INSTRUCTION
for medical use of the medicinal product
CITRAMON - GIFT
(SITRAMON-DARNITSA)
Storage:
active substances: acetylsalicylic acid, paracetamol, caffeine;
1 tablet contains: acetylsalicylic acid 240 mg, paracetamol 180 mg, caffeine 30 mg;
excipients: citric acid monohydrate, potato starch, povidone, cocoa, calcium stearate.
Medicinal form. Tablets.
Main physico-chemical properties: tablets of light brown color with inclusions, flat-cylindrical shape with a bevel and a line, with the smell of cocoa.
Pharmacotherapeutic group. Analgesics and antipyretics. Acetylsalicylic acid, combinations without psycholeptics. ATX code N02B A51.
Pharmacological properties.
Pharmacodynamics.
The drug has an analgesic, antipyretic and anti-inflammatory effect. The components that make up the medicinal product enhance each other's effects.
The antipyretic effect of acetylsalicylic acid is realized through the central nervous system by inhibiting the synthesis of RGF2 in the hypothalamus in response to the influence of endogenous pyrogens. Analgesic effect has both peripheral and central origin: peripheral effect – inhibition of synthesis of prostaglandins of inflamed tissues; the central effect is the effect on the centers of the hypothalamus. Acetylsalicylic acid also reduces platelet aggregation.
Paracetamol has an analgesic, antipyretic and very weak anti-inflammatory effect, which is associated with its effect on the center of thermoregulation in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins in peripheral tissues.
Caffeine stimulates the central nervous system. Caffeine increases positive conditioned reflexes, stimulates motor activity, weakens the effect of sleeping pills and narcotic substances, enhances the effect of analgesics and antipyretics.
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indication.
Therapy of mild or moderate pain syndrome in headache or toothache, primary dysmenorrhea, migraine, arthralgia, neuralgia, diseases accompanied by hyperthermia of various etiologies (as an antipyretic).
Contraindication.
Hypersensitivity to the components of the drug, other salicylates; severe disorders of liver and/or kidney function, congenital hyperbilirubinemia, Gilbert's syndrome, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, hemophilia, hemorrhagic diathesis, severe anemia, leukopenia, thrombosis, thrombophlebitis, hemorrhagic diseases, acute peptic ulcers, a state of increased agitation, sleep disturbances, severe arterial hypertension, organic diseases of the cardiovascular system (including atherosclerosis), angle-closure glaucoma, epilepsy, hyperthyroidism, decompensated heart failure, cardiac conduction disorders, severe atherosclerosis, tendency to vasospasm, coronary heart disease, acute pancreatitis, hypertrophy of the prostate gland, severe forms of diabetes, bronchial asthma caused by the use of salicylates, in the anamnesis, old age.
Do not use together with monoamine oxidase (MAO) inhibitors and within 2 weeks after discontinuation of MAO inhibitors; contraindicated in patients taking tricyclic antidepressants, b-blockers; a combination with methotrexate at a dose of 15 mg/week or more is contraindicated (see "Interaction with other medicinal products and other types of interactions").
Interaction with other medicinal products and other types of interactions.
Paracetamol
Metoclopramide and domperidone can increase the rate of absorption of paracetamol, and cholestyramine can decrease it. Anticoagulant effect of warfarin and other coumarins can increase with simultaneous long-term use of paracetamol, which increases the risk of bleeding. Barbiturates reduce the antipyretic effect of paracetamol. Anticonvulsant drugs (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of microsomal liver enzymes, can increase the toxic effect of paracetamol on the liver due to an increase in the degree of transformation of the drug into hepatotoxic metabolites. The simultaneous use of paracetamol with hepatotoxic drugs increases the toxic effect of drugs on the liver.
Simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome. Paracetamol reduces the effectiveness of diuretics. Do not use simultaneously with alcohol.
Caution should be exercised when paracetamol is co-administered with flucloxacillin, as such co-administration is associated with metabolic acidosis with a high anion gap, especially in patients with risk factors (see section "Particulars of use").
