Instructions for Eurofast soft gelatin capsules 400 mg blister No. 20
Composition
active ingredient: ibuprofen;
1 capsule contains 200 mg or 400 mg of ibuprofen;
excipients (200 mg): polyethylene glycol, sorbitol-sorbitan solution, sorbitan oleate (sorbitan 80), potassium hydroxide, purified water;
capsule shell: gelatin, polyethylene glycol 400, sorbitol-sorbitan solution, FD&C Green No. 3, purified water, medium chain triglycerides (Miglyol 812);
excipients (400 mg): polyethylene glycol 400, povidone PVP K-30, sorbitan oleate, potassium hydroxide, purified water;
capsule shell: gelatin, polyethylene glycol 400, sorbitol-sorbitan solution, purified water, medium chain triglycerides.
Dosage form
Soft gelatin capsules.
Main physicochemical properties:
200 mg capsules: oval soft gelatin capsules from blue-green to light green in color, containing a transparent viscous liquid from colorless to pale yellow in color, marked "133" in black on the capsule shell. (The shade of the capsule contents of the finished product may change to light green during the shelf life);
400 mg capsules: oval soft gelatin capsules containing a clear, viscous liquid from colorless to pale yellow, marked "125" in black on the capsule shell.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. ATX code M01A E01.
Pharmacological properties
Pharmacodynamics.
It has analgesic, antipyretic and anti-inflammatory effects.
The mechanism of action is to inhibit the synthesis of prostaglandins – mediators of pain, inflammation, and temperature response.
Pharmacokinetics.
After oral administration, ibuprofen is rapidly absorbed from the gastrointestinal tract. The maximum concentration of the active substance in the blood plasma is determined 1-2 hours after administration, in the synovial fluid - 3 hours after administration. Ibuprofen is metabolized in the liver, excreted by the kidneys in an unchanged state and in the form of metabolites.
The half-life is almost 2 hours.
Indication
Symptomatic treatment of headache, toothache, menstrual pain, fever, neuralgia, back pain, joints, muscles, and rheumatic pain.
Contraindication
- Hypersensitivity to ibuprofen or to any of the components of the drug.
- Hypersensitivity reactions (e.g. bronchial asthma, rhinitis, angioedema or urticaria) previously observed after taking ibuprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
- Gastric ulcer/bleeding in active form or history of recurrence (two or more severe episodes of ulcer or bleeding).
- History of gastrointestinal bleeding or perforation associated with NSAID use.
- Severe hepatic impairment, severe renal impairment, severe heart failure (NYHA class IV).
- The last trimester of pregnancy.
- Cerebrovascular or other bleeding in the active phase.
- Hemorrhagic diathesis or blood clotting disorder.
- Hematopoietic disorders of unknown etiology.
- Severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
Interaction with other medicinal products and other types of interactions
Ibuprofen, like other NSAIDs, should not be used in combination with:
- Acetylsalicylic acid, as this may increase the risk of adverse reactions, except in cases where acetylsalicylic acid (dose not exceeding 75 mg per day) has been prescribed by a doctor.
Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when used concomitantly. However, the limitations of extrapolation of these data to the clinical situation prevent definitive conclusions that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. Such clinically significant effects are considered unlikely with non-systematic use of ibuprofen.
- Other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors:
The simultaneous use of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect. Therefore, concomitant use of ibuprofen with other NSAIDs should be avoided.
Ibuprofen should be used with caution in combination with the following drugs:
Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the concomitant use of an ACE inhibitor or angiotensin II antagonist and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such combinations should be prescribed with caution, especially in elderly patients. If long-term treatment is necessary, the patient should be adequately hydrated and consideration should be given to monitoring renal function at the beginning of the combination treatment and periodically thereafter. Diuretics may increase the risk of nephrotoxicity of ibuprofen.
Concomitant use of ibuprofen and potassium-sparing diuretics may lead to hyperkalemia (serum potassium monitoring is recommended).
