Voltaren pills enteric-coated 25mg N30
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Active ingredients
Diclofenac
Release form
Pills
Composition
1 tab. Diclofenac Sodium 25 mg. Excipients: colloidal anhydrous silicon dioxide - 6 mg, microcrystalline cellulose - 10 mg, lactose monohydrate - 16 mg, magnesium stearate - 1 mg, corn starch - 50 mg, povidone K30 - 2 mg, sodium carboxymethyl starch - 20 mg.
Pharmacological effect
NSAIDs. Voltaren. contains diclofenac sodium, a nonsteroidal substance that has a pronounced anti-inflammatory, analgesic and antipyretic effect. The main mechanism of action of diclofenac, established in the experimental conditions, is the inhibition of the biosynthesis of prostaglandins. Prostaglandins play an important role in the genesis of inflammation, pain and fever. In vitro, diclofenac sodium at concentrations equivalent to those achieved in the treatment of patients does not inhibit the biosynthesis of cartilage proteoglycans. In rheumatic diseases, the anti-inflammatory and analgesic properties of Voltaren provide a clinical effect characterized by a significant decrease in the severity of such manifestations of diseases as pain at rest and on movement, morning stiffness and swelling of the joints, as well as an improvement in functional status. In post-traumatic and postoperative inflammatory phenomena Voltaren. quickly relieves pain (arising both at rest and when moving), reduces inflammatory swelling and swelling of a postoperative wound. With the use of Voltaren in pills and suppositories, a marked analgesic effect of the drug was noted with moderate and severe pain of non-rheumatic origin. When using the drug in the form of a solution for i / m administration, the effect of the drug occurs in 1-15 minutes. It was also found that Voltaren. able to reduce pain and reduce blood loss in primary dysmenorrhea.
Indications
- inflammatory and degenerative diseases of the musculoskeletal system, incl. rheumatoid arthritis, chronic arthritis dentistry and orthopedics) - algodysmenorrhea - inflammatory processes in the pelvis (incl.adnexitis) - infectious-inflammatory diseases of the upper respiratory tract with severe pain (as part of complex therapy): pharyngitis, tonsillitis, otitis media. Isolated fever is not an indication for the use of the drug. The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.
Contraindications
- exacerbation of gastric ulcer and duodenal ulcer in the acute phase, peptic ulcer bleeding, perforation - inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase - patients with asthma attacks, nettle rash or acute rhinitis, which is triggered by acetylcilitis. - renal failure severe (CC less than 30 ml / min) - severe heart failure - severe liver failure - active diseases of the furnace Eni - conditions associated with the risk of bleeding - coronary artery bypass surgery (perioperative period) - confirmed hyperkalemia - III trimester of pregnancy - lactation period (breastfeeding) - hypersensitivity to the drug. Voltaren. contains lactose and therefore is not recommended for patients with rare hereditary intolerance to galactose, severe lactase deficiency and with glucose-galactose malabsorption. Voltaren is not recommended. enteric-coated pills, 50 mg in children under the age of 14 years.
Use during pregnancy and lactation
The safety of diclofenac in pregnant women has not been studied. Therefore, Voltaren. It should be appointed in the I and II trimesters of pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Voltaren. Like other NSAIDs inhibitors of prostaglandin synthesis, is contraindicated in the third trimester of pregnancy (suppression of uterine contractility is possible and premature closure of the arterial duct in the fetus). Since Voltaren., Like other NSAIDs, may have a negative effect on fertility, women planning pregnancy are not recommended to take the drug. In patients undergoing examination and treatment for infertility, the drug should be discontinued.Despite the fact that diclofenac, like other NSAIDs, is excreted in breast milk in small quantities, Voltaren. should not be prescribed to lactating women in order to avoid undesirable effects on the child. If necessary, the appointment of the drug during lactation breastfeeding should be discontinued.
