Voltaren tablets enteric-soluble 50mg No. 10×2

Name:
Voltaren tablets. Forms of release Tablets. MNNDiclofenac. FTGNpvp. Active ingredient: each tablet contains 50 mg diclofenac sodium; excipients: tablet core: corn starch, sodium starch glycolate, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silicon dioxide, povidone KZO, magnesium stearate; sub-coating: hypromellose, talc, iron oxide yellow (E172), titanium dioxide (E171), polyethoxylated 40 hydrogenated castor oil, iron oxide red (E172). gastro-resistant coating: methacrylic acid copolymer, talc, polyethylene glycol 8000, simethicone. color film coating: hypromellose, talc, iron oxide yellow (E172), titanium dioxide (E171), polyethoxylated 40 hydrogenated castor oil, iron oxide red (E172).
Description:
Light brown, round, biconvex tablets with beveled edges, debossed with “CG” on one side and “GT” on the other. Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of acetic acid. ATX code: M01A B05. Indications for use Inflammatory and degenerative forms of rheumatic diseases (rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis), pain syndromes localized in the spine; extra-articular rheumatism; Acute attacks of gout; Post-traumatic and postoperative pain syndromes, which are accompanied by inflammation and swelling, for example, after dental, surgical and orthopedic interventions; Gynecological diseases that are accompanied by pain and inflammation, such as primary dysmenorrhea or adnexitis; As an aid in severe inflammatory diseases of the ENT organs, which are accompanied by a sensation of pain, for example, with pharyngotonsillitis, otitis. Adhering to general therapeutic principles, the underlying disease should be treated with basic therapy. Fever in itself is not an indication for the use of the drug. Contraindications Known hypersensitivity to the active substance or to any other component of the drug; last trimester of pregnancy; Active stomach or intestinal ulcer, bleeding or perforation. Inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis); Liver failure; Renal failure (GFR < 15 ml / min / 1.73 m2); The use of diclofenac is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease; Voltaren, like other NSAIDs, is contraindicated in patients in whom taking acetylsalicylic acid or other NSAIDs provokes attacks of bronchial asthma, angioedema, urticaria or acute rhinitis (i.e. cross-reactivity reactions caused by NSAIDs); Diclofenac is contraindicated for the reduction of pain in the perioperative period in the case of coronary artery bypass surgery (or using a heart-lung machine). Dosing and Administration Tablets should be swallowed whole with a liquid, preferably before meals. The dose should be selected individually. Side effects can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms (see Precautions). For adults, the recommended initial daily dose is 100-150 mg. In mild cases, as in long-term therapy, 75-100 mg is usually sufficient. The total daily dose for adults is usually divided into 2-3 doses. If it is necessary to relieve night pain and morning stiffness, in addition to taking the drug during the day, Voltaren is prescribed in the form of rectal suppositories at bedtime. The daily dose of the drug should not exceed 150 mg. In primary dysmenorrhea, the daily dose is selected individually, and in general it is 50-150 mg. The initial dose can be 50-100 mg, but if necessary, it can be increased over several menstrual cycles, but not more than 200 mg / day. The use of the drug should be started as early as possible after the appearance of the first pain symptoms; the duration of treatment, depending on the symptoms, is up to several days. Use in special groups of patients. Children under 18 years of age Voltaren tablets 50 mg can be administered to adolescents aged 14 years and older. For adolescents, the daily dose is 0.5-2 mg/kg body weight, depending on the severity of symptoms; this dose is divided into 2-3 doses. In the treatment of juvenile rheumatoid arthritis, the daily dose may be increased to a maximum daily dose of 3 mg/kg. Do not exceed the maximum daily dose of 150 mg. Voltaren enteric-coated tablets 50mg are not recommended for use in children due to the high content of the active substance. Elderly patients (65 years and older) For this group of patients, adjustment of the starting dose is usually not required. However, based on generally accepted approaches, caution is required when prescribing the drug, especially in debilitated or low-weight elderly patients. Patients with congestive heart failure (NYHA-I) or significant cardiovascular risk factors In patients with congestive heart failure (NYHA-I) or significant cardiovascular risk factors, diclofenac should be used only after careful evaluation, and with a duration of therapy of more than 4 weeks - only at doses < 100 mg per day (see Precautions). Patients with impaired renal function Voltaren is contraindicated in patients with renal insufficiency (GFR < 15 ml / min / 1.73 m2) (see Contraindications). Since special studies have not been conducted in patients with impaired renal function, specific recommendations for dose adjustment cannot be made. Caution is advised when using Voltaren in patients with impaired renal function (see Precautions). Patients with impaired liver function Voltaren is contraindicated in patients with hepatic impairment (see Contraindications). Since special studies have not been conducted in patients with impaired liver function, specific recommendations for dose adjustment cannot be made. Caution is advised when using Voltaren in patients with mild to moderate hepatic impairment (see Precautions). Adverse reactions are classified according to the frequency of occurrence: often (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, < 1/1000), very rarely ( < 1/10000), including single messages. From the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis. From the immune system: rarely - hypersensitivity reactions, anaphylactic reactions, including arterial hypotension and anaphylactic shock; very rarely - angioedema (including swelling of the face). Mental disorders: very rarely - disorientation, depression, insomnia, nightmares, irritability, psychotic disorders. From the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, cerebrovascular accident. On the part of the organs of vision: very rarely - visual disturbances, blurred vision, diplopia. From the hearing organs: often - vertigo; very rarely - ringing in the ears, hearing disorders. From the side of the cardiovascular system: infrequently * - myocardial infarction, heart failure, palpitations, chest pain; very rarely - arterial hypertension, vasculitis; frequency unknown - Kounis syndrome. On the part of the respiratory system: rarely - asthma (including shortness of breath); very rarely - pneumonitis. From the gastrointestinal tract: often - nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia; rarely - gastritis, gastrointestinal bleeding, vomiting with blood, hemorrhagic diarrhea, melena, gastric or intestinal ulcer (accompanied or not accompanied by bleeding, gastrointestinal stenosis or perforation, which can lead to peritonitis); very rarely - colitis (including hemorrhagic colitis, ischemic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, esophageal disorders, diaphragm-like intestinal strictures, pancreatitis. From the hepatobiliary system: often - an increased level of transaminases; rarely - hepatitis, jaundice, liver disorders; very rarely - fulminant hepatitis, liver necrosis, liver failure. From the side of the skin and subcutaneous tissue: often - rash; rarely - urticaria; very rarely - bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reactions, purpura, allergic purpura, itching. From the urinary system: often - fluid retention, edema and arterial hypertension; very rarely - acute kidney injury (acute renal failure), hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. General disorders: rarely - edema. *Frequency reflects data from long-term therapy using a high dose (150 mg per day).