Dex tablets p/o 25mg №10×1

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Dex tab. p/o 25mg in cont. cell pack. No. 10×1
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Round tablets, white, biconvex film-coated. The main active ingredient Dexketoprofen Release formCoated tablets Dosage 25 mg Pharmacotherapeutic group Anti-inflammatory and antirheumatic drugs. Nonsteroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. Dexketoprofen. Indications for use Symptomatic short-term treatment for pain of mild or moderate intensity, for example, in cases of musculoskeletal pain, algomenorrhea, toothache. Dosage and administration The drug DEKS is taken orally with a sufficient amount of water. Simultaneous ingestion of food slows down the absorption of dexketoprofen, therefore, in case of acute pain, it is recommended to use the drug at least 30 minutes before a meal. Adults Depending on the nature and intensity of the pain syndrome, the recommended dose for adults is 12.5 mg dexketoprofen every 4-6 hours or 25 mg dexketoprofen every 8 hours. The maximum daily dose is 75 mg. It is possible to reduce the risk of manifestations of adverse reactions if the drug is taken at the lowest effective dose for the shortest possible period of time necessary to control symptoms (see section “Precautions”). The drug DEX is not intended for long-term use. The duration of administration should be limited to the period necessary to eliminate pain. Patients 65 years of age and older Elderly patients should take DEKS starting at the lowest recommended dose. The maximum daily dose is 50 mg. If well tolerated, doses recommended for the general population may be used. Patients with hepatic impairment Patients with mild to moderate hepatic impairment should take DEKS starting at the lowest recommended dose. The maximum daily dose is 50 mg. The use of the drug DEX in patients with severe hepatic insufficiency is contraindicated. Patients with renal insufficiency In patients with mild renal insufficiency (creatinine clearance 60-80 ml / min), the initial dose should not exceed 50 mg per day. DEX should not be used in patients with moderate or severe renal insufficiency (creatinine clearance ? 59 ml/min). Children and adolescents Studies of the effects of dexketoprofen on children and adolescents have not been conducted. Therefore, DEX should not be used in children and adolescents, as its safety and efficacy have not been established. If a dose is missed, the next dose should be taken at the usual time, according to the regimen recommended by the doctor. Do not take a double dose to make up for a missed one. Use during pregnancy and lactation The use of the drug DEX is contraindicated during the third trimester of pregnancy and during lactation. Do not take DEX during the first or second trimester of pregnancy unless absolutely necessary. When prescribing dexketoprofen trometamol to women planning a pregnancy, or during the first or second trimester of pregnancy, the lowest effective dose should be used for the shortest possible duration of treatment. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis cause the possibility of the fetus developing: cardiopulmonary toxic syndrome (with obliteration of the arterial duct and pulmonary hypertension); impaired renal function, which can progress to renal failure with the development of oligohydroamnion. As well as the following risks for mother and child at the end of pregnancy: prolongation of bleeding time (the effect of inhibition of platelet aggregation), which is possible even when used at low doses; delay in uterine contractions with a corresponding delay in labor and prolonged labor. Breastfeeding There are no data on the penetration of dexketoprofen trometamol into breast milk. Influence on the ability to drive vehicles and control mechanisms Taking the drug DEX can cause dizziness and fatigue, therefore, a slight or moderate effect on the ability to drive vehicles and work with mechanisms is possible. Precautions Use with caution in patients with a history of allergic reactions. The use of dexketoprofen concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Unwanted side effects can be minimized by using the drug at the lowest effective dose for the shortest duration of use necessary to relieve pain. Gastrointestinal Disorders Gastrointestinal bleeding, ulceration, or perforation, sometimes fatal, has been reported with all NSAIDs at various stages of treatment, regardless of the presence of warning symptoms or a history of serious gastrointestinal disease. If gastrointestinal bleeding develops while taking DEKS, it should be discontinued. The risk of gastrointestinal bleeding, the appearance or perforation of an ulcer increases with an increase in the dose of NSAIDs in patients with a history of ulcers, especially with complications in the form of bleeding or perforation, as well as in elderly patients. Therefore, treatment of this category of patients should be started with the lowest recommended doses. Before using dexketoprofen in patients with a history of esophagitis, gastritis and / or peptic ulcer, as in the case of taking other NSAIDs, you should make sure that these diseases