Instructions Bofen 600 film-coated tablets blister pack No. 20
Composition
active ingredient: ibuprofen;
1 tablet contains 600 mg of ibuprofen;
excipients: lactose monohydrate; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate;
film coating: polyethylene glycol graft copolymer with polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocaprate, polyvinyl alcohol.
Dosage form
Film-coated tablets.
Main physicochemical properties: oval-shaped tablets with a biconvex surface, coated with a white film coating.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. ATC code M01A E01.
Pharmacological properties
Pharmacodynamics.
Ibuprofen is a propionic acid derivative, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic activity. The therapeutic effects of the drug are believed to be due to its inhibitory effect on the enzyme cyclooxygenase, which leads to a marked decrease in prostaglandin synthesis. These properties provide relief from symptoms of inflammation, pain, and fever.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid/aspirin on platelet aggregation when both drugs are administered concomitantly. Some pharmacodynamic studies have shown that a single dose of ibuprofen 400 mg administered 8 hours before or 30 minutes after immediate-release acetylsalicylic acid/aspirin (81 mg) reduced the effect of acetylsalicylic acid/aspirin on thromboxane formation or platelet aggregation. Although there is uncertainty regarding the extrapolation of the data to the clinical situation, it cannot be excluded that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid/aspirin. Clinically significant changes are unlikely with irregular use of ibuprofen (see section 4.5).
Pharmacokinetics.
Ibuprofen is rapidly absorbed from the gastrointestinal tract (GI), peak serum concentrations are reached within 1-2 hours after administration. The elimination half-life is approximately 2 hours. Ibuprofen is metabolized in the liver to two inactive metabolites, which are excreted by the kidneys together with unchanged ibuprofen in pure form or in the form of conjugates. Renal excretion is rapid and complete. Ibuprofen is extensively bound to plasma proteins.
Indication
Rheumatoid arthritis, ankylosing spondylitis including juvenile rheumatoid arthritis or Still's disease), osteoarthritis and other non-rheumatoid (seronegative) arthropathies.
Non-articular rheumatic and periarticular lesions, such as shoulder scapular periarthritis (capsulitis), bursitis, tendonitis, tendosynovitis and low back pain; soft tissue injuries, such as sprains and strains.
For the relief of mild to moderate pain, such as dysmenorrheal pain, dental and postoperative pain, and for the symptomatic relief of headache, including migraine.
Contraindication
Known hypersensitivity to the active substance or to any of the excipients.
History of asthma, urticaria or allergic reactions after taking acetylsalicylic acid/aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
Severe heart failure (IV functional class according to the criteria of the New York Heart Association (NYHA).
Severe liver failure.
Severe renal failure (glomerular filtration rate <30 ml/min).
History of gastrointestinal bleeding or perforation associated with NSAID use.
Conditions with an increased risk of bleeding or active bleeding.
Acute or previous ulcerative colitis, Crohn's disease, recurrent gastric ulcer or gastrointestinal bleeding (2 or more episodes of confirmed ulceration or bleeding).
Third trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
Caution should be exercised when used concomitantly with the following drugs due to possible drug interactions noted in some patients.
Antihypertensives, β-blockers, and diuretics. NSAIDs may reduce the effect of antihypertensive drugs such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, β-blockers, and diuretics. Diuretics may also increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides. NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides. Cholestyramine. Concomitant use of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical significance of this is unknown.
Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and reduce the clearance of methotrexate.
Cyclosporine: Increased risk of nephrotoxicity when used with NSAIDs.
Mifepristone: A reduction in the efficacy of the medicinal product is theoretically possible due to the antiprostaglandin properties of NSAIDs. Limited data suggest that concomitant use of NSAIDs on the day of prostaglandin administration does not alter the effect of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical abortion.
Other NSAIDs, including selective COX-2 inhibitors: Concomitant use of ibuprofen and other NSAIDs, including cyclooxygenase-2 inhibitors, should be avoided due to the risk of increased adverse reactions (see section 4.4).
Acetylsalicylic acid/aspirin. As with other NSAIDs, concomitant administration of ibuprofen and acetylsalicylic acid/aspirin is generally not recommended due to the risk of increased adverse reactions. Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid/aspirin on platelet aggregation when administered concomitantly.