Corticosteroids: increased risk of gastrointestinal (GI) ulcers and bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): The risk of gastrointestinal bleeding may be increased.
Cardiac glycosides: ibuprofen may exacerbate cardiac dysfunction, reduce renal glomerular filtration rate, and increase plasma glycoside levels.
Lithium: There is evidence of a potential increase in plasma lithium levels.
Methotrexate: Use of ibuprofen within 24 hours before or after administration of methotrexate may lead to increased concentrations of methotrexate and increased toxicity.
Cyclosporine: increased risk of nephrotoxicity.
Mifepristone: Ibuprofen should not be used earlier than 8-12 days after mifepristone administration, as they may reduce its effectiveness.
Tacrolimus: There may be an increased risk of nephrotoxicity with concomitant use of NSAIDs and tacrolimus.
Zidovudine: There is an increased risk of haematological toxicity when zidovudine is used concomitantly with ibuprofen. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-infected patients with haemophilia when zidovudine is used concomitantly with ibuprofen.
Quinolone antibiotics: Concomitant use with ibuprofen may increase the risk of seizures.
Sulfonylurea: with concomitant use, monitoring of blood glucose levels is recommended as a precautionary measure.
Probenecid and sulfinpyrazone: may delay the excretion of ibuprofen.
Application features
Side effects of ibuprofen and the entire group of NSAIDs in general can be reduced by using the minimum effective dose necessary to treat symptoms for the shortest period of time.
Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
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
Concomitant use of ibuprofen with other NSAIDs, including selective COX-2 inhibitors, increases the risk of adverse reactions and should be avoided.
Systemic lupus erythematosus and mixed connective tissue diseases
Ibuprofen should be used with caution in cases of systemic lupus erythematosus and mixed connective tissue diseases due to the increased risk of aseptic meningitis.
Porphyrin metabolism
Caution should be exercised in patients with congenital disorders of porphyrin metabolism (e.g. acute intermittent porphyria).
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), as cases of fluid retention, hypertension and edema have been reported with ibuprofen therapy.
Clinical trial data and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low-dose ibuprofen (e.g. ≤ 1200 mg/day) may lead to an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful clinical assessment. High doses (2400 mg/day) should be avoided.
Cases of Kounis syndrome have been reported in patients treated with Eurofast. Kounis syndrome is defined as cardiovascular symptoms caused by an allergic or hypersensitivity reaction associated with narrowing of the coronary arteries, potentially leading to myocardial infarction.
Effects on the kidneys
Ibuprofen should be used with caution in patients with renal impairment, as renal function may deteriorate.
Effect on the liver
Liver dysfunction is possible.
Surgical interventions
Caution should be exercised immediately after major surgical procedures.
Impact on fertility in women
There is limited evidence that long-term use of cyclooxygenase/prostaglandin synthesis inhibitors (>2400 mg/day and >10 days of treatment) may impair female fertility by affecting ovulation. This is reversible upon discontinuation of treatment.
Effects on the gastrointestinal tract
The drug should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated. There are reports of cases of gastrointestinal bleeding, perforation, ulcers (possibly fatal), which occurred at any stage of drug use, regardless of the presence of warning symptoms or the presence of severe gastrointestinal disorders in history.
The risk of gastrointestinal bleeding, perforation, ulceration increases with increasing doses of the drug, in patients with a history of ulcer, especially complicated by bleeding or perforation, and in elderly patients. Such patients should start treatment with minimal doses. For such patients, as well as for those who require concomitant use of low doses of acetylsalicylic acid or other drugs that may increase the risk for the gastrointestinal tract, the need for combination therapy with protective drugs (for example, misoprostol or proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal disorders, especially elderly patients, should be informed of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.
Caution should be exercised when treating patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), SSRIs or antiplatelet agents (e.g. acetylsalicylic acid).
In the event of gastrointestinal bleeding or ulceration in patients receiving ibuprofen, treatment should be discontinued immediately.
