Ascophen ULTRA pills 250mg + 65mg + 250mg, 10pcs

Composition

Active ingredients:

acetylsalicylic acid – 250.0 mg,

paracetamol-250.0 mg,

caffeine (anhydrous caffeine) – 65.0 mg.

Auxiliary substances: microcrystalline cellulose-66.01 mg, hyprolose (low-substituted hydroxypropylcellulose) – 21.50 mg, talc-10.00 mg, hyprolose (hydroxypropylcellulose) – 7.30 mg, colloidal silicon dioxide (aerosil) – 3.40 mg, stearic acid-2.50 mg, calcium stearate-1.29 mg.

Shell: Opadray 20 A 28380 WHITE – 13.5 mg [hypromellose (hydroxypropylmethylcellulose 2910) – 4.556 mg, hydroxypropylcellulose-4.556 mg, talc-2,700 mg, titanium dioxide-1,688 mg].

Pharmacological action

Pharmacotherapeutic group: combined analgesic agent (nonsteroidal anti-inflammatory agent + non-narcotic analgesic agent + psychostimulant agent).

ATX code: [N02BA71].

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics :

A combination drug containing paracetamol, acetylsalicylic acid and caffeine.

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

Caffeine increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, expands the blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation; reduces drowsiness, fatigue, increases mental and physical performance.

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

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

Pharmacokinetics

of Acetylsalicylic acid

When taken orally, the absorption is complete. During absorption, it undergoes presystemic elimination in the intestinal wall and systemic elimination in the liver (deacetylated). It is rapidly hydrolyzed by cholinesterases and albuminesterase, so the half-life is no more than 15-20 minutes.

It circulates in the body (by 75-90% due to albumin) and is distributed in the tissues in the form of salicylic acid anion. The time to reach the maximum concentration is 2 hours. It is mainly metabolized in the liver with the formation of 4 metabolites found in many tissues and urine.

It is mainly excreted by active secretion in the renal tubules in the form of salicylate (60%) and its metabolites. The excretion of unchanged salicylate depends on the pH of the urine (when the urine is alkalinized, the ionization of salicylates increases, their reabsorption worsens, and the excretion increases significantly).

The rate of elimination depends on the dose: when taking small doses, the half-life is 2-3 hours, with an increase in the dose it can increase to 15-30 hours. In newborns, salicylate elimination is much slower than in adults.

Caffeine

When taken orally, the absorption is good, occurs throughout the intestine. Absorption is mainly due to lipophilicity, rather than water solubility.

The time to reach the maximum concentration is 50-75 minutes after oral use, the maximum concentration is 1.6-1.8 mg/l. It is rapidly distributed in all organs and tissues of the body; it easily penetrates the blood-brain barrier and placenta.

The volume of distribution in adults is 0.4 – 0.6 l / kg, in newborns-0.78-0.92 l/kg. The relationship 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 caffeine dose is metabolized to paraxanthin, about 10% to theobromine, and about 4% to theophylline.

These compounds are subsequently demethylated to monomethylxanthines, and then to methylated uric acids. The half-life in adults is 3.9-5.3 hours (sometimes up to 10 hours). The elimination of caffeine and its metabolites is carried out by the kidneys (1-2% is excreted unchanged in adults).

Paracetamol

Absorption is high, the maximum concentration is reached in 0.5-2 hours; the maximum concentration is 5-20 mcg / ml. Binding to plasma proteins is 15%. Penetrates the blood-brain barrier. Less than 1% of the dose of paracetamol taken by a nursing mother passes into breast milk. The therapeutic effective concentration of paracetamol in plasma is achieved when it is prescribed at a dose of 10-15 mg / kg. It is metabolized in the liver (90-95%): 80% enters conjugation reactions with the formation of inactive glucuronides and sulfates; 17% undergoes hydroxylation with the formation of 8 active metabolites, which conjugate with glutathione to form already inactive metabolites. When glutathione is deficient, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. CYP2E1, CYP1A2 and, to a lesser extent, CYP3A4 are also involved in drug metabolism. The elimination 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

Moderate and mild pain syndrome of various origins in adults and children over 15 years of age:

• headache;
• migraine;
• toothache;
• neuralgia;
• arthralgia;
• myalgia;
• algodismenorrhea (pain during menstruation).

Febrile syndrome in adults: with acute respiratory diseases, flu.

Use during pregnancy and lactation

Taking the drug is contraindicated during pregnancy and during breastfeeding, since the safety of this combination in pregnant and lactating women has not been studied. If it is necessary to use the drug during lactation, stop breastfeeding.

