Darfen Kids Forte oral suspension 200mg/5ml 100ml

Instructions for use Darfen Kids Forte oral suspension 200mg/5ml 100ml

Composition

active ingredient: ibuprofen;

5 ml of suspension contains 200 mg of ibuprofen;

excipients: sodium benzoate, anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose 15 CP, xanthan gum, liquid maltitol, glycerin (E 422), thaumatin, strawberry flavoring, purified water.

Dosage form

Oral suspension.

Main physicochemical properties: viscous suspension, free from foreign substances, white or almost white in color with a characteristic strawberry odor.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives.

Ibuprofen. ATX code M01A E01.

Pharmacological properties

Pharmacodynamics

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID), a propionic acid derivative, which has demonstrated its effectiveness by inhibiting prostaglandin synthesis. Ibuprofen has analgesic, antipyretic and anti-inflammatory effects. The onset of the analgesic and antipyretic effects of ibuprofen occurs within 30 minutes. In addition, ibuprofen reversibly inhibits platelet aggregation.

The clinical efficacy of ibuprofen has been demonstrated in the symptomatic treatment of mild to moderate pain, such as toothache, headache, and in the symptomatic treatment of fever.

The analgesic dose for children is 7 to 10 mg/kg body weight with a maximum dose of 30 mg/kg/day. Ibuprofen has been shown in an open-label study to have an onset of antipyretic effect within 15 minutes of administration and to reduce fever in children for up to 8 hours.

Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid (aspirin) on platelet aggregation when these drugs are used concomitantly. In a study in which a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate-release aspirin (81 mg), a reduced effect of acetylsalicylic acid on thromboxane formation or platelet aggregation was observed. However, the limitations of these data and the uncertainty regarding the extrapolation of ex vivo data to the clinical picture do not allow for firm conclusions to be drawn regarding the routine use of ibuprofen. Therefore, such clinically significant effects are considered unlikely with non-routine use of ibuprofen.

Pharmacokinetics

Ibuprofen is rapidly absorbed after administration and is rapidly distributed throughout the body. Excretion is rapid and complete and occurs via the kidneys.

Maximum plasma concentrations are reached 45 minutes after oral administration in the fasted state. Peak levels are observed 1-2 hours after administration with food.

This time may vary for different dosage forms.

The half-life is approximately 2 hours.

In limited studies, ibuprofen has been found in breast milk at very low concentrations.

Indication

Symptomatic treatment of fever and pain of various origins in children aged 6 months to 12 years with a body weight of at least 8 kg (including fever after immunization, acute respiratory viral infections, influenza, teething pain, pain after tooth extraction, toothache, headache, sore throat, pain from sprains and other types of pain, including inflammatory genesis).

Contraindication

Hypersensitivity to ibuprofen or to any of the components of the drug.

History of hypersensitivity reactions (such as bronchospasm, asthma, rhinitis, angioedema or urticaria) after taking ibuprofen, acetylsalicylic acid or other NSAIDs.

History of active or recurrent gastric or duodenal ulcer/bleeding (two or more severe episodes of confirmed ulceration or bleeding).

History of gastrointestinal bleeding or perforation associated with NSAID use.

Inflammatory bowel disease in active form.

Cerebrovascular or other bleeding.

Hemorrhagic diathesis or other blood clotting disorders.

Severe heart failure (NYHA class IV), severe hepatic failure or severe renal failure.

The last trimester of pregnancy.

Severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake).

Hereditary fructose intolerance.

Interaction with other medicinal products and other types of interactions

Ibuprofen, like other NSAIDs, should not be used in combination with:

with other NSAIDs, including selective cyclooxygenase-2 inhibitors, as this may increase the risk of side effects.

Ibuprofen should be used with caution in combination with the following drugs:

Anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin;

Antihypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists): NSAIDs may reduce the effect of these drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), the concomitant use of ACE inhibitors, beta-blockers or angiotensin II antagonists and cyclooxygenase inhibitors may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such a combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter;

corticosteroids: increased risk of ulcers and bleeding in the gastrointestinal tract;

Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding;

Cardiac glycosides, such as digoxin: NSAIDs may exacerbate cardiac dysfunction, reduce glomerular filtration rate and increase plasma glycoside levels. NSAIDs may increase plasma digoxin levels and therefore increase the risk of digoxin toxicity.

Pentoxifylline: Patients receiving ibuprofen therapy in combination with pentoxifylline have an increased risk of hemorrhage.

Lithium: NSAIDs may increase plasma lithium levels, possibly due to decreased renal clearance. Concomitant use of these drugs should be avoided if lithium levels are not controlled. A reduction in the lithium dose may be considered.