Caffeine
The simultaneous use of caffeine with MAO inhibitors can cause a dangerous increase in blood pressure. Caffeine increases the effect (improves bioavailability) of analgesics-antipyretics, potentiates the effects of xanthine derivatives, a- and b-adrenomimetics, psychostimulants. Cimetidine, hormonal contraceptives, isoniazid enhance the effect of caffeine. Caffeine reduces the effect of opioids analgesics, anxiolytics, hypnotics and sedatives, is an antagonist of anesthetics and other drugs that suppress the central nervous system, a competitive antagonist of adenosine drugs, ATP. With the simultaneous use of caffeine and ergotamine, the absorption of ergotamine from the gastrointestinal tract improves, with thyroid-stimulating agents - their effect increases. Caffeine reduces the concentration of lithium in the blood.
Acetylsalicylic acid
Contraindicated combinations.
The use of methotrexate in doses of 15 mg/week and more increases the hematological toxicity of methotrexate (reduction of renal clearance of methotrexate by anti-inflammatory agents and displacement of methotrexate from the connection with plasma proteins by salicylates).
Combinations that should be used with caution.
Simultaneous use of ibuprofen interferes with the irreversible inhibition of platelets by acetylsalicylic acid. Ibuprofen treatment of patients at risk of cardiovascular disease may limit the cardioprotective effect of acetylsalicylic acid. With the simultaneous use of acetylsalicylic acid and anticoagulants, the risk of bleeding increases. With the simultaneous use of high doses of salicylates with NSAIDs (due to mutual strengthening of the effect), the risk of ulcers and gastrointestinal bleeding increases. Simultaneous use with uricosuric agents, such as benzobromarone, probenecid, reduces the effect of uric acid removal (due to competition with the removal of uric acid by the renal tubules). With simultaneous use with digoxin, the concentration of the latter in the blood plasma increases due to a decrease in renal excretion. With the simultaneous use of high doses of acetylsalicylic acid and oral antidiabetic drugs of the group of sulfonylurea derivatives or insulin, the hypoglycemic effect of the latter is enhanced due to the hypoglycemic effect of acetylsalicylic acid and the displacement of sulfonylurea bound to plasma proteins. Diuretics in combination with high doses of acetylsalicylic acid reduce glomerular filtration due to a reduction in the synthesis of prostaglandins in the kidneys. Systemic glucocorticosteroids (except hydrocortisone), which are used for replacement therapy in Addison's disease, reduce the level of salicylates in the blood during treatment with corticosteroids and increase the risk of overdose after the end of treatment. When used with corticosteroids, the risk of gastrointestinal bleeding increases. Acetylsalicylic acid enhances the effect of phenytoin. Angiotensin-converting enzyme (ACE) in combination with high doses of acetylsalicylic acid causes a decrease in glomerular filtration due to inhibition of vasodilator prostaglandins and a decrease in the antihypertensive effect. When used simultaneously with valproic acid, acetylsalicylic acid displaces it from binding to plasma proteins, increasing the latter's toxicity. When used with selective serotonin reuptake inhibitors, the risk of gastrointestinal bleeding increases due to a possible synergistic effect. Ethyl alcohol promotes damage to the mucous membrane of the gastrointestinal tract and prolongs the bleeding time due to the synergism of acetylsalicylic acid and alcohol.
Features of application.
In patients with allergic complications, including bronchial asthma, allergic rhinitis, urticaria, skin itching, edema of the mucous membrane and nasal pollinosis, as well as in their combination with chronic respiratory tract infections and in patients with hypersensitivity to NSAIDs during treatment the drug may cause bronchospasm or an attack of bronchial asthma.
During surgical operations (including dental), the use of drugs containing acetylsalicylic acid can increase the likelihood of bleeding.
Use with caution for the treatment of patients with liver and kidney diseases, with erosive-ulcerative lesions and bleeding of the gastrointestinal tract in the anamnesis, with increased bleeding or with simultaneous anti-inflammatory therapy.