Side effects
The following are undesirable effects that have been identified during clinical trials, as well as in the application of diclofenac in clinical practice. The following criteria were used to estimate the frequency of adverse events: very often (& # 8805 .1 / 10), often (& # 8805. 1/100, less than 1/10), infrequently (& # 8805 .1 / 1000, less than 1 / 100), rarely (& # 8805 .1 / 10 000, less than 1/1000), very rare (less than 1/10 000). For each organ system, adverse events are grouped in decreasing order of their frequency of occurrence. Within each group identified by frequency of occurrence, adverse events are distributed in order of decreasing importance. On the part of the digestive system: often - abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, loss of appetite, anorexia, increased serum aminotransferase activity. rarely - gastritis, gastrointestinal bleeding, vomiting of blood, melena, diarrhea mixed with blood, stomach and intestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, abnormal liver function. very rarely - stomatitis, glossitis, esophageal damage, diaphragm-like strictures in the intestine, colitis (non-specific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis, hepatic necrosis, hepatic failure. On the part of the nervous system: often - headache, dizziness. rarely - drowsiness. very rarely - sensitivity disorders, including paresthesias, memory disorders, tremor, convulsions, anxiety, acute cerebral circulation disorders, aseptic meningitis. very rarely - disorientation, depression, insomnia, nightmares, irritability, mental disorders. From the senses: often - vertigo. very rarely - visual impairment (blurred vision), diplopia, hearing impairment, tinnitus, dysgeusia. Dermatological reactions: often - skin rash. rarely - urticaria. very rarely - bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exfoliative dermatitis, itching, hair loss, photosensitivity reactions. Purpura, Schonlein-Henoch Purpura.From the genitourinary system: very rarely - acute renal failure, hematuria, proteinuria, tubulointerstitial nephritis. nephrotic syndrome. papillary necrosis. From the hematopoietic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis. Allergic reactions: rarely - hypersensitivity, anaphylactic / anaphylactoid reactions, including reduction of blood pressure and shock. very rarely - angioedema (including swelling of the face). Since the cardiovascular system: very rarely - a feeling of heartbeat, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction. On the part of the respiratory system: rarely - asthma (including shortness of breath). very rarely - pneumonitis. General reactions: rarely - edema.
special instructions
The following are undesirable effects that have been identified during clinical trials, as well as in the application of diclofenac in clinical practice. The following criteria were used to estimate the frequency of adverse events: very often (& # 8805 .1 / 10), often (& # 8805. 1/100, less than 1/10), infrequently (& # 8805 .1 / 1000, less than 1 / 100), rarely (& # 8805 .1 / 10 000, less than 1/1000), very rare (less than 1/10 000). For each organ system, adverse events are grouped in decreasing order of their frequency of occurrence. Within each group identified by frequency of occurrence, adverse events are distributed in order of decreasing importance. On the part of the digestive system: often - abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, loss of appetite, anorexia, increased serum aminotransferase activity. rarely - gastritis, gastrointestinal bleeding, vomiting of blood, melena, diarrhea mixed with blood, stomach and intestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, abnormal liver function. very rarely - stomatitis, glossitis, esophageal damage, diaphragm-like strictures in the intestine, colitis (non-specific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis, hepatic necrosis, hepatic failure. On the part of the nervous system: often - headache, dizziness. rarely - drowsiness. very rarely - sensitivity disorders, including paresthesias, memory disorders, tremor, convulsions, anxiety, acute cerebral circulation disorders, aseptic meningitis. very rarely - disorientation, depression, insomnia, nightmares, irritability, mental disorders.From the senses: often - vertigo. very rarely - visual impairment (blurred vision), diplopia, hearing impairment, tinnitus, dysgeusia. Dermatological reactions: often - skin rash. rarely - urticaria. very rarely - bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exfoliative dermatitis, itching, hair loss, photosensitivity reactions. Purpura, Schonlein-Henoch Purpura. From the genitourinary system: very rarely - acute renal failure, hematuria, proteinuria, tubulointerstitial nephritis. nephrotic syndrome. papillary necrosis. From the hematopoietic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis. Allergic reactions: rarely - hypersensitivity, anaphylactic / anaphylactoid reactions, including reduction of blood pressure and shock. very rarely - angioedema (including swelling of the face). Since the cardiovascular system: very rarely - a feeling of heartbeat, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction. On the part of the respiratory system: rarely - asthma (including shortness of breath). very rarely - pneumonitis. General reactions: rarely - edema.