However, despite the uncertainties regarding the possibility of extrapolating these data to the clinical situation, it cannot be excluded that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With irregular use of ibuprofen, clinically significant effects are unlikely (see section "Pharmacodynamics").
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding when administered with NSAIDs (see section "Special warnings and precautions for use").
Anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin (see section 4.4).
Quinolone antibiotics: Animal data suggest that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients receiving NSAIDs and quinolones concurrently are at increased risk of seizures.
Sulfonylureas: NSAIDs may potentiate the effects of sulfonylureas. Hypoglycemia has been reported rarely in patients receiving sulfonylureas while receiving ibuprofen.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) (e.g. clopidogrel and ticlopidine). Increased risk of gastrointestinal bleeding when taken with NSAIDs (see section "Special warnings and precautions for use").
Tacrolimus: There may be an increased risk of nephrotoxicity when NSAIDs are administered to patients taking tacrolimus.
Zidovudine: NSAIDs increase the risk of hematological toxicity when administered concomitantly with zidovudine. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia when ibuprofen is administered concomitantly with zidovudine.
Aminoglycosides: NSAIDs may reduce the excretion of aminoglycosides.
Herbal extracts. Ginkgo biloba may potentiate the risk of bleeding associated with NSAIDs.
CYP2C9 inhibitors. Co-administration of ibuprofen with CYP2C9 inhibitors may increase the exposure of ibuprofen (a CYP2C9 substrate). In one study, voriconazole and fluconazole (CYP2C9 inhibitors) were shown to increase the exposure of S(+)-ibuprofen by approximately 80–100%. A reduced ibuprofen dose should be considered when co-administered with CYP2C9 inhibitors, especially when prescribing high doses of ibuprofen to patients taking voriconazole or fluconazole.
Application features
General warnings.
Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time necessary to control symptoms (see section “Method of administration and dosage” and gastrointestinal, cardiovascular risks below).
As with other NSAIDs, ibuprofen may mask the symptoms of infection, which may delay appropriate treatment and thus worsen the course of the disease. This has been observed in bacterial community-acquired pneumonia and bacterial complications of varicella. If ibuprofen is used for fever or for pain relief in an infection, monitoring for the presence of the infection is recommended. In outpatient settings, the patient should seek medical advice if symptoms persist or worsen.
With prolonged use of any painkillers, headaches may occur, which should not be treated with increased doses of the drug.
Concomitant use of NSAIDs with alcohol may increase side effects associated with the active substance, particularly those affecting the gastrointestinal tract or central nervous system (CNS).
Patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The drug contains sodium. This should be taken into account by patients who need to limit their sodium intake.
Elderly patients.
Pediatric population
There is a risk of kidney dysfunction in dehydrated children and adolescents.
Gastrointestinal bleeding, ulceration and perforation.
NSAIDs should be used with caution in patients with a history of peptic ulcer and other gastrointestinal diseases, as their condition may be aggravated (see section "Contraindications").
Gastrointestinal bleeding, ulceration, or perforation have been reported with all NSAIDs at any time during treatment. These adverse reactions can be fatal and may occur with or without warning symptoms, regardless of a prior history of serious gastrointestinal disease.
The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing ibuprofen dose in patients with a history of ulcer, particularly if complicated by bleeding or perforation (see section 4.3), and in the elderly. Such patients should start treatment with the lowest effective dose.
The possibility of concomitant administration of protective drugs (e.g. misoprostol or proton pump inhibitors) should be considered in such patients, as well as in patients taking concomitant acetylsalicylic acid/low-dose aspirin or other drugs that increase the risk of gastrointestinal damage (see section “Interaction with other medicinal products and other forms of interaction”).
The use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided due to an increased risk of ulceration or bleeding (see section "Interaction with other medicinal products and other types of interactions").
Patients, especially the elderly, with a history of gastrointestinal (GI) disease should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.
Ibuprofen should be prescribed with caution to patients receiving concomitant treatment with drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (SSRIs) or antiplatelet agents (in particular aspirin) (see section "Interaction with other medicinal products and other forms of interaction").
