Upsarin UPSA with vit.C tab.ship.330mg/200mg in tubes No. 10 in pack No. 1

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Upsarin UPSA With vit.C tab.ship.330mg/200mg in tubes No. 10 in pack No. 1
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White tablets with bevelled edges and a notch for division, dissolve in water with an effervescent reaction. Main active ingredient Acetylsalicylic acid Dosage 330 mg/200 mg in tubes No. 10 in pack No. 1 Pharmacological action Analgesics and antipyretics. Acetylsalicylic acid in combination with other drugs. Code ATX:N02BA01. Pharmacodynamics Acetylsalicylic acid belongs to the group of non-steroidal anti-inflammatory drugs and has analgesic, antipyretic and anti-inflammatory properties. The mechanism of its action is due to the irreversible inhibition of cyclooxygenase enzymes involved in the synthesis of prostaglandin. Acetylsalicylic acid inhibits platelet aggregation by blocking the synthesis of thromboxane A2 in platelets. Ascorbic acid, which is part of the preparation, is involved in the regulation of redox processes, reduces vascular permeability and increases the body’s resistance to infections. Pharmacokinetics Acetylsalicylic acid is rapidly absorbed after oral administration. Peak plasma concentrations are reached in 15-40 minutes. Acetylsalicylic acid undergoes rapid hydrolysis to form an active metabolite, salicylic acid. Bioavailability depends on the dose and is 60% for doses less than 500 mg and 90% for doses over 1 g. Acetylsalicylic acid and salicylic acid are rapidly distributed to all tissues. Penetrate through the placental barrier and enter the mother’s milk. Salicylic acid is largely bound to plasma proteins (90%). The plasma half-life is 15-20 minutes for acetylsalicylic acid and 2-4 hours for salicylic acid. Acetylsalicylic acid is largely metabolized in the liver, excreted mainly in the urine in the form of salicylic acid and glucuronic conjugates. Ascorbic acid is well absorbed in the digestive tract. If its intake exceeds the required amount, the excess is excreted in the urine. Indications for use Symptomatic treatment of mild to moderate pain and/or feverish conditions. Method of administration and doses For oral administration. Dissolve the tablet completely in a large glass of water and drink immediately. This form of release is intended for adults and children over 15 years of age. Adults and children weighing more than 50 kg (approximately 15 years of age and older): The maximum recommended daily dose is 3 g of aspirin, i.e. 9 effervescent tablets per day. A single dose is 2 effervescent tablets of 330 mg. If necessary, the dose can be repeated at intervals of at least 4 hours, without exceeding a dose of 9 effervescent tablets per day. Special patient groups Elderly patients The recommended maximum daily dose for the elderly is 2 g of aspirin, i.e. 6 effervescent tablets per day. A single dose is 1 effervescent tablet of 330 mg. If necessary, the dose can be repeated after an interval of at least 4 hours. In case of more intense pain or fever, a dose of 2 x 330 mg effervescent tablets can be taken, which, if necessary, can be repeated at intervals of at least 4 hours, without exceeding a dose of 6 effervescent tablets per day. Children The use of the drug is possible on the recommendation of a doctor and in the case when other measures are not enough (see section “Precautions”). Patients with impaired liver and kidney function It is necessary to conduct enhanced monitoring of treatment in cases of renal or hepatic insufficiency, as well as in cases of use in combination with other drugs (see Sections “Contraindications”, “Interaction with other drugs”, “Precautions” ). Frequency of Dosing Regular dosing helps avoid fluctuations in pain or fever. In children, a regular interval between doses, both day and night, should be observed, preferably 6 hours, but not less than 4 hours; the above doses should be observed. In adults, the interval between doses should be at least 4 hours. The duration of treatment (without consulting a doctor) should not exceed 5 days when prescribed as an anesthetic and not more than 3 days as an antipyretic. Use during pregnancy and lactation The drug is intended for adults and children over 15 years of age. However, if it is used under exceptional circumstances in women of reproductive age, the following must be remembered: as a rule, acetylsalicylic acid should not be prescribed during pregnancy. Pregnancy Doses of acetylsalicylic acid below 100 mg daily may be safe in very limited obstetric applications requiring specialized monitoring. Doses of acetylsalicylic acid in the range of 100-500 mg per day – clinical experience with doses in the range of 100-500 mg per day is insufficient. Therefore, the recommendations for doses greater than 500 mg per day apply to these doses. Doses of acetylsalicylic acid? 500 mg a day – prostaglandin synthesis may affect the development of pregnancy and / or the development of the embryo