Acetylsalicylic acid, which is part of the medicine, even in small doses, reduces the excretion of uric acid from the body, which can cause an acute attack of gout in sensitive patients.
It is not recommended to use the medicine without consulting a doctor for more than 5 days as an analgesic and for more than 3 days as an antipyretic.
In case of impaired kidney and liver function, the interval between doses should be at least 8 hours.
During treatment, it is necessary to refrain from drinking alcohol. With long-term use, it is necessary to control the blood coagulation system and the level of hemoglobin.
During treatment, it is not recommended to consume an excessive amount of drinks that contain caffeine (such as coffee, tea). This can cause sleep problems, tremors, discomfort behind the sternum due to palpitations.
Paracetamol
Before using the drug, it is necessary to consult a doctor if the patient uses warfarin or similar drugs that have an anticoagulant effect. The risk of overdose is greatest in patients with non-cirrhotic alcoholic liver disease. The drug can affect the results of laboratory studies of glucose and uric acid in the blood.
Patients who take analgesics every day for mild arthritis should consult a doctor. In patients with severe infections, such as sepsis, which are accompanied by a decrease in the level of glutathione, the risk of metabolic acidosis increases when taking paracetamol. Symptoms of metabolic acidosis are deep, accelerated or difficult breathing, nausea, vomiting, loss of appetite. You should consult a doctor immediately if these symptoms appear.
Caution should be exercised when paracetamol is used concurrently with flucloxacillin due to the increased risk of metabolic acidosis with a high anion gap, especially in patients with severe renal failure, sepsis, malnutrition or other causes of glutathione deficiency (e.g. chronic alcoholism), and if maximum doses are used. daily doses of paracetamol. Careful monitoring, including measurement of urinary 5-oxoproline levels, is recommended.
Do not exceed the indicated doses. Do not take the medicine with other means containing paracetamol.
If the symptoms do not disappear, it is necessary to consult a doctor.
If the headache becomes constant, you should consult a doctor.
Keep the medicine out of the sight of children and in a place inaccessible to children.
Acetylsalicylic acid
Use with caution in case of hypersensitivity to analgesic, anti-inflammatory, anti-rheumatic agents, with simultaneous use of anticoagulants, in patients with circulatory disorders (for example, renal vascular pathology, congestive heart failure, hypovolemia, extensive operations, sepsis or severe bleeding), since acetylsalicylic acid can also increase risk of impaired kidney function and acute renal failure. Ibuprofen can reduce the inhibitory effect of acetylsalicylic acid on platelet aggregation. In the case of using a medicinal product, before starting to take ibuprofen as a pain reliever, the patient should consult a doctor.
Use during pregnancy or breastfeeding.
The drug is not used during pregnancy or breastfeeding.
The ability to influence the speed of reaction when driving vehicles or other mechanisms.
When using high doses of the drug, one should refrain from driving vehicles or working with other mechanisms due to possible side effects from the nervous system (dizziness, increased excitability, impaired orientation and attention).
Method of application and dosage.
The drug is prescribed to adults for 1 tablet 2-3 times a day after meals. The maximum daily dose of the drug is 6 tablets (in 3 doses). Citramon-Darnytsia tablets should not be taken for more than 5 days as an analgesic and for more than 3 days as an antipyretic.
Do not exceed the recommended dose.
Do not take together with other medicines containing paracetamol.
Children.
Medicinal products containing acetylsalicylic acid should not be used in children with acute respiratory viral infection (ARVI) with or without fever. With some viral diseases, especially influenza A, influenza B and chicken pox, there is a risk of developing Reye's syndrome, which requires immediate medical intervention. The risk may be increased if acetylsalicylic acid is used as a concomitant medication, but a causal relationship in this case has not been proven. If these conditions are accompanied by prolonged vomiting, this may be a sign of Reye's syndrome. Taking into account the above reasons, the use of the drug is contraindicated for children without special indications (Kawasaki's disease).
Overdose.
Symptoms of overdose may appear with long-term use of the drug or with use in doses many times higher than recommended.
