Citropak-Darnitsa tablets No. 6

Instructions for Citropak-Darnitsa tablets No. 6

Composition

active ingredients: acetylsalicylic acid; paracetamol; caffeine;

1 tablet contains: acetylsalicylic acid 240 mg, paracetamol 180 mg, caffeine 30 mg;

Excipients: citric acid monohydrate, potato starch, povidone, calcium stearate.

Dosage form

Pills.

Main physicochemical properties: tablets of white or white with a creamy or pinkish tint, flat-cylindrical shape, with a bevel and a score.

Pharmacotherapeutic group

Analgesics and antipyretics. Acetylsalicylic acid, combinations without psycholeptics. ATX code N02B A51.

Pharmacological properties

Pharmacodynamics

Combined drug.

Due to the presence of acetylsalicylic acid and paracetamol in the tablet, the drug has anti-inflammatory, antipyretic, and analgesic effects.

The components that make up the medicine enhance each other's effects.

Acetylsalicylic acid has analgesic, antipyretic and anti-inflammatory effects, reduces pain, especially caused by the inflammatory process, and also moderately inhibits platelet aggregation and thrombus formation, and improves microcirculation in the focus of inflammation.

The antipyretic effect of acetylsalicylic acid is realized through the central nervous system by inhibiting the synthesis of PGF2 in the hypothalamus in response to the influence of endogenous pyrogens.

The analgesic effect has both peripheral and central origin: peripheral effect - inhibition of prostaglandin synthesis in inflamed tissues; central effect - influence on hypothalamic centers.

Paracetamol has analgesic, antipyretic and weak anti-inflammatory effects, which are associated with its effect on the thermoregulation center in the hypothalamus and a less pronounced ability to inhibit prostaglandin synthesis in tissues.

Caffeine increases the reflex excitability of the spinal cord, stimulates the respiratory and hemodynamic centers, dilates the blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation; reduces drowsiness, fatigue, increases mental and physical performance. Caffeine weakens the effect of hypnotics and narcotics, enhances the effect of analgesics and antipyretics.

In this combination, caffeine in a small dose has practically no stimulating effect on the central nervous system, but it helps normalize the tone of brain vessels and accelerate blood flow.

Pharmacokinetics

Acetylsalicylic acid.

Absorbed rapidly and completely after oral administration. Predominantly hydrolyzed in the gastrointestinal tract, liver and blood to salicylate, which is then metabolized mainly in the liver.

Paracetamol.

After ingestion, it is absorbed in the gastrointestinal tract, the peak concentration of paracetamol in the blood plasma is observed after 30–120 minutes. Paracetamol is metabolized in the liver and excreted mainly in the urine in the form of glucuronides and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol. The half-life is 1–4 hours. At normal therapeutic concentrations, binding to plasma proteins is insignificant, but proportional to increasing concentrations.

A side hydroxylated metabolite, which is normally formed in the liver in very small amounts and is detoxified mainly by conjugation with hepatic glutathione, can accumulate in paracetamol overdose and cause liver damage.

Caffeine.

The maximum concentration of caffeine is observed between 5 and 90 minutes after taking the drug Citropak®-Darnitsa on an empty stomach. There is no data on its presystemic metabolism. In adults, it is almost completely metabolized in the liver. The elimination rate in adults is individual. The average half-life from blood plasma is 4.9 hours with a range of 1.9–12.2 hours. Caffeine is evenly distributed in all body fluids. Binding to blood plasma proteins is on average 35%.

Caffeine is almost completely metabolized by oxidation, demethylation and acetylation and is excreted in the urine. Its main metabolites are 1-methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine (paraxanthine). Among the associated metabolites: 1-methyluracilic acid and 5-acetylamino-6-formylamino-3-methyluracil (AMFU).

There is no cross-interaction of the three active ingredients, as well as an increased risk of interaction with other drugs when using the active ingredients in combination. Due to the combination of the three active ingredients, the content of each of them is low, therefore, the toxicity of the drug is reduced.

