Naklofen Duo capsules with modified high. 75mg N20
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Active ingredients
Diclofenac
Composition
1 caps Diclofenac sodium 75 mg, including Sodium Diclofenac (in enteric pellets) 25 mg Diclofenac Sodium (in slow release pellets) 50 mg. Excipients: L-methionine - 0.447 mg, sodium sulfate anhydrous - 1.704 mg, sodium dihydrogen phosphate monohydrate - 0.414 mg, mannitol - 9 mg, poloxamer 188 - 0.03 mg, dilute hydrochloric acid or sodium hydroxide solution (qs to pH 6.2), water di.
Pharmacological effect
Diclofenac is a non-steroidal anti-inflammatory drug that has an analgesic, anti-inflammatory and antipyretic effect. The main mechanism of its action and the associated side effects are the indiscriminate inhibition of the activity of the cyclooxygenase 1 and 2 enzyme (COX1 and COX2), which leads to disruption of arachidonic acid metabolism, reduced synthesis of prostaglandins, prostacyclin and thromboxane. Synthesis of prostaglandins in the kidneys, gastric mucosa and synovial fluid is reduced. Most effective for inflammatory pain. In rheumatic diseases, the anti-inflammatory and analgesic action of diclofenac significantly reduces the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. With injuries in the postoperative period, diclofenac reduces pain and inflammatory edema. Like all nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac has antiplatelet activity. At therapeutic doses, diclofenac has virtually no effect on bleeding time. With long-term treatment, the analgesic effect of diclofenac is not reduced.
Indications
- inflammatory and degenerative diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis), gouty arthritis, Reiter's disease arthritis, rheumatic soft tissue, osteoarthritis peripheral joints and spine, including with radicular syndrome, tendovaginitis, periarthritis, bursitis, myositis, synovitis). - pain syndrome of mild or moderate severity (neuralgia, myalgia, lumboischalgia, post-traumatic pain syndrome,accompanied by inflammation, postoperative pain, headache, migraine, algomenorrhea, adnexitis, proctitis, toothache, renal and biliary colic). - as part of the treatment of infectious and inflammatory diseases of the upper respiratory tract with severe pain (pharyngitis, tonsillitis, otitis media). - febrile syndrome. The drug is intended for symptomatic therapy and does not affect the progression of the disease.
Contraindications
- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including history) - the period after coronary artery bypass surgery - erosive and ulcerative changes of the mucous membrane of the stomach or duodenal ulcer, a vaginal syndrome, a vaginal syndrome, a vaginal syndrome, a vaginal discharge, a erosive and ulcerative changes of the mucous membrane of the stomach or duodenal ulcer, a vomiting of the gastric mucosa or duodenal ulcer, and intestinal bleeding - inflammatory bowel disease in the acute phase (UC, Crohn's disease) - cerebrovascular bleeding or other hemorrhages and hemostasis disorders - severe hepatic I am deficient or active liver disease - severe renal insufficiency (CC less than 30 ml / min), including confirmed hyperkalemia, progressive kidney disease - decompensated heart failure - bone marrow hematopoietic suppression - III trimester of pregnancy - lactation (breastfeeding) - children's age (up to 18 years) - hypersensitivity to diclofenac. Precautions should be prescribed for CHD, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery diseases, smoking, QA less than 60 ml / min, anamnestic data on the development of ulcerative gastrointestinal lesions, the presence of Helicobacter pylori infection, with prolonged use of NSAIDs , frequent use of alcohol, severe somatic diseases, inducible porphyria, epilepsy, diverticulitis, systemic diseases of the connective tissue, a significant decrease in the BCC (including after massive surgical intervention), elderly patients (prescribed in lower doses), incl. receiving diuretics, impaired patients and patients with low body weight, in the I and II trimesters of pregnancy, with concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel),oral glucocorticoids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).
Use during pregnancy and lactation
Use of diclofenac during pregnancy is possible only when the expected benefit outweighs the potential risk to the fetus. Diclofenac is not recommended for use during the last trimester of pregnancy. Despite the fact that diclofenac is found in breast milk in small quantities, its use during breastfeeding is not recommended.
Dosage and administration
The drug is taken orally. The capsule should be swallowed whole, with water at the end or after a meal, usually in the morning. Appointed individually, taking into account the severity of the disease. Adults are usually prescribed 75 mg (1 capsule) 1-2 times / day. The maximum daily dose is 150 mg.
Side effects
Often - 1-10%. sometimes 0.1-1%. rarely 0.01–0.1%. very rarely - less than 0.01%, including some cases. On the part of the digestive system: often - epigastric pain, abdominal cramps, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased activity of aminotransferases. rarely - gastritis, bleeding from the gastrointestinal tract (vomiting with blood, melena, diarrhea with blood), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, abnormal liver function. very rarely - stomatitis, glossitis, dry mucous membranes (including mouth), esophageal damage, diaphragm-like intestinal strictures (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis. On the part of the nervous system: often - headache, dizziness. rarely - drowsiness. very rarely - a violation of sensitivity, incl. paresthesias, memory disorders, tremor, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmarish dreams, irritability, agitation, mental disorders. From the senses: often - vertigo. very seldom - visual impairment (blurred vision, diplopia), hearing loss, tinnitus, taste impairment. On the part of the urinary system: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis, edema. On the part of the blood-forming organs: very rarely - thrombocytopenia, leukopenia, eosinophilia, hemolytic and aplastic anemia, agranulocytosis.Allergic reactions: anaphylactic / anaphylactoid reactions, including a pronounced decrease in blood pressure and shock. very rarely - angioedema (including faces). The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions. Since the cardiovascular system: very rarely - palpitations, tachycardia, extrasystole, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction. On the part of the respiratory system: rarely - cough, bronchial asthma (including shortness of breath). very rarely - pneumonitis, laryngeal edema. Dermatological reactions: often - skin rash. rarely - urticaria. very rarely - bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, pruritus, hair loss, photosensitivity, purpura, incl. allergic.
special instructions
Often - 1-10%. sometimes 0.1-1%. rarely 0.01–0.1%. very rarely - less than 0.01%, including some cases. On the part of the digestive system: often - epigastric pain, abdominal cramps, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased activity of aminotransferases. rarely - gastritis, bleeding from the gastrointestinal tract (vomiting with blood, melena, diarrhea with blood), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, abnormal liver function. very rarely - stomatitis, glossitis, dry mucous membranes (including mouth), esophageal damage, diaphragm-like intestinal strictures (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis. On the part of the nervous system: often - headache, dizziness. rarely - drowsiness. very rarely - a violation of sensitivity, incl. paresthesias, memory disorders, tremor, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmarish dreams, irritability, agitation, mental disorders. From the senses: often - vertigo. very seldom - visual impairment (blurred vision, diplopia), hearing loss, tinnitus, taste impairment. On the part of the urinary system: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis, edema.On the part of the blood-forming organs: very rarely - thrombocytopenia, leukopenia, eosinophilia, hemolytic and aplastic anemia, agranulocytosis. Allergic reactions: anaphylactic / anaphylactoid reactions, including a pronounced decrease in blood pressure and shock. very rarely - angioedema (including faces). The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions. Since the cardiovascular system: very rarely - palpitations, tachycardia, extrasystole, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction. On the part of the respiratory system: rarely - cough, bronchial asthma (including shortness of breath). very rarely - pneumonitis, laryngeal edema. Dermatological reactions: often - skin rash. rarely - urticaria. very rarely - bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, pruritus, hair loss, photosensitivity, purpura, incl. allergic.