Ibufen ultra capsules 200mg №10×1

NameIbufen ultra. Release formCapsules. Dosage 200 mg. Pack quantity: 10 pcs. ProducerMedana pharma s.a. INNIBuprofen. FTGNpvp. Short description Light yellow gelatin capsules containing a viscous liquid. Composition Each capsule contains: active ingredient: ibuprofen 200 mg excipients: macrogol 600, potassium hydroxide, purified water; gelatin capsule: liquid maltitol, liquid sorbitol, non-crystallizing, gelatin, purified water. Pharmacotherapeutic group Nonsteroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. Pharmacological properties Ibuprofen is a derivative of propionic acid. It has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action of ibuprofen is primarily due to the suppression of prostaglandin biosynthesis by reducing the activity of cyclooxygenase (COX), an enzyme that regulates the conversion of arachidonic acid into prostaglandins, prostacyclin and thromboxane. At the same time, as a result of irreversible inhibition of the cyclooxygenase pathway of arachidonic acid metabolism, the formation of prostaglandins decreases. A decrease in the concentration of prostaglandins at the site of inflammation is accompanied by a decrease in the formation of bradykinin, endogenous nirogens, other biologically active substances, oxygen radicals and NO. All this leads to a decrease in the activity of the inflammatory process (anti-inflammatory effect of ibuprofen) and is accompanied by a decrease in pain reception (analgesic effect). A decrease in the concentration of prostaglandins in the cerebrospinal fluid leads to the normalization of body temperature (antipyretic effect). Ibufen® Ultra capsules contain liquid ibuprofen. The gelatin capsule ensures high dosing accuracy of the substances placed in them. The capsule shell protects the active substance from light, air and moisture, and also eliminates the unpleasant taste and smell of the active substance when taken. The capsule disintegrates in the gastrointestinal tract faster than dragees and tablets, and its liquid contents are absorbed faster and more easily in the human body, providing high bioavailability of ibuprofen. Indications for use Increased body temperature of various origins in: – colds – acute respiratory viral infections – influenza – tonsillitis (pharyngitis) – childhood infections accompanied by fever – post-vaccination reactions. Pain syndrome of various origins of mild and moderate intensity with: – ear pain with inflammation of the middle ear – toothache, painful teething – headache, migraine – painful menstruation – neuralgia – rheumatic pains – pain in muscles, joints – injuries of the musculoskeletal system. Contraindications Hypersensitivity to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the excipients History of allergies in the form of bronchospasm, bronchial asthma, runny nose, angioedema or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) Gastric ulcer and duodenal or active ulcer bleeding or a history of (two or more confirmed episodes of peptic ulcer or ulcer bleeding) Bleeding or perforation of an ulcer in the gastrointestinal tract in the anamnesis, provoked by the use of NSAIDs Severe liver failure, severe renal failure Severe heart failure (IV NYHA class) Children weighing less than 40 kg Cerebrovascular or other bleeding Hemorrhagic diathesis Hematopoietic disorders of undetermined origin (eg, thrombocytopenia) III trimester of pregnancy names. Precautions for use Caution should be exercised when using the drug in patients with: systemic lupus erythematosus and mixed connective tissue disease, due to an increased risk of developing aseptic meningitis diseases of the gastrointestinal tract and chronic inflammatory bowel diseases, since these diseases may worsen (non-specific ulcerative colitis, Crohn’s disease) should be used with caution before starting treatment in patients with a history of arterial hypertension and (or) heart failure, since in connection with the treatment of NSAIDs, fluid retention, hypertension and the appearance of edema with impaired renal function are observed, since renal failure may increase impaired liver function disorders of blood clotting (ibuprofen may increase bleeding time). Caution should be exercised when using the drug immediately after surgery. Taking the drug at the lowest effective dose for the shortest time necessary to relieve symptoms reduces the risk of side effects (see below: effects on the gastrointestinal tract and circulatory system). In elderly patients, the risk of side effects (mainly bleeding and perforation) as a result of taking the drug is greater than in younger patients. In persons with bronchial asthma and other allergic diseases, active or in history, taking the drug may cause bronchospasm. The combined use of the drug with other non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, should be avoided. Children and adolescents with dehydration are at risk of kidney failure. Effects on the gastrointestinal tract Gastrointestinal bleeding, ulceration, or perforation, which in some cases resulted in death, have been reported after all NSAIDs in each treatment period, with or without prior symptoms or episodes of gastrointestinal bleeding (including non-specific ulcerative colitis, Crohn’s disease). The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing dose of NSAIDs, in patients with a history of ulceration, especially if complicated by bleeding