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DICLOFENAC SODIUM
Release form
Rectal suppositories.
For children
From 14 years old
For pregnant women
Contraindicated
For nursing mothers
Contraindicated
For drivers
Not recommended
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: diclofenac; 1 suppository contains diclofenac sodium 0.05 g; excipient: solid fat.
Medicinal form
Rectal suppositories. Main physicochemical properties: white suppositories with a slightly yellowish tint.
Pharmacotherapeutic group
Non-steroidal anti-inflammatory and anti-rheumatic drugs. ATX code M01A B05.
Pharmacological properties
Pharmacodynamics. Diclofenac sodium exhibits an anti-inflammatory and analgesic effect due to inhibition of biosynthesis of prostaglandins, kinins and other mediators of inflammation and pain, reduction of capillary permeability and stabilizing effect on lysosomal membranes. During the course treatment of diseases of the musculoskeletal system, the drug intensively penetrates into the cavities of the joints, helping to reduce pain in the joints at rest and during movements, increase the range of motion, reduce morning stiffness and swelling of the joints. A lasting effect is observed 1–2 weeks after the start of treatment. In case of post-traumatic or postoperative inflammation, it contributes to the rapid reduction of pain syndrome, reduces inflammation and swelling of the wound. Pharmacokinetics. When administered rectally, diclofenac sodium is quickly absorbed by the mucous membrane of the rectum. The maximum concentration in blood plasma is reached after 1–2 hours. The half-life is on average 2 hours. About 70% of the administered amount of the drug is excreted from the body by the kidneys in the form of metabolites, less than 1% - in unchanged form, the rest is excreted with feces.
Indication
• Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, including spondyloarthritis; • pain syndromes from the spine; • rheumatic diseases of extra-articular soft tissues; • post-traumatic and postoperative pain syndromes accompanied by inflammation and swelling, in particular after dental and orthopedic operations; • gynecological diseases accompanied by pain and inflammation, such as primary dysmenorrhea and adnexitis; • migraine attacks; • acute attacks of gout; • as an auxiliary agent in severe inflammatory diseases of the ENT organs, which are accompanied by a painful sensation, for example, in pharyngotonsillitis, otitis. According to general therapeutic principles, the main disease should be treated with basic therapy. Fever in itself is not an indication for the use of the drug.
Contraindication
• Hypersensitivity to the active substance or to any of the auxiliary substances of the drug; • bleeding or perforation of the gastrointestinal tract in history, associated with previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs); • active ulcer disease/bleeding or history of recurrent ulcer disease/bleeding (two or more separate episodes of established ulceration or bleeding); • the last trimester of pregnancy; • inflammatory bowel diseases (for example, Crohn's disease or ulcerative colitis); • liver failure (class C according to Child-Pugh) (liver cirrhosis and ascites); • renal failure (glomerular filtration rate (GFR) <15 ml/min/1.73 m2); • severe congestive heart failure (NYHA II-IV); • treatment of perioperative pain during aorto-coronary shunting (or use of an artificial blood circulation device); • ischemic heart disease in patients with angina pectoris, myocardial infarction; • cerebrovascular diseases in patients who have suffered a stroke or have episodes of transient ischemic attacks; • diseases of peripheral arteries; • diclofenac sodium, like other NSAIDs, is contraindicated in patients who develop bronchial asthma attacks, urticaria, angioedema, acute rhinitis or nasal polyps in response to taking acetylsalicylic acid or other NSAIDs; • proctitis.
Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with the use of diclofenac in the form of enteric-dissolving tablets and/or in other dosage forms. Lithium. Under the conditions of simultaneous use, diclofenac can increase the concentration of lithium in the blood plasma. Monitoring of serum lithium levels is recommended. Digoxin. Under the conditions of simultaneous use, diclofenac can increase the concentration of digoxin in the blood plasma. Monitoring of serum digoxin levels is recommended. Diuretics and antihypertensive drugs. As with the use of other NSAIDs, concomitant use of diclofenac with diuretics and antihypertensive agents (for example, β-blockers, angiotensin-converting enzyme (ACE) inhibitors) can lead to a decrease in their antihypertensive effect by inhibiting the synthesis of vasodilating prostaglandins. Therefore, such a combination should be used with caution, and patients, especially the elderly, should be closely monitored for blood pressure. Patients should receive adequate hydration, and monitoring of renal function after initiation of concomitant therapy and on a regular basis thereafter, particularly with diuretics and ACE inhibitors, is also recommended due to the increased risk of nephrotoxicity. Drugs known to cause hyperkalemia. Concomitant treatment with potassium-sparing diuretics, ciclosporin, tacrolimus, or trimethoprim may be associated with an increase in the level of potassium in blood serum, so monitoring of the patient's condition should be carried out more often. Anticoagulants and antithrombotics. Concomitant use may increase the risk of bleeding, so precautions are recommended. Although clinical studies do not indicate an effect of diclofenac on the activity of anticoagulants, there are separate data on an increased risk of bleeding in patients who use diclofenac and anticoagulants at the same time. Therefore, careful monitoring of such patients is recommended to ensure that no changes in anticoagulant dosage are required. Like other NSAIDs, diclofenac in high doses can temporarily inhibit platelet aggregation. Other NSAIDs, including cyclooxygenase-2 selective inhibitors, and corticosteroids. Concomitant use of diclofenac and other NSAIDs or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. The simultaneous use of two or more NSAIDs should be avoided. Selective serotonin reuptake inhibitors (SSRIs). Concomitant use of NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding. Antidiabetic drugs. Clinical studies have shown that diclofenac can be used together with oral antidiabetic agents and not change their therapeutic effect. However, there are some reports of the development of such cases of hypoglycemia and hyperglycemia, which necessitated a change in the dose of antidiabetic agents during the use of diclofenac. For this reason, it is recommended to control the level of glucose in the blood during combined therapy. There are also separate reports of cases of metabolic acidosis with simultaneous use with diclofenac, especially in patients with pre-existing renal dysfunction. Methotrexate. Diclofenac can inhibit the clearance of methotrexate in the renal tubules, which leads to an increase in the level of methotrexate. Care should be taken when prescribing NSAIDs, including diclofenac, less than 24 hours before the use of methotrexate, as in such cases the concentration of methotrexate in the blood may increase and its toxic effect may increase. Cases of serious toxicity have been reported when the interval between the use of methotrexate and NSAIDs, including diclofenac, was within 24 hours. This interaction is mediated through the accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs. Cyclosporine. The effect of diclofenac, like other NSAIDs, on the synthesis of prostaglandins in the kidneys can increase the nephrotoxicity of cyclosporine, therefore, diclofenac should be used in lower doses than for patients who do not use cyclosporine. Tacrolimus. The use of NSAIDs with tacrolimus may increase the risk of nephrotoxicity, which may be mediated by the renal antiprostaglandin effects of NSAIDs and a calcineurin inhibitor, and therefore should be used at lower doses than in patients not taking cyclosporine. Antibacterial quinolones. There are separate data on the development of convulsions in patients who used quinolone derivatives and NSAIDs at the same time. This can be observed in patients with or without a history of epilepsy and seizures. Thus, caution should be exercised when deciding whether to use a quinolone in patients already receiving NSAIDs. Phenytoin. When using phenytoin simultaneously with diclofenac, it is recommended to monitor the concentrations of phenytoin in the blood plasma due to the expected increase in the effect of phenytoin. Colestipol and cholestyramine. These drugs may delay or decrease 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. The simultaneous use of cardiac glycosides and NSAIDs in patients can aggravate heart failure, reduce GFR and increase the level of glycosides in the blood plasma. Mifepristone. NSAIDs should not be used for 8–12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone. Potent inhibitors of CYP2C9. Caution should be exercised when diclofenac is co-administered with potent CYP2C9 inhibitors (eg, voriconazole), as this may result in a significant increase in peak plasma concentration and diclofenac exposure due to inhibition of its metabolism. SYP2C9 inducers. Caution should also be exercised when diclofenac is co-administered with CYP2C9 inducers (e.g.
