Instructions for Flamidez tablets No. 30
Composition
active ingredients: paracetamol, diclofenac potassium, serratiopeptidase;
1 film-coated tablet contains: paracetamol 500 mg, diclofenac potassium 50 mg, serratiopeptidase in the form of enteric-coated granules containing 15 mg of serratiopeptidase, which is equivalent to an enzyme activity of 30,000 IU per tablet;
excipients: microcrystalline cellulose; corn starch; povidone (K-30); lactose, monohydrate; hypromellose; polyethylene glycols (PEG 6000); titanium dioxide (E 171); talc; polysorbates (80); tartrazine (E 102); Opadry white 58901 (hypromellose; lactose, monohydrate; titanium dioxide (E 171); polyethylene glycol; talc);
excipients of serratiopeptidase granules: croscarmellose sodium, magnesium stearate, colloidal anhydrous silicon dioxide, microcrystalline cellulose.
Dosage form
Film-coated tablets.
Main physicochemical properties: yellow, oval, biconvex tablets, with a score on one side, film-coated.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs.
ATX code M01A B55.
Pharmacological properties
Pharmacodynamics.
Paracetamol acts as an analgesic and antipyretic. The analgesic and antipyretic effects of paracetamol are associated with the drug's effect on the thermoregulatory center in the hypothalamus and its ability to inhibit prostaglandin synthesis.
Diclofenac potassium has anti-inflammatory, analgesic, antipyretic, antirheumatic, antiaggregatory effects. Inhibits cyclooxygenase, resulting in blocking of arachidonic cascade reactions and disruption of the synthesis of prostaglandins PGE2, PGE2a, thromboxane A2, prostacyclin, leukotrienes and release of lysosomal enzymes; inhibits platelet aggregation; in vitro - causes a slowdown in proteoglycan biosynthesis in cartilage, in concentrations corresponding to those observed in humans.
Serratiopeptidase is a proteolytic enzyme isolated from the non-pathogenic intestinal bacterium Serratia E15. It exhibits fibrinolytic, anti-inflammatory and anti-edematous activity. In addition to reducing the inflammatory process, serratiopeptidase reduces pain by blocking the release of pain amines from inflamed tissues.
Serratiopeptidase binds in a 1:1 ratio to blood alpha-macroglobulin, which masks its antigenicity but retains its enzymatic activity. It slowly passes into the exudate at the site of inflammation, and gradually its levels in the blood decrease. By hydrolyzing bradykinin, histamine and serotonin, serratiopeptidase directly reduces capillary dilation and controls their permeability. Serratiopeptidase blocks plasmin inhibitors, thus promoting the fibrinolytic activity of plasmin. Therefore, Flamidez can be used in all pathological conditions accompanied by edema.
Pharmacokinetics.
Paracetamol after oral administration is rapidly and almost completely absorbed from the digestive tract, the maximum concentration in the blood plasma is reached after 10–60 minutes. Binding to blood plasma proteins is approximately 10%. It is metabolized in the liver mainly into pharmacologically active metabolites - glucuronide (60–80%) and paracetamol sulfate (20–30%). Less than 4% is metabolized by oxidation with the formation of cysteine and mercaptopuric acid (with the participation of cytochrome P450). The half-life is approximately 2–2.5 hours. It is excreted in the urine, mainly in the form of metabolites. About 5% is excreted unchanged. The metabolism of paracetamol in liver failure does not change.
Diclofenac potassium is rapidly absorbed after oral administration, food can slow down the rate of absorption without affecting its completeness. The maximum concentration in blood plasma is reached after 1–2 hours. Bioavailability is 50%; it is intensively subjected to presystemic elimination. The connection with blood plasma proteins is more than 99%. It penetrates well into tissues and synovial fluid, where its concentration increases more slowly, after 4 hours it reaches higher values than in blood plasma. Approximately 35% is excreted in the form of metabolites with feces; about 65% is metabolized in the liver and excreted by the kidneys in the form of inactive derivatives (less than 1% is excreted unchanged). The half-life is about 2 hours; synovial fluid – 3–6 hours; if the recommended interval between doses is observed, diclofenac potassium does not accumulate.
