Citramonum maksi-Darnitsa

General characteristics. Structure:

Active ingredients: paracetamol, acetylsalicylic acid, caffeine;

1 tablet contains paracetamol 325 mg, acetylsalicylic acid of 160 mg, caffeine of 65 mg;

excipients: starch prezhelatinizirovanny, povidone, cellulose microcrystallic, croscarmellose sodium, silicon dioxide colloid anhydrous, calcium stearate.

Pharmacological properties:

Maxi's Citramonum – the combined drug. Acetylsalicylic acid has febrifugal and antiinflammatory effect, reduces the pain which is especially caused by inflammatory process and also suppresses aggregation of thrombocytes and a thrombogenesis, improves microcirculation in the inflammation center.

Paracetamol renders the analgeziruyushchy, febrifugal and very weak antiinflammatory action connected with its influence on the center of thermal control in a hypothalamus and poorly expressed ability to inhibit synthesis of prostaglandins in peripheral fabrics.

Caffeine increases reflex irritability of a spinal cord, excites the respiratory and vasomotor centers, expands blood vessels of bone muscles, a brain, heart, kidneys, reduces aggregation of thrombocytes; reduces drowsiness, feeling of fatigue, increases intellectual and physical effeciency. In this combination caffeine in a small dose has practically no the stimulating influence on TsNS, but contributes to normalization of a tone of vessels of a brain and acceleration of a blood-groove.

The combination of acetylsalicylic acid and paracetamol exponentiates analgetichesky effect of a combination in the ratio 1:4 to initial level. Both analgetichesky, and antipyretic effects of acetylsalicylic acid and paracetamol increase at accession to a caffeine combination.

Indications to use:

Symptomatic treatment of a pain syndrome of various origin: head or a dentagra, pain at primary dysmenorrhea; migraine, an arthralgia, a mialgiya, neuralgia, especially diseases of an inflammatory origin (a frontal sinusitis, antritis), rheumatic diseases, diseases which are followed by a hyperthermia of various etiology (as an antipyretic).

Route of administration and doses:

Drug is appointed to adults and children 15 years on 1-2 tablets to 3 times a day are more senior.

The maximum daily dose for adults and children is more senior than 15 years makes 6 tablets. The pill Maxi's Citramonum should be taken inside, without chewing, plentifully washing down with water or dissolving in a small amount of water. Administration of drug after food slows down the beginning of effect of medicine.

It is not necessary to accept drug more than 5 days as anesthetic and more than 3 days – as an antipyretic without appointment and observation of the doctor.

Features of use:

Appropriate security measures at use.

The reception of analgetics which became a habit is dangerous as it can do irreparable harm to health.

Without appointment of the doctor drug should be used only for elimination of acute pain syndromes.

It is necessary to avoid frequent and prolonged use of drug to the people sick with a diabetes mellitus, alcoholism, with dehydration (severe dehydration of an organism, for example, after diarrhea, influence of high temperature of the environment, excessive exercise stresses which are followed by strong sweating), with a renal failure, with chronic disturbance of arterial pressure.

Prolonged use of anesthetics in high doses without observation of the doctor can lead to a headache, fatigue, nervousness, disturbance of the autonomic nervous system, and also to be followed by muscle pain. At the sharp termination of reception of analgetics similar symptoms disappear within several days. Until then resuming of reception of anesthetics is forbidden. Also resuming of administration of drug without consultation with the doctor is not allowed.

At the patients suffering from a hyperthyroidism, use of analgetics is allowed only after consultation of the doctor.

Owing to febrifugal effect of drug perhaps wrong improvement of the state of health. If necessary it is necessary to consult with the doctor.

At use of drug before an operative measure it is necessary to consult with the doctor (stomatologist) or to inform him.

At the patients having asthma and/or hypersensitivity (allergy), such reactions to nonsteroid antirheumatic means as hypostasis of mucous membranes, local skin reactions happen more often than at other patients. It, generally, concerns also other patients suffering from hypersensitivity (allergy).

Acetylsalicylic acid reduces removal of uric acid. At patients with gout under certain circumstances the attack can develop.

Instruction! Not to apply analgetics a long time or in the raised doses without consultation with the doctor.

Use during pregnancy or feeding by a breast.