are in remission. In patients with obvious symptoms of a pathology of the digestive tract and with a history of diseases of the digestive tract, while taking the drug, it is necessary to monitor the condition of the digestive tract in order to identify possible disorders, especially gastrointestinal bleeding. The drug DEX should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn’s disease), as exacerbation of these diseases is possible. Patients of the above categories, as well as patients who require the simultaneous use of low doses of acetylsalicylic acid or other drugs that increase the risk of complications from the gastrointestinal tract, are recommended to additionally use gastroprotectors (misoprostol or proton pump blockers). The drug should be administered with caution to patients who are simultaneously taking antiplatelet agents (eg, acetylsalicylic acid) or anticoagulants (eg warfarin), corticosteroids, selective serotonin reuptake inhibitors, as the risk of gastrointestinal bleeding or ulcers increases. Patients with a history of adverse reactions from the gastrointestinal tract, especially elderly patients, should be careful and immediately report the manifestation of any unpleasant symptoms from the gastrointestinal tract, especially in the initial phase of treatment. Renal disorders In patients with impaired renal function, the drug should be administered with caution, since against the background of taking NSAIDs, deterioration in kidney function, fluid retention in the body and edema are possible. Caution should be exercised when using the drug in patients who simultaneously use diuretics and patients who may develop hypovolemia, due to an increased risk of nephrotoxicity. During treatment, the body must receive enough fluid to avoid dehydration, which can lead to increased toxic effects on the kidneys. As with other NSAIDs, DEX may increase plasma creatinine and nitrogen concentrations. As with other prostaglandin synthesis inhibitors, DEX may cause urinary side effects that may lead to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. The greatest number of renal dysfunction occurs in elderly patients. Liver disorders Caution should be exercised in patients with impaired liver function. As with the use of other NSAIDs, a slight transient increase in the activity of “liver” enzymes may be observed during therapy with the drug DEX. Elderly patients require monitoring of liver and kidney function. In the event of a significant increase in the corresponding indicators, the use of the drug DEKS should be discontinued. Cardiovascular and cerebrovascular disorders The drug may cause fluid retention in the body, therefore, in patients with arterial hypertension, with a history of mild to moderate heart failure, DEX should be used with extreme caution. In case of deterioration of the condition, the use of the drug DEKS must be discontinued. In patients with uncontrolled arterial hypertension, coronary heart disease, congestive heart failure, peripheral arterial disease and / or cerebrovascular disease, the drug should be used with caution. A similar approach is applicable to patients with risk factors for the development of cardiovascular diseases (arterial hypertension, hyperlipidemia, diabetes mellitus, smoking). Caution must be exercised when prescribing DEX to patients with a history of cardiovascular disease, especially in patients with heart failure, due to the possible risk of progression. Clinical studies and epidemiological data suggest that NSAIDs, especially at high doses and with long-term use, may lead to a small risk of developing acute myocardial infarction or stroke. There are not enough data to exclude the risk of these events when using dexketoprofen. Non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by inhibiting prostaglandin synthesis. Therefore, it is not recommended to prescribe dexketoprofen to patients taking drugs that affect hemostasis, such as warfarin or other coumarins, or heparins. Elderly patients are especially susceptible to the influence of drugs on the functions of the cardiovascular system. Skin reactions Rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with NSAIDs. At the first manifestations of a skin rash, mucosal lesions or other signs of an allergic reaction, the use of the drug DEX should be stopped immediately and consult a doctor. Other information Caution should be exercised when prescribing the drug to patients with congenital disorders of porphyrin metabolism, patients with dehydration, and immediately after major surgical interventions. In the case of long-term use of dexketoprofen, liver and kidney function should be monitored regularly. In very rare cases, severe hypersensitivity reactions (eg, anaphylactic shock) may develop. Treatment should be discontinued at the first sign of a severe allergic reaction after taking DEKS. In some cases, it is possible to develop severe infectious complications from the skin and soft tissues against the background of chicken pox. It is currently impossible to completely exclude the possibility of an association between NSAIDs and the development of such infectious complications. Therefore, in chickenpox, the