Citramon P - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline - 102.5 mg, croscarmellose sodium-24.8 mg; povidone-K25 - 18.6 mg; citric acid monohydrate 6.0 mg; cocoa bean powder - 15.0 mg; magnesium stearate-3.1 mg.

Description:Tabletki light-brown color with impregnations, round flat-cylindrical shape, with a risk on one side and a chamfer on both sides, with a characteristic odor.

Pharmacotherapeutic group:analgesic agent combined (NSAIDs + analgesic non-narcotic remedy + psychostimulant)

ATX: & nbsp

N.02.B.A.51 Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Combined drug containing acetylsalicylic acid, caffeine and paracetamol.

Acetylsalicylic acid has antipyretic and anti-inflammatory effect, relieves pain, especially caused by the inflammatory process, and also inhibits platelet aggregation and thrombosis, improves microcirculation in the inflammatory focus.

Caffeine increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, dilates the blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation; reduces drowsiness, a feeling of fatigue, increases mental and physical performance. In this combination caffeine in a small dose practically does not have a stimulating effect on the central nervous system, but it increases the tone of cerebral vessels and promotes the acceleration of blood flow.

Paracetamol has analgesic, antipyretic and extremely weak anti-inflammatory effect, which is associated with its influence on the center of thermoregulation in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins (Pg) in peripheral tissues.

Pharmacokinetics:

Acetylsalicylic acid

At intake the absorption is complete.During absorption is subjected to presystemic elimination in the intestinal wall and systemic - in the liver (deacetylated). Quickly hydrolyzed by cholinesterases and albumin esterase, therefore the half-life is no more than 15-20 minutes.

In the body it circulates (75-90% in association with albumin) and is distributed in tissues as an anion of salicylic acid. Time to reach the maximum concentration - 2 hours Metabolized mainly in the liver with the formation of 4 metabolites, found in many tissues and urine.

It is excreted mainly by active secretion in the renal tubules in the form of salicylate (60%) and its metabolites. Removal of unchanged salicylate depends on the pH of urine (urine alkalinization increases the ionization of salicylates, their reabsorption deteriorates and the excretion increases significantly). The rate of excretion depends on the dose: when taking small doses, the half-life period is 2-3 hours, with an increase in the dose may increase to 15-30 hours. In newborns, the elimination of salicylates is much slower than in adults.

Caffeine

When ingested absorption is good, occurs throughout the intestine.Absorption occurs mainly due to lipophilicity, and not water solubility.

The time to reach the maximum concentration is 50-75 minutes after ingestion, the maximum concentration is 1.6-1.8 mg / l. Quickly distributed in all organs and tissues of the body; easily penetrates the blood-brain barrier and the placenta. The volume of distribution in adults is 0,4-0,6 l / kg, in newborns - 0,78-0,92 l / kg. Communication with blood proteins (albumins) is 25-36%.

More than 90% is metabolized in the liver, in children of the first years of life up to - 10-15%. In adults, about 80% of the dose of caffeine is metabolized to paraxanthin, about 10% to theobromine and about 4% to theophylline. These compounds are subsequently demethylated into monomethylxanthines, and then into methylated uric acids.

The half-life in adults is 3.9-5.3 hours (sometimes up to 10 hours). The excretion of caffeine and its metabolites is carried out by the kidneys (in the unchanged form in adults, 1-2% is excreted).

Paracetamol

Absorption is high, the maximum concentration is reached after 0.5-2 h; the maximum concentration is 5-20 μg / ml. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier. Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk.The therapeutic effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg.

Metabolised in the liver (90-95%): 80% enters the conjugation reaction with the formation of inactive glucuronides and sulfates; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isozymes CYP2E1, CYP1A2 and, to a lesser extent, the isoenzyme CYP3A4 also participate in the metabolism of the preparation.

The half-life is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, less than 5% unchanged. In elderly patients, the clearance of the drug decreases and the half-life increases.

Indications:

Pain syndrome of mild and moderate severity (of various origins): headache, migraine, toothache, neuralgia, myalgia, arthralgia, algodismenorea.

Feverish syndrome: with acute respiratory infections, influenza.