Contraindications

• Hypersensitivity to the main or auxiliary components of the drug;
• erosive-ulcerative lesions of the gastrointestinal tract (GIT) (in acute phase), gastrointestinal bleeding or perforation, peptic ulcer in the anamnesis;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including in the anamnesis);
• hemophilia and other blood coagulation disorders; haemorrhagic diathesis, hypoprothrombinemia;
• a vitamin K deficiency;
• portal hypertension;
• severe renal or hepatic insufficiency;
• chronic heart failure III-IV NYHA functional class;
• arterial hypertension III degree;
• pregnancy;
• breastfeeding;
• glaucoma;
• deficiency of glucose-6-phosphate dehydrogenase;
• increased nervous irritability, sleep disorders;
• surgical intervention, accompanied by profuse bleeding;
• children’s age up to 15 years in an analgesic, in a feverish syndrome – up to 18 years;
• concomitant use of methotrexate in a dose of 15 mg/week.

With caution

Mild to moderate renal or hepatic insufficiency, advanced age, gout, alcoholism, epilepsy and a tendency to convulsive seizures, chronic heart failure of NYHA functional class I-II, ischemic heart disease, cerebrovascular diseases, peripheral artery diseases, smoking, chronic obstructive pulmonary disease, concomitant use of methotrexate at a dose of less than 15 mg/week, concomitant anticoagulant therapy, elderly, concomitant use with other medications. nonsteroidal anti-inflammatory drugs, glucocorticosteroids, anticoagulants, antiplatelet agents, and selective serotonin reuptake inhibitors.

Side effects

Many of these adverse reactions are clearly dose-dependent and vary from patient to patient. The frequency of adverse drug reactions is classified according to the World Health Organization guidelines: very common (>1/10), common (>>1/100 to ≤1/10), uncommon (>>>1/1000 to ≤1/100), rare (>>>>1/10000 to ≤1/1000), very rare (<1/10000), frequency unknown (frequency of occurrence cannot be determined based on available data).

Infections and infestations:  rarely – pharyngitis.

Metabolic and nutritional disorders:  rarely-decreased appetite.

Mental disorders:  often – nervousness; infrequently-insomnia; rarely-anxiety, euphoric mood, internal tension.

Nervous system disorders:  often – dizziness; infrequently-tremor, paresthesia, headache; rarely-taste disorder, attention disorder, amnesia, impaired coordination of movement, hyperesthesia, pain in the paranasal sinuses.

Visual disturbances:  rarely-visual impairment.

Hearing disorders:  infrequently-tinnitus.

Disorders of the cardiovascular system:  infrequently-arrhythmia.

Vascular disorders:  rarely-hyperemia, peripheral circulatory disorders.

Respiratory, thoracic and mediastinal disorders:  rarely-nosebleeds, hypoventilation, rhinorrhea.

Disorders of the digestive system: often – nausea, abdominal discomfort; infrequently – dry mouth, diarrhea, vomiting; rarely-belching, flatulence, dysphagia, paresthesia in the mouth, increased salivation.

Skin and subcutaneous tissue disorders: rarely – hyperhidrosis, pruritus, urticaria.

Musculoskeletal disorders: rarely – musculoskeletal stiffness, neck pain, back pain, muscle spasms.

Common disorders: infrequently-fatigue, increased excitability; rarely-asthenia, heaviness in the chest.

Other services: infrequently – increased heart rate.

Post-marketing surveillance data

There are no data on the enhancement or expansion of the spectrum of adverse events of individual components when used in combination in accordance with the instructions for use.

The increased risk of bleeding after taking acetylsalicylic acid persists for 4-8 days. Very rarely, severe bleeding (for example, cerebral hemorrhage) is possible, especially in patients with untreated arterial hypertension and /or with simultaneous use of anticoagulants, in some cases life-threatening.

If you experience any of the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