Indication

Treatment of mild or moderate pain syndrome: headache or toothache, primary dysmenorrhea, migraine, arthralgia, neuralgia, diseases accompanied by hyperthermia of various etiologies (as an antipyretic).

Contraindication

Hypersensitivity to any of the components of the drug, hypersensitivity to other xanthine derivatives (theophylline, theobromine), other salicylates; history of bronchial asthma, urticaria or rhinitis caused by the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs; erosive-ulcerative lesions of the gastrointestinal tract (in the acute phase), gastrointestinal bleeding or perforation, as well as the presence of gastric ulcer in the past; blood diseases: hemophilia, hemorrhagic diathesis, hypoprothrombinemia, anemia, leukopenia, increased tendency to bleeding, thrombosis, thrombophlebitis, hemorrhagic diseases; severe renal or hepatic failure, portal hypertension, congenital hyperbilirubinemia, Gilbert's syndrome; glucose-6-phosphate dehydrogenase deficiency; organic diseases of the cardiovascular system (in particular, pronounced atherosclerosis), rhythm disorders, cardiac conduction disorders, paroxysmal tachycardia, severe hypertension, severe ischemic heart disease, acute myocardial infarction, decompensated heart failure, tendency to vasospasm; glaucoma, hyperthyroidism, acute pancreatitis, prostatic hypertrophy, severe forms of diabetes mellitus; use together with monoamine oxidase inhibitors (MAO) and within 2 weeks after discontinuation of MAO inhibitors, simultaneous use with tricyclic antidepressants or beta-blockers; alcoholism, epilepsy, increased excitability, sleep disorders; combined use with methotrexate at a dosage of 15 mg per week or more; surgical interventions accompanied by significant bleeding; age over 60 years.

Interaction with other medicinal products and other types of interactions

Possible types of interactions between active substances.

Acetylsalicylic acid (ASA)

Paracetamol

Caffeine

Impact on laboratory test results:

The use of high doses of acetylsalicylic acid may affect the results of several clinical chemistry laboratory tests. The use of paracetamol may affect the results of uric acid determinations when the analysis is performed using the phosphotungstic acid reagent method and the results of glycemia determinations when the analysis is performed using the glucose oxidase/peroxidase method. Caffeine may antagonize the effect of dipyridamole on myocardial blood flow and thus affect the results of this test. It is recommended to stop taking caffeine 8–12 hours before the start of this test.

Application features

Regarding paracetamol: before using the medicine, it is necessary to consult a doctor if the patient is using warfarin or similar medicines that have an anticoagulant effect, as well as in case of liver or kidney diseases.

The risk of overdose is greatest in patients with non-cirrhotic alcoholic liver disease. The drug may affect the results of laboratory tests for blood glucose and uric acid.

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 glutathione levels, the risk of metabolic acidosis is increased when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. You should consult a doctor immediately if these symptoms occur.

During treatment with the drug, it is not recommended to consume excessive amounts of beverages containing caffeine (such as coffee, tea). This may lead to sleep problems, tremors, and an unpleasant feeling behind the sternum due to palpitations.

Do not exceed the indicated doses.

Do not use the medicine with other products containing paracetamol.

If symptoms persist, you should consult a doctor.

If the headache becomes persistent, you should see a doctor.

Ibuprofen may reduce the inhibitory effect of acetylsalicylic acid on platelet aggregation. In the case of using the drug, the patient should consult a doctor before starting to take ibuprofen as an analgesic.

Medicines containing acetylsalicylic acid should not be used in children with acute respiratory viral infections (ARI), with or without fever. Some viral diseases, especially influenza A, influenza B and chickenpox, carry a risk of developing Reye's syndrome, which requires urgent medical intervention. The risk may be increased if acetylsalicylic acid is used as a concomitant medicine, 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.

Keep the medicine out of the sight and reach of children.

Ability to influence reaction speed when driving vehicles or other mechanisms

When using high doses of the drug, one should refrain from driving or operating other mechanisms due to the possibility of adverse reactions from the central nervous system (dizziness, psychomotor agitation, and impaired orientation and attention).