Features of use
General Gastrointestinal ulcers, bleeding, or perforation may occur at any time during the use of NSAIDs, regardless of whether they are COX-2 selective, even in the absence of warning symptoms or history of predisposition. In order to minimize unwanted effects, the minimum effective dose should be used for the shortest period of time. Placebo-controlled studies have indicated an increased risk of thrombotic cardiovascular and cerebrovascular complications with the use of certain selective COX-2 inhibitors. Whether this risk directly correlates with the COX-1/COX-2 selectivity of individual NSAIDs is still unknown. Concomitant use of diclofenac sodium with systemic NSAIDs, such as cyclooxygenase-2 selective inhibitors, should be avoided due to lack of any evidence of a synergistic effect and due to potential additive side effects. Since there are no comparative data from clinical studies on long-term treatment with the maximum dose of diclofenac, the possibility of such an increase in risk cannot be excluded. Until such data are available, a careful benefit-risk assessment should be performed before using diclofenac in patients with clinically proven coronary heart disease, cerebrovascular disease, peripheral artery occlusive disease, or significant risk factors (eg, hypertension, hyperlipidemia, diabetes, smoking). Because of this risk, the lowest effective dose should be used for the shortest period of time. Caution is required for elderly patients. In particular, it is recommended to use the lowest effective dose in debilitated, elderly or underweight patients. In rare cases, as with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur even without prior exposure to diclofenac. Due to its pharmacodynamic properties, diclofenac sodium, like other NSAIDs, can mask the signs and symptoms of infection. Effects on the digestive tract With the use of all NSAIDs, including diclofenac, cases of gastrointestinal bleeding (hemorrhage, melena), ulceration or perforation, which can be fatal and can occur at any time during treatment, have been reported. the presence or absence of warning symptoms or a previous history of serious gastrointestinal (GI) events. These phenomena usually have more serious consequences in elderly patients. If patients receiving diclofenac experience gastrointestinal bleeding or ulceration, the drug should be discontinued. As with the use of other NSAIDs, including diclofenac, medical supervision and special caution are required for patients with symptoms suggestive of gastrointestinal disturbances. The risk of bleeding, ulcers or perforations in the gastrointestinal tract increases with an increase in the dose of NSAIDs, including diclofenac, and in patients with a history of ulcers, especially with complications in the form of bleeding or perforation, and in elderly patients. Elderly patients have an increased incidence of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal. To reduce the risk of such gastrointestinal toxicity, treatment should be initiated and maintained at the lowest effective dose. For such patients, as well as for those who require concomitant use of drugs containing low doses of acetylsalicylic acid (ASA) or other drugs likely to increase the risk of adverse effects on the gastrointestinal tract, consideration should be given to the use of combination therapy with the use of protective agents (for example, proton pump inhibitors or misoprostol). Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is also required in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants (eg, warfarin), antithrombotic agents (eg, ASA), or SSRIs. Effects on the liver Careful medical supervision is required when diclofenac sodium must be prescribed to patients with impaired liver function, as their condition may worsen. As with other NSAIDs, including diclofenac, the level of one or more liver enzymes may increase. This occurred very frequently in clinical trials with diclofenac (approximately 15% of patients), but was very rarely accompanied by clinical symptoms. Most of these cases are associated with an increase in limit values. Moderate elevations (≥3 to <8 times the upper limit of normal) were common (2.5% of cases), while the frequency of significant elevations (≥ 8 times the upper limit of normal) remained around 1%. In the above-mentioned clinical studies, in 0.5% of patients, an increase in the level of liver enzymes was accompanied by clinically pronounced liver damage. After stopping the use of the drug, the level of liver enzymes returned to the original value. During long-term treatment with Diclofenac sodium, regular monitoring of liver functions should be prescribed as a precautionary measure. If liver dysfunction persists or worsens and if clinical signs or symptoms may be associated with progressive liver disease or if other manifestations (eg, eosinophilia, rash) are observed, diclofenac sodium should be discontinued. In addition to elevations in liver enzymes, there have been isolated reports of severe hepatic reactions, including jaundice and fulminant hepatitis, liver necrosis and hepatic failure, with fatal outcomes in some cases. The course of diseases such as hepatitis can pass without prodromal symptoms. Precautions are necessary if Diclofenac sodium is used in patients with hepatic porphyria, due to the possibility of provoking an attack. Effects on the kidneys Due to the importance of prostaglandins in maintaining renal blood flow, long-term treatment with large doses of NSAIDs, including diclofenac, often (1-10%) leads to edema and hypertension. Since cases of fluid retention and edema have been reported with NSAIDs, including diclofenac, special attention should be paid to patients with cardiac or renal dysfunction, a history of hypertension, elderly patients, patients receiving concomitant