Protecon fast®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROTECHON FAST® (PROTECHON FAST®)

Composition:

Active substances: glucosamine, chondroitin sulfate, diclofenac;

One film-coated tablet contains: glucosamine sulfate 500 mg, sodium chondroitin sulfate 400 mg, potassium diclofenac 50 mg;

Excipients: microcrystalline cellulose, magnesium stearate, povidone (K-30), sodium starch glycolate, colloidal anhydrous silicon dioxide, talc, sodium croscarmellose, hypromellose, polyethylene glycol (PEG-6000), titanium dioxide (E 171), sunset yellow dye (E 110), isopropyl alcohol.

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: film-coated tablets of orange color, oval-shaped, biconvex, with a score line on one side.

Pharmacotherapeutic group.

Drugs affecting the musculoskeletal system. Combined anti-inflammatory and antirheumatic agents. ATC code M01B X.

Pharmacological Properties

The medicinal product exerts anti-inflammatory, analgesic, chondroprotective, and regenerative effects.

It slows down the processes of cartilage tissue damage and bone resorption, restores cartilage tissue, accelerates bone callus formation following injuries, and promotes restoration of joint functions.

Pharmacodynamics

Glucosamine is a building block for joint cartilage and stimulates regeneration of cartilage tissue. Any adverse influence (disease, age-related metabolic disorders, trauma) reduces its synthesis and concentration in connective tissue, leading to structural and functional impairment of joints and the development of pain. Glycosaminoglycans and proteoglycans are components of the complex matrix from which cartilage is composed.

Glucosamine is a constituent of endogenous glycosaminoglycans in cartilage tissue, stimulates proteoglycan synthesis, and enhances sulfate uptake by articular cartilage.

Thus, glucosamine replenishes endogenous glucosamine deficiency, participates in the biosynthesis of proteoglycans and hyaluronic acid, thereby counteracting the progression of degenerative processes in joints, spine, and surrounding soft tissues; stimulates the formation of chondroitin sulfate, normalizes calcium deposition in bone tissue, and promotes restoration of joint functions and relief from pain syndrome.

Chondroitin sulfate is a high-molecular-weight mucopolysaccharide that affects phosphorus-calcium metabolism in cartilage tissue, slows down bone resorption and reduces calcium loss, and retards degenerative processes in cartilage tissue. It exerts chondroprotective, anti-inflammatory, and analgesic effects, providing chondroprotection under both normal conditions and conditions of cartilage tissue destruction. It prevents compression of connective tissue, "lubricates" joint surfaces, and normalizes the production of synovial fluid.

Diclofenac potassium is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic activity, characterized by a rapid onset of action, which makes it particularly suitable for the treatment of acute pain under inflammatory conditions. Its mechanism of action is based on inhibition of prostaglandin synthesis, which play a key role in the development of inflammation, pain, and fever. The anti-inflammatory, analgesic, and antipyretic properties of NSAIDs are related to their ability to inhibit prostaglandin synthesis by blocking the enzyme cyclooxygenase. It reduces pain at rest and during movement, decreases morning stiffness in joints, soft tissue swelling, and improves functional status of the musculoskeletal system. Diclofenac potassium predominantly suppresses the exudative phase and, to a lesser extent, the proliferative phase, reducing collagen synthesis and associated tissue sclerosis.

Pharmacokinetics

Glucosamine sulfate. Oral bioavailability of glucosamine is 25–26%. After distribution in tissues, the highest concentrations are found in the liver, kidneys, and cartilage tissue. Approximately 90% of orally administered glucosamine, in the form of glucosamine salt, is absorbed from the small intestine and enters the liver via the portal circulation. A significant portion of absorbed glucosamine is metabolized in the liver and broken down into urea, water, and carbon dioxide. About 30% of the administered dose persists in connective tissue for a prolonged period. It is excreted mainly by the kidneys and in very small amounts in feces.

Chondroitin sulfate. After a single dose, maximum plasma concentration (Cmax) is reached within 3–4 hours and in synovial fluid within 4–5 hours. Concentration in synovial fluid exceeds that in plasma. Bioavailability of chondroitin sulfate is 13–15%. It is excreted by the kidneys within 24 hours.