Contraindications:

- Hypersensitivity to the main or auxiliary components of the drug;

- erosive and ulcerative lesions of the gastrointestinal tract (at phase exacerbations),

- gastrointestinal bleeding or perforation, peptic ulcer in anamnesis;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in anamnesis);

- hemophilia and other disorders of blood clotting;

- hemorrhagic diathesis, hypoprothrombinemia;

- avitaminosis K;

- portal hypertension;

- severe renal or hepatic insufficiency;

- chronic heart failure III-IV functional class for NYHA;

- arterial hypertension III degree;

- pregnancy and the period of breastfeeding;

- glaucoma;

- deficiency of glucose-6-phosphate dehydrogenase;

- increased nervous excitability, sleep disturbance;

- surgical interventions, accompanied by heavy bleeding;

- Children under 15 years of age as an anesthetic, with febrile syndrome - up to 18 years;

- simultaneous reception of methotrexate in a dose of more than 15 mg / week.

Carefully:

Renal or hepatic insufficiency of mild and moderate degree, elderly age, gout, alcoholism, epilepsy and propensity to convulsive seizures, chronic heart failure I-II functional class for NYHAischemic heart disease, cerebrovascular disease, peripheral arterial disease, smoking, chronic obstructive pulmonary disease, concomitant use of methotrexate in a dose of less than 15 mg / week, concomitant anticoagulant therapy, advanced age, concomitant use with nonsteroidal anti-inflammatory drugs, glucocorticosteroids, anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors.

Pregnancy and lactation:

Application during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

Adults

Inside (during or after a meal with plenty of water after taking each dose).

With headache the recommended dose of 1-2 tablets, in the case of severe headache, the next dose after 4-6 hours.

With migraine the recommended dose of 2 tablets when symptoms appear, if necessary, repeated intake after 4-6 hours. For treatment of headache and migraine, the drug is used no more than 4 days.

With pain syndrome - 1-2 tablets; the average daily dose is 3-4 tablets, the maximum daily dose is 8 tablets.The drug should not be taken more than 5 days as an analgesic and more than 3 days - as an antipyretic.

Elderly (over 65 years of age)

Care should be taken in elderly patients, especially with low body weight.

Patients with hepatic and renal insufficiency

The effect of impaired liver or kidney function on the pharmacokinetics of the drug has not been studied. Given the mechanism of action of acetylsalicylic acid and paracetamol, their use can aggravate renal or hepatic insufficiency. In this regard, the drug is contraindicated in patients with severe hepatic or renal insufficiency (see the section "Contraindications"), and for hepatic and renal failure of mild to moderate degree, it should be used with caution.

Side effects:

Many of these unwanted reactions are clearly dose-dependent and vary from patient to patient.

The frequency of adverse drug reactions is classified according to the recommendations of the World Health Organization.

System-Organ Classes for MedDRA	Often ≥1 / 100 to <1/10	Infrequently ≥1 / 1000 to <1/100	Rarely ≥1 / 10,000 to <1/1000
Infections and invasions			Pharyngitis
Metabolic and nutritional disorders			Decreased appetite
Mental disorders	Nervousness	Insomnia	Anxiety, euphoric mood, internal tension
From the nervous system	Dizziness	Tremor, paresthesia, headache	Anxiety disorder, attention disorder, amnesia, impaired coordination of movement, hyperesthesia, pain in the area of the paranasal sinuses
From the side of the organ of vision			Visual impairment
From the side of the hearing organ		Noise in ears
From the side of the cardiovascular system		Arrhythmia
From the side of the vessels			Hyperemia, peripheral circulatory disorders
On the part of the respiratory system, the organs of the thorax and the mediastinum			Nasal bleeding, hypoventilation, rhinorrhea
From the digestive system	Nausea, abdominal discomfort	Dry mouth, diarrhea, vomiting	Belching, flatulence, dysphagia, paresthesia in the mouth, increased salivation
From the skin and subcutaneous tissues			Hyperhidrosis, itching, hives
From the musculoskeletal system			Musculoskeletal stiffness, neck pain, back pain, muscle spasms
Are common disorders		Fatigue, increased excitability	Asthenia, heaviness in the chest
Other		Increase heart rate

Post-registration data

System-Organ Class
From the immune system	Hypersensitivity
Mental disorders	Anxiety
From the nervous system	Migraine, drowsiness
From the skin and subcutaneous tissues	Erythema. rash, angioedema, erythema multiforme
From the side of the cardiovascular system	Heart palpitations
From the side of the vessels	Reduction of blood pressure
On the part of the respiratory system, the organs of the thorax and the mediastinum	Shortness of breath, bronchospasm
From the digestive system	Pain in epigastrium, dyspepsia, abdominal pain, gastrointestinal bleeding (including from the upper parts of the gastrointestinal tract, bleeding from the stomach, from the stomach ulcer, from the duodenal ulcer, from the rectum), erosive-ulcerative lesions of the gastrointestinal tract, intestinal tract (including gastric ulcer, duodenum, colon, peptic ulcer)
From the liver and biliary tract	Liver failure
Common violations	Malaise, discomfort

Data on the enhancement or expansion of the spectrum of adverse events of individual components when applied in combination in accordance with the instructions for use are not available.