therapy with diuretics or drugs that significantly affect on kidney function, as well as in patients with a significant decrease in extracellular fluid volume for any reason, such as before or after major surgery. In such cases, monitoring of renal function is recommended as a precautionary measure. Discontinuation of therapy usually results in a return to pre-treatment status. Effects on the skin In connection with the use of NSAIDs, including the drug Diclofenac sodium, serious skin reactions (some of which have been fatal) have been reported very rarely, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. In patients, the highest risk of developing these reactions is observed at the beginning of the course of therapy: the appearance of the reaction is noted in most cases during the first month of treatment. The use of the drug Diclofenac sodium should be stopped at the first appearance of skin rashes, lesions of the mucous membrane or at the appearance of any other signs of hypersensitivity. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur in individual cases, even without prior exposure to diclofenac. Systemic lupus erythematosus (SLE) and mixed connective tissue disease Patients with SLE and mixed connective tissue disease may be at increased risk of developing aseptic meningitis. Cardiovascular and cerebrovascular effects Diclofenac sodium is generally not recommended in patients with established cardiovascular disease (eg, heart failure, established coronary heart disease, peripheral artery disease) or uncontrolled hypertension. For patients with a history of arterial hypertension and/or congestive heart failure of mild or moderate severity, appropriate monitoring and recommendations are required, as cases of fluid retention and edema have been reported in connection with the use of NSAIDs, including diclofenac. Data from clinical studies and epidemiological data indicate that the use of diclofenac, especially in high doses (150 mg per day) and with long-term treatment, may be associated with a slight increase in the risk of arterial thrombotic events (eg, myocardial infarction or stroke). It is not recommended to prescribe diclofenac to patients with uncontrolled arterial hypertension, congestive heart failure, stable coronary heart disease, diseases of peripheral arteries and/or cerebrovascular disease, if necessary, it can be used only after a careful risk-benefit assessment, only in a dosage of no more than 100 mg per day. A similar evaluation should be performed before starting long-term treatment in patients with risk factors for the development of cardiovascular events (for example, with arterial hypertension, hyperlipidemia, diabetes mellitus, and patients who smoke). The patient's need for symptom relief and response to therapy should be periodically evaluated, especially if the duration of therapy is longer than 4 weeks. Patients should be advised to monitor for signs and symptoms of serious arterial thromboembolic events (eg, chest pain, shortness of breath, weakness, slurred speech) that may occur without warning. In the event of such a phenomenon, patients should immediately consult a doctor. Diclofenac can be prescribed to patients with significant risk factors for cardiovascular events (for example, arterial hypertension, hyperlipidemia, diabetes, smoking) only after careful clinical evaluation and only in doses up to 100 mg per day, if the duration of therapy is more than 4 weeks. Because the cardiovascular risks of diclofenac may increase with increasing dose and duration of treatment, it should be used for the shortest possible duration and at the lowest effective dose. The patient's need for diclofenac should be periodically reviewed for symptom relief and response to therapy. Use with caution in patients over 65 years of age. Effect on hematological indicators With long-term use of this drug, as with other NSAIDs, monitoring of a complete blood count is recommended. Diclofenac sodium can reversibly inhibit platelet aggregation. Patients with hemostasis disorders, hemorrhagic diathesis, or hematological disorders should be carefully monitored. History of asthma Patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (ie, nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections (especially those associated with allergic rhinitis-like symptoms) are more likely to experience reactions to NSAIDs, such as asthma exacerbations (so-called intolerance to analgesics/analgesic asthma), angioedema or urticaria. In this regard, special precautionary measures (readiness to provide emergency care) are recommended for such patients. This also applies to patients with allergic reactions to other substances, such as rashes, itching or hives. Like other drugs that inhibit the activity of prostaglandin synthetase, diclofenac sodium and other NSAIDs can provoke the development of bronchospasm when used in patients suffering from bronchial asthma or patients with a history of bronchial asthma. Use during pregnancy or breastfeeding. Pregnancy. In the absence of an absolute need, diclofenac should not be used in the I or II trimester of pregnancy. In the I and II trimesters of pregnancy, Diclofenac sodium can be prescribed only when the expected benefit to the mother exceeds the potential risk to the fetus and only in the minimum effective dose, the duration of treatment should be as short as possible. Like other NSAIDs, the drug is contraindicated in the 3rd trimester of pregnancy (possible inhibition of uterine contractility and premature closure of the ductus arteriosus in the fetus). Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetus development. Data from epidemiological studies indicate an increased risk of miscarriage and/or the risk of developing heart defects and gastroschisis after using a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular disease was increased from less than 1% to approximately 1.5%. It is possible that the risk increases with the dose and duration of treatment. It has been shown that in animals, administration of a prostaglandin synthesis inhibitor leads to an increase in pre- and post-implantation loss and embryo/fetal lethality. In addition, in animals treated with prostaglandin synthesis inhibitor during the period of organogenesis, an increased frequency of various malformations, including those of the cardiovascular system, was registered. If diclofenac sodium is used by a woman who is trying to get pregnant or is pregnant in the first trimester of pregnancy, the dose of the drug should be as low as possible, and the duration of treatment should be as short as possible. During the III trimester of pregnancy, all prostaglandin synthesis inhibitors can affect the fetus in the following ways: • cardiopulmonary toxicity with premature closure of the ductus arteriosus and pulmonary hypertension; • impaired kidney function, which can progress to renal failure with oligohydroamniosis. Impact 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, which leads to delay or prolongation of childbirth. Therefore, Diclofenac sodium is contraindicated during the third trimester of pregnancy. Breastfeeding period. Like other NSAIDs, diclofenac is excreted in breast milk in small amounts. In this regard, Diclofenac sodium suppositories should not be used by women during breastfeeding in order to avoid unwanted effects on the baby. If the treatment is vitally necessary, it is necessary to transfer the child to artificial feeding. Fertility in women Like other NSAIDs, diclofenac sodium can negatively affect female fertility, so it is not recommended to prescribe the drug to women who are planning pregnancy. For women, who have problems conceiving or are undergoing research for infertility, the expediency of withdrawing the drug should be considered. In animals, based on the relevant data, it cannot be excluded that male fertility is impaired. The relevance of these data for humans is uncertain. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Patients who experience visual disturbances, dizziness, vertigo, drowsiness, disturbances from the central nervous system, lethargy or fatigue during therapy with Diclofenac sodium should not drive vehicles or operate other mechanisms.
Methods of application
The dose of the drug depends on the nature, severity and clinical course of the disease. The drug should be used in the smallest effective doses for the shortest period of time, taking into account the task of treatment in each individual patient. Suppositories should be inserted into the rectum, as deeply as possible, preferably after cleaning the intestines. The initial dose for adults is usually 100–150 mg (2–3 suppositories) per day. With unexpressed symptoms, as well as with long-term therapy, a dose of 75*–100 mg per day is sufficient. * Use suppositories with the active substance diclofenac in the appropriate dosage. Divide the daily dose into 2-3 doses. To avoid night pain or morning stiffness before taking the drug during the day, prescribe Diclofenac sodium in the form of rectal suppositories at bedtime (the daily dose of the drug should not exceed 150 mg). With primary dysmenorrhea, the daily dose is selected individually, usually it is 50–150 mg per day (1–3 suppositories). The initial dose can be 50–100 mg per day (1–2 suppositories), but if necessary, it can be increased over several menstrual cycles to a maximum of 150 mg per day (3 suppositories). The use of the drug should be started after the appearance of the first painful symptoms and continue for several days, depending on the dynamics of the regression of symptoms. For the treatment of migraine attacks, start the course at a dose of 100 mg (2 suppositories) at the first signs of an attack. If necessary, another 50 mg of diclofenac (1 suppository) can be used on the same day. If necessary, the treatment can be continued in the following days (the daily dose of the drug should not exceed 150 mg (3 suppositories), the dose should be divided into 3 applications). Children over 14 years of age can be prescribed 50 mg (1 suppository). Due to the high concentration of the active substance Diclofenac sodium, suppositories 50 mg, it is not recommended to be used by children and adolescents under the age of 14. Elderly patients: Although the pharmacokinetics of diclofenac sodium are not impaired to any clinically significant degree in elderly patients, NSAIDs should be used with particular caution, as such patients are generally more prone to adverse reactions. In particular, the lowest effective doses are recommended for debilitated elderly patients or patients with low body weight; also, patients should be examined for gastrointestinal bleeding during treatment with NSAIDs. Impaired renal function The use of diclofenac sodium is contraindicated in patients with renal insufficiency (GFR <15 ml/min/1.73 m2; see section "Contraindications"). Specific studies in patients with impaired renal function have not been performed, so recommendations for dose adjustments cannot be made. Diclofenac sodium should be used with caution in patients with impaired renal function (see the section "Peculiarities of use"). Impaired liver function The use of diclofenac sodium is contraindicated in patients with hepatic insufficiency (see section "Contraindications"). Specific studies in patients with impaired liver function have not been performed, so recommendations for dose adjustments cannot be made. Diclofenac sodium should be used with caution in patients with mild and moderate impairment of liver function (see the section "Peculiarities of use"). Children. This medicinal form of the drug should be used by children aged 14 and over.