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug-induced eosinophilia with systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported with ibuprofen (see section 4.8). The majority of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear, ibuprofen should be discontinued immediately and alternative treatment considered (if necessary).
In exceptional cases, chickenpox can cause severe skin and soft tissue infections. It cannot be ruled out that ibuprofen may worsen these infections, so it is recommended to avoid ibuprofen in case of chickenpox.
Allergy
Caution should be exercised when administering the drug to patients who have allergic reactions to other substances, as such patients are also at increased risk of developing hypersensitivity reactions when using ibuprofen.
Patients suffering from hay fever, nasal polyps, chronic obstructive airway diseases, or a history of allergic diseases are at increased risk of allergic reactions, which may manifest as asthma attacks (so-called analgesic asthma), angioedema, or urticaria.
This medicine contains sorbitol. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take ibuprofen.
Masking of symptoms of underlying infections: Eurofast 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 Eurofast 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.
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed very rarely. At the first signs of a hypersensitivity reaction after the use of Eurofast, therapy should be discontinued. In such cases, both symptomatic and specialized therapy should be carried out.
Ibuprofen may temporarily inhibit platelet function (affect platelet aggregation). Therefore, it is recommended to carefully monitor the condition of patients with blood clotting disorders.
With long-term use of the drug Eurofast, it is necessary to regularly check liver and kidney function indicators, as well as monitor the blood picture.
Long-term use of any painkiller for headache may worsen this condition. If this condition is suspected or confirmed, consult a doctor and discontinue treatment. A diagnosis of medication overuse headache should be considered in patients who suffer from frequent or daily headaches despite (or because of) regular use of headache medications.
Habitual use of analgesic drugs, especially combinations of several analgesics, may lead to persistent renal impairment with the risk of renal failure (analgesic nephropathy). This risk may be increased by salt loss and dehydration.
When using the drug while drinking alcohol, the risk of adverse effects associated with the active substance may increase, especially from the gastrointestinal tract or CNS.
Use during pregnancy or breastfeeding
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonal/fetal development. Epidemiological data suggest an increased risk of miscarriage, congenital heart defects and gastroschisis following exposure to prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from 1% to approximately 1.5%. The risk is believed to increase with increasing dose and duration of therapy.
The drug should not be taken during the first and second trimesters of pregnancy unless, in the opinion of the physician, the expected 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.
From the 20th week of pregnancy onwards, the use of Eurofast may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after initiation of treatment and is usually reversible after discontinuation of treatment. In addition, there have been reports of narrowing of the ductus arteriosus following treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, Eurofast should not be administered during the first and second trimesters of pregnancy unless clearly necessary. If this medicine is used by a woman attempting to conceive or pregnant during the first and second trimesters 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 after exposure to Eurofast for several days, starting from the 20th week of gestation. Eurofast 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 (characterized by premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure, accompanied by oligohydramnios;
for the mother and 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, which leads to a delay or increase in the duration of labor, therefore ibuprofen is contraindicated during the third trimester of pregnancy.
In limited studies, ibuprofen has been found in breast milk at very low concentrations, so it is unlikely that it would have any adverse effects on a breastfed infant. The drug is not recommended for use during breast-feeding.
Fertility
The use of ibuprofen may affect female fertility. This effect is reversible upon discontinuation of treatment. Therefore, the use of ibuprofen is not recommended in women who have difficulty conceiving.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients who experience dizziness, drowsiness or visual disturbances while taking ibuprofen should avoid driving or operating machinery. No special precautions are required for single or short-term use of the drug. This mainly applies to the simultaneous use of the drug with alcohol.
When used in accordance with the recommended doses and duration of treatment, the drug does not affect the reaction speed when driving or working with other mechanisms.
Method of administration and doses
The lowest effective dose should be used for the shortest time necessary to relieve symptoms.
The drug is recommended for adults and children over 12 years of age: the initial dose is
1-2 capsules, then, if necessary, 1-2 capsules every 4-6 hours. Do not use more than 1200 mg (6 or 3 capsules, respectively) in 24 hours.