Increased risk of bleeding after taking acetylsalicylic acid persists for 4-8 days. Very rarely, there may be severe bleeding (eg, cerebral hemorrhage), especially in patients with untreated hypertension and (or) with simultaneous use of anticoagulants, in some cases life threatening.

Overdose:

Acetylsalicylic acid

With mild intoxication - dizziness, noise in the ears, deafness, increased sweating, nausea, vomiting, headache and confusion. Occurs at plasma concentration 150-300 μg / ml. Treatment - dose reduction or cancellation of therapy.

At concentrations above 300 μg / ml there is a more severe intoxication, manifested by hyperventilation, fever, anxiety, ketoacidosis, respiratory alkalosis and metabolic acidosis. Oppression of the central nervous system can lead to coma, cardiovascular collapse and respiratory failure can also occur.

The greatest risk of developing chronic intoxication is noted in children and the elderly with more than 100 mg / kg / day for several days.

Treatment

If you suspect a receipt more than 120 mg / kg salicylates during the last hour repeatedly injected Activated carbon inside.

When taking more than 120 mg / kg salicylates should determine their plasma concentration, although it is impossible to predict its severity on the basis of this indicator, it is also necessary to take into account the clinical and biochemical indicators.

If the plasma concentration exceeds 500 μg / ml (350 mcg / ml for children under 5 years), intravenous sodium bicarbonate effectively removes salicylates from plasma.

If the plasma concentration exceeds 700 μg / ml (lower concentrations in children and the elderly) or in severe metabolic acidosis, the therapy of choice is hemodialysis or hemoperfusion.

Paracetamol overdose

Overdose may lead to intoxication, especially in elderly patients, children, patients with liver diseases (caused by chronic alcoholism), in patients with eating disorders, as well as in patients,receiving inducers of microsomal liver enzymes, at which fulminant hepatitis, hepatic insufficiency, cholestatic hepatitis, cytolytic hepatitis, in the cases mentioned above, sometimes with lethal outcome, can develop.

The clinical picture of acute overdose develops within 24 hours after taking paracetamol.

Symptoms: gastrointestinal disorders (nausea, vomiting, decreased appetite, a feeling of discomfort in the abdominal cavity and (or) abdominal pain), pallor of the skin.

With the simultaneous administration of 7.5 g or more to adults or children over 140 mg / kg, cytolysis of hepatocytes occurs with complete and irreversible necrosis of the liver, the development of hepatic insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and fatal outcome. After 12-48 hours after the injection of paracetamol, the activity of microsomal liver enzymes, lactate dehydrogenase, bilirubin concentration and a decrease in prothrombin content are noted. Clinical symptoms of liver damage are manifested after 2 days after drug overdose and reach a maximum of 4-6 days.

Treatment

Immediate hospitalization.

Determination of the quantitative content of paracetamol in blood plasma before the start of treatment at the earliest possible time after an overdose.

Introduction donators SH-groups and the precursors of the synthesis of glutathione - methionine and acetylcysteine - most effectively in the first 8 hours.

The need for additional therapeutic measures (further introduction of methionine, intravenous injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Symptomatic treatment.

Laboratory studies of the activity of microsomal liver enzymes should be performed at the beginning of treatment and then every 24 hours.

In most cases, the activity of microsomal liver enzymes is normalized within 1-2 weeks. In very serious cases, liver transplantation may be required.

Caffeine

Common symptoms include gastralgia, agitation, delirium, anxiety, nervousness, anxiety, insomnia, mental agitation, muscle twitching, confusion, convulsions, dehydration, frequent urination, hyperthermia, headache, increased tactile or pain sensitivity, nausea and vomiting (sometimes with blood), noise in the ears.In severe overdose, hyperglycemia may occur. Cardiac disorders are manifested by tachycardia and arrhythmia.