or fetus. Except when absolutely necessary, acetylsalicylic acid should not be used in women who are planning a pregnancy or in women who are less than six months pregnant (five completed months). The lowest possible dose should be used for the shortest period of treatment. After 24 weeks of pregnancy, all inhibitors of prostaglandin synthesis can cause the following in the fetus: cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios. At the end of pregnancy, the mother and newborn may experience: prolongation of bleeding time due to antiplatelet action, which can occur even after administration of very small doses of the drug; a decrease in uterine contractions, leading to a prolonged pregnancy or a longer period of childbirth. Acetylsalicylic acid is contraindicated after 24 weeks of amenorrhea (5 completed months). Lactation Since acetylsalicylic acid is excreted in breast milk, it is not recommended to use this drug during breastfeeding. Precautions To avoid the risk of overdose when combined with other drugs, you should make sure that other drugs do not contain acetylsalicylic acid. With prolonged use of large doses of painkillers, headache may occur, which should not be treated by further increasing the dose of the drug. Regular use of painkillers, especially in combination, can cause permanent kidney damage with a risk of kidney failure. Children with symptoms of viral infections (in particular, chicken pox, influenza-like illnesses) who received acetylsalicylic acid showed signs of Reye’s syndrome, a very rare pathology that poses a threat to life. Therefore, in children, the use of the drug is possible only on the recommendation of a doctor and in the case when other measures are not enough. With the appearance of persistent vomiting, impaired consciousness, abnormal behavior, treatment should be stopped immediately. In some cases of severe deficiency of glucose-6-phosphate dehydrogenase, high doses of acetylsalicylic acid can cause hemolysis. In cases of insufficiency of glucose-6-phosphate dehydrogenase, acetylsalicylic acid should be taken under medical supervision. It is necessary to conduct enhanced monitoring of treatment in the following cases: the presence of gastrointestinal ulcers in history, gastrointestinal bleeding or gastritis; kidney or liver failure; Asthma: In some individuals, an asthma attack may be due to an allergy to NSAIDs or acetylsalicylic acid. In such cases, this drug is contraindicated. metrorrhagia or menorrhagia (risk of increased menstrual bleeding and prolongation of menstruation); Gastrointestinal bleeding or ulcers/perforations are possible, including a history. The relative risk is increased in the elderly, people with low body weight and in patients receiving anticoagulant or antiplatelet therapy (see section “Interaction with other drugs”). If gastrointestinal bleeding occurs, treatment with the drug should be stopped immediately. Given the antiplatelet effect of acetylsalicylic acid, which is manifested at the lowest doses and persists for several days, patients should be warned about the risk of bleeding that may occur during surgical interventions (for example, tooth extraction). Acetylsalicylic acid reverses uricemia (an analgesic dose of acetylsalicylic acid increases uricemia by inhibiting uric acid excretion). The use of this drug is not recommended during lactation. 1 effervescent tablet contains 485 mg of sodium, which should be considered in patients on a strict sodium restricted diet. Since ascorbic acid has a stimulating effect, the drug is not recommended to be taken at the end of the day. Interactions with other drugs Risks associated with inhibition of platelet aggregation The combined use of several drugs that can inhibit platelet aggregation: abciximab, acetylsalicylic acid, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost trometamol, tirofiban and ticlopidine, increases the risk of bleeding. When antiplatelet drugs are combined with heparin or oral anticoagulants and thrombolytics, careful clinical and laboratory monitoring should be carried out. Combinations that are contraindicated (see section “Contraindications”) + Oral anticoagulants: for anti-inflammatory doses (? 1 g per dose and / or ? 3 g per day) or analgesic or antipyretic doses (? 500 mg per dose and / or < 3 g per day) of acetylsalicylic acid and in case of gastric and duodenal ulcers in history. There is an increased risk of bleeding, especially in the case of a history of gastric and duodenal ulcers. + Methotrexate used at doses greater than 20 mg/week: for anti-inflammatory doses (? 1 g per dose and/or ? 3 g per day) or for analgesic and antipyretic doses (? 500 mg per dose and/or <3 g per day) per day) acetylsalicylic acid. Increased toxicity of methotrexate, especially hematological toxicity (decrease in renal clearance of methotrexate under the influence of anti-inflammatory drugs). Combinations that are not recommended (see Precautions section) + Oral anticoagulants: for analgesic and antipyretic doses (? 