Drug is contraindicated during pregnancy and feeding by a breast.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

Drug can influence the neuromuscular transmission speed in this connection at treatment by drug it is worth refraining from control of motor transport and from work with dangerous mechanisms.

Children.

Drug is contraindicated to children aged up to 15 years because of risk of development of a syndrome Reja at a hyperthermia against the background of viral diseases (a hyper pyrexia, a metabolic acidosis, disturbance from a nervous system and mentality, vomiting, an abnormal liver function). There are no sufficient data concerning use of drug for children aged up to 15 years.

Side effects:

At use of drug for certain patients the side reactions characteristic of drugs of acetylsalicylic acid, paracetamol or caffeine can be observed.

From a digestive tract: gastrointestinal frustration: dyspepsia, nausea, vomiting, heartburn, pain in epigastric area and abdominal pain; in some cases – an inflammation and erosive cankers of a digestive tract which sometimes involve gastrointestinal hemorrhages and perforation; seldom – a tranzitorny liver failure with increase in level of transaminases of a liver; гепатонекроз (dozozavisimy effect);

from bodies of a hemopoiesis: a leukopenia, an agranulocytosis, hemolitic anemia, a methemoglobinemia, a sulfhemoglobinemia, at prolonged use in high doses – aplastic anemia, a pancytopenia, a neutropenia, a leukopenia, thrombocytopenia; hemorrhages which can lead to acute and chronic posthemorrhagic anemia / an iron deficiency anemia (as a result of the so-called latent microbleeding) with the corresponding laboratory manifestations and clinical symptoms, such as an adynamy, pallor of an integument, hypoperfusion;

from immune system: at patients with individual hypersensitivity to salicylates development of allergic reactions of skin, including such symptoms as a dermahemia, feeling of heat, a rash, urticaria, hypostasis, an itch, a Quincke's disease is possible. At patients with bronchial asthma increase in frequency of emergence of a bronchospasm is possible; allergic reactions from insignificant to moderate degree, potentially affecting skin, the airways, digestive tract and cardiovascular system which are shown in the form of rashes, a small tortoiseshell, hypostasis, an itch, not cardiogenic fluid lungs; very seldom – heavy reactions, including an acute anaphylaxis;

from skin and hypodermic cellulose: multiformny exudative erythema (including Stephens-Johnson's syndrome), toxic epidermal necrolysis (Lyell's disease);

from the central and peripheral nervous system: tremor, nervousness, concern; dizziness and a ring in ears, a vision disorder which can demonstrate overdose, sleeplessness, a hyperexcitability, orientation disturbance;

from urinogenital system (at reception of high doses): nephrotoxicity (renal colic, intersticial nephrite, papillary necrosis);

from cardiovascular system: short-term tachycardia and increase in arterial pressure, arrhythmia, heart consciousness;

from endocrine system: a hypoglycemia up to a hypoglycemic coma;

from system of a blood coagulation: as a result of antiagregantny action on thrombocytes acetylsalicylic acid can increase risk of development of bleedings. Such bleedings as intraoperative hemorrhages, hematomas, bleedings of bodies of urinogenital system, nasal bleedings, bleedings of gums were observed; seldom or very seldom – serious bleedings, such as hemorrhages of digestive tract, brain (especially at patients with uncontrollable arterial hypertension and/or at simultaneous use of anti-hemostatics) which in single cases could threaten life potentially.

Interaction with other medicines:

The methotrexate – at the combined use with salicylates in a dose of 15 mg/week and more raises hematologic toxicity of a methotrexate owing to decrease in renal clearance of a methotrexate by antiinflammatory agents and its replacement from communication with plasma proteins. Therefore such combination is contraindicated.

MAO inhibitors – at the combined use with caffeine perhaps dangerous increase in arterial pressure. Therefore such combination is contraindicated.

Peroral anticoagulants – at the combined use with acetylsalicylic acid in a dose higher than 3 g/days anticoagulants are forced out from bonds with proteins of a blood plasma. Therefore such combination is contraindicated.

Combinations which need to be applied with care.

Acetylsalicylic acid.

Allopyrinolum, anti-hypertensive means, antidepressants, antikholinesterazny means, hormonal contraceptives, griseofulvin, digitoxin, doxycycline, Sulfinpyrazonum, are oestrogenic – at the combined use with acetylsalicylic acid the effect of the above-stated medicines is weakened.