Treatment - lowering the dose or eliminating caffeine.

Interaction:

Acetylsalicylic acid

	Possible effects
Other non-steroidal anti-inflammatory drugs	Increase the damaging effect on the mucous membrane of the gastrointestinal tract (GIT), increase the risk of developing gastrointestinal bleeding. If it is necessary to use simultaneously, it is recommended to use gastroprotectors for the prevention of NSAID-induced gastrointestinal ulcers, therefore, simultaneous use is not recommended.
Glucocorticosteroids	Increase the damaging effect on the mucosa of the gastrointestinal tract, increase the risk of developing gastrointestinal bleeding. If it is necessary to simultaneously use it is recommended to use gastroprotectors, especially in persons over 65 years of age, so simultaneous use is not recommended.
Oral anticoagulants (eg, coumarin derivatives)	Acetylsalicylic acid (ASA) can potentiate the effect of anticoagulants.Clinical and laboratory monitoring of bleeding time and prothrombin time is necessary. Simultaneous use is not recommended.
Thrombolytics	Increased risk of bleeding. The use of ASA in patients during the first 24 hours after acute stroke is not recommended. Simultaneous use is not recommended.
Heparin	Increased risk of bleeding. Clinical and laboratory monitoring of bleeding time is required. Simultaneous use is not recommended.
Inhibitors of platelet aggregation (ticlopidine, paracetamol, clopidogrel, cilostazol)	Increased risk of bleeding. Clinical and laboratory monitoring of bleeding time is required. Simultaneous use is not recommended.
Selective serotonin reuptake inhibitors (SSRIs)	Simultaneous use may affect blood clotting or platelet function, leading to an increased risk of bleeding in general, and in particular gastrointestinal bleeding, therefore simultaneous use is not recommended.
Phenytoin	ASA increases the plasma concentration of phenytoin, which requires its monitoring.
Valproic acid	ASA disrupts communication with plasma proteins and, therefore, can lead to an increase in its toxicity. It is necessary to monitor the plasma concentration of valproic acid.
Antagonists of aldosterone (spironolactone, canrenoate)	ASA can reduce their activity due to a violation of sodium excretion, proper blood pressure control is necessary.
Loop diuretics (for example, furosemide)	ASA can reduce their activity due to a glomerular filtration disorder caused by inhibition of prostaglandin synthesis in the kidneys. Simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs) can lead to acute renal failure, especially in dehydrated patients. If diuretics are used simultaneously with ASA, it is necessary to ensure sufficient rehydration of the patient and monitor kidney function and blood pressure, especially at the beginning of treatment with diuretics.
Hypotensive drugs (ACE inhibitors, angiotensin II receptor antagonists, blockers of "slow" calcium channels)	ASA may reduce their activity due to inhibition of prostaglandin synthesis in the kidneys.Simultaneous application can lead to acute renal failure in elderly or dehydrated patients. If diuretics are used simultaneously with ASA, it is necessary to ensure adequate rehydration of the patient and monitor kidney function and blood pressure. When used concomitantly with verapamil, bleeding time should be monitored.
Uricosuric agents (eg, probenecid, sulfinpyrazone)	ASA can reduce their activity by inhibiting tubular reabsorption, resulting in a high plasma concentration of ASA.
Methotrexate <15 mg / week	ASA, like all NSAIDs, reduces the tubular secretion of methotrexate, increasing its plasma concentration and thus toxicity. In this regard, the simultaneous use of NSAIDs in patients receiving high doses of methotrexate is not recommended (see section "Contraindications"). Patients taking low doses of methotrexate should also consider the risk of interaction between methotrexate and NSAIDs, especially if the kidney function is impaired. If combined therapy is necessary, it is necessary to monitor the general blood test, liver and kidney function, especially in the first days of treatment.
Derivatives of sulfonylureas and insulin	ASA enhances their hypoglycemic effect, so a high dose of salicylates may require a reduction in the dose of hypoglycemic drugs. It is recommended to more often monitor the glucose in the blood.
Alcohol	Increases the risk of gastrointestinal bleeding, concomitant use should be avoided.