Diclofenac potassium does not accumulate. Maximum plasma concentration is reached within 2 hours after administration. Plasma protein binding is 99.7%. It penetrates into synovial fluid. Systemic clearance of the active substance is 263 ml/min. Plasma half-life is 1–2 hours. 60% is excreted by the kidneys as metabolites, less than 1% unchanged in urine, and the remainder is excreted as metabolites in bile.

Clinical characteristics.

Indications.

• Treatment of musculoskeletal disorders associated with signs of inflammation, pain, degenerative-dystrophic changes in joint and spinal cartilage, and reduced joint mobility.
• Osteoarthritis (including osteoarthritis of the knee and hip joints, intervertebral osteochondrosis, spondyloarthritis).

Contraindications.

• Hypersensitivity to the active substance or to any other component of the medicinal product.
• Active gastric or intestinal ulcer; gastrointestinal hemorrhage or perforation.
• History of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs).
• Active peptic ulcer/hemorrhage or recurrent peptic ulcer/hemorrhage in history (two or more separate episodes of confirmed ulcer or bleeding).
• Pregnancy and breastfeeding period.
• Inflammatory bowel diseases (e.g., Crohn’s disease or ulcerative colitis).
• Hepatic failure.
• Renal failure (glomerular filtration rate <15 mL/min/1.73 m²).
• Congestive heart failure (NYHA functional class II–IV — New York Heart Association).
• Uncontrolled arterial hypertension.
• Treatment of perioperative pain in coronary artery bypass grafting (or use of cardiopulmonary bypass machine).
• Ischemic heart disease in patients with angina pectoris or history of myocardial infarction, uncontrolled arterial hypertension.
• Cerebrovascular diseases in patients with history of stroke or transient ischemic attacks.
• Peripheral arterial disease, thrombophlebitis.
• PROTECON FAST®, like other nonsteroidal anti-inflammatory drugs, is contraindicated in patients who experience attacks of bronchial asthma, angioedema, urticaria, or acute rhinitis, nasal polyps, or other allergic symptoms in response to administration of ibuprofen, acetylsalicylic acid, or other NSAIDs.
• Hypersensitivity reactions to mollusks.
• Impaired glucose tolerance, diabetes mellitus, phenylketonuria.
• High risk of postoperative bleeding, coagulation disorders, hemostatic disorders, hematological disorders, or cerebrovascular hemorrhage.
• Age under 18 years.

Interaction with other medicinal products and other types of interactions.

Concomitant use of this medicinal product with other drugs may result in the following interactions:

with selective serotonin reuptake inhibitors (SSRIs) — concomitant administration of systemic NSAIDs and SSRIs increases the risk of gastrointestinal bleeding;

with cardiac glycosides — possible exacerbation of heart failure, decreased glomerular filtration rate (GFR), and increased plasma concentrations of cardiac glycosides;

with lithium, digoxin, phenytoin — possible increase in plasma concentrations of these drugs; monitoring of plasma concentrations of these medicinal products is recommended;

with antidiabetic agents — clinical studies have shown that diclofenac can be used concomitantly with oral antidiabetic agents without affecting their clinical efficacy; however, individual cases of both hypoglycemic and hyperglycemic effects have been reported after diclofenac administration, requiring dose adjustment of antidiabetic agents; in such cases, monitoring of plasma glucose levels is recommended;

with agents causing hyperkalemia (such as potassium-sparing diuretics, cyclosporine, tacrolimus, trimethoprim) — possible increase in serum potassium levels; monitoring of such patients is recommended;

with anticoagulants, antithrombotic agents — concomitant use increases the risk of bleeding and inhibition of platelet aggregation (like other NSAIDs, diclofenac at high doses may temporarily inhibit platelet aggregation). Although clinical studies do not indicate an effect of diclofenac on anticoagulant activity, data exist on increased risk of bleeding in patients taking diclofenac and anticoagulants simultaneously. Therefore, careful monitoring of patients receiving both diclofenac and anticoagulants is recommended, and dose adjustment of anticoagulants may be necessary;

