastrointestinal disorders and respiratory depression. It is unlikely that specific therapeutic measures such as forced diuresis, dialysis or hemoperfusion will be useful for the removal of Diclofenac Euro, since the active substances of the drug are highly bound to plasma proteins and undergo extensive metabolism.
Activated charcoal may be used after ingestion of potentially toxic doses, and gastric decontamination (e.g., induction of vomiting, gastric lavage) may be used after ingestion of potentially life-threatening doses.
Adverse reactions
The following undesirable effects include those reported with short-term or long-term use of the drug.
Blood and lymphatic system disorders: agranulocytosis, haemolytic anaemia; aplastic anaemia; anaemia associated with internal bleeding; ecchymosis; leukopenia; neutropenia; thrombocytopenia, with or without purpura, pancytopenia. The first signs may be fever, pharyngitis, superficial mouth ulcers, flu-like symptoms, severe apathy, nosebleeds, skin bleeding.
Immune system disorders: hypersensitivity, anaphylactic/anaphylactoid reactions (including hypotension and shock), angioedema, including facial swelling, tongue swelling
