Instructions for Ibuprom Sprint Caps soft capsules 200 mg blister No. 10
Composition
active ingredient: ibuprofen;
1 soft capsule contains 200 mg of ibuprofen;
excipients: polyethylene glycol 600, potassium hydroxide, purified water, gelatin, sorbitol solution partially dehydrated, patent blue V (E 131).
Dosage form
Soft capsules.
Main physicochemical properties: oval soft capsules with a transparent blue shell, the contents of the capsule are a clear oily liquid from colorless to slightly blue.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives.
ATX code M01A E01.
Pharmacological properties
Pharmacodynamics.
Ibuprofen has analgesic, antipyretic and anti-inflammatory effects. Its mechanism of action is to inhibit the synthesis of prostaglandins - mediators of pain, inflammation and temperature reactions.
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 aspirin (acetylsalicylic acid) 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.
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. Ibuprofen is metabolized in the liver, excreted by the kidneys (90%) in an unchanged form and in the form of metabolites, as well as with bile. The half-life in healthy people is almost 1.8 hours, in patients with liver and kidney diseases - 1.8-3.5 hours. Ibuprofen actively (99%) binds to plasma proteins, slowly penetrates into the synovial fluid, where its concentration can remain high, while the concentration in the blood plasma decreases.
Indication
Symptomatic treatment of headache, toothache and periodic menstrual pain. Fever and muscle pain with colds.
Contraindication
Hypersensitivity to ibuprofen or to any of the components of the drug.
Patients with a history of bronchospasm, asthma, rhinitis, angioedema or skin rash associated with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
The use of IBUPROM Sprint Caps concomitantly with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
Current or history of gastric and duodenal ulcer/bleeding (two or more distinct episodes of exacerbation of ulcer or bleeding).
Patients with a history of gastrointestinal bleeding or perforation after NSAID use.
Patients with severe renal, cardiac (NYHA class IV) or hepatic insufficiency.
Children weighing less than 20 kg.
Patients with cerebrovascular or other active forms of bleeding.
Patients with dehydration caused by vomiting, diarrhea, or insufficient fluid intake.
Third trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
Ibuprofen (like other NSAIDs) should be used with caution in concomitant treatment with the following drugs:
other NSAIDs, including salicylates: increased risk of gastrointestinal ulcers and bleeding;
digoxin: the blood plasma level of both drugs increases;
corticosteroids: increased risk of gastrointestinal bleeding or ulceration;
antithrombotic agents: the risk of gastrointestinal bleeding increases;
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin;
antiplatelet and selective serotonin inhibitors: the risk of gastrointestinal bleeding may increase;
Acetylsalicylic acid or other NSAIDs and glucocorticosteroids: the risk of gastrointestinal side effects of these drugs may increase.
Antihypertensives and diuretics: NSAIDs may reduce the therapeutic effect of these drugs; in patients with impaired renal function, the simultaneous use of ACE inhibitors, beta-blockers or angiotensin II receptor antagonists and cyclooxygenase inhibitors may lead to further deterioration of renal function. Therefore, the combination of drugs should be used with caution, especially in elderly patients;
Lithium and methotrexate: there is evidence of a potential increase in plasma levels of lithium and methotrexate;
potassium-sparing diuretics: may lead to hyperkalemia (checking the level of potassium in the blood plasma is recommended);
cyclosporine and tacrolimus: increased risk of nephrotoxicity;
zidovudine: there is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients receiving concomitant treatment with zidovudine and ibuprofen;
sulfonylurea: it is necessary to monitor blood glucose levels;
quinoline antibiotics: there may be a risk of convulsions;
Cytochrome CYP2C9 inhibitors, such as voriconazole or fluconazole, may enhance the effects of ibuprofen.
Application features
Side effects can be reduced by using the minimum effective dose needed to treat symptoms for a short period of time.
The drug should be used with caution in patients with:
§ systemic lupus erythematosus and systemic connective tissue diseases;
§ congenital disorders of porphyrin metabolism (e.g. acute intermittent porphyria);
§ a history of arterial hypertension and/or heart failure, which were accompanied by fluid retention and edema during the use of NSAIDs;
§ impaired kidney and/or liver function;
§ immediately after operations.
Elderly people are at increased risk of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs and regardless of duration of treatment, with or without a history of serious gastrointestinal events.
Increasing the dose of NSAIDs, older age, and a history of peptic ulcer disease are risk factors for gastrointestinal adverse reactions. During treatment in these cases, it is recommended to use the minimum effective dose.
Combination therapy with protective drugs (e.g. misoprostol or proton pump inhibitors) should be considered, especially for patients requiring long-term use of low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal side effects.
Patients who have experienced gastrointestinal disorders, generally elderly, should discontinue treatment and consult a doctor if any adverse symptoms occur (especially gastrointestinal bleeding).
The drug should be used with caution in patients receiving concomitant therapy with drugs that may increase the risk of ulceration or bleeding, in particular oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid.