or perforation, and in the elderly. Treatment of these patients should begin with the lowest available dose. Patients with a history of gastrointestinal disease, especially the elderly, should be told that they should inform the doctor about all atypical symptoms associated with the gastrointestinal tract (especially bleeding), especially during the initial period of therapy. Caution should be exercised when using the drug in patients who are simultaneously using other drugs that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. In the event of bleeding from the gastrointestinal tract or ulceration, you should immediately stop taking the drug. Skin reactions Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have very rarely been described in connection with the use of drugs from the NSAID group. The greatest risk of these severe reactions occurs at the beginning of therapy, in most cases in the first month of the drug. You should stop using the drug after the first symptoms appear: skin rash, damage to the mucous membranes or other symptoms of allergy. In exceptional cases, chicken pox can be the cause of severe infectious complications of the skin and soft tissues. A role for NSAIDs in the enhancement of these infections cannot be ruled out at this time. In this regard, it is recommended to avoid the use of the drug in case of chicken pox. Effects on the circulatory system The results of clinical studies indicate that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a slight increase in the risk of arterial thrombotic complications (eg, myocardial infarction or stroke). In general, the results of epidemiological studies do not indicate that the use of ibuprofen at low doses (eg, ≤1200 mg / day) is associated with an increased risk of developing arterial thromboembolic complications. In patients with poorly controlled arterial hypertension, congestive heart failure (NYHA class II-III), diagnosed coronary heart disease, peripheral arterial disease and/or cerebrovascular insufficiency, ibuprofen should be prescribed only after careful risk assessment, and high doses should be avoided (2400 mg/day). A careful assessment of the risk / benefit ratio is also necessary before prescribing long-term ibuprofen therapy to patients with risk factors for cardiovascular complications (for example, arterial hypertension, hyperlipidemia, diabetes mellitus, smokers), especially if high doses of ibuprofen (2400 mg / day) are required. . Effects on fertility in women There is evidence that drugs that inhibit cyclooxygenase (prostaglandin synthesis) may affect ovulation, causing fertility problems in women. This action is temporary and stops after the end of therapy. Other notes Severe acute allergic reactions (eg anaphylactic shock) are very rare. After the first symptoms of an allergic reaction appear after taking Ibufen® Ultra, treatment should be interrupted. Specialized personnel should carry out the necessary medical procedures depending on the symptoms that have appeared. Long-term simultaneous use of different pain medications can lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may be increased during exercise leading to salt loss and dehydration, and therefore concomitant, prolonged use of different pain medications should be avoided. NSAIDs may mask the symptoms of an infection. When using ibuprofen, there have been isolated cases of toxic amblyopia, so all visual impairment should be reported to the doctor. The drug contains sorbitol and maltitol and should not be used in patients with rare hereditary fructose intolerance. One capsule contains 10.5 mg of potassium. Use with caution in persons with impaired renal function or who have controlled dietary potassium intake. Use during pregnancy and lactation Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or fetal development. Epidemiological data show that the use of prostaglandin synthesis inhibitors in the initial period of pregnancy increases the risk of spontaneous abortion, the occurrence of malformations of the heart and gastrointestinal tract of the fetus. It is believed that this risk increases in parallel with increasing dose and duration of treatment. Animal studies have shown that the use of inhibitors of prostaglandin synthesis in the pre-implantation and post-implantation phase of the fetus increases the risk of miscarriage, and also causes an increase in fetal or fetal mortality. Taking inhibitors of prostaglandin synthesis during fetal organogenesis increases the incidence of various malformations, including malformations of the circulatory system. In the first and second trimesters of pregnancy, ibuprofen should not be taken unless absolutely necessary. If ibuprofen is taken by a woman who is trying to conceive, or during the first or second trimester of pregnancy, the dose should be as low as possible and the duration of treatment should be as short as possible. All prostaglandin synthesis inhibitors when used during the third trimester of pregnancy can cause the following effects: on the fetus: – cardiopulmonary toxicity (with premature closure of the ductus arteriosus and the development of pulmonary hypertension), – impaired renal function, which can progress to renal failure with the development of oligohydramnios on the mother at the end of pregnancy and the newborn: – a possible increase in bleeding time, an antiplatelet effect that can occur even at very low doses – inhibition