of Acetylsalicylic acid Other nonsteroidal anti-inflammatory drugs: Increased damaging effect on the mucous membrane of the gastrointestinal tract( GIT), increased risk of gastrointestinal bleeding. If simultaneous use is necessary, it is recommended to use gastroprotectors for the prevention of NSAID-1-induced ulcers of the gastrointestinal tract, so simultaneous use is not recommended. Glucocorticosteroids: Increased damaging effect on the gastrointestinal mucosa, increased risk of gastrointestinal bleeding. If simultaneous use is necessary, it is recommended to use gastroprotectors, especially in people over 65 years of age, so simultaneous use is not recommended. Oral anticoagulants (e. g. coumarin derivatives): Acetylsalicylic acid (ASA) may potentiate the action 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 within the first 24 hours after an 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. Platelet aggregation inhibitors (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): Concomitant use may affect blood clotting or platelet function, leading to an increased risk of bleeding in general, and in particular gastrointestinal bleeding, so concomitant use is not recommended. Phenytoin: ASA increases the plasma concentration of phenytoin, which requires its monitoring. Valproic acid: ASA disrupts the binding to plasma proteins and, therefore, can lead to an increase in its toxicity. It is necessary to control the plasma concentration of valproic acid. Aldosterone antagonists (spironolactone, canrenoate): ASA may reduce their activity due to impaired sodium excretion, and proper blood pressure monitoring is necessary. Loop diuretics (for example, furosemide): ASA may reduce their activity due to glomerular filtration disorders due to inhibition of prostaglandin synthesis in the kidneys. Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) can lead to acute renal failure, especially in dehydrated patients. If diuretics are used concomitantly with ASA, adequate rehydration of the patient should be ensured and renal function and blood pressure should be monitored, especially at the beginning of treatment with diuretics. Antihypertensive agents (ACE inhibitors, angiotensin II receptor antagonists, slow calcium channel blockers): ASA may reduce their activity due to inhibition of prostaglandin synthesis in the kidneys. Concomitant use may lead to acute renal failure in elderly or dehydrated patients. If diuretics are used simultaneously with ASA, adequate rehydration of the patient should be ensured and renal function and blood pressure should be monitored. When used concomitantly with verapamil, the bleeding time should be monitored. Uricosuric agents (e. g. probenecid, sulfinpyrazone): ASA may reduce their activity by inhibiting tubular reabsorption, resulting in high plasma concentrations of ASA. Methotrexate <15 mg / week: ASA, like all NSAIDs, reduces the tubular secretion of methotrexate, increasing its plasma concentration and thus toxicity. Therefore, concomitant use of NSAIDs in patients receiving high doses of methotrexate is not recommended (see section “Contraindications”). In patients taking low doses of methotrexate, the risk of interaction between methotrexate and NSAIDs should also be considered, especially in patients with impaired renal function. If combination therapy is necessary, it is necessary to monitor the general blood count, liver and kidney function, especially in the first days of treatment. Sulfonylurea derivatives and insulin: ASA enhances their hypoglycemic effect, so when taking a high dose of salicylates, it may be necessary to reduce the dose of hypoglycemic drugs. It is recommended to monitor the blood glucose level more often. Alcohol: Increases the risk of gastrointestinal bleeding; concomitant use should be avoided. Paracetamol Inducers of microsomal liver enzymes or potentially hepatotoxic substances (for example, alcohol, rifampicin, isoniazid, sleeping pills and antiepileptic drugs, including phenobarbital, phenytoin and carbamazepine): Increased toxicity of paracetamol, which can lead to liver damage even at non-toxic doses of paracetamol, so liver function should be monitored. 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, and therefore hematological parameters should be monitored. Simultaneous use 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: Repeated use of paracetamol for more than one week increases the anticoagulant effect. Occasional use of paracetamol has no significant effect. Propanthelin and other drugs that slow gastric evacuation: Reduce the rate of absorption of paracetamol, which may delay or reduce rapid pain relief. Metoclopramide and other drugs that accelerate gastric evacuation: Increases the rate of absorption of paracetamol and, accordingly, the effectiveness and onset of analgesic action. Colestyramine: Reduces the rate of absorption of paracetamol, so if you need maximum analgesia, colestyramine is taken no earlier than 1 hour after taking paracetamol.Caffeine Hypnotics (e. g., benzodiazepines, barbiturates, H1-histamine receptor blockers): Concomitant use may reduce the hypnotic effect or reduce the anticonvulsant effect of barbiturates, so concomitant use is not recommended. If simultaneous use is necessary, it is advisable to take the combination in the morning. Lithium: Withdrawal of caffeine may increase the plasma concentration of lithium, since caffeine increases the renal clearance of lithium, so when caffeine is withdrawn, a reduction in the lithium dose may be required. Simultaneous use is not recommended. Disulfiram: Patients treated with disulfiram should be warned to avoid the use of caffeine in order to avoid the risk of aggravation of alcohol withdrawal syndrome, due to the stimulating effect of caffeine on the cardiovascular and central nervous systems. Ephedrine-like substances: Increased risk of drug addiction. Simultaneous use is not recommended. Sympathomimetics or levothyroxine: Due to mutual potentiation, they can enhance the chronotropic effect. Simultaneous use is not recommended. Theophylline: Concomitant use reduces theophylline excretion. Quinolone antibacterial drugs, enoxacin and pipemidic acid, terbinafine, cimetidine, fluvoxamine and oral contraceptives: Increased half-life of caffeine due to inhibition of liver cytochrome P 450, so patients with impaired liver function, cardiac arrhythmia and latent epilepsy should avoid the use of caffeine. Nicotine, phenytoin and phenylpropanolamine: Reduce the terminal half-life of caffeine. Clozapine: Caffeine increases the serum concentration of clozapine, probably due to both pharmacokinetic and pharmacodynamic mechanisms. It is necessary to monitor the serum concentration of clozapine. Simultaneous use is not recommended. Impact on laboratory tests High doses of ASA can distort the results of a number of clinical and biochemical laboratory studies. The use of paracetamol may affect the results of uric acid determination by the phosphor-wolframic acid method and glycemia by the glucose oxidase/peroxidase method. Caffeine may reverse the effects of dipyridamole on myocardial blood flow, thus distorting the results of this study. During the study, it is necessary to refrain from taking caffeine for 8-12 hours.