Capsules are usually taken during meals, without chewing, with water.
Elderly patients do not require special dose adjustment.
If symptoms of the disease persist for more than 3 days, you should consult a doctor to clarify the diagnosis and adjust the treatment regimen.
Children.
Contraindicated for children under 12 years of age.
Overdose
The use of the drug in children in doses exceeding 400 mg/kg may cause symptoms of intoxication. In adults, the dose effect is less pronounced. The half-life in case of overdose is 1.5-3 hours.
Symptoms. Most patients who have used clinically significant amounts of the drug have developed only nausea, vomiting, epigastric pain, very rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding may also occur. In more severe poisoning, toxic CNS lesions are possible, which manifest as vertigo, drowsiness, sometimes - an excited state and disorientation or coma. Sometimes patients have convulsions. In severe poisoning, hyperkalemia and metabolic acidosis may develop, an increase in prothrombin time / increase in prothrombin index may be observed, possibly due to the effect on circulating blood clotting factors. Acute renal failure, liver damage, arterial hypotension, respiratory failure and cyanosis may develop. In patients with bronchial asthma, exacerbation of the disease is possible.
Treatment. Treatment should be symptomatic and supportive, and include maintaining a patent airway and monitoring cardiac and vital signs until the condition returns to normal. Oral administration of activated charcoal or gastric lavage is recommended within 1 hour of ingestion of a potentially toxic dose. If ibuprofen has already been absorbed, alkaline agents may be administered to promote urinary excretion of acidic ibuprofen. Intravenous diazepam or lorazepam should be used for frequent or prolonged seizures. Bronchodilators should be used for acute asthma.
Adverse reactions
The following adverse reactions have been observed with short-term use of ibuprofen, not exceeding 1200 mg per day. Additional adverse reactions may occur with long-term use of the drug for the treatment of a chronic condition.
Adverse reactions that have occurred with ibuprofen are listed 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 not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The most common adverse reactions are gastrointestinal in nature and are mostly dose-dependent, in particular the risk of gastrointestinal bleeding, which is dose- and duration-dependent. Adverse reactions are less common when the maximum daily dose does not exceed 1200 mg.
Clinical trial data suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a slightly increased risk of arterial thrombotic complications, such as myocardial infarction or stroke.
Blood and lymphatic system disorders
Very rare: haematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
On the part of the immune system
Rare: hypersensitivity reactions including urticaria and pruritus; very rare: severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension, anaphylactic reactions, angioedema or severe shock; frequency unknown: airway reactivity including bronchial asthma, exacerbation of asthma, bronchospasm.
From the nervous system
Uncommon: headache; very rare: aseptic meningitis, some symptoms of which (rigidity of the occipital muscles, headache, nausea, vomiting, fever or disorientation) may occur in patients with existing autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease; frequency unknown: dizziness, paraesthesia, drowsiness.
From the side of the cardiovascular system
Frequency unknown: heart failure, edema, Kounis syndrome.
From the vascular system
Frequency unknown: arterial hypertension.
From the digestive tract
very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, haematemesis, sometimes fatal (especially in elderly patients), ulcerative stomatitis, gastritis; frequency unknown: exacerbation of colitis and Crohn's disease.
Liver
Very rare: liver dysfunction.
Skin and subcutaneous tissue disorders
Rare: various skin rashes; very rare: severe cutaneous adverse reactions (SCARs) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis); frequency unknown: photosensitivity reactions, drug-induced eosinophilia with systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP).
Renal and urinary disorders
Very rare: acute renal failure, papillonecrosis, especially with prolonged use, associated with increased serum urea levels, and edema.
Laboratory studies
Very rare: decreased hemoglobin level.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 ºС.
Keep out of reach of children.
Packaging
10 capsules in a blister; 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Marxans Pharma Ltd.
Location of the manufacturer and address of its place of business.
Plot No. L-82, L-83, Verna Industrial Estate, Verna Goa, IN-403 722, India.
