Name:
Diclofenac 50mg No. 20 (Pharmland)
Description:
Tablets with a dosage of 50 mg are round, biconvex, orange-coated, smooth on both sides. The main active ingredient Diclofenac Release form: coated tablets Dosage 50 mg Pharmacological action When taken orally, Diclofenac is absorbed almost completely. The maximum concentration in the blood is reached after 1-2 hours. It has anti-inflammatory, analgesic and antipyretic effects, relieves pain at rest and during movement, reduces inflammatory edema, swelling of the joints, improves their functional ability. 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 accompanied by pain and inflammation, for example, primary dysmenorrhea or adnexitis; as an adjunct in severe inflammatory diseases of the ENT organs, which are accompanied by a sensation of pain, for example, with pharyngotonsillitis, otitis media. 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. Dosage and administration It is taken orally, without chewing, during or after meals. The dose is selected individually, it is advisable to take the lowest effective dose for the shortest possible period of time. Adults: the initial daily dose is 75-150 mg in divided doses, the frequency of administration depends on the severity of the course of the disease. Upon reaching the therapeutic effect, 25 mg is prescribed 3 times a day. The daily dose of Diclofenac should not exceed 150 mg. With dysmenorrhea, the daily dose is 50-150 mg. Treatment should begin after the first pain symptoms appear. Depending on the symptoms, the duration of treatment can be up to several days. Children (6-15 years old): take Diclofenac 25 mg tablets at a dose of 0.5-2 mg/kg of body weight daily in divided doses. In juvenile rheumatoid arthritis, the daily dose may be increased to a maximum daily dose of 3 mg/kg. The drug Diclofenac, coated tablets 25 mg, is approved for use in children from 6 years of age. Diclofenac 50 mg film-coated tablets are for use in adults only. Use during pregnancy and lactation Diclofenac is contraindicated during pregnancy due to possible negative effects on pregnancy and intrauterine development of the fetus. Like other NSAIDs, it can adversely affect the ability of women to conceive, so it is not recommended to prescribe to women planning a pregnancy. In women who have problems conceiving or who are undergoing examination for infertility, Diclofenac should be discontinued. Diclofenac is contraindicated during lactation. When prescribing Diclofenac, be sure to inform your doctor if you are taking any of the medicines listed below. It may be necessary to adjust the dose or additional tests for digoxin, phenytoin, or lithium preparations (may increase the risk of adverse reactions); diuretics and antihypertensives (the effectiveness of these drugs may decrease); potassium-sparing diuretics (hyperkalemia may occur); other NSAIDs or glucocorticoids (increased risk of side effects from the gastrointestinal tract); acetylsalicylic acid (there may be a decrease in the effectiveness of Diclofenac); antidiabetic drugs (may cause changes in blood sugar levels); methotrexate (its toxicity may increase); cyclosporine (the toxic effect on the kidneys may increase); anticoagulants (requires regular monitoring of blood clotting); mifepristone (NSAIDs should not be used within 8-12 days after taking mifepristone, so as not to reduce the effectiveness of mefipristone); quinolone antibacterial agents (may increase the risk of seizures); cyclosporine, tacrolimus or trimethoprim (hyperkalemia is possible, monitoring of this indicator is required); cardiac glycosides (may aggravate heart failure and increase plasma concentrations of cardiac glycosides); colestipol, cholestyramine (the absorption of Diclofenac decreases by about 30% and 60%, respectively, drugs should be taken at intervals of several hours). antithrombotic agents (possibly increased risk of bleeding; monitoring of clotting parameters is recommended). Precautions With all NSAIDs, gastrointestinal bleeding, ulcers and perforations are possible, which can be life-threatening and develop both gradually and acutely. Such phenomena are most dangerous for patients with serious gastrointestinal diseases in the past and for the elderly. With the development of these complications, Diclofenac should be discontinued. To reduce the risk of toxic effects on the gastrointestinal tract in the above groups of patients, treatment should begin with the lowest effective dose and adhere to it in the future. In these patients and patients requiring concomitant use of medicinal products containing acetylsalicylic acid/aspirin or other medicinal products that may increase the risk of gastrointestinal adverse reactions, combination therapy with medicinal products that protect the gastrointestinal mucosa (eg, inhibitors) is considered. proton pump or misoprostol). Long-term use of NSAIDs or at high