Serratiopeptidase penetrates the stomach wall unchanged and is absorbed in the intestine. It is detected in small amounts in the urine.
Indication
Acute pain (myositis, myalgia, headache, toothache, radicular syndrome), rheumatic soft tissue damage, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, acute attacks of gout, primary dysmenorrhea, adnexitis, pharyngotonsillitis, otitis.
Contraindication
Hypersensitivity to the components of the drug.
Angioedema.
Contraindicated in patients who develop attacks of bronchial asthma ("aspirin asthma"), urticaria, or acute rhinitis in response to the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
Ischemic heart disease in patients with angina pectoris and post-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 in coronary artery bypass grafting (or the use of a cardiopulmonary bypass machine).
High risk of developing postoperative bleeding, blood clotting disorders, hemostasis disorders, hematopoietic disorders, or cerebrovascular bleeding.
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 established ulceration or bleeding).
Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Severe liver failure.
Severe renal failure.
Blood diseases.
Leukopenia.
Severe anemia.
Congenital hyperbilirubinemia.
Glucose-6-phosphate dehydrogenase deficiency.
Alcoholism.
Interaction with other medicinal products and other types of interactions
Diclofenac.
Alcohol: Flamidez should not be used simultaneously with alcohol.
Lithium: The drug may increase plasma lithium concentrations. Monitoring of serum lithium levels is recommended.
Phenytoin: when used simultaneously with diclofenac, it is recommended to monitor the plasma concentration of phenytoin due to a possible increase in the effects of phenytoin.
Cardiac glycosides: Concomitant use of cardiac glycosides and NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma glycoside levels.
Digoxin: The drug may increase plasma concentrations of digoxin. Monitoring of serum digoxin levels is recommended.
Diuretics and antihypertensives: As with other NSAIDs, concomitant use of Flamidez with diuretics or antihypertensives (e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors) may lead to a reduction in their antihypertensive effect. Therefore, such a combination should be used with caution and patients, especially the elderly, should be closely monitored for blood pressure. Patients should be adequately hydrated and monitoring of renal function is recommended after initiation of concomitant therapy and regularly thereafter, especially with diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium supplements may be associated with increases in serum potassium levels, which requires close monitoring.
Other NSAIDs and corticosteroids: Concomitant use of Flamidez and other systemic NSAIDs or corticosteroids may increase the incidence of gastrointestinal adverse reactions. Concomitant use of the drug with other NSAIDs, including selective COX-2 inhibitors, should be avoided.
Anticoagulants and antithrombotic agents: Regular and long-term concomitant use of the drug with anticoagulants, especially warfarin and other coumarins and antiplatelet agents, may increase the risk of bleeding. Occasional use has no significant effect. Serratiopeptidase potentiates the effect of anticoagulants when used concomitantly, therefore, close and regular monitoring of the patient is recommended in the case of such a combination of drugs.
Selective serotonin reuptake inhibitors (SSRIs): Concomitant administration of systemic NSAIDs and SSRIs increases the risk of gastrointestinal bleeding.
Potent CYP2C9 inhibitors: Caution is advised when co-administering diclofenac with potent CYP2C9 inhibitors (e.g. voriconazole), which may lead to a significant increase in maximum plasma concentrations and exposure to diclofenac due to inhibition of its metabolism.
Antidiabetic drugs: the drug can be used together with oral antidiabetic drugs without affecting their effectiveness, however, there are isolated cases of both hypoglycemic and hyperglycemic effects, when changes in the dosage of antidiabetic drugs were required during treatment with Flamidez. Monitoring of blood glucose levels is required as a precautionary measure during concomitant therapy.