If gastrointestinal bleeding or ulceration occurs in a patient taking ibuprofen, the drug should be discontinued.
NSAIDs should be prescribed with caution to patients with a history of ulcerative colitis and Crohn's disease due to possible exacerbation of these conditions (see section "Adverse reactions").
Respiratory disorders and hypersensitivity reactions.
Ibuprofen should be prescribed with caution to patients with or with a history of bronchial asthma, chronic rhinitis, allergic diseases, as NSAIDs have been reported to cause bronchospasm, urticaria, or angioedema in such patients.
Impaired heart, kidney and liver function.
NSAIDs should be used with caution in patients with renal, hepatic, or cardiac impairment, as this may lead to deterioration of renal function.
Habitual concomitant use of similar painkillers further increases this risk.
Systematic use of analgesics, especially combinations of different painkillers, further increases this risk.
Patients with impaired renal, hepatic or cardiac function should be given the lowest effective dose for the shortest period of time and renal function should be monitored, especially with long-term treatment (see section "Contraindications").
Cardiovascular and cerebrovascular effects.
Ibuprofen should be used with caution in patients with a history of hypertension and/or heart failure, as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trials have suggested that ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke. Overall, epidemiological data do not suggest an association between low-dose ibuprofen use (≤ 1200 mg/day) and an increased risk of arterial thrombotic events.
Patients with uncontrolled arterial hypertension, congestive heart failure (II-III functional class according to NYHA criteria), diagnosed ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be prescribed ibuprofen after careful analysis of the situation, and high doses of ibuprofen (2400 mg per day) should be avoided.
Careful consideration is also necessary before initiating long-term ibuprofen therapy in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required.
Caution should be exercised when initiating ibuprofen in patients with significant dehydration. There is a risk of renal dysfunction, especially in children, adolescents and elderly patients with dehydration. As with other NSAIDs, prolonged use of ibuprofen may lead to renal papillary necrosis and other pathological changes in the kidneys. Renal toxicity has also been observed in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. The administration of NSAIDs to such patients may result in a dose-dependent decrease in prostaglandin formation and, secondarily, a decrease in renal blood flow, which may lead to renal failure. Patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and angiotensin-converting enzyme (ACE) inhibitors, and the elderly are at high risk of developing this reaction. Discontinuation of NSAIDs is usually accompanied by a return to the condition that preceded treatment.
Systemic lupus erythematosus and mixed connective tissue disease.
Ibuprofen should be used with caution in patients with systemic lupus erythematosus and mixed connective tissue disease due to an increased risk of aseptic meningitis (see Adverse Reactions and Aseptic Meningitis below).
Dermatological effects.
Very rarely, serious skin reactions, including fatal ones, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with NSAIDs (see section 4.8). Patients are at greatest risk of developing these reactions at the start of treatment. In most cases, the reaction develops within the first month of treatment. Acute generalized exanthematous pustulosis has also been reported in association with ibuprofen-containing products.
Ibuprofen should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity.
In exceptional cases, serious skin and soft tissue infections may occur in association with chickenpox. The role of NSAIDs in worsening these infections is currently unknown, and it is recommended that ibuprofen be avoided in chickenpox.
Hematological effects.
Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time in healthy volunteers.
Aseptic meningitis.
Aseptic meningitis has been reported rarely in patients treated with ibuprofen. Although aseptic meningitis is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, cases of aseptic meningitis have been reported in patients without these chronic diseases.
Use during pregnancy or breastfeeding
Fertility.
Ibuprofen may impair female fertility and is not recommended for use in women attempting to conceive. For women who have difficulty conceiving or who are undergoing investigation for infertility, discontinuation of ibuprofen should be considered.
Pregnancy.
Inhibition of prostaglandin synthesis may adversely affect the course of pregnancy and/or embryo/foetal development. Epidemiological data indicate an increased risk of miscarriage and of cardiac malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The risk is believed to increase with increasing dose and duration of therapy. In animal studies, the use of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses and embryo/foetal death. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals treated with prostaglandin synthesis inhibitors during organogenesis.