doses (150 mg/day) may increase the risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be life-threatening. The use of Diclofenac is contraindicated in patients with established congestive heart failure, ischemic heart disease, peripheral arterial disease or cerebrovascular disease. Patients with significant risk factors for the development of cardiovascular complications (for example, arterial hypertension, hyperlipidemia, diabetes mellitus, smoking) Diclofenac is prescribed after a thorough assessment of the patient’s condition. Severe, life-threatening skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have very rarely been reported with NSAIDs, including Diclofenac. The highest risk of these reactions exists at the beginning of therapy, and the development of these reactions is noted in most cases in the first month of treatment. Diclofenac should be discontinued at the first sign of skin rash, mucosal ulcers, or any other sign of hypersensitivity. In patients who have not previously taken Diclofenac, during the period of treatment, in rare cases, allergic reactions of varying severity may develop. In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa, chronic obstructive pulmonary disease or chronic respiratory infections, allergic reactions to NSAIDs are more common than in other patients. Special care should be taken when treating such patients. Diclofenac may mask symptoms characteristic of infectious and inflammatory diseases. Diclofenac should be used with caution in elderly patients. Weakened patients and patients with low body weight are recommended to take the lowest effective dose. Diclofenac tablets contain lactose, therefore their use is not recommended in patients with hereditary galactose intolerance, severe lactose deficiency or glucose-galactose malabsorption. In the case of long-term use of Diclofenac or other NSAIDs, patients with liver disease need regular monitoring of liver function: it is possible to increase the level of liver enzymes. If violations of the functional indicators of the liver persist or intensify, complaints or symptoms develop that indicate a disease; liver, as well as in the case when other side effects occur (eosinophilia, rash, etc.), Diclofenac is stopped. Caution is necessary when taking Diclofenac in patients with impaired heart or kidney function (including with functional renal failure against the background of hypovolemia, nephrotic syndrome, lupus nephropathy and decompensated cirrhosis of the liver), the elderly, with a history of hypertension, while taking diuretics , as well as with a significant decrease in BCC of any etiology, for example, in the period before and after major surgical interventions. In these cases, while taking Diclofenac, monitoring of kidney function is necessary. Cancellation of the drug usually leads to the restoration of kidney function to its original level. With long-term use of Diclofenac, as well as other NSAIDs, a systematic monitoring of the state of peripheral blood is shown. Diclofenac, like other NSAIDs, can temporarily inhibit platelet aggregation, so patients with impaired hemostasis need careful monitoring of relevant laboratory parameters. It is necessary to inform the doctor in case of any deterioration in the condition while taking Diclofenac! For all the above groups of patients, it is recommended to take Diclofenac at the minimum effective dose and for the shortest possible time necessary to reduce the severity of symptoms. The need for NSAIDs may be reviewed. Interaction with other drugs With the simultaneous use of diclofenac and: digoxin, phenytoin or lithium preparations – the level of these drugs in the blood plasma may increase; diuretics and antihypertensive drugs – the effect of these drugs may decrease; potassium-sparing diuretics – hyperkalemia may occur; other NSAIDs or glucocorticoids – the risk of side effects from the gastrointestinal tract increases; acetylsalicylic acid – there may be a decrease in the concentration of diclofenac in the blood serum; antidiabetic agents – can cause hypo- or hyperglycemia; methotrexate – within 24 hours before or after taking it, the concentration of methotrexate may increase and its toxicity may increase; cyclosporine – the toxic effect of the latter on the kidneys may increase; anticoagulants – regular monitoring of blood clotting is necessary; mifepristone – non-steroidal anti-inflammatory drugs should not be used within 8-12 days after taking mifepristone, since taking non-steroidal anti-inflammatory drugs can reduce the effect of mefipristone, quinolone antibacterials – non-steroidal anti-inflammatory drugs can increase the risk of seizures associated with taking quinolone antibacterials. cyclosporine, tacrolimus or trimethoprim – an increase in the level of potassium in the blood serum is possible, which requires constant monitoring of this indicator. cardiac glycosides – can