Paracetamol

	Possible interactions
Inducers of microsomal liver enzymes or potentially hepatotoxic substances (eg, alcohol, rifampicin. isoniazid, hypnotics and antiepileptics, including phenobarbital, phenytoin and carbamazepine)	An increase in the toxicity of paracetamol, which is liable to liver damage even with non-toxic doses of paracetamol, should therefore be monitored for liver function. Simultaneous use is not recommended.
Chloramphenicol	Paracetamol may increase the risk of increased concentrations of chloramphenicol. Simultaneous use is not recommended.
Zidovudine	Paracetamol may increase the propensity to develop neutropenia, in connection with which hematologic parameters should be monitored. Simultaneous application is possible only with the permission of the doctor.
Probenecid	Probenecid reduces the clearance of paracetamol, which requires a reduction in the dose of paracetamol. Simultaneous use is not recommended.
Indirect anticoagulants	Multiple paracetamol administration for more than one week increases the anticoagulant effect. Episodic reception of paracetamol has no significant effect.
Propanthenin and other drugs that slow the evacuation from the stomach	Reduce the rate of absorption of paracetamol, which can delay or reduce the rapid relief of pain.
Metoclopramide and other drugs that accelerate evacuation from the stomach	Increases the rate of absorption of paracetamol and, accordingly, the effectiveness, and the beginning of analgesic action.
Colestriamine	Reduces the rate of absorption of paracetamol, so if you need maximum analgesia, colestramine is taken no earlier than 1 hour after taking paracetamol.

Caffeine

Combination of caffeine	Possible interactions
Sleeping pills (for example, benzodiazepines, barbiturates, blockers H₁-gistaminovyh receptors)	Simultaneous use can reduce the hypnotic effect or reduce the anticonvulsant effect of barbiturates,therefore, simultaneous use is not recommended. If it is necessary to apply simultaneously, the combination should be taken in the morning.
Lithium	The abolition of caffeine can increase the plasma concentration of lithium, since caffeine increases the renal clearance of lithium, so if you cancel caffeine, you may need to reduce the dose of lithium. Simultaneous use is not recommended.
Disulfiram	Patients on disulfiram should be warned against the use of caffeine to avoid the risk of alcohol abstinence, due to the stimulating effect of caffeine on the cardiovascular and central nervous system.
Ephedrine-like substances	Increased risk of drug dependence. Simultaneous use is not recommended.
Sympathomimetics or levothyroxine	Due to mutual potentiation, the chronotropic effect can increase. Simultaneous use is not recommended.
Theophylline	Simultaneous use reduces the excretion of theophylline.
Antibacterial drugs from the group of quinolones (ciprofloxacin, enoxacin and piperidic acid), terbinafine, cimetidine, fluvoxamine and oral contraceptives	An increase in the half-life of caffeine due to inhibition of liver cytochrome P450, therefore, patients with impaired liver function, heart rhythm disorder and latent epilepsy should avoid using caffeine.
Nicotine, phenytoin and phenylpropanolamine	Decrease the terminal half-life of caffeine.
Clozapine	Caffeine increases serum concentrations (rusapine, probably due to both pharmacokinetic and pharmacodynamic mechanisms.) Control of serum concentration of clozapine is necessary. Simultaneous use is not recommended.

Impact on laboratory research

High doses of ASA can distort the results of a number of clinical and biochemical laboratory studies.

The use of paracetamol can affect the results of determination of uric acid by the method of phosphotungstic acid and glycemia by glucose oxidase / peroxidase method.

Caffeine can reverse the effects of dipyridamole on the bloodstream in the myocardium, thus distorting the results of this study. During the study, it is necessary to refrain from taking caffeine within 8-12 hours.

Special instructions:

Are common

This drug should not be taken concomitantly with medicines containing ASA or paracetamol.

Like other means for treating migraine, care should be taken to exclude other potentially serious neurological disorders prior to initiating treatment for suspected migraine in patients who have not previously been diagnosed with migraine, or for those patients with migraine who have atypical symptoms.

If patients develop vomiting during> 20% of migraine attacks, or> 50% of seizures require bed rest, the drug should not be used.

If migraine after taking the first two tablets of the drug is not stopped, you need to seek medical help.

The drug should not be used if the patient has had more than 10 headache attacks per month for at least the last three months. In this case, you should suspect a headache due to excessive use of drugs and cancel treatment. In addition, patients should seek medical help. Caution should be exercised in patients with risk factors for dehydration, for example, with vomiting, diarrhea, or before or after a major operation.

Due to its pharmacodynamic properties, the drug can.mask the signs and symptoms of infection.

