Sertofen 20s 25 mg film-coated tablets

The instruction for medical use of Sertofen Torgovoye medicine a name Sertofen Mezhdunarodnoye the unlicensed name Deksketoprofen Lekarstvennaya the Tablet form, film coated 25 mg Structure One tablet contains active agent - a deksketoprofen trometamol 36.91 mg (it is equivalent to a deksketoprofen of 25 mg) excipients: cellulose microcrystalline (PH 101), cellulose microcrystalline (PH 102), corn starch, sodium krakhmalglikolit (type A), glycerin distearate structure of a cover: Opadri II white 85F18422, polyvinyl alcohol, titan dioxide (E 171), macrogoal, talc. The description Round biconvex tablets, film coated white color, with dividing risky on both sides Pharmacotherapeutic group Anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. Deksketoprofen. The ATX M01AE17 code the Pharmacological Pharmacokinetics Later properties of administration of drug inside the maximum concentration of a deksketoprofen in plasma is reached on average in 30 minutes. The concomitant use of food slows down drug absorption. High level of linking with proteins of blood plasma – 99% is characteristic of a deksketoprofen. The volume of distribution averages 0.25 l/kg. Elimination half-life makes 1.65 hours. The main part of drug is removed with urine in the form of metabolites (after a glyukuronirovaniye). At elderly people the lengthening of elimination half-life on average up to 48% and decrease in the general clearance of drug is observed. The pharmacodynamics Deksketoprofen – derivative propionic acid, has anti-inflammatory, analgeziruyushchy and febrifugal effect. The mechanism of effect of drug is based on oppressions of synthesis of prostaglandins which play a major role in pathogenesis of pain and inflammation, owing to suppression of cyclooxygenase-1 and cyclooxygenase-2. Analgeziruyushchy action comes in 30 minutes after administration of drug, its duration is from 4 to 6 hours. Indications the Pain syndrome of light and average intensity in the following diseases and states: - - a dysmenorrhea - a toothache the Route of administration and Sertofen's doses accept acute and chronic inflammatory diseases of the musculoskeletal system (pseudorheumatism, a spondylarthritis, arthrosis, osteochondrosis) inside at meal time, washing down with enough liquid. The mode of dosing is set individually, depending on a look and intensity of pain. The average recommended single dose makes 12.5 mg (1/2 tablets) from 1 to 6 times a day with an interval between receptions of 4-6 hours as required or 25 mg (1 tablet) from 1 to 3 times a day with an interval between receptions of 8 hours. The maximum daily dose makes 75 mg (3 tablets). At patients with abnormal liver functions or kidneys, at elderly people Sertofen's reception should be begun in lower doses - no more than 50 mg a day. Drug is not intended for prolonged use: duration of reception should not exceed 7 days. Side effects Often: - nausea and/or vomiting - pains in the injection site of drug, local reactions in the field of an injection, including inflammation, bruises or bleedings Sometimes: - anemia - insomnia - headaches, dizzinesses, drowsiness - illegibility of sight - hypotension, hyperaemia - abdominal pain, diarrhea, dyspepsia, a konstipation, a hematemesis, dryness in an oral cavity - dermatitis, a skin itching, rash, the increased sweating - a hyperthermia, fatigue, pains, a fever Seldom: - a laryngeal edema - a hyperglycemia, a hypoglycemia, a gipertriglitseridemiya, anorexia - paresthesia, faints - a ring in ears - disturbance of warm activity (extrasystole, tachycardia) - disturbance of activity of a cardiovascular system (hypertensia, thrombophlebitis) - disturbances from the respiratory system, bodies of a thorax and mediastinum (bradipnoe) - a round ulcer, bleeding of a round ulcer, a perforation of a round ulcer, a stomacace, exacerbations of colitis and Crohn's disease - hepatitis, a bilious attack - allergic rash, eels - muscle tension, constraint in joints, muscular spasms, dorsodynias - an acute renal failure, a polyuria, pains in kidneys, a ketonuria, a proteinuria - disturbance of a menstrual cycle, prostatic disturbances - a shiver and peripheral hypostasis - disturbance of functional trials of a liver is Very rare: - a neutropenia, thrombocytopenia, a purpura, aplastic and hemolytic anemia, an agranulocytosis, a marrow hypoplasia - reaction of an anaphylaxis, including an acute anaphylaxis - a bronchospasm, breath difficulty - pancreatitis, gastritis - hepatocellular damages - Stephens's syndrome – Johnson, a toxic necrolysis (Lyell's disease), a Quincke's edema, a face edema, photosensitivity - nephrite or a nephrotic syndrome - a myocardial infarction or a stroke, increase in risk of developing arterial thrombosis. Contraindications - hypersensitivity to a deksketoprofen or other NPVS or to any of the excipients which are a part of drug - existence in the anamnesis of attacks of asthma, a bronchospasm, acute rhinitis, the urtikariya or a Quincke's disease which arose in connection with use of substances with the similar mechanism of action (acetylsalicylic acid and other NPVS) - existence at patients of an active peptic ulcer of a stomach and duodenum or existence of the repeating episodes of a peptic ulcer (two and more episodes) - gastrointestinal bleedings (including NPVS connected with the previous reception), other active bleedings - Crohn's disease, nonspecific ulcer colitis - heavy abnormal liver functions (10-15 points on a scale of Chayld-Pyyu) - heavy renal failures (clearance of creatinine & lt, 50 ml/min.) - bronchial asthma (including in the anamnesis) - heavy heart failure - hemorrhagic diathesis or other coagulopathies - III - y a trimester of pregnancy and the period of a lactation - children's and teenage age up to 18 years Medicinal interactions Undesirable