Instructions for Ibuprom Sprint Max soft capsules 400 mg blister No. 10
Composition
active ingredient: ibuprofen.
1 soft capsule contains 400 mg of ibuprofen;
excipients: polyethylene glycol 600, potassium hydroxide, purified water;
capsule shell: gelatin, sorbitol (E 420), purified water.
Dosage form
Soft capsules.
Main physicochemical properties: oval gelatinous transparent soft capsules of pale yellow color.
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 in inhibiting the synthesis of prostaglandins - mediators of pain and inflammation. Ibuprofen has analgesic, antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when these drugs are used concomitantly. Some pharmacodynamic studies have shown that single doses of ibuprofen 400 mg administered within 8 hours before or within 30 minutes after immediate-release acetylsalicylic acid (81 mg) have been shown to reduce the effect of acetylsalicylic acid (aspirin) on thromboxane formation or platelet aggregation. Although there is uncertainty about the extrapolation of 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. Such a clinically significant effect is considered unlikely with non-systematic use of ibuprofen.
Inside the Ibuprom Sprint MAX capsule, ibuprofen is dissolved in a hydrophilic solvent. After oral administration, the gelatin capsule disintegrates under the action of gastric juice, as a result of which the already dissolved ibuprofen is released.
Pharmacokinetics
When taken orally, ibuprofen is rapidly absorbed, partly in the stomach and then completely in the small intestine. After metabolism in the liver (hydroxylation, carboxylation, conjugation), pharmacologically inactive metabolites are completely excreted mainly in the urine (90%) and also in the bile. The elimination half-life in healthy volunteers, as well as in patients with liver and kidney diseases, is 1.8-3.5 hours. Plasma protein binding is approximately 99%. With oral administration of the usual release dosage form, maximum plasma concentrations are reached after 1-2 hours. Peak plasma levels after oral administration with food are reached after 1-2 hours.
In a pharmacokinetic study, the time to peak plasma levels (Tmax) in the fasting state for the tablet formulation was 90 minutes, while for the soft capsules it was 40 minutes. Thus, the analgesic effect of Ibuprom Sprint MAX occurs twice as quickly as that of ibuprofen tablets. Ibuprofen is detected in the blood plasma for 8 hours after taking Ibuprom Sprint MAX, soft capsules.
Indication
Symptomatic treatment of mild to moderate pain of various origins (headache, toothache, painful menstruation), including colds and fever.
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 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 the use of NSAIDs.
· Last trimester of pregnancy.
· Cerebrovascular or other bleeding in active form.
Interaction with other medicinal products and other types of interactions
Ibuprofen, like other NSAIDs, should not be used in combination with:
- acetylsalicylic acid (aspirin), as this may increase the risk of adverse reactions, except when aspirin (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 (aspirin) on platelet aggregation when used concomitantly. However, limitations in extrapolating 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 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.
Anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin;
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 NSAIDs.
Concomitant use of ibuprofen and potassium-sparing diuretics may lead to hyperkalemia (serum potassium monitoring is recommended);
corticosteroids: increased risk of ulcers and bleeding in the gastrointestinal tract;
Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding;
cardiac glycosides: NSAIDs can exacerbate cardiac dysfunction, reduce glomerular filtration function of the kidneys, and increase the level of glycosides in blood plasma;
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: NSAIDs should not be used earlier than 8-12 days after mifepristone administration, as they may reduce its effectiveness;
Tacrolimus: possible increased risk of nephrotoxicity with concomitant use of NSAIDs with tacrolimus;
Zidovudine: Increased risk of hematological toxicity with concomitant use of zidovudine and NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia when treated concomitantly with zidovudine and ibuprofen.
quinolone antibiotics: simultaneous administration with ibuprofen may increase the risk of seizures;
Sulfonylurea: with concomitant use, it is recommended to check blood glucose values as a precautionary measure;
Probenecid and sulfinpyrazone: may delay the excretion of ibuprofen.
Application features
Side effects associated with ibuprofen can be minimized by using the lowest 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.
The concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided as this increases the risk of adverse reactions.
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.
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), since cases of fluid retention, hypertension and edema have been reported with ibuprofen therapy, as with other NSAIDs.
Clinical trial data and epidemiological data suggest that the use of ibuprofen, especially 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 data 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.
The clinical picture should also be carefully assessed before starting long-term treatment in patients with risk factors for cardiovascular complications (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required.
Risk of renal failure due to deterioration of kidney function.
Effect on the liver.
Liver function disorders are possible.
Surgical interventions.
Caution should be exercised immediately after major surgical procedures.
Impact on fertility in women.
There is limited evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may affect the ovulation process. This process is reversible after discontinuation of treatment.
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.