Symptoms of an overdose due to acetylsalicylic acid.
Toxicity of salicylates can occur due to prolonged use of therapeutic doses or acute intoxication with use > 100 mg/kg/day for more than 2 days (accidental ingestion by children or accidental overdose), potentially life-threatening. Chronic poisoning with salicylates can be asymptomatic, as it has no specific symptoms. Moderate salicylate intoxication, or salicylism, usually develops only after repeated use of high doses.
Symptoms: Dizziness, tinnitus, deafness, increased sweating, nausea, vomiting, headache and depression - can be controlled by reducing the dose. Tinnitus may occur at blood plasma concentrations of 150 to 300 μg/ml. More severe side effects occur at a concentration of pon
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ad 300 μg/ml. The main feature of acute poisoning is a severe disturbance of the acid-alkaline balance, which may vary depending on the age of the patient and the severity of intoxication. Metabolic acidosis is a common symptom in children. The severity of poisoning cannot be assessed only by the concentration in the blood plasma. The absorption of acetylsalicylic acid can be slowed down due to inhibition of gastric emptying, the formation of calculi in the stomach, or due to the use of drugs covered with an enteric coating.
Emergency care for acetylsalicylic acid poisoning is determined by the degree of severity, stage and clinical symptoms and corresponds to standard methods of providing emergency care for poisoning. Primary measures should be aimed at accelerating the elimination of the drug, as well as at restoring the electrolyte and acid-base balance. As a result of the complex pathophysiological effects of salicylate poisoning, some symptoms and laboratory changes may occur.
Mild and moderate poisoning: tachypnea, hyperventilation, respiratory alkalosis, increased sweating, nausea, vomiting. Laboratory data: alkalosis, alkaline reaction of urine.
Severe poisoning: respiratory alkalosis with compensatory metabolic acidosis, hyperpyrexia, tinnitus, deafness. Respiratory system: from hyperventilation, non-cardiogenic pulmonary edema to respiratory arrest and asphyxia; laboratory data: alkalosis, alkaline reaction of urine. Cardiovascular system: from heart rhythm disorders, arterial hypotension to cardiac arrest. Loss of fluid and electrolytes: dehydration, oliguria, renal failure. Laboratory data: hypokalemia, hypernatremia, hyponatremia, impaired renal function. Violations of glucose metabolism, ketosis are manifested in the laboratory in the form of hyperglycemia, hypoglycemia (especially in children), an increase in the level of ketone bodies. Gastrointestinal tract: gastrointestinal bleeding. From the side of the blood: from inhibition of platelet function to coagulopathy. Laboratory data: prolongation of prothrombin time, hypoprothrombinemia. Neurological: toxic encephalopathy and depression of the central nervous system from lethargy, depression of consciousness to coma and convulsions.
Symptoms of overdose in the first 24 hours caused by paracetamol: pale skin, loss of appetite, anorexia, nausea, vomiting, abdominal pain, hepatonecrosis, increased activity of liver transaminases, increased prothrombin index. Symptoms of liver damage are observed 12-48 hours after an overdose. Glucose metabolism disorders and metabolic acidosis may occur. With severe poisoning, liver failure can progress and lead to the development of toxic encephalopathy with impaired consciousness, hemorrhages, hypoglycemia, coma, in some cases - with a fatal outcome. Acute renal failure with acute tubular necrosis can be manifested by severe lumbar pain, hematuria, proteinuria and can develop even in the absence of severe kidney damage. Cardiac arrhythmia and pancreatitis were also noted.
With long-term use of the drug in large doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop on the part of hematopoietic organs. When taking large doses from the side of the central nervous system, dizziness, psychomotor agitation and disorientation are possible; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).
Liver damage is possible in adults who have taken 10 g or more of paracetamol, and in children who have taken more than 150 mg/kg of body weight. In patients with risk factors (long-term use of carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; alcohol abuse; insufficiency of the glutathione system, for example: digestive disorders, HIV infection, starvation, cystic fibrosis, cachexia ) taking 5 g or more of paracetamol can cause liver damage.