of uterine contractions, leading to a delay or increase in the duration of labor. In connection with the above actions, the use of ibuprofen in the third trimester of pregnancy is contraindicated. Breastfeeding According to the results of a small number of studies, NSAIDs can pass into breast milk in very low concentrations. In view of the fact that there are still no reports of the harmful effects of ibuprofen on infants, stopping feeding during short-term treatment with ibuprofen at doses used in the treatment of pain and fever is not necessary. Influence on the ability to drive vehicles and maintain mechanisms Due to the fact that when using ibuprofen in high doses, side effects are possible that affect the central nervous system, such as fatigue and dizziness, in some cases, it is possible to weaken the reactivity and ability to actively participate in road traffic. movement and control mechanisms in motion. This warning has particular application when the drug is taken with alcohol. Interaction with other drugs and other types of interaction Ibuprofen (as well as other drugs from the NSAID group) should not be used in conjunction with the following drugs: Acetylsalicylic acid: simultaneous therapy with ibuprofen and acetylsalicylic acid is generally not recommended, due to the possible aggravation of undesirable effects. Other NSAIDs, especially selective cyclooxygenase-2 inhibitors: the simultaneous use of two or more NSAIDs should be avoided, as this may increase the risk of unwanted effects. Caution must be exercised when used simultaneously with these drugs: Corticosteroids: the risk of side effects from the gastrointestinal tract increases. Antihypertensive and diuretic drugs: drugs from the NSAID group may reduce the effectiveness of antihypertensive drugs; Diuretics may increase the risk of NSAID nephrotoxicity. In some patients with renal insufficiency (eg, in a state of dehydration or the elderly), the concomitant use of NSAIDs with ACE inhibitors, beta-adrenolytics or angiotensin II antagonists can lead to an increase in renal insufficiency, up to acute renal failure (most often reversible). Therefore, caution is required when prescribing combination therapy, especially in elderly patients. In the case of such patients, hydration and strict monitoring of renal function are indicated at the beginning of the course of treatment, as well as periodically during therapy. Concomitant therapy with potassium-sparing drugs may be accompanied by an increase in serum potassium levels. Anticoagulants: NSAIDs may increase the effect of drugs that reduce blood clotting, such as warfarin. Antiplatelet drugs and some selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Cardiac glycosides: NSAIDs may exacerbate heart failure by causing a decrease in glomerular filtration rate (GFR) and an increase in plasma glycoside concentrations. Lithium: Non-steroidal anti-inflammatory drugs have been shown to increase plasma lithium levels. Methotrexate: It has been proven that non-steroidal anti-inflammatory drugs can cause an increase in the concentration of methotrexate in the blood plasma. Phenytoin: Ibuprofen may increase the concentration of the pharmacologically active phenytoin. Cyclosporine: risk of kidney damage. Mifepristone: NSAIDs should not be used within 8-12 days after mifepristone has been used, as NSAIDs may reduce its effect. Zidovudine: The simultaneous use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia receiving concomitant treatment with zidovudine and ibuprofen. Ritonavir: increased plasma concentration of NSAIDs. Quinolone antibiotics: Animal studies have shown that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones together are at an increased risk of seizures. Aminoglycoside antibiotics: NSAIDs may reduce the excretion of aminoglycosides. Oral antidiabetic agents: possible decrease in the metabolism of sulfonylurea derivatives, prolongation of the half-life and increased risk of hypoglycemia. Probenecid and sulfinpyrazone: may slow down the excretion of ibuprofen. Cholestyramine: May slow down or decrease (25%) the rate of absorption of ibuprofen. In this regard, ibuprofen is recommended to be administered at least one hour before or no earlier than 4-6 hours after taking cholestyramine. Voriconazole or fluconazole: In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increase in S(+)-ibuprofen exposure of approximately 80-100% was observed. When co-administered with strong inhibitors of CYP2C9, the need to reduce the dose of ibuprofen should be considered, especially in cases where the drug is administered in high doses with voriconazole or fluconazole. Route of administration and doses Route of administration For oral administration. The capsule must be swallowed whole with a small amount of water. Capsules should not be cracked, sucked or chewed. When using the drug in children for accurate dosing, the weight of the child should be taken into account. Doses Adults and children over 12 years old (more than 40 kg): single dose 200-400 mg (1-2 capsules). Then, if necessary, 1-2 capsules every 4-6 hours. The maximum daily dose is 6 capsules (1200 mg ibuprofen). The minimum interval between successive doses is 4-6 hours. If, while taking the drug, the symptoms persist for more than 3 days or intensify, you should consult a doctor. The occurrence and severity of side effects can be reduced by taking the lowest effective dose