Overdose
Symptoms There is no typical clinical picture characteristic of diclofenac overdose. Overdose may cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, tinnitus, or seizures. Acute kidney failure and liver damage are possible in case of severe intoxication. Treatment. If necessary, the treatment is symptomatic. Supportive measures and symptomatic treatment should be prescribed for complications such as arterial hypotension, renal failure, convulsions, gastrointestinal disturbances, and respiratory depression. Specific measures such as forced diuresis, dialysis, or hemoperfusion are unlikely to be effective in eliminating NSAIDs, including diclofenac, due to their extensive protein binding and extensive metabolism. Within 1 hour after using a potentially toxic amount of the drug, the possibility of using activated charcoal should be considered. In addition, in adults, gastric lavage should be considered for 1 hour after administration of a potentially toxic amount of the drug. Diazepam should be administered intravenously in case of frequent or prolonged convulsions. Taking into account the clinical condition of the patient, other measures may be indicated.
Side effects
From the gastrointestinal tract: pain in the epigastric region, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, decreased appetite; gastritis; gastrointestinal bleeding (bloody vomiting, melena, diarrhea with blood impurities), stomach and intestinal ulcers, accompanied or not accompanied by bleeding, gastrointestinal stenosis or perforation (sometimes fatal, especially in elderly patients), which can lead to peritonitis, proctitis ; very rarely - colitis (including hemorrhagic colitis, ischemic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal dysfunction, diaphragmatic intestinal stenosis, pancreatitis, exacerbation of hemorrhoids. From the side of the hepatobiliary system: an increase in the level of transaminases; hepatitis, jaundice, liver disorders; fulminant hepatitis, liver necrosis, liver failure. From the side of the nervous system: headache, dizziness; drowsiness, fatigue; paresthesias, memory impairment, convulsions, anxiety, tremors, aseptic meningitis, taste disorders, stroke; confusion, hallucinations, impaired sensitivity, general malaise. Mental disorders: disorientation, depression, insomnia, irritability, night terrors, psychotic disorders. On the part of the organs of vision: visual disturbances, blurred vision, diplopia, optic neuritis. On the part of the organs of hearing and the labyrinth of the ear: vertigo; ringing in the ears, hearing disorders. From the hematopoietic system: thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis. From the side of the immune system: hypersensitivity, anaphylactic and anaphylactoid reactions (including arterial hypotension and shock), angioedema (including facial edema). From the cardiovascular system: palpitations, chest pain, heart failure, myocardial infarction, arterial hypertension, arterial hypotension, vasculitis, Kounis syndrome. From the respiratory system: asthma (including shortness of breath), bronchospasm, pneumonitis. From the side of the skin and subcutaneous tissue: rash; urticaria; very rarely - rash in the form of blisters, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exfoliative dermatitis, hair loss, photosensitivity reactions; purpura, including allergic purpura, Schönlein-Henoch purpura, itching. From the kidneys and urinary system: fluid retention, edema, acute kidney injury, acute renal failure, hematuria, proteinuria, tubulointerstitial nephritis; nephrotic syndrome; papillary necrosis of the kidney. From the reproductive system and mammary glands: very rarely - impotence. General disorders and disorders at the injection site: irritation at the injection site, swelling. Data from clinical studies and epidemiological data indicate an increased risk of thrombotic complications (for example, myocardial infarction or stroke) associated with the use of diclofenac, in particular at high therapeutic doses (150 mg per day) and with long-term use. Visual disturbances. Visual disturbances such as visual impairment, visual impairment, and diplopia are effects of the NSAID class and are usually reversible after discontinuation of the drug. The most likely mechanism of visual disturbances is the inhibition of the synthesis of prostaglandins and other related compounds, which, by disrupting the regulation of retinal blood flow, contribute to the development of visual disturbances. If such symptoms occur during treatment with diclofenac, an ophthalmological examination should be performed to rule out other possible causes.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.
Packaging
5 suppositories in strips. 2 strips in a cardboard pack.
Leave category
By prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.