Colestipol and cholestyramine. The simultaneous use of Flamidez and colestipol or cholestyramine reduces the absorption of diclofenac by approximately 30% and 60%, respectively. The drugs should be taken with an interval of several hours.
Drugs that induce drug-metabolizing enzymes: Drugs that induce enzymes, such as rifampicin, carbamazepine, phenytoin, barbiturates, St. John's wort (Hypericum perforatum), are theoretically capable of reducing diclofenac plasma concentrations.
Drugs causing hyperkalemia: Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may be associated with increases in serum potassium levels, therefore patients should be monitored more frequently.
Cyclosporine and tacrolimus: NSAIDs may increase the nephrotoxicity of cyclosporine through their effects on renal prostaglandin synthesis. Therefore, it should be used at lower doses than in patients not receiving cyclosporine. This risk also occurs with tacrolimus treatment.
Quinoline antibiotics: there are isolated reports of convulsions that may result from the concomitant use of quinolones and NSAIDs.
Mifepristone: NSAIDs should not be used for 8–12 days after mifepristone administration, as NSAIDs may reduce its effect.
Paracetamol.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine) that stimulate the activity of liver microsomal enzymes: may enhance the toxic effect of paracetamol on the liver due to an increase in the degree of conversion of the drug to hepatotoxic metabolites.
Barbiturates: reduce the antipyretic effect of paracetamol.
Drugs that induce drug-metabolizing enzymes. Drugs that induce enzymes, such as rifampicin, carbamazepine, phenytoin, barbiturates, St. John's wort (Hypericum perforatum), may increase the toxic effect of paracetamol on the liver due to an increase in the degree of conversion of the drug to hepatotoxic metabolites.
With the simultaneous use of paracetamol with hepatotoxic drugs, the toxic effect of the drugs on the liver increases.
Isoniazid: simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome.
Metoclopramide and domperidone: may increase the rate of absorption of paracetamol.
Diuretics: paracetamol reduces the effectiveness of diuretics.
Coumarin derivatives (warfarin): long-term use of paracetamol increases the risk of bleeding. Single doses do not have a significant effect.
Caution should be exercised when using paracetamol with flucloxacillin, as such co-administration is associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section "Special warnings and precautions for use").
Application features
Do not exceed the indicated doses.
The medicine contains paracetamol, so it should not be taken together with other medicines containing paracetamol and used, for example, to reduce fever, treat pain, flu and cold symptoms or insomnia. Simultaneous use with other medicines containing paracetamol may lead to overdose. Overdose of paracetamol can cause liver failure, which may require a liver transplant or be fatal.
Cases of liver dysfunction/liver failure have been reported in patients with reduced glutathione levels, such as those with severe wasting, anorexia, low body mass index, chronic alcoholism, or sepsis.
Patients with low glutathione levels are at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or labored breathing, nausea, vomiting, and loss of appetite. You should seek immediate medical attention if you experience these symptoms.
Caution is advised when using paracetamol with flucloxacillin due to the increased risk of high anion gap metabolic acidosis, especially in patients with severe renal insufficiency, sepsis, malnutrition and other causes of glutathione deficiency (e.g. chronic alcoholism), and when maximum daily doses of paracetamol are used. Close monitoring of the patient, including measurement of urinary 5-oxoproline, is recommended.
The simultaneous use of Flamidez with systemic NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the possibility of additional side effects.
NSAIDs increase the risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal, and therefore the drug is not recommended for the treatment of postoperative pain and during coronary artery bypass graft surgery.
Diclofenac should only be prescribed to patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking) after careful clinical evaluation. Clinical trial data and epidemiological data suggest that the use of diclofenac, especially at high doses (150 mg/day) and for long periods, is associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Diclofenac is not recommended for use in patients with uncontrolled hypertension, congestive heart failure, stable ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. If necessary, use should only be considered after careful risk-benefit assessment and only at doses not exceeding 100 mg/day. A similar assessment should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking).
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.