aggravate heart failure and lead to an increase in plasma concentrations of cardiac glycosides. colestipol and cholestyramine – a decrease in the absorption of Diclofenac by approximately 30% and 60%, respectively, for colestipol and cholestyramine. These medicines should be taken at intervals of several hours. antithrombotic agents – may increase the risk of bleeding; continuous monitoring is recommended. Contraindications inflammatory bowel disease (eg Crohn’s disease, ulcerative colitis); erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, bleeding from the gastrointestinal tract; past gastrointestinal bleeding or perforation associated with previous use of non-steroidal anti-inflammatory drugs (NSAIDs); previous peptic ulcer / bleeding (two or more episodes of a verified ulcer or bleeding in history); “aspirin” asthma, “aspirin” triad (a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid and pyrazolone drugs); known hypersensitivity to diclofenac or other components of the drug; blood clotting disorders (including hemophilia, prolonged bleeding time, bleeding tendency), hematopoietic disorders (leukopenia and anemia); children’s age up to 6 years; hepatic, renal, heart failure in severe form; pregnancy and lactation; co-administration with non-steroidal anti-inflammatory drugs, including specific inhibitors of cyclooxygenase 2; diclofenac is contraindicated to relieve pain in the perioperative period in the case of coronary artery bypass grafting (CABG). Be sure to consult your doctor if: if you have mild to moderate heart or kidney failure, if the elderly are taking diuretics, or if for any reason there is a decrease in circulating blood volume (CBV), for example, after major surgery . When prescribing Diclofenac in such cases, it is necessary to monitor kidney function. in the presence of mild to moderate hepatic insufficiency, it is necessary to monitor liver function, a picture of peripheral blood, and a stool test for occult blood during long-term therapy. Diclofenac should be discontinued if elevated liver enzymes persist or increase. Undesirable effects can be minimized by using the lowest possible dose for the shortest duration of treatment necessary to control symptoms. In patients with significant cardiovascular risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking), diclofenac should be administered only after careful consideration of this possibility. , lactose monohydrate, talc, magnesium stearate. Shell composition: cellulose acetate phthalate, talc, titanium dioxide, polyethylene glycol, ethyl acetate, quinoline yellow (E104) (25 mg dosage), orange yellow (E 110) (50 mg dosage). Overdose Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, disorientation, agitation, dizziness, tinnitus, drowsiness, fainting, coma, sometimes convulsions. In case of severe poisoning, acute renal failure and liver damage may develop. Treatment: There is no specific antidote. It is necessary to wash the stomach, the introduction of activated charcoal, symptomatic therapy aimed at eliminating the increase in blood pressure, impaired renal function, convulsions, irritation of the gastrointestinal tract, respiratory depression. Forced diuresis, hemodialysis are ineffective. 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.On the part of the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.On the part of 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 - the viewer nye violations, blurred vision, diplopia. On the part of the hearing organs: often - vertigo; very rarely - ringing in the ears, hearing disorders. From the side of the cardiovascular system: very rarely - palpitations, chest pain, heart failure, myocardial infarction, arterial hypertension, vasculitis. On the part of the respiratory system: rarely - asthma (including shortness of breath), bronchospasm; 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, stomach or intestinal ulcer (with / without bleeding or perforation); very rarely - colitis (including hemorrhagic 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 - fulminant hepatitis, liver necrosis, liver failure. On the part of the skin and subcutaneous tissue: often - a 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, scabies. From the urinary system: very rarely - acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. Clinical studies and epidemiological data suggest that Diclofenac, especially at high doses (150 mg per day) and for a long time, may be associated with a slight increase in the risk of arterial thrombosis (eg, myocardial infarction or stroke). 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 Diclofenac tablets p/o 50mg No. 10x2
INN | DICLOFENAC |
---|---|
The code | 74 900 |
Barcode | 4 810 368 009 067 |
Dosage | 50mg |
Active substance | Diclofenac |
Manufacturer | Pharmland/Golden Medical, Belarus |
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