Dolaren tablets 50mg/325mg №12×2

Name:
Dolaren
Description:
Tablets are flat-cylindrical, with a bevel, orange color with white and dark orange patches. The main active ingredient Diclofenac + paracetamol Release form tablets 12 tablets in a blister pack made of PVC film and aluminum foil. Two blister packs, together with a leaflet, are placed in a pack of cardboard boxes. Dosage 50 mg + 325 mg Use by children Contraindicated. Fertility Dolaren may affect a woman’s fertility, so its use is not recommended for women who plan to become pregnant. Women who have difficulty conceiving or who have had an examination due to infertility should stop using Dolaren. Indications for use Short-term treatment of acute pain of mild to moderate severity: – headache (including migraine and tension headache), dental, muscular and rheumatic; – with neuralgia, back pain, dysmenorrhea, pharyngotonsillitis; – with post-traumatic and postoperative pain syndrome. Dosage and administration It is administered orally (swallow the tablet without chewing), preferably during or after a meal. Adults: Take 1 tablet orally 2 times a day. Children are contraindicated. If the next dose of the drug was missed, the next dose should be taken as soon as possible. However, if the next dose was completely missed, the next dose should not be doubled. Elderly people should be careful when using the drug Dolaren. For the elderly and for patients with low body weight, it is recommended to take the minimum effective dose. Due to the possible increased risk of cardiovascular events with long-term use or at a high dose of diclofenac, patients should take Dolaren at the lowest effective dose and take it for the shortest possible time necessary to reduce the severity of symptoms. The need for symptomatic relief in response to treatment should be periodically reassessed. Patients with significant risk factors for the development of cardiovascular complications (for example, arterial hypertension, hyperlipidemia, diabetes mellitus, smoking) should be prescribed Dolaren only after careful consideration of this possibility. Use during pregnancy and lactation It is not recommended to take the drug during pregnancy, taking the drug is possible only in extreme cases, when the possible benefit to the mother outweighs the potential risk to the fetus. It is not recommended to use the drug during breastfeeding. If it is necessary to take the drug, it is necessary to consider the possibility of not breastfeeding. Precautions Caution should be exercised in the presence of a history of blood disease or coagulation disorders, since the drug, by inhibiting the synthesis of prostaglandins, has an effect on platelets. The co-administration of Dolaren with NSAIDs, including selective COX-2 inhibitors, as well as certain other drugs that may increase the risk of bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or such as aspirin, should be avoided. Since fluid retention and edema have been reported with the use of NSAIDs, special attention should be paid to patients with impaired cardiac or renal function (including functional renal failure against the background of hypovolemia, nephrotic syndrome, lupus nephropathy and decompensated liver cirrhosis), a history of arterial hypertension , elderly patients, patients receiving concomitant therapy with diuretics or drugs that significantly affect renal function, as well as patients with a significant decrease in extracellular fluid volume for any reason, for example, before and after surgery. In such cases, monitoring of renal function is recommended as a precautionary measure. When using the drug, there is a risk of developing hyperkalemia. The drug can cause nephritis with hematuria, proteinuria and, in rare cases, nephrotic syndrome. When using the drug, serious hepatic reactions are possible, including jaundice and hepatitis. If there is a need to use the drug in violation of liver function, medical supervision is necessary. With prolonged use, it is necessary to regularly monitor liver function. Severe (some of them fatal) skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely 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. Dolaren should be discontinued at the first manifestation of skin rash, mucosal ulcers, or any other manifestations of hypersensitivity. NSAIDs may increase the risk of serious cardiovascular complications (arterial thrombosis, myocardial infarction and stroke). 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. In the case of prescribing the drug Dolaren, patients with impaired liver function require medical monitoring of their condition, since complications may worsen. During the use of the drug, as well as other NSAIDs, the level of one or more liver enzymes may increase. If violations of the functional parameters of the liver persist or increase, if complaints or symptoms develop that indicate liver disease, and also in the event that other side effects occur (for example, eosinophilia, rash, etc.), Dolaren should be canceled. It must be borne in mind that hepatitis when taking the drug can occur without prodromal phenomena. Caution should be exercised when prescribing Dolaren to patients with hepatic porphyria, as it can provoke an exacerbation. Diclofenac sodium should not be used in conjunction with diclofenac potassium. When taking non-steroidal anti-inflammatory drugs, including diclofenac sodium, it is possible to develop stomach ulcers, bleeding in the gastrointestinal tract (sometimes life-threatening), regardless of the presence or absence of previous symptoms. For patients prone to irritation of the gastrointestinal tract (especially with a history of diseases such as stomach ulcers, melena, diverticulosis, ulcerative colitis or other inflammatory process), diclofenac sodium is recommended to be taken under medical supervision. Clinical studies and data from epidemiological studies indicate that the use of diclofenac increases the risk of thrombotic complications (for example, myocardial infarction or stroke), especially with long-term use or at high doses (150 mg per day). Paracetamol should be used with caution in patients with hepatic impairment. In chronic alcoholism, therapeutic doses of paracetamol can cause hepatotoxicity and severe liver failure. In case of development of allergic reactions to paracetamol, it is recommended to stop taking the drug. Driving and working with moving mechanisms During the period of taking the drug, it is recommended to refrain from driving and work that requires increased attention. Interaction with other drugs When taken together with aspirin, the concentration of diclofenac in serum may decrease, the bioavailability of aspirin decreases. When used together, diclofenac may increase plasma concentrations of digoxin. Plasma lithium concentrations increase with