Patients should be informed about the possibility of serious complications (chest pain, shortness of breath, weakness, speech disorders) that may occur at any time. In this case, a doctor should be consulted immediately.
Since the cardiovascular risks of diclofenac increase with increasing dose and duration of treatment, it should be used for the shortest possible period and at the lowest effective dose. The patient's need for diclofenac for symptom relief and response to therapy should be reviewed periodically.
Caution should be exercised when administering the drug to patients with hepatic porphyria.
It should be prescribed with caution in patients with a history of liver, kidney, gastrointestinal diseases, dyspeptic manifestations, after surgical interventions, elderly patients, bronchial asthma, congestive heart failure. If there is a history of allergic reactions, prescribe only in emergency cases.
Gastrointestinal bleeding (hemorrhage, melena), ulceration or perforation, which can be fatal, have been reported with all NSAIDs, including diclofenac, and can occur at any time during treatment, with or without warning symptoms, or with a 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.
Patients with systemic lupus erythematosus and mixed connective tissue diseases are at increased risk of developing aseptic meningitis.
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients are at greatest risk of these reactions at the beginning of treatment, with most occurring within the first month of treatment. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may also occur, even after the first dose.
Like other NSAIDs, Flamidez may mask the symptoms of an infection. If the symptoms of the underlying disease persist, you should consult a doctor.
With prolonged use, peripheral blood parameters and liver function should be monitored.
General warnings
The use of the drug with systemic NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the lack of any synergistic benefit and the possibility of developing additional side effects.
Due to the risk of thrombotic cardiovascular and cerebrovascular complications; gastrointestinal ulceration, bleeding or perforation, the lowest effective dose of the drug should be used for the shortest possible time.
Patients who take analgesics every day for mild arthritis should consult a doctor.
Caution should be exercised when prescribing the drug to the elderly. In particular, the lowest effective dose is recommended for the elderly and for patients with low body mass index.
The drug contains lactose, if you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.
Hypersensitivity reactions may also progress to Kounis syndrome, a serious allergic reaction that can cause myocardial infarction. Symptoms of such reactions may include chest pain that occurs in conjunction with an allergic reaction to diclofenac.
History of bronchial asthma
Patients with bronchial asthma, seasonal allergic rhinitis, nasal mucosal edema (i.e. nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially those associated with allergic rhinitis-like symptoms) are more likely to experience asthma-like reactions to NSAIDs (which are also associated with analgesic/analgesic asthma tolerance), angioedema or urticaria. Therefore, special precautions (emergency medical attention) are recommended for such patients. This also applies to patients allergic to other substances, e.g. with skin reactions, itching or urticaria.
Effects on the gastrointestinal tract
As with other NSAIDs, medical supervision and special caution are required when prescribing the drug to patients with symptoms suggestive of gastrointestinal (GI) disorders or with a history suggesting gastric or intestinal ulcer, bleeding or perforation. The risk of GI bleeding increases with increasing dose and in patients with a history of ulcer, especially complicated by bleeding or perforation, and in the elderly.
To reduce the risk of gastrointestinal toxicity in patients with a history of ulcer, especially those complicated by bleeding or perforation, and in the elderly, treatment should be initiated and maintained at the lowest effective dose.
For such patients, as well as patients who require concomitant use of drugs containing low doses of acetylsalicylic acid (ASA) or other drugs that increase the risk of adverse effects on the gastrointestinal tract, the use of combination therapy with protective agents (e.g. proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding).
Caution is also required when treating patients receiving concomitant medications that increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antithrombotic agents, or selective serotonin reuptake inhibitors.
The use of NSAIDs, including diclofenac, is 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
Careful medical supervision is required when Flamidez is prescribed to patients with impaired liver function, as their condition may worsen.
As with other NSAIDs, elevations of one or more liver enzymes may occur. During long-term treatment with the drug, regular monitoring of liver function is indicated as a precautionary measure. If liver function abnormalities persist or worsen, if clinical signs or symptoms suggestive of progressive liver disease occur, or if other manifestations occur (e.g., eosinophilia, rash), the drug should be discontinued. Diseases such as hepatitis may present without prodromal symptoms.