There are reports of cases of gastrointestinal bleeding, perforation, ulceration, which can be fatal, occurring 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, in patients 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. For such patients, as well as for those who require concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk for the gastrointestinal tract, the need for combination therapy with protective drugs (e.g. misoprostol or proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal toxicity, particularly 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 who are concomitantly taking medications 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 (e.g. aspirin).
In the event of gastrointestinal bleeding or ulceration in patients receiving ibuprofen, treatment should be discontinued immediately.
Severe skin reactions.
Rare serious skin reactions, which can be fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.8).
The risk of these reactions is high at the beginning of therapy. The onset of the reaction occurs in most cases 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 rashes, mucosal lesions, or any other signs of hypersensitivity.
Masking of symptoms of underlying infections: Ibuprom Sprint MAX 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 Ibuprom Sprint MAX 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.
It is recommended to avoid the use of ibuprofen in case of chickenpox.
Allergy.
Caution should be exercised in patients who have had 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 medicinal product contains sorbitol. It is not recommended for patients with hereditary fructose intolerance.
Other.
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 Ibuprom Sprint MAX, 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.
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 NSAIDs while drinking alcohol, the risk of adverse effects related to the active substance may increase, especially from the gastrointestinal tract or CNS.
Use during pregnancy or breastfeeding
The drug should be avoided during the first and second trimesters of pregnancy. The drug is contraindicated in the third trimester of pregnancy.
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.
NSAIDs 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.
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, leading to 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. NSAIDs are not recommended during breastfeeding.
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. Single administration or short-term use of ibuprofen usually does not require any special precautions. 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 operating other mechanisms.
Method of administration and doses
For oral use in adults and children aged 12 years and over with a body weight > 40 kg. For short-term use only. Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time necessary to control symptoms.
Capsules should be taken preferably during or after meals, washed down with water, and not chewed.
A single dose for children over 12 years of age with a body weight of > 40 kg and adults is 1 capsule (400 mg ibuprofen). If necessary, 1 capsule can be used every 6 hours. The maximum daily dose is 1200 mg (3 capsules per day). The minimum effective dose necessary to treat symptoms should be used for the shortest possible period of time (see section "Special instructions"). Elderly patients do not require special dose selection, except in cases of severe renal or hepatic insufficiency.
If the symptoms of the disease worsen or persist for more than 3 days, you should consult a doctor to clarify the diagnosis and adjust the treatment regimen. The duration of treatment is determined by the doctor individually, depending on the course of the disease and the patient's condition.
Children.
Contraindicated in children under 12 years of age and weighing < 40 kg.
Overdose
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 may also occur. In severe poisoning, toxic damage to the central nervous system is observed, which manifests itself as drowsiness, sometimes - an excited state and disorientation or coma. Sometimes patients develop convulsions. In more severe poisoning, 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 and liver damage may occur. In patients with bronchial asthma, an exacerbation of the disease may occur.
Treatment. Treatment should be symptomatic and supportive, and include maintaining a patent airway and monitoring cardiac function and vital signs until the patient's condition is normal. Oral administration of activated charcoal is recommended within 1 hour of a potentially toxic dose. Frequent or prolonged muscle spasms should be treated with intravenous diazepam or lorazepam. Bronchodilators should be used in the presence of bronchial asthma.
Adverse reactions
The following adverse reactions have been observed with short-term use of ibuprofen at doses not exceeding 1200 mg/day. Other adverse reactions may occur with the treatment of chronic diseases and with long-term use.
Adverse reactions associated with the use of ibuprofen are classified by system organ class and frequency. The frequency is defined as follows: very common: ≥1/10; common: ≥1/100 and <1/10; uncommon: ≥1/1000 and <1/100; rare: ≥1/10000 and <1/1000; very rare: <1/10000, frequency unknown (frequency 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 of 2400 mg per day, may be associated with a slightly increased risk of arterial thrombotic complications (such as myocardial infarction or stroke).
From the blood and lymphatic system.
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.
From 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 cardiac system.
Frequency unknown: heart failure, edema.
From the vascular system.
Frequency unknown: arterial hypertension.
From the digestive tract.
Uncommon: abdominal pain, nausea and dyspepsia; rare: diarrhoea, flatulence, constipation and vomiting; 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.
From the liver.
Very rare: liver dysfunction.
On the skin and subcutaneous tissue.
Rare: various skin rashes; very rare: severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis may occur. Frequency unknown: acute generalized exanthematous pustulosis, photosensitivity reactions.
On the part of the kidneys and urinary system.
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.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
6 capsules in a blister, 1 blister in a cardboard box; 10 capsules in a blister, 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Location of the manufacturer and address of its place of business
Ul. Ziebicka 40, 50-507 Wroclaw, Poland/ul. Ziebicka 40, 50-507 Wroclaw, Poland.
Applicant
Unilab, LP/Unilab, LP.
Applicant's location
966 Hungerford Drive, suite 3B, Rockville, MD 20850, USA.