500 mg per dose and / or <3 g per day) of acetylsalicylic acid and without the presence of gastric and duodenal ulcers in anamnesis. Increased risk of bleeding. + Oral anticoagulants: for antiplatelet doses (50 mg - 375 mg per day) of acetylsalicylic acid and in case of a history of gastric and duodenal ulcers. Increased risk of bleeding, especially in the case of a history of gastric and duodenal ulcers. Bleeding time should be controlled. + Nonsteroidal anti-inflammatory drugs: for anti-inflammatory doses (? 1 g per dose and / or ? 3 g per day) or analgesic or antipyretic doses (? 500 mg per dose and / or < 3 g per day) of acetylsalicylic acid. Increased risk of ulcer formation and gastrointestinal bleeding. + Clopidogrel (outside the indication validated for this combination in the acute phase of the coronary syndrome): increased risk of bleeding due to additive action against platelet aggregation. + Glucocorticoids (with the exception of hydrocortisone in replacement therapy): for anti-inflammatory doses (? 1 g per dose and / or ? 3 g per day). Increased risk of bleeding. + LMW heparins (and similar drugs) and unfractionated heparins, therapeutic doses and/or the elderly: for anti-inflammatory doses (? 1 g per dose and/or ? 3 g per day) or analgesic or antipyretic doses (? 500 mg per day) intake and / or < 3 g per day) of acetylsalicylic acid. Increased risk of bleeding (inhibition of platelet function) and irritation of the gastroduodenal mucosa by acetylsalicylic acid. The use of other anti-inflammatory, analgesic or antipyretic drugs is recommended. + Pemetrexed: in patients with mild or moderate renal impairment (creatinine clearance 45 ml / min. - 80 ml / min.), there is a risk of increased toxicity of pemetrexed (decrease in renal clearance in combination with anti-inflammatory doses of acetylsalicylic acid, i.e. ? 1 g per dose and/or ≥ 3 g per day). + Ticlopidine: increased risk of bleeding due to additive action against platelet aggregation. If the combination cannot be avoided, careful clinical observation is required. + Uricosuric agents (benzbromatone, probenecid): reduced uricosuric effect due to competition for the excretion of uric acid in the renal tubules. Combinations to be used with caution + Clopidogrel (within the indication validated for this combination in the acute phase of the coronary syndrome): increased risk of bleeding due to additive action against platelet aggregation. Careful clinical monitoring. + Diuretics, angiotensin-converting enzyme inhibitors and, by extrapolation, angiotensin II receptor inhibitors: for anti-inflammatory doses (? 1 g per dose and / or ? 3 g per day) or pain-relieving or antipyretic doses (? 500 mg per dose and / or < 3 g per day) acetylsalicylic acid: acute renal failure in patients with dehydration (reduced glomerular filtration due to reduced synthesis of renal prostaglandins). In addition, the antihypertensive effect is reduced. It is necessary to ensure the flow of fluid into the patient's body and monitor kidney function at the beginning of treatment. + Methotrexate used at doses ? 20 mg/week: for anti-inflammatory doses (? 1 g per dose and/or ? 3 g per day) or analgesic or antipyretic doses (? 500 mg per dose and/or < 3 g per day) of acetylsalicylic acid: increased methotrexate toxicity , especially hematological toxicity (decrease in renal clearance of methotrexate under the influence of an anti-inflammatory agent). A complete blood count should be performed weekly during the first weeks of combination therapy. Particular attention is required for any, even a slight, violation of kidney function, as well as in the elderly. + Methotrexate used at doses ? 20 mg / week: for antiplatelet doses (50 mg - 375 mg per day) of acetylsalicylic acid: increased methotrexate toxicity, especially hematological toxicity (decrease in renal clearance of methotrexate under the influence of an anti-inflammatory drug). A complete blood count should be performed weekly during the first weeks of combination therapy. Particular attention is required for any, even a slight, violation of kidney function, as well as in the elderly. + Pemetrexed: in patients with normal renal function, there is a risk of increased toxicity of pemetrexed (decrease in renal clearance in combination with anti-inflammatory doses of acetylsalicylic acid, i.e. ? 1 g per dose and / or ? 3 g per day). Laboratory monitoring of kidney function. + Local gastrointestinal preparations, antacids and charcoal: reduced gastrointestinal absorption of acetylsalicylic acid. An interval (at least 2 hours) should be observed between taking local gastrointestinal drugs, antacids or charcoal and acetylsalicylic acid Combinations to watch out for + Oral anticoagulants: for antiplatelet doses (50 mg - 375 mg per day) of acetylsalicylic acid. Increased risk of bleeding, especially in the case of gastric and duodenal ulcers. + Non-steroidal anti-inflammatory drugs: for antiplatelet doses (50 mg - 375 mg per day) of acetylsalicylic acid. Increased risk of ulcers and gastrointestinal bleeding. + Glucocorticoids (with the exception of hydrocortisone in replacement therapy): for analgesic or antipyretic doses (? 