with tacrolimus, cyclosporine — diclofenac, like other NSAIDs, may increase cyclosporine nephrotoxicity due to effects on renal prostaglandins. The same risk exists during treatment with tacrolimus. Therefore, lower doses should be used compared to patients not receiving cyclosporine or tacrolimus;

with diuretics, antihypertensive agents — possible reduction of antihypertensive effect; this combination should be used with caution; monitoring of blood pressure (especially in elderly patients), and renal function after initiation of combination therapy, and regularly thereafter, is necessary, particularly when using diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors), due to increased risk of nephrotoxicity; patients should receive adequate fluid intake;

with quinolone antibiotics — seizures may occur in patients receiving concomitant quinolone derivatives and NSAIDs, regardless of history of epilepsy or seizures. Therefore, caution should be exercised when considering quinolone use in patients already receiving NSAIDs;

with mifepristone — NSAIDs should not be used within 8–12 days after mifepristone administration, as NSAIDs may reduce its efficacy;

with methotrexate — possible increase in concentration and toxicity of methotrexate; caution is advised when administering NSAIDs, including diclofenac, less than 24 hours before methotrexate administration;

with other NSAIDs (including selective cyclooxygenase (COX)-2 inhibitors), corticosteroids — possible increased frequency of gastrointestinal adverse reactions; concomitant use of two or more NSAIDs should be avoided;

with colestipol, cholestyramine — concomitant use of diclofenac with colestipol or cholestyramine reduces diclofenac absorption by approximately 30% and 60%, respectively, potentially leading to delayed or reduced absorption of diclofenac; diclofenac should be administered at least 1 hour before or 4–6 hours after colestipol/cholestyramine;

with probenecid — medicinal products containing probenecid may delay elimination of diclofenac;

with medicinal products that are potent inhibitors of CYP2C9 — caution is recommended when co-administering diclofenac with potent CYP2C9 inhibitors (e.g., voriconazole), as significant increases in maximum plasma concentration and exposure of diclofenac may occur due to inhibition of its metabolism;

with inducers of CYP2C9 — caution is required when co-administering diclofenac with CYP2C9 inducers (e.g., rifampicin), as significant reduction in plasma concentration and exposure of diclofenac may occur.

Special precautions for use.

To minimize risks, the lowest effective dose should be used for the shortest duration necessary to control symptoms.

The use of NSAIDs increases the risk of ulceration, perforation, or gastrointestinal bleeding, particularly in elderly patients.

Due to the use of selective COX-1/COX-2 inhibitors and individual NSAIDs, the risk of thrombotic cardiovascular and cerebrovascular complications increases.

Since the cardiovascular risks of diclofenac may increase with higher doses and longer treatment duration, it should be used for the shortest possible period and at the lowest effective dose.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur during diclofenac use.

Hypersensitivity reactions may also progress to Kounis syndrome, a serious allergic reaction that may cause myocardial infarction. Kounis syndrome may present as chest pain occurring in combination with an allergic reaction to diclofenac.

Renal effects of NSAIDs include fluid retention with edema and/or arterial hypertension; therefore, diclofenac should be used with caution in patients with cardiac dysfunction or other factors predisposing to fluid retention.

Caution is also recommended if the patient is taking diuretics or concomitant ACE inhibitors or has an increased risk of hypovolemia.

Cardiovascular and cerebrovascular events.

Patients with hypertension and/or mild to moderate congestive heart failure in their medical history require appropriate medical monitoring and consultation, as fluid retention and edema have been observed during NSAID use, including diclofenac.

The use of diclofenac, especially at high doses and for prolonged periods, is associated with a certain increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke).

It is not recommended for patients with uncontrolled arterial hypertension, congestive heart failure, stable ischemic heart disease, peripheral arterial occlusive disease, and/or cerebrovascular disease.

