Bonifen forte pills coated 550mg N10
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Active ingredients
Naproxen
Release form
Pills
Composition
By production on LLC KRKA-RUS, Russia 1 caps. Active ingredient: celecoxib substance-granules 132.975 mg (the active substance of the substance-granules - celecoxib - 100 mg). Auxiliary substances of the substance granules: lactose monohydrate - 24.875 mg; sodium lauryl sulfate - 4.05 mg; Povidone K30 - 3.375 mg; Croscarmellose sodium - 0.675 mg. Excipients: croscarmellose sodium - 0.675 mg; magnesium stearate - 1.35 mg. Hard gelatin capsules No3: Case: titanium dioxide (E171) - 2%; gelatin - up to 100%. Lid: titanium dioxide (E171) - 2%; gelatin - up to 100% When producing at JSC “KRKA, dd, Novo mesto”, Slovenia 1 caps. Active ingredient: celecoxib 100/200 mg. Excipients: lactose monohydrate 24,875 / 49,75 mg; sodium lauryl sulfate 4.05 / 8.1 mg; Povidone K30 3.375 / 6.75 mg; croscarmellose sodium 1.35 / 2.7 mg; magnesium stearate 1.35 / 2.7 mg. Hard gelatin capsules No3 / 1 Body: titanium dioxide (E171) - 2/1%; iron dye yellow oxide (E172) - - / 1%; gelatin - up to 100/100%. Lid: titanium dioxide (E171) - 1/1%; iron dye yellow oxide (E172) - - / 1%; gelatin - up to 100/100%.
Pharmacological effect
Analgesic, antipyretic, anti-inflammatory
Pharmacokinetics
Absorption from the gastrointestinal tract - fast and complete, bioavailability - 95% (food intake does not affect either the fullness or the rate of absorption). Tmax - 1–2 h, plasma protein binding -> 99%, T1 / 2 - 12–15 h. Metabolism - in the liver to dimethylnaproxen with the participation of the CYP2C9 enzyme system. Clearance - 0.13 ml / min / kg. It is excreted by 98% by the kidneys (of which 10% is unchanged), with bile - 0.5–2.5%. Css is determined to receive 4–5 doses of the drug (2–3 days). In renal failure, accumulation of metabolites is possible.
Indications
Disorders of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis), gouty arthritis, rheumatic soft tissue, osteoarthritis peripheral joints and spine, including with radicular syndrome, tenosynovitis, bursitis); pain syndrome of mild or moderate severity: neuralgia, ossalgia, myalgia, lumboischialgia, post-traumatic pain syndrome (sprains and bruises), accompanied by inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), headache, in traumatology, orthopedics, gynecology, maxillofacial pain, headache, in traumatology, orthopedics, gynecology, maxillofacial pain, headache, in traumatology, orthopedics, gynecology, maxillofacial pain, headache, trauma, orthopedic adnexitis, toothache; in the complex treatment of infectious and inflammatory diseases of the ear, throat, nose with severe pain (pharyngitis, tonsillitis, otitis media); febrile syndrome with colds and infectious diseases.Bonifen forte is used for symptomatic therapy (to reduce pain, inflammation and reduce fever) and does not affect the progression of the underlying disease.
Contraindications
Hypersensitivity to naproxen or naproxen sodium; with anamnestic data about the attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete intolerance syndrome of acetylsalicylic acid - rhinosinusitis, urticaria, nasal mucous polyps, bronchial asthma); the period after coronary artery bypass surgery; erosive and ulcerative changes of the gastric or duodenal mucosa, active gastrointestinal bleeding; inflammatory bowel disease in the acute phase (ulcerative colitis, Crohn's disease); cerebrovascular bleeding or other bleeding and impaired hemostasis; severe liver failure or active liver disease; severe renal insufficiency (Cl creatinine less than 20 ml / min), including confirmed hyperkalemia, progressive kidney disease; oppression of bone marrow hematopoiesis; pregnancy, breastfeeding period; One tablet of Bonifen forte contains 550 mg of naproxen, so the drug is not recommended for children and adolescents under 15 years of age. With care: ischemic heart disease, cerebrovascular diseases, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes, peripheral artery disease, smoking, Cl creatinine less than 60 ml / min; anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, old age, long-term use of NSAIDs, frequent use of alcohol, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel, etc.); (for example, prednisolone), SIOZS (for example, citalopram, fluoxetine, paroxetine, sertraline). To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the minimum possible course. Children under 15 years old are prescribed only on the recommendation of a doctor.