for the shortest possible time to relieve symptoms. Elderly patients: no special dose selection is required. For patients in this group, monitoring for side effects is required. Patients with impaired renal function: in patients with mild to moderate impaired renal function, there is no need to reduce the dose. Patients with impaired liver function: in patients with mild to moderate hepatic impairment, there is no need to reduce the dose. OverdoseSymptoms Most patients taking clinically high doses of NSAIDs experience nausea, vomiting, epigastric pain or, more rarely, diarrhea. May also occur: tinnitus, headache, bleeding from the stomach or intestines. Severe poisoning affects the central nervous system and causes dizziness, headaches, respiratory depression, shortness of breath, drowsiness, and very rarely also agitation and confusion or coma. Seizures are very rare. With severe toxicity, metabolic acidosis is sometimes observed, and an increase in prothrombin time is possible. It was also noted: acute renal failure or liver damage. Patients with asthma may experience an exacerbation of their symptoms. Treatment Symptomatic, with obligatory provision of airway patency, monitoring of ECG and vital signs until the patient’s condition returns to normal. Oral activated charcoal or gastric lavage is recommended within 1 hour of a potentially toxic dose of ibuprofen. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. With the worsening of bronchial asthma, the use of bronchodilators is recommended. Side effects With short-term use of ibuprofen in doses dispensed without a prescription, the following side effects were observed. Long-term use of ibuprofen for other indications may cause other side effects. Side effects are classified by frequency of occurrence using the following definitions: very often: ≥1/10, often: ≥1/100, <1/10, infrequently: ≥1/1000, <1/100, rarely: ≥1/10,000 , <1/1000, very rare: <1/10,000, frequency unknown (cannot be determined from the available data). Infections and parasitic diseases Very rare: aseptic meningitis Blood and lymphatic system disorders Very rare: changes in blood morphological parameters (anemia, hemolytic anemia, aplastic anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds, and subcutaneous hemorrhages. Immune system disorders Uncommon: hypersensitivity reactions with pruritus and urticaria Very rare: in patients with autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease), isolated cases of symptoms characteristic of aseptic meningitis have been observed during treatment with ibuprofen, such as: neck stiffness muscles, headache, nausea, vomiting, fever, confusion. Severe hypersensitivity reactions. Symptoms can be: swelling of the face, tongue and larynx, suffocation, tachycardia, hypotension (anaphylaxis, angioedema, shock). Exacerbation of bronchial asthma and bronchospasm. Psychiatric disorders Very rare: nervousness Nervous system disorders Uncommon: headache Rare: dizziness, insomnia, irritability, irritability and fatigue. In some cases, describe: depression, psychotic disorders. On the part of the organ of vision Very rare: visual impairment. Hearing and vestibular disorders Very rare: tinnitus and dizziness. Cardiac disorders Very rare: the appearance of edema, arterial hypertension and heart failure in connection with the use of drugs from the NSAID group. Respiratory, thoracic and mediastinal disorders Very rare: bronchial asthma, bronchospasm, dyspnea and wheezing. Gastrointestinal disorders Uncommon: dyspepsia, abdominal pain, nausea, abdominal distention. Rarely: diarrhea, flatulence, constipation, vomiting. Very rare: peptic ulcer, gastrointestinal bleeding and perforation, tarry stools, hematemesis, sometimes fatal, especially in the elderly; ulcerative stomatitis, gastritis; exacerbation of ulcerative colitis and Crohn's disease. Liver and biliary tract disorders Very rare: Liver dysfunction, especially during long-term use, hepatitis and jaundice. Skin and subcutaneous tissue disorders Uncommon: various skin rashes. Very rare: severe skin reactions such as bullous rash (including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis). Renal and urinary tract disorders Very rare: acute renal failure, necrosis of the renal papillae, especially with prolonged use, associated with an increase in serum urea and edema; hematuria, interstitial nephritis, nephrotic syndrome, proteinuria. General disorders and condition at the injection site Very rarely: edema, peripheral edema. Diagnostic tests Very rare: decrease in hematocrit and hemoglobin concentration. The results of clinical studies indicate that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a slight increase in the risk of arterial thrombotic complications (eg, myocardial infarction or stroke). In case of adverse reactions, including those not listed in this leaflet, you should immediately consult a doctor. Storage conditionsStore in the original packaging at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life Shelf life: 2 years. Do not use the medicinal product after the expiration date indicated on the package. Expiration date means the last day of the specified month. Medicines must not be flushed down the drain or thrown into the wastebasket. Ask the pharmacist what to do with unused medicines. This is necessary for environmental protection. Buy Ibufen ultra capsules 200mg №10x1 Price for Ibufen ultra capsules 200mg №10x1