How to take, course of use and dosage

The drug is used orally during or after a meal. For relief of pain in adults and children over 15 years of age: 1 tablet every 4-6 hours. At the first sign of migraines, take 2 tablets. In case of febrile syndrome for adults: 2 tablets every 6 hours. The average daily dose is 3-4 tablets per day, the maximum daily dose is 6 tablets per day. After taking 2 tablets, relief of headaches and other types of pain usually occurs quickly – in 15 minutes, with migraines, relief usually occurs in 30 minutes. In case of pain, the drug should not be taken for more than 5 days without consulting a doctor. For the treatment of headaches and migraines, the drug is used for no more than 4 days. In case of febrile syndrome, the drug should not be taken for more than 3 days without consulting a doctor. Elderly (over 65 years of age). Caution should be exercised in elderly patients, especially those 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 may worsen renal or hepatic insufficiency. In this regard, the drug is contraindicated in patients with severe hepatic or renal insufficiency, and in patients with mild to moderate hepatic and renal insufficiency, it should be used with caution.

Overdose of

Acetylsalicylic acid.

With mild intoxications– dizziness, tinnitus, deafness, increased sweating, nausea, vomiting, headache and confusion. Occurs at a plasma concentration of 150-300 mcg / ml.

Treatment– reduction of the dose or discontinuation of therapy.

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

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

Treatment-If the intake of more than 120 mg/kg of salicylates is suspected during the last hour, activated charcoal is repeatedly injected inside. When taking more than 120 mg/kg of salicylates, their plasma concentration should be determined, although it is impossible to predict its severity only on the basis of this indicator, it is also necessary to take into account clinical and biochemical parameters.

If the plasma concentration exceeds 500 mcg / ml (350 mcg / ml for children under 5 years of age), intravenous sodium bicarbonate effectively removes salicylates from the plasma. If the plasma concentration exceeds 700 mcg/ml (lower concentrations in children and the elderly) or in severe metabolic acidosis, the therapy of choice is hemodialysis or hemoperfusion.

Paracetamol overdose. Overdose can lead to intoxication, especially in elderly patients, children, patients with liver diseases (caused by chronic alcoholism), in patients with nutritional disorders, as well as in patients taking inducers of microsomal liver enzymes, which can develop lightning-fast hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis, in the above cases – sometimes with a fatal outcome.

The clinical picture of acute overdose develops within 24 hours after taking paracetamol. Symptoms: gastrointestinal disorders (nausea, vomiting, decreased appetite, abdominal discomfort and / or abdominal pain), pallor of the skin.

With simultaneous use of 7.5 g or more to adults or more than 140 mg/kg to children, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death.

12-48 hours after paracetamol use, there is an increase in the activity of microsomal liver enzymes, lactate dehydrogenase, bilirubin concentration, and a decrease in prothrombin content. Clinical symptoms of liver damage appear 2 days after an overdose of the drug and reach a maximum on day 4-6.

Treatment –immediate hospitalization. Determination of the quantitative content of paracetamol in blood plasma before starting treatment as early as possible after an overdose.

use of SH-group donors and glutathione synthesis precursors-methionine and acetylcysteine-is most effective in the first 8 hours. The need for additional therapeutic measures (further use of methionine, intravenous (iv) use of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its use.

Symptomatic treatment. Laboratory tests 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 normalizes within 1-2 weeks. In very severe cases, a liver transplant may be required.