Use during pregnancy and lactation
Bonifen forte is not recommended for use during pregnancy and lactation
Dosage and administration
Inside You should strictly follow the instructions of the doctor, do not stop treatment and do not change the dosage without prior consultation with the doctor. The usual daily dose used to relieve pain is 1-2 pills. (550–1100 mg). With a very strong pain and the absence of a history of gastrointestinal diseases, it is possible to increase the daily dose to 3 table. (1650 mg), but not more than 2 weeks. When using the drug as a febrifuge, the initial dose is 1 table. (550 mg), then taken 0.5 tab. (275 mg) every 6-8 hours. To prevent migraine attacks, 1 tab. (550 mg) twice a day. However, treatment should be discontinued if the frequency, intensity and duration of migraine attacks do not decrease within 4-6 weeks. At the first sign of a migraine attack, 1.5 pills (825 mg) should be taken, and, if necessary, another 0.5-1 table. (275-550 mg) after 30 minutes. To relieve menstrual pain and spasms, pain after the introduction of the IUD (intrauterine devices) and other gynecological pains (adnexitis, giving birth as an analgesic and tocolytic agent), it is recommended to administer the drug in the initial dose of 1 table. (550 mg), then 0.5 tab. (275 mg) every 6-8 hours. In an acute attack of gout, the initial dose is 1.5. (825 mg), then 1 table. (550 mg) 8 hours later, and then 0.5 tab. (275 mg) every 8 hours until the cessation of the attack. With rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the usual initial dose of the drug is 1-2 pills. (550–1100 mg), twice a day, morning and evening. The initial daily dose of 1.5 (825 mg) –3 table. (1650 mg) is recommended for patients with severe night pain and / or severe morning stiffness, for patients transferred to sodium naproxen for treatment with high doses of other NSAIDs, and for patients whose pain is the leading symptom. Usually the daily dose is 1 table. (550 mg) - 2 tab. (1100 mg), prescribed in two doses. Morning and evening doses may not be the same. With the consent of the attending physician, you can change them depending on the prevalence of symptoms, i.e. night pain and / or morning stiffness. If it seems that the effect of the drug is very strong or weak, you should inform your doctor or pharmacist.
Side effects
Side effects are most frequent when using high doses of the drug Bonifen Forte.On the part of the digestive system: constipation, abdominal pain, dyspepsia, nausea, diarrhea, ulcerative stomatitis, erosive and ulcerative lesions and gastrointestinal bleeding, increased liver enzymes, impaired liver function, jaundice, hematemesh, melena. On the part of the central nervous system: hearing loss, dizziness, headache, drowsiness, depression, sleep disorders, inability to concentrate, insomnia, indisposition, myalgia and muscle weakness, slower reaction rate, aseptic meningitis, cognitive dysfunction. On the part of the skin: itching, ecchymosis, excessive sweating, purpura, alopecia, photodermatosis. On the part of the senses: tinnitus, impaired vision, impaired hearing. On the part of the cardiovascular system: swelling, shortness of breath, palpitations, congestive heart failure, vasculitis. On the part of the urogenital system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual disorders. From the blood-forming organs: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia. On the part of the respiratory system: eosinophilic pneumonitis. Allergic reactions: skin rash, urticaria, angioedema, epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome. Others: thirst, hyperthermia, hyperglycemia, hypoglycemia, increased bleeding time, hemolytic anemia. In case of occurrence of such phenomena, you should stop taking the drug and, if possible, consult a doctor.
Overdose
Symptoms: drowsiness, dyspeptic disorders (heartburn, nausea and vomiting, abdominal pain), weakness, tinnitus, irritability; in severe cases, hematemesis, melena, impaired consciousness, convulsions, and renal failure. Treatment: gastric lavage and symptomatic therapy - activated carbon, antacids, H2-receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.
Interaction with other drugs
When treating with anticoagulants, it should be borne in mind that naproxen may increase bleeding time. Do not use the drug at the same time as other NSAIDs (increased risk of side effects).Patients who simultaneously receive hydantoins, anticoagulants, or other drugs that bind to a large extent with plasma proteins should monitor signs of potentiation of the action or overdose of these drugs. The drug Bonifen forte may reduce the antihypertensive effect of propranolol and other beta-blockers, and may also increase the risk of renal failure associated with the use of ACE inhibitors. Under the action of naproxen, the natriuretic effect of furosemide is inhibited. Inhibition of renal clearance of lithium leads to an increase in plasma lithium concentrations. Taking probenecid increases the level of naproxen in the plasma. Cyclosporine increases the risk of developing renal failure. Naproxen slows the excretion of methotrexate, phenytoin, sulfonamides, increasing the risk of their toxic action. Antacid preparations containing magnesium and aluminum reduce the absorption of naproxen. If the patient has any other diseases or allergies, or when taking any other drugs, it is necessary to inform the attending physician.
special instructions
Do not exceed the dose specified in the instructions. To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the shortest possible course. If pain and fever persist or become stronger, consult a doctor. Patients with bronchial asthma, with bleeding disorders, as well as patients with hypersensitivity to other analgesics before taking Forgesin forte should consult with your doctor. Caution should be given to patients with liver disease and renal failure. In patients with renal insufficiency, it is necessary to control the level of creatinine clearance. At the creatinine Cl level below 20 ml / min, naproxen is not recommended. In chronic alcoholic and other forms of cirrhosis, the concentration of unbound naproxen increases, so lower doses are recommended for these patients. Bonifen forte should not be taken with other anti-inflammatory and analgesic drugs, with the exception of doctor's prescriptions. Elderly patients are also recommended lower doses.Naproxen should be avoided within 48 hours prior to surgery. If it is necessary to determine 17-corticosteroids, the drug should be discontinued 48 hours before the study. Similarly, naproxen can influence the determination of 5-hydroxyindolecetic acid in urine. The use of naproxen, as well as other drugs that block the synthesis of GHGs, can affect fertility, therefore it is not recommended for women who want to become pregnant. Each tablet of Bonifen forte contains approximately 50 mg of sodium. When limiting salt intake, this must be taken into account. Influence on the ability to drive and other mechanisms: Naproxen slows down the response rate in patients. This should be considered when driving a car and performing tasks that require increased attention.