The use of ibuprofen from the 20th week of pregnancy may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after the start of treatment and is usually reversible after discontinuation of the drug. In addition, cases of narrowing of the ductus arteriosus in the fetus have been reported after treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, ibuprofen should not be taken during the first and second trimesters of pregnancy unless clearly necessary. When ibuprofen is used by women planning a pregnancy or during the first or second trimester of pregnancy, the dose should be kept as low and the duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus should be considered in case of exposure to ibuprofen for several days from the 20th week of gestation. The use of Bofen 600 should be discontinued if oligohydramnios or narrowing of the ductus arteriosus in the fetus is detected.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may affect the fetus, causing:
cardiopulmonary toxicity (with premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
At the end of pregnancy, prostaglandin synthesis inhibitors expose the mother and newborn to the following risks:
possible prolongation of bleeding time, antiplatelet effect, which may develop even at very low doses;
suppression of uterine contractions, which can lead to delayed or prolonged labor.
Therefore, ibuprofen is contraindicated during the third trimester of pregnancy.
Labor and delivery.
It is not recommended to take ibuprofen during labor and delivery.
The onset of labor may be delayed and its duration prolonged, with an increased tendency to hemorrhage in both mother and child.
Breast-feeding.
Limited studies have shown that NSAIDs, including ibuprofen, pass into breast milk in very low concentrations. Ibuprofen is not recommended for use in women who are breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Taking ibuprofen may affect the reaction speed of patients, which should be borne in mind when engaging in activities that require increased concentration, such as driving or operating other mechanisms. The effect on the reaction speed is significantly increased when combined with alcohol.
After taking NSAIDs, undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible. If such effects occur during the use of NSAIDs, patients should not drive or operate other mechanisms.
Method of administration and doses
Doses.
Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time necessary to control symptoms of the disease (see section "Special instructions").
Adults and children over 12 years of age. The recommended daily dose of the drug is 1200-1800 mg, which should be taken in 2-3 divided doses. Some patients may require 600-1200 mg per day. In general, the maximum daily dose should not exceed 2400 mg, which should be taken in several divided doses. Children.
The daily dose of the drug for children is 20 mg/kg of body weight, divided into several doses.
For juvenile rheumatoid arthritis, the drug can be used at a rate of up to 40 mg/kg of body weight per day, divided into several doses.
Elderly patients.
There is an increased risk of serious adverse reactions when using the drug in elderly patients. If NSAIDs are necessary, the lowest effective dose should be prescribed for the shortest possible period of time. The patient should be regularly monitored for gastrointestinal bleeding during NSAID therapy. The dose should be adjusted individually in cases of impaired liver or kidney function.
Method of application.
For oral use.
The drug is preferably taken during or after meals, with sufficient liquid. The tablets should be swallowed whole, without chewing, dividing, crushing or dissolving, to avoid discomfort in the mouth and irritation in the throat.
Children.
Not recommended for children under 12 years of age.
More convenient forms of the drug are available for young children.
Overdose
Toxicity.
Symptoms of toxicity have not usually been observed at doses below 100 mg/kg in children and adults. However, supportive measures may be necessary in some cases. In children, symptoms of toxicity have been observed after ibuprofen doses of 400 mg/kg or higher.
Symptoms.
In most patients, symptoms of overdose develop within 4-6 hours after taking a significant amount of ibuprofen.
The most common symptoms of overdose include: nausea, vomiting, abdominal pain, lethargy and drowsiness. Central nervous system (CNS) effects: headache, tinnitus, dizziness, convulsions and loss of consciousness. Rarely reported are nystagmus, metabolic acidosis, hypothermia, renal symptoms, gastrointestinal bleeding, coma, apnea, CNS and respiratory depression.
In severe poisonings, metabolic acidosis may occur. Disorientation, agitation, syncope, and cardiovascular toxicity, including hypotension, bradycardia, and tachycardia, have been reported. In case of significant overdose, renal failure and liver damage may occur. Overdose with large doses of the drug is usually well tolerated if other drugs are not taken at the same time.
Treatment.