Caffeine. Common symptoms are gastralgia, agitation, delirium, anxiety, nervousness, restlessness, insomnia, mental agitation, muscle twitching, confusion, convulsions, dehydration, frequent urination, hyperthermia, headache, increased tactile or pain sensitivity, nausea and vomiting (sometimes with blood), tinnitus.

With severe overdose, hyperglycemia may occur. Cardiological disorders are manifested by tachycardia and arrhythmia.

Treatment– reducing the dose or eliminating caffeine.

Special instructions

Common This medicine should not be taken simultaneously with medications containing ASA or paracetamol. Similar to other migraine medications, caution should be exercised before starting treatment for suspected migraines in patients who have not previously been diagnosed with migraines, or in patients who have atypical symptoms of migraines, to exclude other potentially serious neurological disorders. If patients experience vomiting in >20% of migraine attacks or require bed rest in >50% of migraine attacks, the drug should not be used. If migraines do not stop after taking the first two tablets of the drug, you should seek medical help. The drug should not be used if the patient has experienced 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 medications and cancel treatment. In addition, patients should seek medical attention. Caution should be exercised in patients with risk factors for dehydration, such as vomiting, diarrhea, or before or after major surgery. Due to its pharmacodynamic properties, the drug can mask the signs and symptoms of infection.Due to the content of acetylsalicylic acid in the preparation The drug should be used with caution in patients with gout, impaired renal or hepatic function, dehydration, uncontrolled arterial hypertension, glucose-6-phosphate dehydrogenase deficiency, and diabetes mellitus. Due to the inhibition of ASA platelet aggregation, the drug can 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 interfere with blood clotting, without the supervision of a doctor (see the section “Interaction with other drugs”). Patients with blood clotting disorders should be carefully monitored. Caution should be exercised in case of metro-or menorrhagia. If the patient develops bleeding or ulceration of the gastrointestinal tract while taking the drug, it should be stopped immediately. Potentially fatal bleeding, ulceration, and perforation of the gastrointestinal tract may occur at any time during treatment with any NSAID, with or without a history of premonitory and severe gastrointestinal complications. These complications tend to be more severe in older patients. Alcohol, glucocorticosteroids, and NSAIDs may increase the risk of gastrointestinal bleeding (see section “Interactions with other medications”). The drug may contribute to the development of bronchospasm and the occurrence of exacerbation of bronchial asthma (including bronchial asthma caused by intolerance to analgesics) or other hypersensitivity reactions. Risk factors include bronchial asthma, seasonal allergic rhinitis, nasal polyposis, chronic obstructive pulmonary disease, and chronic respiratory tract infections (especially those associated with symptoms characteristic of allergic rhinitis). Such phenomena may also occur in patients with allergic reactions (for example, skin reactions, including pruritus and urticaria) to other substances. Special care is recommended in these patients. Children under 18 years of age 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 Reye’s syndrome. Symptoms of Reye’s syndrome include hyperpyrexia, prolonged vomiting, metabolic acidosis, disorders of the nervous system and psyche, hepatomegaly and liver function disorders, acute encephalopathy, respiratory disorders, convulsions, coma. ASA can distort the results of laboratory tests of thyroid function due to false-positive low concentrations of levothyroxine (T4) and triiodothyronine (Tk) (see the 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, sleeping pills and anticonvulsants, including phenobarbital, phenytoin and carbamazepine). Patients with a history of alcoholism are particularly at risk for liver damage (see the section “Interaction with other drugs”). When using the drug, serious skin reactions can develop, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, which can lead to death. Patients should be informed about signs of serious skin reactions. The drug should be discontinued at the first appearance of skin reactions or any other signs of hypersensitivity. Due to the content of caffeine in the preparation The drug should be used with caution in patients with gout, hyperthyroidism and arrhythmia. When using the drug, you should limit the consumption of products containing caffeine, since excessive intake of caffeine can lead to nervousness, irritability, insomnia and, in some cases, palpitations. Influence on the ability to drive vehicles, mechanisms Studies on the effect on the ability to drive vehicles and work with mechanisms have not been conducted. If you experience any adverse reactions such as dizziness or drowsiness, you should refrain from these activities and inform your doctor.

Form of production

Tablets,250 mg + 65 mg + 250 mg. Film-coated tablets. 10 tablets in a contour cell package made of polyvinyl chloride film or PA / Al / PVC film and aluminum foil printed varnished. 1,2 or 3 contour cell packages together with instructions for medical use are placed in a pack of cardboard.

Storage conditions

Store in the original packaging, in a dry place at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredients

: Acetylsalicylic acid, Caffeine, Paracetamol

Dosage form

Tablets