Diclofenac should be prescribed to patients with cardiovascular risk factors (e.g., hypertension, hyperlipidemia, diabetes, smoking) only after careful clinical evaluation and only at a dose ≤ 100 mg daily if treatment lasts no more than four weeks. The need for diclofenac use and the patient's response to therapy should be periodically reassessed. Patients should be vigilant for signs and symptoms of serious arterial thrombotic events (e.g., chest pain, shortness of breath, weakness, speech difficulties), which may occur suddenly. Patients should be informed that immediate medical attention is required if such symptoms occur.

Renal effects.

Since fluid retention and edema have been observed during the use of NSAIDs, including diclofenac, particular caution is required in patients with cardiac or renal dysfunction, history of arterial hypertension, elderly patients, patients receiving concomitant diuretic therapy or drugs that may significantly affect renal function, and patients with significant reduction in extracellular fluid volume due to any cause, such as before or after surgical procedures. In such cases, monitoring of renal function is recommended during diclofenac use. After discontinuation of therapy, the condition of patients usually returns to the pre-treatment state.

One tablet contains 3.921 mmol (90.11 mg of sodium). This should be taken into account for patients on a low-sodium diet.

Gastrointestinal effects.

Gastrointestinal bleeding (hematemesis, melena), ulceration, or perforation, which may be fatal, have been reported with the use of nonsteroidal anti-inflammatory drugs, including diclofenac. These events may occur at any time during treatment, regardless of the presence or absence of warning symptoms or a history of serious gastrointestinal events.

In elderly patients, such complications usually have more serious consequences. In the event of gastrointestinal bleeding or ulceration in patients receiving diclofenac therapy, the drug should be discontinued. As with all NSAIDs, careful medical supervision and special caution are required when prescribing diclofenac to patients with symptoms indicating gastrointestinal disturbances, suspected ulceration, bleeding, perforation, or such conditions in their history.

The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher doses of NSAIDs, including diclofenac, and in patients with a history of peptic ulcer, especially complicated by bleeding or perforation, and in elderly patients.

To reduce the risk of gastrointestinal toxicity, treatment should be initiated and maintained at the lowest effective doses.

Consideration should be given to combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) for such patients, as well as for patients requiring concomitant use of drugs containing low-dose acetylsalicylic acid (aspirin) or other drugs that increase the risk of gastrointestinal disorders.

Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding).

Caution is advised for patients receiving concomitant therapy with drugs that increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as acetylsalicylic acid.

The use of NSAIDs, including diclofenac, is associated with an increased risk of gastrointestinal anastomosis failure. Close medical supervision and caution are recommended when using diclofenac after gastrointestinal surgery.

Patients with ulcerative colitis or Crohn's disease require careful medical monitoring and caution during drug use, as these conditions may worsen.

Skin effects.

Very rarely, serious skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported with the use of NSAIDs, including diclofenac. The highest risk of these reactions occurs at the beginning of therapy, mostly within the first month of treatment. The drug should be discontinued at the first signs of skin rash, mucosal lesions, or any other signs of hypersensitivity.

Hepatic effects.

Careful medical supervision is required when the drug is prescribed to patients with impaired liver function, as their condition may worsen. As with all NSAIDs, including diclofenac, the levels of one or more liver enzymes may increase. Elevated liver enzyme levels may occur without clinical symptoms. This elevation may be moderate (≥ 3 to < 8 times the upper limit of normal) or marked (≥ 8 times the upper limit of normal). Increases in enzyme levels are usually reversible after discontinuation of the drug. In most cases, elevations were observed to borderline levels.

Monitoring of liver function tests is recommended throughout the treatment course. If abnormalities in liver function tests persist or worsen, clinical symptoms of liver disease appear, or other manifestations occur (e.g., eosinophilia, rash), the drug should be discontinued. Hepatitis may develop during diclofenac use without prodromal symptoms. In addition to elevated liver enzyme levels, severe hepatic reactions, including jaundice and fulminant hepatitis, liver necrosis, and liver failure, some of which have been fatal, have been rarely reported. Diclofenac should be used with caution in patients with hepatic porphyria, as it may provoke an acute attack.

Use in patients with asthma.