use of the drug DEX should be avoided. DEX should be used with caution in patients with hematopoietic disorders, systemic lupus erythematosus and mixed connective tissue diseases. Like other NSAIDs, dexketoprofen may mask the symptoms of infectious diseases. Like other NSAIDs, dexketoprofen has an effect on female fertility, so its use is not recommended for women who want to become pregnant. Dexketoprofen should be discontinued in women who have problems conceiving or who are being tested for suspected infertility. Interaction with other drugs The following interactions are typical for all NSAIDs. Undesirable combinations With other NSAIDs, including salicylates in high doses (more than 3 g / day): the simultaneous use of several NSAIDs due to a synergistic effect increases the risk of gastrointestinal bleeding and ulcers. With anticoagulants: Dexketoprofen, like other NSAIDs, may enhance the effect of anticoagulants such as warfarin due to high plasma protein binding, inhibition of platelet aggregation and gastrointestinal mucosal damage. If necessary, simultaneous use requires careful monitoring of the patient’s condition and regular monitoring of laboratory parameters. With heparin: with simultaneous use, the risk of bleeding increases (due to the inhibition of platelet aggregation and the damaging effect on the mucous membrane of the gastrointestinal tract). If necessary, simultaneous use requires careful monitoring of the patient’s condition and regular monitoring of laboratory parameters. With glucocorticosteroids: with simultaneous use, the risk of ulcerative lesions of the gastrointestinal tract and bleeding increases. With lithium preparations: NSAIDs increase the concentration of lithium in the blood plasma up to toxic, and therefore this indicator must be monitored when used simultaneously with dexketoprofen, changing the dosage, and also after discontinuing NSAIDs. With methotrexate in high doses (15 mg / week or more): it is possible to increase the hematological toxicity of methotrexate due to a decrease in its renal clearance while using NSAIDs. With hydantoins and sulfonamides: their toxic effect may be increased. Combinations requiring caution With diuretics, angiotensin-converting enzyme (ACE) inhibitors, antibiotics from the aminoglycoside group, angiotensin-II receptor antagonists: simultaneous use with NSAIDs is associated with a risk of developing acute renal failure in dehydrated patients (decrease in glomerular filtration due to reduced synthesis of prostaglandins). With the simultaneous use of NSAIDs can reduce the antihypertensive effect of certain drugs. With the simultaneous use of dexketoprofen and diuretics, it is necessary to ensure that the patient has no signs of dehydration, and also to monitor renal function at the beginning of simultaneous use. With methotrexate in low doses (less than 15 mg / week): an increase in hematological toxicity of methotrexate is possible due to a decrease in its renal clearance against the background of simultaneous use with NSAIDs. It is necessary to count blood cells at the beginning of simultaneous use. In the presence of impaired renal function, even mild, as well as in the elderly, careful medical supervision is necessary. With pentoxifylline: there may be an increased risk of bleeding. Careful clinical monitoring and regular checking of bleeding time (blood clotting time) is essential. With zidovudine: there is a risk of increased erythrocyte toxicity due to effects on reticulocytes, with the development of severe anemia a week after the start of NSAID use. It is necessary to conduct a general blood test with counting the number of reticulocytes in 1-2 weeks. after initiation of NSAID therapy. With oral hypoglycemic agents: NSAIDs may enhance the hypoglycemic effect of sulfonylurea drugs by displacing sulfonylurea from plasma protein binding sites. Combinations to be taken into account C-blockers: when used simultaneously with NSAIDs, the antihypertensive effect of ?-blockers may decrease due to inhibition of prostaglandin synthesis. With cyclosporine and tacrolimus: NSAIDs may increase nephrotoxicity, which is mediated by the action of renal prostaglandins. With simultaneous use, it is necessary to monitor kidney function. With thrombolytics: increased risk of bleeding. The risk of bleeding from the gastrointestinal tract increases with simultaneous use with serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline) and anticoagulants. With probenecid: an increase in plasma concentrations of NSAIDs is possible, which may be due to the inhibitory effect of probenecid on renal tubular secretion and / or conjugation with glucuronic acid; dose adjustment of NSAIDs may be required. With cardiac glycosides: simultaneous use with NSAIDs can lead to an increase in the concentration of cardiac glycosides in the blood plasma. With mifepristone: due to the theoretical risk of changing the effectiveness of mifepristone under the influence of prostaglandin synthesis inhibitors, NSAIDs should not be used earlier than after 8-12 days. after discontinuation of mifepristone. With quinolones: data obtained in experimental studies in animals indicate a high risk of