Use during pregnancy or breastfeeding

The medicine should not be used during pregnancy.

Acetylsalicylic acid has a teratogenic effect; when used during pregnancy in the first trimester, it leads to a malformation - cleft palate; in the third trimester - to inhibition of labor activity (inhibition of prostaglandin synthesis), closure of the ductus arteriosus in the fetus, which causes pulmonary vascular hyperplasia and hypertension in the vessels of the small circulation; impaired renal function with the possible subsequent development of renal failure with oligohydramnios; the possibility of prolongation of bleeding time, antiplatelet effect, which can occur even after the use of very low doses.

Caffeine increases the risk of spontaneous miscarriage.

Breastfeeding should be discontinued during treatment. The drug passes into breast milk, which increases the risk of bleeding in children due to impaired platelet function.

Method of administration and doses

Citropak®-Darnitsa is prescribed 1 tablet 2–3 times a day, after meals. The maximum daily dose is 6 tablets (2 tablets 3 times a day). Citropak®-Darnitsa tablets should not be taken for more than 5 days as an analgesic and more than 3 days as an antipyretic.

Do not exceed the recommended dose. Do not take with other medicines containing paracetamol.

Take each dose of the medicine with a full glass of water.

Patients with hepatic or renal insufficiency should be aware that although the effect of hepatic and renal disease on the pharmacokinetics of Citropak®-Darnitsa has not been studied, given the mechanism of action of acetylsalicylic acid and paracetamol, hepatic and renal disorders may be exacerbated. For this reason, Citropak®-Darnitsa is contraindicated in patients with severe hepatic or renal insufficiency and should be used with caution in patients with mild to moderate hepatic or renal insufficiency.

Children

The use of the drug is contraindicated in children under 16 years of age without specific indications (Kawasaki disease).

Overdose

Symptoms of overdose may occur with prolonged use of the drug or when used in doses that are many times higher than recommended.

Since Citropak®-Darnitsa is a combination drug, its overdose should be considered for each active ingredient that is part of it.

Acetylsalicylic acid.

Salicylate poisoning is usually observed at plasma concentrations > 350 mg/L (2.5 mmol/L). Most fatalities have occurred at plasma concentrations of acetylsalicylic acid > 700 mg/L (5.1 mmol/L). Single doses < 100 mg/kg body weight are unlikely to cause serious poisoning.

Symptoms of overdose. Very often, the development of such adverse reactions as nausea, vomiting, dehydration, a feeling of noise/ringing in the ears, dizziness, deafness, increased sweating, a feeling of heat in the extremities, palpitations, extrasystole and hyperventilation, impaired acid-base balance of the blood is observed. The combination of respiratory alkalosis and metabolic acidosis with a normal or increased level of arterial blood pH is observed in adults and children. Acidosis can contribute to increased transport of salicylates through the blood-brain barrier.

Less commonly, the development of adverse reactions such as vomiting with blood, hyperpyrexia, hypoglycemia, hypokalemia, thrombocytopenia, increased prothrombin time, intravascular coagulation, renal failure, pulmonary edema of non-cardiac origin is observed. The development of adverse reactions from the central nervous system is also possible: disorientation, psychomotor agitation or depression of the central nervous system, drowsiness, impaired consciousness, dizziness, tremor, hyperreflexia, convulsions and coma.

Salicylate toxicity can result from intoxication due to prolonged use of therapeutic doses or acute intoxication (when used > 100 mg/kg/day for more than 2 days), which is potentially life-threatening (from accidental ingestion by children to accidental poisoning).

Chronic salicylate poisoning may 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, sweating, nausea, vomiting, headache and depression of consciousness can be controlled by reducing the dose. Tinnitus can occur at plasma concentrations of 150 to 300 μg/ml. More serious side effects occur at concentrations > 300 μg/ml. The main feature of acute poisoning is severe acid-base imbalance, which may vary with age and severity of intoxication. The most common symptom in children is metabolic acidosis. The severity of poisoning cannot be assessed using plasma concentrations alone. The absorption of acetylsalicylic acid may be delayed due to inhibition of gastric emptying, the formation of gastric calculi or the use of enteric-coated medicinal products.