NSAIDs should be used with caution in patients with a history of ulcerative colitis or Crohn's disease, as their condition may worsen.
Clinical trial data suggest that ibuprofen use, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological data do not suggest that low-dose ibuprofen use (e.g. ≤ 1200 mg/day) is associated with 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 prescribed 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 (such as hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required.
Effects on the cardiovascular and cerebrovascular systems.
Cases of Kounis syndrome have been reported in patients treated with ibuprofen. 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.
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). Most of these reactions occurred within the first month of treatment.
If signs and symptoms suggestive of these reactions occur, ibuprofen should be discontinued immediately and alternative treatment considered (if necessary).
Masking of symptoms of underlying infections: Ibuprom Sprint Caps 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 Caps 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.
Patients who have or have had bronchial asthma or allergic diseases may experience bronchospasm.
With prolonged use of painkillers in large doses, a headache may occur, which cannot be treated by increasing the dose of the drug.
Prolonged and uncontrolled use of painkillers, especially combinations of different painkilling active ingredients, can lead to chronic kidney damage with the risk of kidney failure (analgesic nephropathy).
There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility through effects on ovulation. This can be reversed by discontinuing these drugs.
Ibuprofen may temporarily inhibit blood function/platelet aggregation. Therefore, special monitoring is recommended in patients with bleeding disorders.
In case of long-term use of the drug, it is necessary to regularly check liver and kidney function indicators, as well as the number of blood cells.
In case of chickenpox, treatment with the drug should be avoided.
Drinking alcohol after taking NSAIDs may increase side effects, especially those affecting the gastrointestinal tract or central nervous system.
There is a risk of kidney failure in children and adolescents with dehydration.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase or isomaltase insufficiency should not take this medicine.
Use during pregnancy or breastfeeding
Pregnancy.
Prostaglandin synthesis inhibitors may have adverse effects on pregnant women and/or on the development of the embryo/foetus. Epidemiological data indicate an increased risk of miscarriage and cardiac malformations following the use of prostaglandin synthesis inhibitors in early pregnancy. The risk is believed to increase with increasing dose and duration of treatment.
Do not use NSAIDs from the 20th to the 28th week of pregnancy, without a doctor's prescription.
From the 20th week of pregnancy onwards, ibuprofen 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, cases of ductus arteriosus have been reported following treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, ibuprofen should not be given during the first and second trimesters of pregnancy unless clearly necessary. Antenatal monitoring for oligohydramnios and ductus arteriosus should be considered after exposure to ibuprofen for several days from the 20th week of gestation onwards. If ibuprofen is used in women attempting to conceive or during the first and second trimesters of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. Monitoring of amniotic fluid levels by ultrasound should be considered if ibuprofen treatment is continued for more than 48 hours.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose risks:
for the fetus:
cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction (see above);
for the mother at the end of pregnancy and for the newborn:
possible prolongation of bleeding time, anti-aggregation effect, which may occur even when using very low doses;
suppression of uterine contractions, leading to delayed or prolonged labor.
Ibuprofen is contraindicated during the third trimester of pregnancy.
Ibuprofen and its metabolites may pass into breast milk in low concentrations. There is currently no known harmful effect on the infant, so as a rule, for short-term treatment of pain and fever at recommended doses, it is not necessary to discontinue breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
With short-term use, IBUPROM Sprint Caps does not affect or has a negligible effect on the ability to drive and use other mechanisms, but with long-term use, side effects such as increased fatigue and dizziness may occur.
Method of administration and doses
For oral administration for short-term use.
Adults and children weighing ≥ 40 kg: the recommended initial dose is 1–2 capsules, then, if necessary, 1–2 capsules (200–400 mg ibuprofen) every 4–6 hours. Do not use more than 6 capsules (1200 mg) in 24 hours.
Children weighing ≤ 39 kg. The drug can be used in children weighing more than 20 kg (approximately 6 years). The maximum daily dose of ibuprofen is 20–30 mg/kg body weight, divided into 3–4 doses with an interval of 6–8 hours. Do not exceed the maximum daily dose.
Children weighing 20-29 kg: the recommended starting dose is 1 capsule (equivalent to 200 mg ibuprofen). The maximum daily dose is 3 capsules (equivalent to 600 mg ibuprofen).
Children weighing 30 to 39 kg: the recommended starting dose is 1 capsule (equivalent to 200 mg ibuprofen). The maximum daily dose is 4 capsules (equivalent to 800 mg ibuprofen).
Capsules are usually taken during meals, without chewing, with water.
Elderly people do not require special dose adjustment.
The lowest effective dose necessary to treat symptoms should be used for the shortest possible period of time (see section "Special warnings and precautions for use").
If symptoms of the disease persist for more than 3 days, and when used for pain relief - for more than 4 days, you should consult a doctor to clarify the diagnosis and adjust the treatment regimen.
Children
Do not use in children weighing less than 20 kg (approximately 6 years).