the combined use of diclofenac sodium and lithium preparations. When taking hypoglycemic drugs simultaneously with diclofenac sodium, hypoglycemic and hyperglycemic reactions are possible, so the dose of hypoglycemic drugs should be reviewed. NSAIDs may increase the effect of anticoagulants. There is evidence of an increased risk of bleeding with the simultaneous use of diclofenac sodium, paracetamol and anticoagulants, such as warfarin (see section “Precautions”). Careful monitoring of such patients is recommended. Antithrombotic agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding. Diuretics and antihypertensive agents: concomitant use of Dolaren with diuretics and antihypertensive agents (eg, beta-blockers, ACE inhibitors) may lead to a decrease in their antihypertensive effect. Thus, such a combination should be used with caution, and patients, especially the elderly, should be closely monitored for blood pressure. Patients should be adequately hydrated, and monitoring of renal function is also recommended after initiation of concomitant therapy and regularly thereafter, especially when diuretics and ACE inhibitors are used due to an increased risk of nephrotoxicity. Concomitant treatment with potassium preparations may be associated with an increase in the level of potassium in the blood serum, which requires patients to stay under constant supervision. The combined use of diclofenac sodium and corticosteroids may increase the risk and increase side effects. The combined use of diclofenac sodium and other non-steroidal anti-inflammatory drugs may increase the risk of side effects. Taking diclofenac sodium less than 24 hours before or 24 hours after taking methotrexate can increase the concentration of the latter in the blood and increase its toxicity. With the joint use of diclofenac sodium and cyclosporine, the nephrotoxicity of cyclosporine increases. There are cases of seizures with the combined use of non-steroidal anti-inflammatory drugs, including diclofenac, and quinolone antibacterial drugs. Diclofenac sodium may reduce the antihypertensive effect of propranol and other β-blockers. Paracetamol slightly affects the hypoprothrombinemic properties of warfarin. Anticonvulsants (barbiturates, carbamazepine, phenytoin): acceleration of the process of converting acitaminophen into hepatotoxic metabolites; increased risk of hepatotoxicity. Anticoagulants, oral: possible increase in prothrombin time. Aspirin: no inhibition of the antiplatelet action of acetylsalicylic acid. Isoniazid: possible increased risk of hepatotoxicity. Phenothiazines: Possible increased risk of severe hypothermia. With the simultaneous appointment of chlorzoxazone and antipsychotics, an increase in the depressive effect on the central nervous system may be observed. Phenytoin: when taken together, it is recommended to monitor the concentration of phenytoin in the blood plasma due to its possible increase. Cholestyramine and colestipol: Co-administration of diclofenac and cholestyramine or colestipol reduces the absorption of diclofenac. Thus, Dolaren is recommended to be taken one hour before and 4-6 hours after taking cholestyramine or colestipol. Potent CYP2C9 inhibitors: Caution is advised when prescribing Dolaren in conjunction with potent CYP2C9 inhibitors, as this can lead to a significant increase in the maximum diclofenac plasma concentrations due to inhibition of the metabolism of diclofenac. It is not recommended to drink alcohol during the period of drug use. Contraindications Hypersensitivity to any of the components of the drug; history of hypersensitivity to acetylsalicylic acid and other NSAIDs (including asthma attacks, angioedema, urticaria or rhinitis); bleeding disorders, leukopenia, anemia, deficiency of glucose-6-phosphate dehydrogenase; recent diseases of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, enteritis, ulcerative colitis, acute porphyria; liver failure; pregnancy, breastfeeding; childhood; severe heart failure; impaired renal function; intensive therapy with diuretics; active bleeding; hemorrhagic diathesis; concomitant treatment with anticoagulants; previous gastrointestinal bleeding or perforation of the gastrointestinal tract associated with the use of non-steroidal anti-inflammatory drugs; congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease. Composition Each tablet contains: active ingredients: diclofenac sodium granules (enteric-coated) – 50.0 mg, paracetamol – 325.0 mg; excipients: corn starch, purified talc, magnesium stearate, sodium starch glycolate type A, gelatin, microcrystalline cellulose, orange yellow dye (E 110). Overdose Diclofenac sodium: Treatment of acute poisoning with NSAIDs consists primarily of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment are necessary to manage complications such as hypotension, renal failure, convulsions, gastrointestinal disturbances, and respiratory depression. Special measures, such as forced diuresis, dialysis or hemoperfusion, cannot guarantee the elimination of NSAIDs due to their high binding to plasma proteins and intensive metabolism. Paracetamol: Treatment of overdose – immediate hospitalization; before starting treatment, as soon as possible after an overdose, a blood sample is necessary to determine the concentration of paracetamol in plasma, since the symptoms may not correspond to the severity of the overdose. Treatment with activated charcoal is possible within 1 hour after an overdose. The use of N-acetylcysteine for the treatment of overdose within 24 hours of overdose, including intravenous or oral administration of an antidote. The introduction of N-acetylcysteine is most effective within 8 hours after dosing. Side effects Diclofenac sodium: Adverse reactions are classified according to the frequency of occurrence: often (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10 000, < 1/1000) , very rare (< 1/10 000), including single messages. From the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis. From the immune system: rarely - hypersensitivity reaction, 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. 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, disorders of the esophagus, diaphragm-like structures of the intestine, pancreatitis. From the hepatobiliary system: often - an increased level of transaminases; rarely - hepatitis, jaundice, liver disorders; very 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. Paracetamol: - cyanosis, methemoglobinemia, sulfhemoglobinemia, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, uric and erythematous skin reactions, fever, hypoglycemia, CNS stimulation, jaundice, glossitis, dizziness. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 4 years. Do not use after the expiry date stated on the packaging. 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