Ibuflex rectal suppositories 60mg №5×2

Name:
Ibuflex. Release form Suppositories. INNIBuprofen. FTGNpvp.
Description:
Suppositories torpedo-shaped, from almost white to yellowish white. Color heterogeneity in the form of marbling, the presence of an air or porous rod, a funnel-shaped recess with a rough surface is allowed. CompositionFor one suppository: active substance: ibuprofen 60 mg; excipients: solid fat. Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs. Derivatives of propionic acid. Ibuprofen. Indications for use For children from 3 months to 2 years: – as an anesthetic for pain syndrome of mild or moderate intensity (for headache and toothache, including teething, otitis media, sore throat, muscle strain) ; – As an antipyretic for colds and flu. Method of application and dosage For rectal use. In order to minimize the risk of developing adverse reactions, ibuprofen should be taken at the lowest effective dose and for the shortest period necessary to achieve a clinical effect. Prescribing the drug Ibuflex to children under 3 months of age is permissible after a careful assessment by the doctor of the risk/benefit ratio for each patient. Do not use the drug in children weighing less than 6 kg. For short term use. The maximum daily dose for children aged 3 months to 2 years is 20-30 mg / kg in 3-4 doses. Fever and pain syndrome: Age (weight) Single dose Daily dose 3-9 months (6-8 kg) 1 suppository 3 times a day, between doses 6-8 hours 9 months – 2 years (8-12 kg) 1 suppository 4 once a day, 6 hours between doses If the symptoms persist or worsen when taking the drug for 24 hours (in children aged 3-5 months) or within 3 days (in children aged 6 months and older), stop treatment and contact to the doctor. Side effects In order to minimize the risk of adverse reactions, ibuprofen should be taken at the lowest effective dose and for the shortest period necessary to achieve a clinical effect. Information on adverse reactions is presented in accordance with the system-organ classification and frequency of occurrence. The frequency of occurrence was determined according to the following scheme: very often (≥1/10), often (≥1/100, but <1/10), infrequently (≥1/1000, but <1/100), rare (≥1/100). 10,000 but <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from the available data). Side effects are predominantly dose-dependent. The most commonly observed side effects are from the gastrointestinal tract. The following adverse reactions have been observed with short-term use of ibuprofen in doses not exceeding 1200 mg / day. System organ class Frequency Side effect Blood and lymphatic system disorders Very rare Anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis. The first symptoms of such disorders are fever, sore throat, superficial ulcers, flu-like symptoms, severe weakness, nosebleeds, and subcutaneous hemorrhages. Immune system disorders Uncommon Urticaria and itching. Very rarely Severe hypersensitivity reactions, including swelling of the face, tongue and throat, dyspnea, tachycardia, hypotension (anaphylaxis, angioedema or anaphylactic shock). Frequency unknown Reaction of the respiratory tract: bronchial asthma, including its exacerbation, bronchospasm, shortness of breath. Nervous system disorders Uncommon Headache. Very rare Aseptic meningitis (more common in patients with autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue diseases) with symptoms of neck stiffness, headache, nausea, vomiting, fever and confusion. Cardiac disorders Not known Heart failure and edema. Vascular disorders Frequency not known Arterial hypertension. Gastrointestinal disorders Uncommon Abdominal pain, nausea, dyspepsia. Rare Diarrhea, flatulence, constipation, vomiting. Very rarely Ulcers of the stomach and intestines, tarry stools, perforation or bleeding from the gastrointestinal tract, ulcerative stomatitis, gastritis. Frequency unknown Exacerbation of colitis and Crohn's disease. Liver and biliary tract disorders Very rare Liver dysfunction, hepatitis, jaundice, elevated liver transaminases. Skin and subcutaneous tissue disorders Uncommon Various skin rashes. Very rarely Severe skin reactions such as bullous rash including Stevens-Johnson syndrome, erythema multiforme exudative and toxic epidermal necrolysis. Frequency unknown Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Acute generalized exanthematous pustulosis (red, scaly widespread rash protruding above the surface of the skin, blisters located mainly on skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment). It is necessary to stop taking Ibuflex and immediately consult a doctor if the described symptoms appear. Renal and urinary tract disorders Very rare Acute renal failure, papillary necrosis, especially with prolonged use, occurring with an increase in serum urea and edema. Infections and invasions Very rarely Exacerbation of the inflammatory process caused by infection (for example, the development of necrotizing fasciitis), in exceptional cases, with chickenpox, serious complications from the skin and soft tissues may occur. If these or other side effects appear, stop using the drug and consult to the doctor. Contraindications Hypersensitivity to ibuprofen or any of the ingredients that make up the drug. Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) in history (for example, asthma, rhinitis, angioedema, urticaria). Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute stage, Crohn's disease, ulcerative colitis). History of bleeding or perforation of a gastrointestinal ulcer associated with previous NSAID therapy. Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis. Patients with impaired renal function with a decrease in glomerular filtration rate less than 30 ml / min. Severe liver failure. Severe heart failure (NYHA class IV). Proctitis. The body weight of the child is up to 6 kg. This medicine is for use only in children aged 3 months to 2 years and is therefore not intended for the elderly or pregnant or breastfeeding women. OverdoseSymptoms Nausea, vomiting, epigastric pain, diarrhea, tinnitus, headache, gastrointestinal bleeding. 