Methotrexate at a dose of 15 mg/week or higher: the use of NSAIDs within 24 hours before or after methotrexate administration may lead to an increase in the plasma concentration of methotrexate (presumably the renal clearance of methotrexate may be reduced by the effect of NSAIDs) and a further increase in its toxic effect. Therefore, the use of ibuprofen should be avoided in patients receiving high doses of methotrexate;

Methotrexate at a dose below 15 mg/week: ibuprofen increases methotrexate levels. When ibuprofen is used in combination with low doses of methotrexate, the patient's blood picture should be carefully monitored. Monitoring should be intensified in cases of even minimal deterioration of renal function and in elderly patients, and renal function should be monitored to prevent a possible decrease in methotrexate clearance;

Cyclosporine and tacrolimus: possible increased risk of nephrotoxicity with concomitant use of NSAIDs due to decreased renal prostaglandin synthesis. Renal function should be closely monitored when these drugs are used concomitantly with NSAIDs;

Mifepristone: NSAIDs should not be used earlier than 8–12 days after mifepristone administration, as they may reduce the effectiveness of the latter;

Sulfonylurea drugs: NSAIDs have been observed to interact with hypoglycemic agents (sulfonylureas). NSAIDs may enhance the hypoglycemic effect of sulfonylureas by displacing them from plasma protein binding; it is recommended to monitor blood glucose levels when sulfonylureas are used concomitantly with ibuprofen.

Probenecid and sulfinpyrazone: possible increase in ibuprofen plasma concentration and delay in ibuprofen elimination; which may be due to an inhibitory mechanism at the site of renal tubular secretion and glucuronidation; therefore, ibuprofen dose adjustment may be required;

Baclofen: there is a risk of developing baclofen toxicity after starting ibuprofen;

Ritonavir: possible increase in plasma concentrations of NSAIDs;

Aminoglycosides: NSAIDs may reduce the excretion of aminoglycosides;

Captopril: experimental studies have shown that ibuprofen inhibits the effect of captopril on sodium excretion;

Voriconazole and fluconazole (CYP2C9 inhibitors): Concomitant use of ibuprofen with CYP2C9 inhibitors may increase the exposure of ibuprofen (CYP2C9 substrate). A study with voriconazole and fluconazole (CYP2C9 inhibitors) demonstrated an increase in the exposure of S(+) ibuprofen by approximately 80-100%. When ibuprofen is co-administered with strong CYP2C9 inhibitors, a reduction in ibuprofen doses is recommended, especially if high doses of ibuprofen are required with voriconazole or fluconazole;

Quinolone antibiotics: animal studies have shown that NSAIDs may increase the risk of convulsions associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may be at increased risk of developing convulsions; - hydantoins and sulfonamides: possible increase in the toxic effect of these drugs. Plasma levels of phenytoin may increase with concomitant treatment with ibuprofen. When used correctly (maximum 4 days), monitoring of phenytoin serum levels is usually not necessary;

Thiazides, thiazide-like substances, loop diuretics and potassium-sparing diuretics: NSAIDs may antagonize the diuretic effect of these medicinal products. Concomitant use of NSAIDs and diuretics may increase the risk of NSAID-induced nephrotoxicity (e.g. in dehydrated patients or in elderly patients with compromised renal function) due to decreased renal blood flow. Therefore, this combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter. As with other NSAIDs, concomitant therapy with potassium-sparing diuretics may be associated with increases in potassium levels, and plasma potassium levels should be monitored.

Taking ibuprofen with food slows down absorption, although it does not affect the extent of absorption (see section "Pharmacokinetics").

Application features

Side effects of ibuprofen therapy can be minimized by using the lowest effective dose necessary to treat symptoms for the shortest period of time.

Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Elderly patients are at increased risk of adverse reactions. Long-term use of NSAIDs in elderly patients is not recommended. In case of long-term therapy, patients should be regularly monitored.

Caution should be exercised in patients with the following conditions:

systemic lupus erythematosus, as well as mixed connective tissue disease – due to an increased risk of aseptic meningitis;

congenital disorder of porphyrin metabolism, such as acute concomitant porphyria;

gastrointestinal disorders and chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

history of hypertension and/or heart failure, as fluid retention and edema have been reported with NSAID therapy;

renal failure – due to the possibility of worsening kidney function;

liver dysfunction;

immediately after extensive surgical interventions;

hay fever, nasal polyps or chronic obstructive airway diseases – due to an increased risk of allergic reactions, which include asthma attacks (so-called analgesic asthma), angioedema or urticaria;

history of allergic reactions to other substances – due to an increased risk of hypersensitivity reactions to ibuprofen.