In patients with asthma, seasonal allergic rhinitis, nasal mucosal edema (e.g., nasal polyps), chronic obstructive pulmonary diseases, or chronic respiratory tract infections (especially if associated with symptoms resembling allergic rhinitis), reactions to NSAIDs resembling asthma exacerbations (so-called aspirin-induced asthma with analgesic intolerance), Quincke's edema, and urticaria occur more frequently than in other patients. Therefore, special precautions (readiness for emergency intervention) are recommended when treating such patients. This also applies to patients who have allergic reactions, such as rash, itching, or urticaria, to other substances.

Hematological effects.

The drug is used for short-term treatment to relieve symptoms during the acute phase of illness. If this drug is prescribed for a longer duration, regular monitoring of the hemogram is recommended (as with other NSAIDs).

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation; therefore, careful monitoring is required in patients with coagulation disorders, hemorrhagic diathesis, or hematological abnormalities.

Masking signs of infection.

Due to its pharmacodynamic properties, diclofenac, like other NSAIDs, may mask the signs of infection.

SLE and mixed connective tissue diseases.

Patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases have an increased risk of aseptic meningitis.

Precautions.

Concomitant use of this drug with systemic NSAIDs, such as selective cyclooxygenase-2 inhibitors, should be avoided due to the lack of evidence for synergistic effects and the potential for additional adverse effects.

In rare cases, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur with diclofenac use, even without prior exposure to diclofenac.

The drug should be used with caution in patients over 65 years of age, especially those who are physically weakened or have body weight below normal.

Important information on excipients.

The colorant "Sunset Yellow" (E 110) may cause allergic reactions.

Use during pregnancy or breastfeeding.

Pregnancy.

The drug should not be used during pregnancy.

From the 20th week of pregnancy, the use of the medicinal product PROTECON FAST® may cause oligohydramnios due to fetal renal dysfunction.

Breastfeeding.

The drug should not be used during breastfeeding.

Like other NSAIDs, diclofenac is excreted in small amounts in breast milk. Therefore, PROTECON FAST® should not be used in 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 affect female fertility and therefore is not recommended for women planning pregnancy. Consideration should be given to discontinuing the drug in women who are unable to conceive and in women undergoing infertility investigations.

Ability to influence reaction speed when driving or operating machinery.

Generally, when the drug is taken at the recommended dose and for a short treatment period, no effect on reaction speed is observed. However, patients who experience central nervous system disturbances during drug use should not drive or operate machinery.

Method of Administration and Dosage.

The medicinal product is administered to adults at a dose of 1 tablet 3 times daily. In cases of moderate pain symptoms, the dose may be reduced to 1 tablet 2 times daily. Tablets should be taken orally after meals with water. The total duration of treatment at the recommended dose should not exceed 10 days.

The treatment regimen should be individually adjusted. Under medical supervision, treatment may be prolonged. After alleviation of pain symptoms and consultation with a physician, treatment may be continued with drugs containing glucosamine sulfate and chondroitin sulfate, such as «Protekon®», coated tablets.

The product should be used at the lowest effective dose for the shortest possible duration.

Children.

The medicinal product is not used in pediatric practice.

Overdose.

May result in an exacerbation of adverse effects.

Symptoms: There is no typical clinical picture of diclofenac overdose. Symptoms may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, loss of consciousness, or convulsions. In severe poisoning, acute renal failure and hepatic injury may develop.

Treatment: supportive and symptomatic therapy for complications such as arterial hypotension, renal failure, seizures, gastrointestinal disturbances, and respiratory depression. Specific interventions such as forced diuresis, dialysis, or hemoperfusion do not promote rapid elimination of the drug from the body due to its high degree of protein binding and extensive metabolism. In cases of potentially toxic overdose, evacuation of gastric contents (induced vomiting, gastric lavage) and administration of activated charcoal are required.

Adverse Reactions

The medicinal product is usually well tolerated.

Most adverse effects following administration of PROTECON FAST® are due to the presence of diclofenac and are dose-dependent.

Blood and lymphatic system disorders: thrombocytopenia, leukopenia, anemia, including hemolytic anemia and aplastic anemia, agranulocytosis.