developing seizures with the simultaneous use of NSAIDs with high doses of quinolones. If it is necessary to simultaneously use the drug DEKS with the above drugs, you should consult your doctor. Contraindications hypersensitivity to dexketoprofen or any other component of the drug and other NSAIDs; administration to patients for whom it has been established that substances with a similar mechanism of action (for example, acetylsalicylic acid and other NSAIDs) can provoke asthma attacks, bronchospasm, acute rhinitis, the occurrence of nasal polyps, urticaria or angioedema; peptic ulcer / active or recurrent gastrointestinal bleeding (two or more confirmed cases of ulceration or bleeding), chronic dyspepsia; history of gastrointestinal bleeding or perforation, including those associated with previous use of NSAIDs; other active bleeding or other disorders of the circulatory system; inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute stage; severe liver failure (10-15 points on the Child-Pugh scale); history of bronchial asthma; impaired renal function: moderate or severe (creatinine clearance ? 59 ml / min). severe heart failure (III-IV class according to the NYHA classification); hemorrhagic diathesis and other blood clotting disorders; age up to 18 years (due to lack of data on efficacy and safety); severe dehydration (due to vomiting, diarrhea or insufficient fluid intake); photoallergic or phototoxic reactions due to a history of taking ketoprofen or fibrates; third trimester of pregnancy, lactation period. Composition Each tablet contains: Active substance: dexketoprofen (in the form of dexketoprofen trometamol) – 25 mg. Excipients: sodium starch glycolate, magnesium stearate, microcrystalline cellulose. Sheath composition: Opadray II 85F18422 white (polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc). Overdose Symptoms of overdose are not known. An overdose of similar medicinal products causes the following symptoms: disorders of the gastrointestinal tract (vomiting, anorexia, abdominal pain) and the nervous system (headache, dizziness, disorientation, drowsiness). Treatment: symptomatic therapy, when an adult or child takes more than 5 mg / kg of body dexketoprofen – taking activated charcoal within the first hour after ingestion. Dexketoprofen trometamol is excreted from the body by dialysis. Side effects Possible side effects are given in accordance with the classifications of the World Health Organization below in descending order of frequency of occurrence: very often (> 1/10), often (> 1/100, < 1/10), infrequently (> 1/1000, < 1 / 100), rare (> 1/10000, < 1/1000), very rare (< 1/10000), including isolated reports. Blood and lymphatic system disorders: very rare: neutropenia, thrombocytopenia. Immune system disorders: rare: swelling of the larynx. Very rare: anaphylactic reactions, including anaphylactic shock. Nervous system disorders: infrequently: headache, dizziness, drowsiness. Rarely: parasthesia, syncope (transient short-term fainting). Mental disorders: infrequently: insomnia, a feeling of anxiety. On the part of the organ of hearing and labyrinth disorders: infrequently: vertigo. Very rare: tinnitus. On the part of the organ of vision: very rarely - blurred vision. From the side of the cardiovascular system: infrequently: palpitations, a feeling of heat, flushing of the skin. Rarely: increased blood pressure. Very rare: tachycardia, hypotension. Respiratory system disorders: Rare: Bradypnea. Very rarely: bronchospasm, shortness of breath. Gastrointestinal disorders: Common: Nausea, vomiting, abdominal pain, dyspepsia, diarrhea. Uncommon: gastritis, constipation, dry mouth, flatulence. Rarely: erosive and ulcerative lesions of the gastrointestinal tract (GIT), bleeding from an ulcer or its perforation. Very rare: pancreatitis. On the part of the liver and biliary tract: rarely - hepatitis, increased activity of "liver" enzymes (ALT, ACT). Very rare: liver damage. Renal and urinary disorders: Rare: polyuria, acute renal failure. Very rare: nephritis or nephrotic syndrome. Reproductive system disorders: rarely: in women - menstrual irregularities, in men - transient dysfunction of the prostate gland with prolonged use. Musculoskeletal disorders: rare: back pain. Skin and subcutaneous tissue disorders: Uncommon: skin rash. Rare: urticaria, acne, increased sweating. Very rarely: severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)), angioedema, facial edema, allergic dermatitis, photosensitivity, pruritus. Metabolic disorders: rare: anorexia. General disorders: infrequently: increased fatigue, asthenia, chills, general malaise. Very rare: peripheral edema. As with the use of other NSAIDs, the following side effects may develop: aseptic meningitis, which develops mainly in patients with systemic lupus erythematosus or other systemic connective tissue diseases, hematological disorders (thrombocytopenic purpura, aplastic and hemolytic anemia, in rare cases, agranulocytosis and bone hypoplasia brain). If you experience any of these or any other adverse reactions not listed in this leaflet, you should consult a doctor. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Dex tablets p/o 25mg No. 10x1