Emergency care for acetylsalicylic acid poisoning is determined by the 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 restoring electrolyte and acid-base balance.

Due to the complex pathophysiological effects of salicylate poisoning, several symptoms and laboratory changes may occur.

Mild to moderate poisoning: tachypnea, hyperventilation, respiratory alkalosis, sweating, nausea, vomiting. Laboratory data: alkalosis, alkaline urine reaction.

Severe poisoning: respiratory alkalosis with compensatory metabolic acidosis, hyperpyrexia, tinnitus, deafness. Respiratory system: from hyperventilation, noncardiogenic pulmonary edema to respiratory arrest and asphyxia; laboratory data - alkalosis, alkaline urine reaction. Cardiovascular system: from cardiac arrhythmias, hypotension to cardiac arrest. Fluid and electrolyte loss: dehydration, oliguria, renal failure. Laboratory data - hypokalemia, hypernatremia, hyponatremia, changes in renal function, prolonged prothrombin time, hypoprothrombinemia. Glucose metabolism disorders, ketosis laboratory manifestations in the form of hyperglycemia, hypoglycemia (especially in children), increased ketone bodies. Gastrointestinal tract: gastrointestinal bleeding. Blood changes: from platelet function suppression to coagulopathies.

Neurological: toxic encephalopathy and CNS depression ranging from lethargy, to depression of consciousness to coma and seizures.

Symptoms of overdose caused by paracetamol: Liver damage is possible in adults who have taken 10 g or more of paracetamol and in children who have taken > 150 mg/kg of body weight.

In patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; regular intake of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia) taking 5 g or more of paracetamol can lead to liver damage.

Symptoms of overdose. During the first 24 hours, nausea, vomiting, loss of appetite, anorexia, abdominal pain, pale skin are observed. Within 12–48 hours, liver damage, impaired glucose metabolism, and metabolic acidosis may occur. In case of a significant overdose, liver damage can cause encephalopathy, hemorrhage, hypoglycemia, cerebral edema, coma, and death. Acute renal failure with acute tubular necrosis can manifest as severe lumbar pain, hematuria, and proteinuria and develop even in the absence of severe kidney damage.

With prolonged use of the drug in large doses, the following may develop from the side of the hematopoietic organs: aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.

Treatment. In case of overdose, urgent medical attention is required. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment should begin with gastric lavage followed by activated charcoal (if the overdose was taken within 1 hour) and symptomatic therapy. The specific antidote for paracetamol overdose is N-acetylcysteine. In the absence of vomiting, the use of methionine orally or N-acetylcysteine intravenously is effective for 24 hours, but the maximum protective effect occurs when they are used within 8 hours of the overdose. The effectiveness of the antidote decreases sharply after this time. General supportive measures should also be taken. Alpha-blockers should be used if necessary.

Symptoms of overdose caused by caffeine. From the central and peripheral nervous system: increased irritability, nervousness, restlessness, insomnia, dizziness, increased emotional excitability, involuntary muscle contractions, convulsions, rapid breathing. From the gastrointestinal tract: pain in the stomach or abdomen. From the cardiovascular system: tachycardia, arrhythmia. Others: flushing of the face, frequent urination.

Treatment. Gastric lavage, in case of suppression of the vomiting reflex, ipecacuanha preparations, activated charcoal, high cleansing enema, correction of acid-base balance, plasma electrolytes, forced diuresis, oxygen therapy, hemodialysis in severe cases. Symptomatic therapy. Diazepam is used for convulsions.

In the first hours of acute poisoning, acetylcysteine is prescribed, if possible orally - at a dose of 140 mg/kg, if orally is not possible - at a dose of 150 mg/kg for the first intravenous injection, then the dose is increased to 300 mg/kg per day.