500 mg per dose and / or ? 3 g per day) of acetylsalicylic acid. Increased risk of bleeding. + Low molecular weight heparins (and similar drugs) and unfractionated heparins, therapeutic doses and / or the elderly: for antiplatelet doses (50 mg - 375 mg per day) of acetylsalicylic acid. Increased risk of bleeding (inhibition of platelet function) and irritation of the gastroduodenal mucosa by acetylsalicylic acid. + Low molecular weight heparins (and similar drugs) and unfractionated heparins, prophylactic doses: the concomitant use of drugs that affect different levels of hemostasis increases the risk of bleeding. Therefore, in patients under 65 years of age, the combination of heparins at prophylactic doses (low molecular weight heparins and similar drugs or unfractionated heparins) and acetylsalicylic acid should be considered and monitored through clinical observation and laboratory monitoring. + Selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluoxamine, paroxetine, sertraline), thrombolytics: increased risk of bleeding. Contraindications Hypersensitivity to acetylsalicylic acid or to any of the excipients, asthma provoked by the intake of salicylates or substances with similar activity, in particular NSAIDs, in history, pregnancy over 24 weeks at doses of more than 100 mg per day, lactation period, acute gastrointestinal intestinal ulcers, any constitutional or acquired hemorrhagic disease, risk of hemorrhage, severe hepatic and renal failure, severe, uncontrolled heart failure, combination with methotrexate at doses greater than 20 mg/week (see section "Interaction with other medicinal products"), and for anti-inflammatory doses (? 1 g per dose and/or ? 3 g per day), or for analgesic or antipyretic doses (? 500 mg per dose and/or < 3 g per day) of acetylsalicylic acid, combination with oral anticoagulants for anti-inflammatory doses (? 1g per dose and/or ? 3 g per day), or for analgesic or antipyretic doses (? 500 mg and/or < 3 g daily) of acetylsalicylic acid and in patients with a history of gastric and duodenal ulcers (see section 4.4). Section "interaction with other drugs"), children under 15 years of age, the use of the drug is not recommended during lactation. Composition 1 tablet contains active substances: acetylsalicylic acid 330 mg, ascorbic acid 200 mg, excipients: glycine, anhydrous citric acid, sodium benzoate, sodium bicarbonate, povidone. OverdoseAssociated with acetylsalicylic acid There is a risk of poisoning in the elderly and especially in young children, which can be life-threatening. Symptoms: - Moderate poisoning: ringing in the ears, feeling of hearing loss, headaches, vertigo. They can be controlled by dose reduction. - Severe poisoning: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, circulatory failure, respiratory failure, severe hypoglycemia. In children, overdose can be fatal at 100 mg/kg or more at one time. Treatment: -Immediate hospitalization, excretion of the drug: gastric lavage and activated charcoal, control of acid-base balance to urine pH 7.5-8, alkaline diuresis. In severe poisoning, hemodialysis is indicated. - Symptomatic treatment. Related to ascorbic acid When taking vitamin C at a dose of ? 2 g/day, ascorbic acid may interfere with the following biological tests: determination of creatinine and glucose in blood and urine (control of diabetes mellitus with a glucose oxidase test). When taking vitamin C at a dose of ? 3 g/day, there is a risk of hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency. Side effectsAssociated with acetylsalicylic acid Gastrointestinal disorders abdominal pain, severe (bloody vomiting, bloody stools, etc.) or latent gastrointestinal bleeding causing iron deficiency anemia, ulcers and perforations of the stomach. Violations of the central nervous system headaches, vertigo, a feeling of hearing loss, ringing in the ears, which may indicate an overdose. Blood disorders - hemorrhagic syndromes (nosebleeds, gum bleeding, purpura, etc.) with increased bleeding time. This effect persists for 4-8 days after discontinuation of acetylsalicylic acid. This may cause a risk of bleeding in patients undergoing surgery. Hypersensitivity reactions - urticaria, skin reactions, anaphylactic reactions, asthma, Quincke's edema. Reye's syndrome (see section "Precautions"). Related to ascorbic acid At a dose of more than 1 g / day, it is possible: digestive disorders (burning sensation in the stomach, diarrhea), urinary tract disorders (formation of oxalate, cystine and / or urate stones). Storage conditionsStore in a dry place at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life 2 years. Do not use after the expiration date. Buy Upsarin UPSA with vit. C tab.ship. No. 1 Instructions for use for Upsarin UPSA with vit. C tab.ship. 330mg / 200mg in tubes No. 10 in pack No. 1