Effects on the respiratory system.

Bronchospasm may occur in patients who suffer from bronchial asthma or allergic diseases or have a history of these diseases.

Other NSAIDs.

The concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided as this increases the risk of adverse reactions.

Like other NSAIDs, ibuprofen can cause allergic reactions, such as anaphylactic/anaphylactoid reactions, even when the drug is used for the first time.

Systemic lupus erythematosus and mixed connective tissue disease.

Ibuprofen should be used with caution in systemic lupus erythematosus and mixed connective tissue disease due to an increased risk of aseptic meningitis.

Effects on the cardiovascular and cerebrovascular systems.

Patients with a history of hypertension and/or heart failure should start treatment with caution (consultation with a doctor is necessary), since cases of fluid retention, hypertension and edema have been reported with ibuprofen therapy, as with other NSAIDs.

Clinical trials and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg per day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (such as myocardial infarction or stroke). Epidemiological studies do not suggest that the use of low doses of ibuprofen (e.g. ≤ 1200 mg per day) increases the risk of myocardial infarction.

The clinical picture should also be carefully assessed before starting long-term treatment in patients with risk factors for cardiovascular complications (such as hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required.

Effects on kidneys and liver.

Caution should be exercised in patients with renal insufficiency due to the possibility of worsening of renal function. Ibuprofen should be used with caution in patients with renal or hepatic disease and especially during concomitant therapy with diuretics, since inhibition of prostaglandins may lead to fluid retention and further deterioration of renal function. In such patients, the lowest possible dose of ibuprofen should be used and renal function should be monitored regularly. In case of dehydration, adequate fluid intake should be ensured. There is a risk of renal failure in children and adolescents with dehydration.

Chronic use of analgesics, especially combinations of different analgesics, can lead to long-term kidney damage with the risk of renal failure (analgesic nephropathy). The risk of this reaction is highest in elderly patients, patients with renal failure, heart failure and liver failure, and those receiving diuretics or ACE inhibitors. After discontinuation of NSAID therapy, renal function usually returns to the state observed before treatment.

Liver function may be impaired. Like other NSAIDs, ibuprofen may cause transient increases in certain liver function tests, including significant increases in AST and ALT. If these values are significantly elevated, treatment should be discontinued.

Effect on the gastrointestinal tract.

NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) as their condition may be exacerbated. Such patients should seek medical advice.

There are reports of cases of gastrointestinal bleeding, perforation, ulcers, potentially fatal, which occurred at any stage of treatment with NSAIDs, regardless of the presence of warning symptoms or the presence of severe gastrointestinal disorders in history.

The risk of gastrointestinal bleeding, perforation or ulceration increases with increasing doses of NSAIDs, with a history of peptic ulcer disease, especially complicated by bleeding or perforation, and in the elderly. These patients should be started on the lowest dose. In such patients, as well as in patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal bleeding, combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) is recommended.

Patients with a history of gastrointestinal toxicity, especially the elderly, should be informed of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.

Caution should be exercised when treating patients who are taking concomitant medications that may increase the risk of ulceration or bleeding, including oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (e.g. acetylsalicylic acid).

In the event of gastrointestinal bleeding or ulceration in patients receiving ibuprofen, treatment should be discontinued immediately.

On the skin and subcutaneous tissue.

Very rarely, severe skin reactions, which can be fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur with NSAIDs. The risk of these reactions is highest at the beginning of therapy. In most cases, these reactions began within the first month of treatment. A case of acute generalized exanthematous pustulosis has also been reported after the use of ibuprofen-containing medicines. Ibuprofen should be discontinued at the first signs and symptoms of skin lesions, such as skin rash, mucosal lesions or any other signs of hypersensitivity.

Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed very rarely. At the first signs of a hypersensitivity reaction after taking ibuprofen, therapy should be discontinued and a doctor should be consulted immediately.

In exceptional cases, chickenpox can cause severe skin and soft tissue infections. It cannot be excluded that NSAIDs may worsen these infections, so it is recommended to avoid ibuprofen in case of chickenpox.

Masking the symptoms of underlying infections.

Darfen® Kids Forte may mask the symptoms of an infectious disease, which may delay the initiation of appropriate treatment and thereby complicate the course of the disease. This has been observed in bacterial community-acquired pneumonia and bacterial complications of chickenpox. When ibuprofen is used for fever or to relieve pain in an infection, monitoring for the infectious disease is recommended. In outpatient settings, the patient should consult a doctor if symptoms persist or worsen.