Adverse reactions

When using the drug, some patients may experience adverse reactions typical of acetylsalicylic acid, paracetamol, or caffeine drugs.

Most of the adverse reactions listed below are clearly dose-dependent and manifest themselves differently in each individual case.

Possible side effects:

	Often from ≥ 1/100 to < 1/10	Infrequently from ≥ 1/1000 to < 1/100	Single from ≥ 1/10000 to < 1/1000
Infections and infestations			Pharyngitis
From the organs of vision			Eye pain; vision impairment
From the side of the organs of hearing and vestibular apparatus		Sensation of noise/ringing in the ears
Respiratory, thoracic and mediastinal disorders			Nosebleed; hypoventilation; rhinorrhea
Gastrointestinal tract	Nausea; abdominal discomfort	Dry mouth; diarrhea; vomiting	Decreased appetite; eructation; flatulence; dysphagia; oral paresthesia; salivary hypersecretion
From the nervous system	Dizziness	Tremor; paraesthesia; headache; feeling restless	Dysgeusia; disturbance in attention; amnesia; coordination disorder; hyperesthesia; sinus headache
From the psyche	Nervousness	Insomnia	Anxiety; euphoric mood; tension
Cardiovascular system		Arrhythmia	Hyperemia; peripheral vascular disorders
Skin and subcutaneous tissue disorders			Hyperhidrosis; itching; urticaria
Musculoskeletal and connective tissue disorders			Musculoskeletal stiffness; neck pain; back pain; muscle spasms
General disorders		Increased fatigue;	General weakness; discomfort in the Specifications Characteristics Active ingredient Acetylsalicylic acid, Caffeine, Paracetamol, Citric acid Adults Can ATC code N AGENTS ACTING ON THE NERVOUS SYSTEM; N02 ANALGETICS; N02B OTHER ANALGETICS AND ANTIPYRETICS; N02B A Salicylic acid and its derivatives; N02B A51 Acetylsalicylic acid, combinations without psycholeptics Country of manufacture Ukraine Diabetics It is impossible. Drivers It is impossible. For allergies With caution For children From the age of 16 Form Tablets Method of application Inside, solid Nursing It is impossible. Pregnant It is impossible. Producer Darnytsia FF PrJSC Quantity per package 6 pcs Trade name Citropack Vacation conditions Without a prescription Reviews There are no reviews for this product. + Add review Write a review Citropak-Darnitsa tablets No. 6 My mark: Continue There are no reviews for this product, be the first to leave your review. Answers & questions Add your question and we will answer as soon as possible. + Ask a question Ask a question Add your question and we will answer as soon as possible. * Your question Continue No questions about this product, be the first and ask your question. You are watched new Hit Neomycin plus ointment 20 g In stock 0 288.62 грн. Add to Cart new Hit Sikaprotect eye drops dropper bottle 10 ml In stock 0 427.43 грн. Add to Cart new Hit Sold out Neemplast bactericidal plaster 19 mm x 72 mm No. 10 Распродано 0 43.00 грн. new Hit Boostrix suspension for injection 1 dose syringe 0.5 ml with 2 needles No. 1 In stock 0 1 052.47 грн. Add to Cart new Hit Xanthase capsules No. 30 In stock 0 680.52 грн. Add to Cart new Hit Fari Verde oral spray 1.5 mg/ml 30 ml In stock 0 411.90 грн. Add to Cart new Hit Spazmolix tablets No. 20 In stock 0 241.00 грн. Add to Cart new Hit Farmazolin with mint and eucalyptus spray nasal solution 1 mg/ml bottle 10 ml In stock 0 275.96 грн. Add to Cart new Hit Methotrexate Rompharm solution for injection 10mg/ml syringe 1 ml No. 1 In stock 0 482.20 грн. Add to Cart new Hit Beloderm ointment for external use 0.05% tube 15 g In stock 0 318.06 грн. Add to Cart 41.74 грн. Add to Cart