combinations Simultaneous use of a deksketoprofen with other NPVS, including salicylates, increases risk of developing of gastrointestinal bleedings. At simultaneous use with oral anticoagulants, heparin the risk of developing bleedings increases. NPVS increase concentration of lithium in blood, control of this indicator at use, change of a dose and after cancellation of NPVS is necessary. Simultaneous use of NPVS and methotrexate in high doses (more than 15 mg a week) increases hematologic toxicity of the last. At combined use with hydantoins and sulfonamides strengthening of toxic properties of these substances is possible. Leads the combinations demanding care at use Simultaneous use with a methotrexate in low doses (less than 15 mg a week) to increase in hematologic toxicity of a methotrexate in connection with decrease in its renal clearance against the background of use of NPVS. Simultaneous use with inhibitors of the return serotonin reuptake, oral glucocorticoids increases risk of developing gastrointestinal bleedings. NPVS strengthen hypoglycemic effect of sulphonylurea owing to replacement it from places of linking with proteins of blood plasma. Simultaneous use with diuretics, APF inhibitors, antagonists of receptors of angiotensin II and blockers of β-adrenoceptors: reduce efficiency of diuretic and other antihypertensive drugs, At simultaneous use with pentoksifilliny increase risk of developing bleedings, active clinical monitoring and frequent control of a bleeding time is necessary, At simultaneous use with a zidovudine there is a risk of increase in the toxic action on erythrocytes caused by impact on reticulocytes with development of heavy anemia in a week after purpose of NPVS. Control of all cellular elements of blood, including reticulocytes in 1-2 weeks after the beginning of therapy of NPVS is necessary. The combinations requiring special attention of NPVS can reduce hypotensive effect of beta blockers that is caused by inhibition of synthesis of prostaglandins. At simultaneous use with cyclosporine and takrolimusy NPVS can increase nephrotoxicity that is mediated by effect of renal prostaglandins. During performing combination therapy it is necessary to control function of kidneys. At co-administration from trombolitika the risk of developing bleedings increases. At simultaneous use with probenetsidy increase in concentration of NPVS in plasma is possible that can be caused by inhibition of renal secretion and/or conjugation with glucuronic acid. It demands dose adjustment of NPVS. NPVS can cause increase in concentration of cardiac glycosides in blood plasma. Due to the theoretical risk of change of efficiency of mifepristone under the influence of inhibitors of synthesis of prostaglandins, NPVS it is not necessary to appoint earlier, than in 8-12 days after mifepristone cancellation. At simultaneous use from hinolona increase risk of developing spasms. Special instructions Should be careful when prescribing drug patients of advanced age (65 years are more senior), patients with allergic reactions, with general diseases of connective tissue and to patients with hemopoiesis disturbance. For patients with disturbances from digestive tract or gastrointestinal diseases in the anamnesis the careful observation is necessary. In case of developing of gastrointestinal bleeding or an ulcer, therapy by drug should be cancelled. As well as other NPVS, Sertofen can lead to increase in concentration of creatinine and nitrogen in blood plasma. Against the background of therapy deksketoprofeny small passing increase in indicators of some hepatic tests and also the significant increase in level of nuclear heating plant and ALT can be observed. At elderly people the periodic monitoring of function of a liver and kidneys is necessary. At simultaneous use of Sertofen with the drugs affecting blood clotting it is necessary to control the system of blood clotting. Deksketoprofen can mask symptoms of infectious diseases. It is necessary to inform patients that in case of side effects and also in the absence of clinical effect within 3-5 days of treatment it is necessary to report about it to the attending physician. Pregnancy and the period of a lactation the Drug Sertofen is contraindicated in the third trimester of pregnancy and in the period of a lactation. In the first and second trimester Sertofen can be applied strictly as necessary, according to the recommendation of the doctor, in the minimum dosages and on an extent the shortest span. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Due to possible dizziness and drowsiness against the background of drug treatment decline in the ability to concentration of attention and speed of psychomotor reactions is possible. Overdose Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia. Treatment: gastric lavage, hemodialysis, symptomatic therapy. The form of release and packing On 10 tablets place in blister strip packaging from an opaque film of PVH/PVDH and aluminum foil. On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard Storage conditions to Store at a temperature not above 25 °C. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer Uorld Meditsin Ilach Sang. ve Tidzh. A.Sh., Turkey Address: Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul. Turkey the Owner of the registration certificate of Dr Sertus Ilach Sanayi Ve Tidzharet Limited Shirketi, Turkey the Name, the address and a contact information (phone, the fax, e-mail) of the organization of the claim (offer) on quality of medicines accepting in the territory of the Republic of Kazakhstan from consumers and responsible for post-registration observation of safety of medicine. TROKA-S PHARMA LLP, Almaty, Suyunbaya Avenue 222-b ph. 8+7 727 251 99 35, +7 727 251 99 45 fax: 8+7 727 252 90 90
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