Immune system disorders: hypersensitivity reactions, including pruritus, rash (including erythematous, bullous), urticaria, eczema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythroderma (exfoliative dermatitis), anaphylactic and anaphylactoid reactions (including hypotension and shock), angioedema (including facial swelling).

Psychiatric disorders: disorientation, depression, insomnia, irritability, night terrors, psychotic disorders.

Nervous system disorders: headache, dizziness, somnolence, fatigue, insomnia, sensory disturbances including paresthesia, memory impairment, disorientation, convulsions, restlessness, tremor, aseptic meningitis, taste disturbances, cerebrovascular disorders including stroke, confusion, hallucinations, malaise, anxiety, generalized weakness, tremor, psychotic disorders, ase游戏副本 meningitis.

Respiratory, thoracic and mediastinal disorders: asthma (including dyspnea, shortness of breath), bronchospasm, pneumonitis.

Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, cramping sensation, dyspepsia, bloating, flatulence, anorexia, stomatitis, aphthous stomatitis (including ulcerative stomatitis), glossitis, esophageal dysfunction, gastritis, gastric and intestinal ulcers with or without bleeding, gastrointestinal stenosis or perforation (sometimes fatal, especially in elderly patients), which may lead to peritonitis, gastrointestinal hemorrhage (hematemesis, melena, bloody diarrhea), development of diaphragm-like strictures in the intestine, lower gastrointestinal tract disorders such as colitis, non-specific hemorrhagic colitis, ischemic colitis, exacerbation of ulcerative colitis or Crohn’s disease, constipation, pancreatitis.

Hepatobiliary disorders: liver function abnormalities, elevated levels of transaminases and aminotransferases in blood serum, hepatitis with or without jaundice, hepatic disorders, fulminant hepatitis, liver necrosis, hepatic failure.

Ear and labyrinth disorders: vertigo, tinnitus, hearing disturbances, ringing in the ears, hearing disorders.

Eye disorders: visual disturbances (blurred vision, clouding of vision, diplopia), optic neuritis.

Visual disturbances such as blurred vision, worsening of vision, and diplopia are class effects of NSAIDs and are usually reversible upon discontinuation of the drug. The most likely mechanism of visual disturbances is inhibition of prostaglandin and related compound synthesis, which disrupts retinal blood flow regulation and contributes to visual disturbances. If such symptoms occur during treatment with diclofenac, an ophthalmological examination should be performed to rule out other possible causes.

If severe adverse effects occur, treatment should be discontinued.

Skin and subcutaneous tissue disorders: alopecia, photosensitivity, purpura including allergic purpura, dermatitis, rash, urticaria, blistering rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome (toxic epidermal necrolysis), exfoliative dermatitis, hair loss, pruritus.

Renal and urinary disorders: edema, acute kidney injury (acute renal failure), hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, papillary necrosis, medullary necrosis of the kidney, tubulointerstitial nephritis, fluid retention.

Reproductive system and breast disorders: impotence.

Cardiovascular disorders: palpitations, chest pain, arterial hypertension or hypotension, vasculitis, heart failure, myocardial infarction. Clinical data indicate an increased risk of thrombotic complications (such as myocardial infarction or stroke) associated with diclofenac use, particularly at high therapeutic doses (150 mg per day) and with prolonged use.

Kounis syndrome (allergic acute coronary syndrome) has been reported. The frequency of this syndrome is unknown.

Clinical studies and epidemiological data suggest an increased risk of thrombotic complications (e.g., myocardial infarction or stroke) associated with diclofenac use, particularly at high therapeutic doses (150 mg daily) and with long-term use.

General disorders: swelling.

Reporting of suspected adverse reactions after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives should report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions.

Store in the original packaging, in a place inaccessible to children, at a temperature not exceeding 25 °C.

Packaging.

30, 60, or 90 film-coated tablets in blisters or in a container.

Prescription status.

Prescription only.

Manufacturer.

Evertogen Life Sciences Limited.

Manufacturer's address.

Plot No: S-8, S-9, S-13/P & S-14/P TSIIC, Pharma SEZ, Green Industrial Park, Polepally (V), Jadcherla (M), Mahabubnagar, Telangana, IN-509 301, India.