Patients with alcoholic liver disease are at increased risk of hepatotoxic effects of paracetamol.
Effects on the kidneys
The effect of NSAIDs on the kidneys causes fluid retention and edema and/or hypertension. Therefore, diclofenac should be used with caution in patients with cardiac disorders or other conditions predisposing to fluid retention. Use with caution in patients receiving concomitant diuretics or ACE inhibitors or at increased risk of hypovolemia. Since fluid retention and edema have been reported with NSAIDs, special care should be taken in patients with impaired cardiac or renal function (including functional renal failure due to hypovolemia, nephrotic syndrome, lupus nephropathy, and decompensated cirrhosis), a history of hypertension, the elderly, patients receiving concomitant therapy with diuretics or drugs that significantly affect renal function, and 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. Discontinuation of therapy usually leads to a return to the state that was before treatment.
Effect on hematological parameters
With prolonged use of the drug, as with other NSAIDs, monitoring of blood parameters is recommended.
The drug may affect the results of laboratory tests for blood glucose and uric acid.
Like other NSAIDs, the drug may temporarily inhibit platelet aggregation. Patients with impaired hemostasis should be carefully monitored.
Use during pregnancy or breastfeeding
The drug is not used.
Fertility in women.
The use of the drug may impair fertility in women and is not recommended in women attempting to conceive. If a woman has difficulty conceiving or is undergoing evaluation for infertility, discontinuation of the drug should be considered.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug Flamidez may slow down psychomotor reactions, so you should refrain from driving or working with complex mechanisms while using the drug.
Method of administration and doses
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The drug should be used in the lowest effective doses for the shortest period of time, taking into account the treatment objectives of each individual patient.
The dose is determined by the doctor for each patient individually, depending on the age, nature and course of the disease, tolerability and therapeutic efficacy of the drug.
The drug is taken orally, after meals, with a small amount of liquid (200 ml).
Adults: 1 tablet 2–3 times a day, depending on the severity of the disease.
Children over 14 years of age: 1 tablet 1–2 times a day.
The maximum daily dose is 3 tablets.
The duration of treatment is determined by the doctor individually depending on the dynamics of symptoms, and is no more than 5–7 days.
The maximum period of use without consulting a doctor is 3 days.
Children.
The drug is used in children aged 14 years and older.
Overdose
Liver damage is possible in adults who have taken 10 g or more of paracetamol, and in children who have taken more than 150 mg/kg of body weight. In patients with risk factors (long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; regular alcohol abuse, glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia) the use of 5 g or more of paracetamol may lead to liver damage.
Symptoms of overdose in the first 24 hours: pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12–48 hours after overdose.
Paracetamol overdose in a single dose can cause reversible or irreversible necrosis of liver cells, which can lead to impaired glucose metabolism and metabolic acidosis, hepatocellular failure, encephalopathy, hemorrhage, hypoglycemia, coma and be fatal. It is believed that an increased amount of the metabolite of paracetamol (which is usually neutralized by the action of glutathione when using normal doses of paracetamol) irreversibly binds to liver tissue.
Acute renal failure with acute tubular necrosis may present with severe back pain, hematuria, and proteinuria and may develop even in the absence of severe liver damage. However, there is an increase in hepatic transaminases (AST, ALT), lactate dehydrogenase, and bilirubin, as well as prothrombin time, occurring 12–48 hours after administration.
In case of overdose, the following may also occur: hypotension, respiratory depression, convulsions, gastrointestinal bleeding, tinnitus, cardiac arrhythmia, and pancreatitis.
With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic system. When taking large doses, dizziness, psychomotor agitation and disorientation may occur from the CNS; nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis) may occur from the urinary system.
In case of an overdose of diclofenac, hypotension, respiratory depression, convulsions, renal failure, diarrhea, gastrointestinal bleeding, dizziness, and tinnitus may occur.