There is no specific antidote for ibuprofen overdose. If the amount of the drug taken exceeds 400 mg/kg, gastric lavage/emptying is recommended within 1 hour after ingestion, followed by symptomatic treatment. Activated charcoal should be administered within 1 hour after ingestion of a potentially toxic amount. Treatment should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient's condition is normal.
Ensure sufficient diuresis.
Kidney and liver function should be carefully monitored.
Patients should be observed for at least 4 hours after ingestion of a potentially toxic amount of the drug.
For the most up-to-date information, contact your local poison control center.
Side effects
The side effects of ibuprofen are similar to those of other NSAIDs.
From the digestive system. Adverse reactions from the gastrointestinal tract are observed most often. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients, are possible (see section "Special instructions").
Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, gastrointestinal bleeding and exacerbation of colitis and Crohn's disease have been reported with ibuprofen (see section 4.3). Less frequently, gastritis, gastric and duodenal ulcers, gastrointestinal perforation and pancreatitis have been reported.
Immune system disorders: Hypersensitivity reactions have been reported with ibuprofen. These include non-specific allergic reactions and anaphylaxis; airway reactivity including asthma, exacerbation of asthma, bronchospasm or dyspnoea; and various skin manifestations including rash of various types, pruritus, urticaria, purpura, angioedema and, very rarely, erythema multiforme, bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis).
Cardiovascular: Edema, hypertension, and heart failure have been reported in association with NSAID treatment.
Clinical trial data suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may slightly increase the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section "Special warnings and precautions for use").
Infections and infestations: Rhinitis and aseptic meningitis (especially in patients with autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue diseases) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).
Cases of exacerbation of infectious inflammations coinciding with the use of NSAIDs have been described. If signs of infection appear or worsen during the use of ibuprofen, the patient should immediately consult a doctor.
Skin and subcutaneous tissue disorders: In exceptional cases, severe skin infections and soft tissue complications may occur in association with chickenpox (see also "Infections and Invasions").
Adverse reactions that occurred with ibuprofen are classified by system organ class and frequency according to MedDRA.
The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and frequency unknown (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Infections and infestations: uncommon - rhinitis; rare - aseptic meningitis (see section "Special warnings and precautions for use").
From the blood and lymphatic system: rarely - leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia.
On the part of the immune system: rarely - anaphylactic reaction.
On the part of the psyche: infrequently - insomnia, anxiety disorders; rarely - depression, confusion.
From the nervous system: often - headache, dizziness; infrequently - paresthesia, drowsiness; rarely - optic neuritis.
On the part of the organs of vision: infrequently - visual impairment; rarely - toxic optic neuropathy.
From the side of the organs of hearing and vestibular apparatus: infrequently - hearing impairment, tinnitus, vertigo.
On the part of the respiratory system: infrequently - bronchial asthma, bronchospasm, dyspnea.
From the digestive system: often - dyspepsia, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, melena, hematemesis, gastrointestinal bleeding; infrequently - gastritis, duodenal ulcer, gastric ulcer, ulcerative stomatitis, gastrointestinal perforation; very rarely - pancreatitis; frequency unknown - colitis and Crohn's disease.
From the hepatobiliary system: infrequently - hepatitis, jaundice, liver dysfunction; very rarely - liver failure.
Skin and subcutaneous tissue disorders: common: rash; uncommon: urticaria, pruritus, purpura, angioedema, photosensitivity reactions; very rare: severe skin reactions (e.g. erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis); frequency unknown: DRESS syndrome (drug rash with eosinophilia and systemic symptoms), acute generalized exanthematous pustulosis.
On the part of the urinary system: infrequently - toxic nephropathy in various forms, including tubulointerstitial nephritis, nephrotic syndrome and renal failure.
General disorders and administration site conditions: often - fatigue; rarely - edema.
From the side of the cardiovascular system: very rarely - heart failure, myocardial infarction (see section "Special instructions").
Reporting of suspected adverse reactions. Reporting of suspected adverse reactions after the authorisation of a medicinal product is of great importance. This allows for continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister, 2 blisters in a pack.
Vacation category
According to the recipe.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Location of the manufacturer and address of its place of business.
Ukraine, 03134, Kyiv, Myru St., 17.