Peroral anti-diabetic drugs of group of derivatives of sulphonylurea, insulin, uricosuric means (except a benzobromaron, a probenetsid), penicillin, antiagregant, anticoagulants, fibrinolitik – at the combined use with acetylsalicylic acid effect of above-mentioned medicines amplifies. The risk of development of bleedings increases.

Raufolfiya alkaloids, propranolol, phenobarbital, antacids – at the combined use with acetylsalicylic acid the effect of the last is weakened.
Phenytoinum, valproic acid – at the combined use with acetylsalicylic acid amplifies effect of both drugs and toxicity of valproic acid as a result of replacement of the last from communication with plasma proteins increases.

Non-steroidal anti-inflammatory drugs (NPVS) – at the combined use with high doses of acetylsalicylic acid the risk of developing of ulcers and gastrointestinal bleedings increases.

System glucocorticoids – at the combined use with acetylsalicylic acid the risk of development of gastrointestinal bleeding increases. Also simultaneous use of glucocorticoids (except a hydrocortisone) and acetylsalicylic acid leads to decrease in level of the last in blood and to increase in risk of overdose after the end of treatment.

Alcohol – at the combined use with acetylsalicylic acid increases injury of a mucous membrane of digestive tract and increases bleeding duration as a result of the additive effect.

Selective serotonin reuptake inhibitors, levamisole – at the combined use with acetylsalicylic acid the risk of developing of gastrointestinal bleedings as a result of possible synergistic action increases.

Antihistaminic drugs, буметанид, ascorbic acid in high doses – at the combined use with acetylsalicylic acid increases risk of development of side effects of the last.

The zidovudine – at the combined use with acetylsalicylic acid amplifies toxicity of both drugs.

Gold drugs – at the combined use with acetylsalicylic acid the probability of damage of kidneys increases.

The ibuprofen – at the combined use with acetylsalicylic acid is suppressed ability of the last to irreversible inhibition of thrombocytes. Therefore treatment by an ibuprofen of the patients having risk of cardiovascular diseases can limit cardiotyre-tread effect of acetylsalicylic acid.

APF inhibitors – at the combined use with high doses of acetylsalicylic acid renal filtering due to oppression of prostaglandins having vasodilating effect decreases and hypotensive action decreases.

Opioid analgetics, anxiolytics, hypnotic drugs, sedative and psychotropic drugs – at the combined use with acetylsalicylic acid dangerous block is possible. Effects of opioid analgetics amplify.

The methotrexate which is applied in a dose of less than 15 mg/week – at the combined use with acetylsalicylic acid raises haemo toxic effect of a methotrexate as a result of decrease in renal clearance of a methotrexate antiinflammatory drugs in general and its replacement from communication with proteins of a blood plasma which contact salicylates.

Digoxin – at the combined use with acetylsalicylic acid concentration of digoxin in plasma raises as a result of decrease in renal excretion.

Barbiturates – at the combined use with acetylsalicylic acid concentration of barbiturates in blood as a result of their replacement from communication with proteins of a blood plasma increases.

Natrii hydrocarbonas – at the combined use with acetylsalicylic acid amplifies renal clearance of the last.

Diuretics – at the combined use with high doses of acetylsalicylic acid filtering of balls owing to decrease in synthesis of prostaglandins in kidneys decreases.

Paracetamol.

M-holinoblokatory, the methotrexate, indirect anticoagulants – at the combined use with paracetamol amplifies effect of the above-stated medicines.

Spironolactonum, Sulfinpyrazonum – at the combined use with paracetamol is weakened effect of the above-stated drugs.

Analgetics – at the combined use with paracetamol the analgetic effect amplifies.

Psychotropic drugs, narcotic analgetics – at the combined use with paracetamol the narcotic effect amplifies.

Antidepressants – at the combined use with paracetamol sedation amplifies.

Peroral hypoglycemic means, insulin – at the combined use with paracetamol the hypoglycemic effect amplifies.

Antihistamines – at the combined use with paracetamol by patients with an abnormal liver function dangerous block is possible.

Organic nitrates – at the combined use with paracetamol perhaps strong falling of arterial pressure.

Nonsteroid antiinflammatory medicines, salicylates – at the combined use with paracetamol the risk of developing of stomach ulcer and bleeding increases; prolonged use increases risk of development of a toxic nephropathy, and also development of cancer diseases of kidneys and a bladder.