Due to the content in the preparation of acetylsalicylic acid

The drug should be used with caution in patients with gout, impaired renal or hepatic function, dehydration, uncontrolled hypertension, deficiency of glucose-6-phosphate dehydrogenase and diabetes mellitus.

Due to the inhibition of ASA platelet aggregation, the drug may lead to prolonged bleeding time during and after surgical interventions (including small ones, for example, tooth extraction).

The drug should not be used simultaneously with anticoagulants and other drugs that violate blood coagulation, without the supervision of a doctor (see section "Interaction with other drugs"). Patients with blood clotting disorders should be carefully monitored. Care should be taken with metro or menorrhagia.

If a patient develops bleeding or ulceration of the gastrointestinal tract when taking the drug, it must be immediately canceled. At any point in the treatment of any NSAID, potentially lethal bleeding, ulceration and perforation of the gastrointestinal tract may occur with and without precursors and severe gastrointestinal complications in the history, and without them.These complications, as a rule, are more severe in elderly patients.

Alcohol, glucocorticosteroids and NSAIDs may increase the risk of gastrointestinal bleeding (see section "Interaction with other drugs").

The drug may contribute to the development of bronchospasm and the appearance of exacerbation of bronchial asthma (including bronchial asthma due to intolerance to analgesics) or other hypersensitivity reactions. Risk factors include bronchial asthma, seasonal allergic rhinitis, nasal polyposis, chronic obstructive pulmonary disease, chronic respiratory tract infections (especially associated with symptoms characteristic of allergic rhinitis). Such phenomena can also occur in patients with allergic reactions (for example, skin, including pruritus and urticaria) on other substances. In such patients it is recommended that special care be taken.

Children under 18 should not be prescribed medications containing acetylsalicylic acid as an antipyretic, since in the case of a viral infection they can increase the risk of developing Reye's syndrome.Symptoms of Reye syndrome include hyperpyrexia, prolonged vomiting, metabolic acidosis, disorders of the nervous system and psyche, hepatomegaly and liver function disorders, acute encephalopathy, respiratory failure, convulsions, coma.

ASA can distort the results of laboratory tests of thyroid function due to a false positive low concentration of levothyroxine (T₄) and triiodothyronine (T₃) (see section "Interaction with other drugs").

Due to the content of paracetamol in the preparation

Caution should be exercised when prescribing the drug to patients with impaired renal or hepatic function or alcohol dependence.

The risk of paracetamol poisoning is increased in patients taking other potentially hepatotoxic drugs or drugs that induce microsomal liver enzymes (for example, rifampicin, isoniazid, chloramphenicol, hypnotics and anticonvulsants, including phenobarbital, phenytoin and carbamazepine).

Patients with an alcoholism in the anamnesis are a special risk group for liver damage (see section "Interaction with other drugs").

Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, which can lead to death, can develop when the drug is used. Patients should be informed of the signs of serious skin reactions. The drug should be discontinued at the first manifestations of skin reactions or any other signs of hypersensitivity.

Due to the caffeine content in the preparation

The drug should be administered with caution to patients with gout, hyperthyroidism and arrhythmia.

When using the drug should limit the consumption of products containing caffeine, as excessive intake of caffeine can lead to nervousness, irritability, insomnia and, in some cases, increased heart rate.

Effect on the ability to drive transp. cf. and fur:

Studies to study the impact on the ability to drive vehicles and work with mechanisms have not been carried out. If such undesirable reactions occur such as dizziness or drowsiness, you should refrain from these activities and inform the doctor about it.

Form release / dosage:Tablets, 240 mg + 30 mg + 180 mg.

Packaging:

By 3, 4, 10 tablets into a contour mesh box made of polyvinyl chloride film and aluminum foil printed lacquered.

For 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets in cans of polyethylene terephthalate for medicinal products sealed with caps screwed on with a first opening control or a "push-turn" system of polypropylene or polyethylene or cans polypropylene for drugs, sealed with lids tightened with the control of the first opening of polyethylene, or polypropylene cans for medicines, sealed with lids pulled with the control of the first opening of high pressure polyethylene.

One bank or 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100 of the contour mesh packages together with the instruction for use are placed in cardboard package (pack) of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003976

Date of registration:22.11.2016

Expiration Date:22.11.2021

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp14.12.2016

Illustrated instructions

Instructions

Citramon P (Citramon P)