Ibuprofen may temporarily inhibit platelet aggregation. Therefore, it is recommended to carefully monitor the condition of patients with blood clotting disorders.

With prolonged use of ibuprofen, liver function tests, kidney function, and hematological function/blood count should be checked regularly.

Prolonged use of any painkiller for headache may worsen this condition. In such cases, a doctor should be consulted and treatment should be discontinued. The possibility of drug overuse headache should be considered in patients who suffer from frequent or daily headaches despite regular use of headache medication.

The concomitant use of alcohol and NSAIDs may increase adverse reactions associated with the active substance, especially those affecting the gastrointestinal tract or central nervous system.

Before taking this medicine, you should consult a doctor: pregnant women, women trying to get pregnant, elderly people, smokers.

Impact on laboratory test results:

Bleeding time may increase up to one day after stopping treatment;

Blood glucose concentration may decrease;

creatinine clearance may decrease;

hematocrit or hemoglobin may decrease;

Blood urea nitrogen concentration and serum creatinine and potassium concentrations may increase;

Liver function tests: increased transaminase levels.

Important information about excipients.

Due to the content of liquid maltitol, this medicinal product may have a mild laxative effect. The energy value of 1 g of maltitol is 2.3 kcal. It should not be prescribed to patients with rare hereditary disorders of fructose tolerance.

The medicinal product contains sodium compounds. Caution should be exercised when used in patients on a controlled sodium diet.

Use during pregnancy or breastfeeding

Pregnancy.

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonal/fetal development. Epidemiological data indicate an increased risk of miscarriage, congenital heart defects and gastroschisis after use of prostaglandin synthesis inhibitors in early pregnancy. The risk is thought to increase with increasing dose and duration of therapy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk increases with increasing dose and duration of treatment.

From the 20th week of pregnancy, the use of ibuprofen may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after the start of treatment and is usually reversible after discontinuation of treatment. In addition, there have been reports of narrowing of the ductus arteriosus after treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Ibuprofen should not be taken during the first two trimesters of pregnancy unless, in the opinion of the physician, the potential benefit to the patient outweighs the potential risk to the fetus. If ibuprofen is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible period of time.

Antenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus should be considered after exposure to ibuprofen for several days, starting from the 20th week of gestation. The use of Darfen® Kids Forte should be discontinued if oligohydramnios or narrowing of the ductus arteriosus is detected.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose the following risks:

for the fetus:

cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);

§ – renal dysfunction (see above);

for the mother and the newborn, at the end of pregnancy: possible increase in bleeding time, antiplatelet effect, which can develop even at very low doses; inhibition of uterine contractions, leading to delay or prolongation of labor. Possible increased risk of edema in the mother. Therefore, ibuprofen is contraindicated during the third trimester of pregnancy.

Fertility. There is limited evidence that cyclooxygenase/prostaglandin synthesis inhibitors may impair female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment. The use of ibuprofen is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing investigation of infertility, withdrawal of the medicinal product should be considered.

Ability to influence reaction speed when driving vehicles or other mechanisms

Patients who experience dizziness, vertigo, visual disturbances or other central nervous system disorders when taking ibuprofen should avoid driving or operating other machinery during therapy with this drug.

No special precautions are required when using a single dose of ibuprofen or when using the drug for a short period of time.

Method of administration and doses

Side effects can be minimized by using the lowest effective dose necessary to control symptoms for the shortest period of time.

For oral use. The drug can be used diluted with water or undiluted. The recommended daily dose of the drug is 20–30 mg per 1 kg of body weight, divided into equal doses, the intervals between doses are 6–8 hours. To ensure accurate dosing, use the syringe-doser included in the package. Do not exceed the recommended dose. For short-term use only. Shake before use.

If your child's symptoms persist for more than 3 days after starting treatment or worsen, you should consult a doctor.

Patients with sensitive stomachs should take the medicine with meals.

Special categories of patients

NSAIDs should be used with caution in patients with renal impairment, as ibuprofen is primarily excreted by the kidneys. Lower doses should be used in patients with mild to moderate renal impairment.

Ibuprofen should not be used in patients with severe renal impairment (see section "Contraindications").

Although no differences in the pharmacokinetic profile of ibuprofen have been observed in patients with hepatic impairment, NSAIDs should be used with caution in such patients. Patients with mild to moderate hepatic impairment should be started on low doses and closely monitored. Ibuprofen should not be used in patients with severe hepatic impairment (see section 4.3).