In case of overdose, urgent medical assistance is required. The patient should be taken to the hospital immediately, even if there are no early symptoms of overdose.
In case of overdose, nausea, vomiting, increased sweating, psychomotor excitement or depression of the central nervous system, drowsiness, impaired consciousness, heart rhythm disturbances, tachycardia, extrasystole, tremor, hyperreflexia, convulsions may be observed, or the severity of overdose or the risk of organ damage may not be reflected. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after intake (earlier determinations of the concentration are unreliable).
Treatment: gastric lavage followed by the use of activated charcoal (if an excessive dose of paracetamol was taken within 1 hour), symptomatic therapy. A specific antidote for paracetamol overdose is N-acetylcysteine. In the absence of vomiting, it is possible to use methionine orally or N-acetylcysteine intravenously, which is effective for 24 hours, but the maximum protective effect occurs when use within 8 hours after an overdose. The effectiveness of the antidote decreases sharply after this time. It is also necessary to take general support measures. If necessary, a-adrenoblockers should be used.
Overdose symptoms caused by caffeine: excitement, dizziness, rapid breathing, vomiting, tremors, convulsions, extrasystole.
Treatment: gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, oxygen therapy, hemodialysis in severe cases, fluid and electrolyte infusion. Symptomatic therapy. Diazepam should be used for convulsions.
Adverse reactions.
From the respiratory system, organs of the chest and mediastinum: rhinitis, nasal congestion, bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.
From the gastrointestinal tract: dyspeptic disorders, including nausea, vomiting, discomfort and pain in the epigastrium, heartburn, abdominal pain; inflammation of the gastrointestinal tract, erosive-ulcerative lesions of the gastrointestinal tract, which can in some cases cause gastrointestinal bleeding and perforations with corresponding laboratory and clinical manifestations.
From the side of the liver and biliary tract: impaired liver function, increased activity of liver enzymes, as a rule, without the development of jaundice, hepatonecrosis (dose-dependent effect).
From the side of metabolism, hypoglycemia, up to hypoglycemic coma.
From the side of the nervous system: headache, dizziness, tremors, paresthesias, excitement, sleep disturbances, insomnia, general weakness, ringing in the ears.
On the part of the psyche: a feeling of fear, restlessness, anxiety, irritability.
From the cardiovascular system: tachycardia, arrhythmia, palpitations, arterial hypertension.
From the side of the blood and lymphatic system: thrombocytopenia, agranulocytosis, bruising and bleeding, anemia, sulfate hemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart area), hemolytic anemia, due to the antiaggregant effect on platelets, acetylsalicylic acid can increase the risk of bleeding. Bleeding events such as intraoperative hemorrhages, hematomas, genitourinary bleeding, epistaxis, gingival bleeding, gastrointestinal bleeding, and cerebral hemorrhage have been observed.
From the side of the immune system: hypersensitivity reactions, including anaphylaxis, anaphylactic shock.
From the side of the skin and subcutaneous tissue: skin itching, rash on the skin and mucous membranes, including generalized and erythematous rashes; urticaria, angioedema, exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
General disorders: bleeding can lead to acute and chronic posthemorrhagic anemia/iron deficiency anemia (due to the so-called hidden microbleeding) with corresponding laboratory manifestations and clinical symptoms, such as asthenia, pallor of the skin, hypoperfusion; non-cardiogenic pulmonary edema.
Expiration date. 3 years.
Do not use the medicine after the expiration date indicated on the package.
Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C. Keep out of the reach of children.
Packaging.
6 or 10 tablets in contour blister packs; 6 or 10 tablets in a contoured envelope, 1 contoured envelope in a pack; 10 tablets in a contour blister pack, 6 or 12 contour blister packs in a pack.
Leave category. Without a prescription.
Producer. PrJSC "Pharmaceutical firm "Darnytsia".
The location of the manufacturer and its address of the place of business.
Ukraine, 02093, Kyiv, st. Boryspilska, 13.