In case of overdose, urgent medical attention is required. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage. Treatment with activated charcoal should be considered if the overdose of paracetamol has been taken within 1 hour. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine can be used within 24 hours of paracetamol ingestion, but the maximum protective effect occurs when it is used within 8 hours of ingestion. The effectiveness of the antidote decreases sharply after this time. If necessary, the patient should be given N-acetylcysteine intravenously, according to the established dose list. In the absence of vomiting, oral methionine can be used as a suitable alternative in remote areas outside the hospital.
Supportive measures and symptomatic treatment are necessary to address complications such as hypotension, renal failure, seizures, gastrointestinal disturbances, and respiratory depression.
Forced diuresis, dialysis or hemoperfusion cannot guarantee the elimination of nonsteroidal anti-inflammatory drugs due to their high binding to blood plasma proteins and intensive metabolism.
Adverse reactions
From the blood and lymphatic system: thrombocytopenia, neutropenia, leukopenia, anemia (including hemolytic and aplastic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency)), agranulocytosis, pancytopenia, sulfhemoglobinemia, methemoglobinemia (cyanosis, shortness of breath, heart pain).
Immune system disorders: hypersensitivity reactions, including skin itching, rash on the skin and mucous membranes, anaphylactic/anaphylactoid reactions (including hypotension and anaphylactic shock), angioedema (including facial swelling).
Mental disorders: disorientation, depression, sleep disorders, insomnia, nightmares, irritability, anxiety, feelings of fear, mental disorders, confusion, psychomotor agitation, hallucinations.
From the nervous system: headache, dizziness, drowsiness, paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbance, cerebral circulation disorders, sensitivity disorders.
From the organs of vision: visual disturbances, blurred vision, diplopia, optic neuritis.
From the side of the organs of hearing and labyrinth of the ear: vertigo; tinnitus, hearing impairment.
Cardiovascular system: increased heartbeat, tachycardia, pain in the heart area, shortness of breath, heart failure, myocardial infarction, Kounis syndrome.
Clinical trial data and epidemiological data suggest an increased risk of thrombotic complications (e.g. myocardial infarction or stroke) associated with the use of diclofenac, particularly at high therapeutic doses (150 mg per day) and with long-term use.
Vascular disorders: hypertension, hypotension, vasculitis.
Respiratory, thoracic and mediastinal disorders: asthma (including dyspnea), bronchospasm (especially in patients sensitive to acetylsalicylic acid), chest pain, pneumonitis, bloody sputum, acute eosinophilic pneumonia.
Gastrointestinal: nausea, vomiting, diarrhea, dyspepsia, epigastric pain, abdominal pain, flatulence, anorexia, gastritis, gastrointestinal bleeding, vomiting with blood, hemorrhagic diarrhea, melena, gastric or intestinal ulcer (with or without bleeding, perforation), colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, esophageal disorders, diaphragmatic strictures of the intestine, pancreatitis.
From the hepatobiliary system: increased transaminase levels, hepatitis, jaundice, impaired liver function; transient hepatitis, hepatonecrosis (when taking high doses), liver failure.
Skin and subcutaneous tissue disorders: rash (usually generalized rash, erythematous, rash on mucous membranes), urticaria, pruritus, bullous rash, exfoliative dermatitis, eczema, erythema, exudative erythema multiforme, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
From the urinary system: acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
On the part of the endocrine system: hypoglycemia (up to hypoglycemic coma).
From the reproductive system: impotence.
General disorders: fluid retention, edema, general weakness, increased fatigue, increased sweating, bruising, bleeding.
Expiration date
2.5 years.
Storage conditions
Store in the original packaging, out of the reach of children at a temperature not exceeding 30 °C.
Packaging
10 tablets in a blister; 1, or 3, or 10 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
Evertogen Life Sciences Limited.
Saga Lifesciences Limited.
Location of the manufacturer and its address of production