Corticosteroids of systemic action – at the combined use with paracetamol action of corticosteroids amplifies, the probability of an ulcerogenic and hepatotoxic action increases, the risk of developing of gastrointestinal bleedings amplifies.

Barbiturates – at the combined use with paracetamol the risk of toxic influence on a liver increases and effect of paracetamol is weakened.

Alkogolsoderzhashchy drugs and drinks, isoniazid, carbamazepine, Primidonum, Sulfinpyrazonum, Phenytoinum, ритонавир, the drugs alkalinizing urine, antiepileptic means, rifampicin, hepatotoxic means – at the combined use with paracetamol toxic influence on a liver considerably amplifies.

Metoclopramidum, домперидон – at simultaneous use with paracetamol increases the speed of absorption of the last.

Holestiramin, antacids – at simultaneous use with paracetamol the speed and extent of absorption of the last decreases.

Tetracyclines – at simultaneous use with paracetamol absorption of tetracyclines worsens.

Bisulfan – at the combined use with paracetamol decrease in clearance of a bisulfan is possible.

Chloramphenicol – at the combined use with paracetamol time of removal of chloramphenicol increases by 5 times.

Caffeine.

Derivatives of xanthine, alpha and beta-adrenergic agonists, psychogogic  means, thyritropic means, analgetics antipyretics – at the combined use with caffeine amplify effects of the above-stated medicines.

Opioid analgetics, anxiolytics, hypnotic drugs and sedatives – at the combined use with caffeine the effect of the above-stated medicines is weakened.

Cimetidinum, hormonal contraceptives, isoniazid – at the combined use with caffeine amplifies action of the last.

Holestiramin, cholinolytics, antidepressants, β-adrenoblockers, alkaline    substances – at the combined use with caffeine weakening of action of the last is possible.

Ciprofloxacin, эноксацин, norfloxacin, ofloxacin, erythromycin, antiarrhytmic drugs (мексилетин) – at the combined use with caffeine raises risk of toxic action of the last owing to decrease in clearance of caffeine.

Ergotamine – at the combined use with caffeine improves absorption of ergotamine from digestive tract.

Lithium drugs – at the combined use with caffeine concentration of lithium in blood decreases.

Contraindications:

Hypersensitivity to components of drug and other non-steroidal anti-inflammatory drugs (NPVS).

Acute round ulcers of a stomach and duodenum, gastrointestinal bleedings in the anamnesis, acute pancreatitis.

The bronchial asthma caused by use of salicylates or NPVS in the anamnesis.

Disturbances in system of a blood coagulation: hemorrhagic diseases (hemophilia, hemorrhagic diathesis).

Oppression of a marrowy hemopoiesis (leukopenia, anemia, including hemolitic), acute hematoporphyria.

The expressed liver and/or renal failure.

Deficit glyukozo-6-fosfatdegidrogenazy.

Combination with a methotrexate in a dosage of 15 mg/week or more (see the section "Interaction with Other Medicines and Other Types of Interactions").

Combination with monoamine oxidase inhibitors (MAO) and within 2 weeks after phase-out of MAO inhibitors (see the section "Interaction with Other Medicines and Other Types of Interactions").

Hyperexcitability, sleeplessness, thrombosis, thrombophlebitis, epilepsy, hyperthyroidism, arterial hypertension, atherosclerosis, organic diseases of cardiovascular system, dekompensirovanny heart failure, disturbance of cordial conductivity, coronary heart disease, prostatauxe, severe forms of a diabetes mellitus, advanced age, glaucoma (in connection with existence in a caffeine tablet).

Overdose:

Symptoms of overdose can be shown at prolonged use of drug or in the doses many times exceeding recommended.

The overdose symptoms caused by acetylsalicylic acid.

Toxicity of salicylates can be result of intoxication as a result of prolonged use of therapeutic doses or acute intoxication (at use> 100 mg/kg/days more than two days) that potentially threatens life (from an accidental proglatyvaniye children to accidental poisoning).

Chronic poisoning with salicylates can pass asymptomatically as has no specific symptoms. Intoxication salicylates of moderate severity or a salitsilizm usually develop only after repeated use of high doses.