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. Occasionally, patients develop seizures. In more severe poisoning, metabolic acidosis, increased prothrombin time, acute renal failure, or liver damage may occur. Patients with asthma may experience an exacerbation of their symptoms. Treatment Treatment should be symptomatic and supportive and should include airway management, monitoring of cardiac function and vital signs until the patient is well. Precautions Undesirable effects can be minimized by selecting the minimum effective dose for the short time necessary for the disappearance of symptoms. Gastrointestinal bleeding, ulceration, and perforation Fatal bleeding, ulceration, or perforation of the gastrointestinal tract has been reported with any NSAID, at any stage of treatment, with or without prior symptoms. The risk of bleeding, ulceration or perforation of the gastrointestinal tract increases with increasing doses of NSAIDs in patients with a history of peptic ulcer disease, especially if they were complicated by bleeding or perforation. These patients are advised to take the drug at the lowest effective dose required to relieve symptoms. Particular attention should be paid to patients who are simultaneously taking drugs that can increase the risk of ulceration or bleeding: oral corticosteroids, anticoagulants, warfarin, selective serotonin reuptake inhibitors, antiplatelet agents such as acetylsalicylic acid. In case of bleeding or ulceration of the gastrointestinal tract, patients taking ibuprofen should immediately stop taking the drug. NSAIDs are prescribed with caution in patients with ulcerative colitis, Crohn's disease, due to the risk of exacerbation of these conditions. Respiratory impairment Ibuprofen should be used with caution in patients with or with a history of bronchial asthma, as NSAIDs may cause bronchospasm in such patients. Cardiovascular and cerebrovascular effects Appropriate monitoring and consultation is necessary in patients with hypertension and / or moderate heart failure, as fluid retention and edema are possible with the use of NSAIDs. Impaired renal function Like other NSAIDs, long-term use of ibuprofen leads to renal capillary necrosis and other renal pathological changes. There is an increased risk of kidney complications in patients for whom prostaglandin synthesis plays a compensatory role in maintaining renal blood flow (dehydration, impaired renal and hepatic function, heart failure, diuretics) and while using other NSAIDs. SLE and mixed connective tissue diseases Patients with systemic lupus erythematosus (SLE) and mixed collagenosis may be at increased risk of aseptic meningitis. Skin reactions Serious skin reactions have been reported with the use of ibuprofen. You should immediately stop taking Ibuflex and consult a doctor if you develop skin rashes, lesions of the mucous membranes, blisters or other signs of allergy, as the described symptoms may be the first signs of a serious skin reaction. In exceptional cases, chickenpox can cause serious complications of skin and soft tissue infections. To date, the role of NSAIDs in the exacerbation of these infections cannot be ruled out. Therefore, it is recommended to avoid the use of Ibuflex 60 mg rectal suppositories in children aged 3 months to 2 years with chickenpox. Hematological Effects Ibuprofen, like other NSAIDs, may interfere with platelet aggregation and increase bleeding time. Aseptic meningitis Aseptic meningitis has rarely been observed in patients treated with ibuprofen. Patients with systemic lupus erythematosus and mixed collagenosis are most susceptible to it; however, cases have also been reported in patients without chronic disease. Caution is also needed in patients with disorders of the anus or rectum. Use during pregnancy or lactation This medicinal product is only for use in children aged 3 months to 2 years. Ibuprofen should not be used in the 1st and 2nd trimesters of pregnancy unless absolutely necessary. Ibuprofen is contraindicated in the third trimester of pregnancy. During the period of taking ibuprofen, breastfeeding, if possible, should be stopped. Influence on the ability to drive vehicles and work with mechanisms When used according to the recommended doses and duration of treatment, the drug does not affect the reaction rate when driving vehicles or working with other mechanisms. Interaction with other drugs Ibuprofen, like other NSAIDs, should not be used in combination with: - acetylsalicylic acid (aspirin), due to a possible increase in the development of adverse events; - other NSAIDs, especially selective cyclooxygenase-2 inhibitors. This may increase the risk of side effects. Ibuprofen should be used with caution in combination with the following drugs: - anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin; - diuretics, ACE inhibitors, beta-blockers and angiotensin II antagonists: NSAIDs may reduce the effectiveness of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, in patients with dehydration), the co-administration of ACE inhibitors, beta-blockers or angiotensin II antagonists, as well as substances that suppress the cyclooxygenase system, can cause a further decrease in kidney function (up to acute renal failure). Therefore, the combination should be used with caution. Patients should receive sufficient fluids. Both after the start of joint therapy, and subsequently, renal function should be carefully monitored periodically; - corticosteroids: increased risk of gastrointestinal ulceration and bleeding; - antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding; - cardiac glycosides: NSAIDs can increase heart failure, reduce glomerular filtration rate and increase the level of glycosides in blood plasma; - lithium: there is evidence that NSAIDs can cause an increase in the concentration of lithium in the blood plasma; - methotrexate: there is evidence that NSAIDs can cause an increase in the concentration of methotrexate in blood plasma; - cyclosporine: increased risk of nephrotoxicity; - tacrolimus: there may be an increased risk of nephrotoxicity with the simultaneous use of NSAIDs with tacrolimus; - zidovudine: increased risk of haematological toxicity with the combined use of zidovudine and NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia in the case of concomitant treatment with zidovudine and ibuprofen; - quinolone antibiotics: Patients taking ibuprofen and quinolone antibiotics at the same time may have an increased risk of seizures. Storage conditionsStore at a temperature of 2 °C to 8 °C, protected from light. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date. Holiday conditions Without a prescription. Packing: 5 suppositories in a blister pack made of polymeric materials (PVC/PE). Two blister packs in a cardboard box with instructions for use. Buy Ibuflex rectal suppositories 60mg No. 5x2