Patients should consult a doctor if symptoms persist or worsen during treatment.

If you use a dose that exceeds the recommended dose, you should immediately consult a doctor.

Children

The medicine should be used in children aged 6 months and over, weighing at least 8 kg, up to 12 years.

Overdose

In children, symptoms of overdose may occur when taking ibuprofen doses exceeding 400 mg/kg. In adults, dose-related reactions are less pronounced. The half-life in overdose is 1.5–3 hours.

Symptoms. In most patients, the use of clinically significant amounts of NSAIDs caused only nausea, vomiting, epigastric pain or, less commonly, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe poisoning, toxic CNS lesions in the form of vertigo, dizziness, drowsiness, sometimes - an excited state and disorientation or coma are possible. Sometimes patients develop convulsions. In severe poisoning, hyperkalemia, metabolic acidosis and an increase in prothrombin time/INR may occur (presumably due to interaction with blood clotting factors circulating in the bloodstream). Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may occur. In patients with bronchial asthma, exacerbation of asthma is possible. Nystagmus, visual impairment and loss of consciousness are possible.

Treatment. There is no specific antidote. Treatment is symptomatic and supportive, including maintaining a patent airway, monitoring cardiac function and vital signs until the patient's condition is normal. Consider oral administration of activated charcoal or gastric lavage if it is less than 1 hour after the patient has taken a potentially toxic dose. If ibuprofen has already been absorbed, alkaline agents can be used to help eliminate acidic ibuprofen in the urine. For frequent or prolonged seizures, administer an intravenous antihistamine (e.g. diazepam or lorazepam). Bronchodilators should be used in the case of bronchial asthma. Medical advice should be sought.

Side effects

The list of adverse reactions includes all adverse reactions known to occur with ibuprofen, including those observed with high doses in long-term treatment of patients with rheumatism. The frequency reported, which goes beyond very rare reports, refers to short-term use (maximum 1200 mg ibuprofen per day) of oral dosage forms.

Adverse reactions that have occurred with ibuprofen are listed below by system organ class and frequency. 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 not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

The most frequently observed adverse reactions are gastrointestinal. Most adverse reactions are dose-related, in particular the risk of gastrointestinal bleeding depends on the dose and duration of treatment. Gastrointestinal ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients. Nausea, vomiting, diarrhoea, abdominal distension, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after the use of ibuprofen. Gastritis has been observed less frequently.

Edema, hypertension, and heart failure have been reported to be associated with NSAID treatment.

Clinical trial data suggest that the use of ibuprofen, especially at high doses of 2400 mg per day and with long-term treatment, may be associated with an increased risk of arterial thrombotic complications (e.g. myocardial infarction or stroke).

There have been reports of exacerbations of inflammation associated with infection, such as necrotizing fasciitis, coinciding with the use of NSAIDs. This may be related to the mechanism of action of NSAIDs.

If signs of infection develop or worsen while taking ibuprofen, the patient is advised to seek immediate medical attention. It is necessary to determine whether antimicrobial/antibiotic therapy is indicated.

With long-term therapy, it is necessary to regularly perform blood tests.

The patient should immediately consult a doctor and stop using ibuprofen if any of the symptoms of hypersensitivity reactions occur, which can develop even with the first use of the drug. In such cases, immediate medical attention is required.

If severe epigastric pain or melena or bloody vomiting occurs, discontinue use of the drug and consult a doctor immediately.

On the part of the organs of vision:

frequency unknown: with prolonged treatment, visual disturbances and optic neuritis may occur.

From the side of the organs of hearing and vestibular apparatus:

frequency unknown: dizziness may occur with prolonged treatment;

Rare: ringing in the ears.

From the respiratory system, chest organs and mediastinum:

frequency unknown: airway reactivity including asthma, bronchospasm or dyspnoea1.

From the gastrointestinal tract:

common: abdominal pain, nausea, dyspepsia, diarrhea, flatulence, constipation, heartburn, vomiting and minor gastrointestinal bleeding, which in exceptional cases may lead to anemia;

Infrequent: gastric and duodenal ulcers, perforations or gastrointestinal bleeding, melena, hematemesis, sometimes fatal (especially in elderly patients), ulcerative stomatitis, gastritis, exacerbation of colitis and Crohn's disease;

very rare: esophagitis, formation of diaphragmatic intestinal strictures, pancreatitis.

On the part of the liver:

very rare: liver dysfunction, liver damage, especially with long-term therapy, liver failure, acute hepatitis.

From the kidneys and urinary system:

Rare: acute renal failure, especially with long-term use of NSAIDs, in combination with increased serum creatinine levels.