Symptoms of chronic poisoning: dizziness, a sonitus, deafness, the increased perspiration, nausea, vomiting, a headache and oppression of consciousness can be controlled by a dose decline. The sonitus can arise at plasma concentration from 150 to 300 mkg/ml. Heavier side effects arise at concentration over 300 mkg/ml.

The main feature of acute poisoning is heavy disturbance of acid-base balance which can differ with age and weight of intoxication. The most widespread sign at children is the metabolic acidosis. Weight of poisoning cannot be estimated, using only data of plasma concentration. Absorption of acetylsalicylic acid can be slowed down as a result of braking of gastric emptying, formation of concrements in a stomach or as a result of use of the drugs covered with an enterosolyubiliziruyushchy cover.

Symptoms of acute poisoning easy and moderate severity: a tachypnea, a hyperventilation, a respiratory alkalosis, the increased perspiration, nausea, vomiting. Datas of laboratory: alkalosis, alkali reaction of urine.

Symptoms of acute poisoning of heavy degree: a respiratory alkalosis with a compensatory metabolic acidosis, a hyper pyrexia, feeling of a sonitus, deafness. Respiratory system: from a hyperventilation, not cardiogenic fluid lungs to an apnoea and asphyxia; datas of laboratory – an alkalosis, alkali reaction of urine. Cardiovascular system: from disturbances of a cordial rhythm, arterial hypotension to a cardiac standstill. Loss of liquid and electrolytes: dehydration, oliguria, renal failure. Datas of laboratory – a hypopotassemia, a hypernatremia, a hyponatremia, change of function of kidneys. Disturbance of exchange of glucose, a ketosis is laboratory shown in the form of a hyperglycemia, a hypoglycemia (especially at children), increases in level of ketonic bodies. Digestive tract: gastrointestinal bleedings. Changes from blood: from suppression of function of thrombocytes to coagulopathies. Datas of laboratory – lengthening of a prothrombin time, a prothrombinopenia. Neurologic: toxic encephalopathy and oppression of TsNS from slackness, oppressions of consciousness to a coma and an attack of spasms.

Treatment. Acute management at poisoning with acetylsalicylic acid is defined by severity, a stage and clinical symptoms and answers standard methods of providing acute management at poisonings. First-priority measures have to be allocated for removal acceleration of medicine, and also resuming of electrolytic and acid-base balance.

The overdose symptoms caused by paracetamol.

Symptoms: pallor of skin, anorexia, nausea, vomiting, an abdominal pain, the increased sweating, psychomotor excitement or oppression of the central nervous system, drowsiness, consciousness disturbance, disturbance of a cordial rhythm, tachycardia, premature ventricular contraction, a tremor, a hyperreflexia, spasms, increase in a prothrombin ratio, increase in activity of "hepatic" transaminases, гепатонекроз, an acute renal failure, are also possible disturbance of metabolism of glucose and a metabolic acidosis. Symptoms of damage of a liver are observed in 12-48 hours after overdose. At a serious poisoning the liver failure can progress and lead to development of toxic encephalopathy with consciousness disturbance, in some cases – with a lethal outcome. Damage of a liver is possible at adults who accepted 10 g and more paracetamol, and at children who accepted more than 150 mg/kg of body weight. The acute renal failure with an acute necrosis of tubules can develop even in the absence of severe damage of kidneys.

Treatment. A gastric lavage with further use of absorbent carbon, symptomatic therapy. Methionine use orally or Acetylcysteinum intravenously is effective within 48 hours after overdose. Also all-supporting measures are necessary. If necessary it is necessary to apply alpha adrenoblockers. A specific antidote at paracetamol overdose – Acetylcysteinum.

The overdose symptoms caused by caffeine.

Symptoms: excitement, dizziness, the accelerated breath, vomiting, trembling, spasms, premature ventricular contraction.

Treatment. A gastric lavage, repeated purpose of absorbent carbon, the forced alkaline diuresis, an oxygenotherapy, a hemodialysis in hard cases, infusion of liquid and electrolytes, symptomatic therapy. At spasms apply diazepam.

Storage conditions:

Period of validity. 2 years. Not to apply after the termination of the period of validity specified on packaging. To store in the place, unavailable to children, in original packaging at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

On 6 tablets in a blister strip packaging, on 1, 2 or 20 blister strip packagings in a pack.