Overdose
In case of acute overdose, the symptoms depend on the amount of the drug taken and the time that has passed since its administration. The first symptoms that are usually observed are: nausea, vomiting, headache and dizziness, epigastric pain, drowsiness. In case of overdose, coma, arterial hypotension, hyperkalemia with cardiac arrhythmia, metabolic acidosis, fever, respiratory disorders and renal dysfunction may occur. After long-term administration, hemolytic anemia, granulocytopenia and thrombocytopenia may occur sporadically.
If no more than 1 hour has passed after an acute overdose, it is recommended to induce vomiting, rinse the stomach, or take activated charcoal.
In cases of ibuprofen overdose, there is no antidote or specific treatment. Symptomatic treatment is based on monitoring vital functions with blood pressure measurement, ECG, and interpretation of symptoms indicating possible gastrointestinal bleeding, metabolic acidosis, and central nervous system disorders.
Side effects
The following is a list of adverse reactions that have been reported in people who have used ibuprofen for short-term treatment of mild to moderate pain and fever, as well as those observed with long-term high-dose therapy in patients with rheumatism.
Clinical trial data suggest that the use of ibuprofen, especially at the high dose of 2400 mg per day, may be associated with a slightly increased risk of arterial thrombotic complications (e.g. myocardial infarction or stroke).
The frequency of side effects is calculated as follows:
Very common: >1/10.
Common: >1/100, <1/10.
Uncommon: >1/1000, <1/100.
Rare: >1/10,000, <1/1,000.
Very rare: <1/10,000, including isolated reports.
General disorders: Uncommon: hypersensitivity in the form of urticaria and itching, increased sweating.
Very rare: severe hypersensitivity reactions with the following manifestations: swelling of the face, tongue and larynx, shortness of breath, tachycardia, decrease in blood pressure, anaphylactoid reactions (anaphylaxis, angioedema up to shock). Exacerbation of asthma and bronchospasm or dyspnoea, allergic rhinitis, eosinophilia.
From the sensory organs. Rare: hearing impairment (hearing loss, ringing or tinnitus).
Uncommon: visual disturbances (toxic optic nerve damage, blurred or diplopia, scotoma, dry and irritated eyes, conjunctival oedema and age of allergic origin).
Gastrointestinal disorders: Uncommon: abdominal pain, melena, haematemesis, dyspepsia and nausea.
Very rare: heartburn, ulcerative stomatitis, gastritis, perforation or gastrointestinal bleeding, which can in some cases be fatal, especially in the elderly. Exacerbation of ulcerative colitis and Crohn's disease, oesophagitis, formation of intestinal diaphragmatic strictures. Irritation or dryness of the oral mucosa, gingival ulcers, aphthous stomatitis, pancreatitis.
Neurological disorders: Uncommon: headache, dizziness, insomnia, anxiety, depression, nervousness and irritability, psychomotor agitation, drowsiness, confusion, hallucinations; rarely - aseptic meningitis (more common in patients with autoimmune diseases).
Cardiovascular system: Very rare: heart failure, tachycardia, increased blood pressure, vasculitis, myocardial infarction. Frequency unknown: Kounis syndrome.
From the urinary system. Very rare: decreased urea excretion and edema. Acute renal failure, allergic nephritis, glomerulonephritis, oliguria, polyuria, cystitis, hematuria. Papillonecrosis, especially with prolonged use. Increased serum urea levels.
Hepatobiliary system: Very rare: liver dysfunction, especially with prolonged use. Hepatitis, pancreatitis, duodenitis, esophagitis.
Blood and lymphatic system disorders: Very rare: haematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are: high fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Skin and subcutaneous tissue disorders: Very rare: severe cutaneous adverse reactions (SCARs) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). Frequency unknown: drug-induced eosinophilia with systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP), photosensitivity reactions.
On the part of the immune system. Uncommon: in patients with autoimmune disorders (systemic lupus erythematosus, systemic connective tissue diseases) during treatment with ibuprofen, isolated cases of symptoms of aseptic meningitis (rigidity of the neck muscles, headache, nausea, vomiting, high fever or disorientation) were noted. Allergic reactions in the form of skin rashes, itching, bronchial asthma attacks, decreased blood pressure.
Infections and infestations: Very rare: exacerbation of inflammation associated with infection.
Laboratory tests: Rare: decreased hemoglobin level.
Expiration date
3 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Packaging
6 or 10 or 12 capsules in a blister, 1 blister in a cardboard box; 12 capsules in a blister, 2 blisters in a cardboard box; 10 capsules in a blister, 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
US Pharmacia Sp. z oo, Poland.
Location of the manufacturer and its business address.
Ul. Ziebicka 40, 50-507 Wroclaw, Poland/Ul. Ziebicka 40, 50-507 Wroclaw, Poland.
Applicant
Unilab, LP, USA.
Location of the applicant and/or the applicant's representative.
966 Hungerford Drive, Office 3B, Rockville, MD 20850, USA/966 Hungerford Drive, Suite 3B, Rockville, MD 20850, USA.
