Description
Release form
Tablets, 250 mg + 65 mg + 250 mg.
film-coated tablets.
10 tablets per blister pack of polyvinyl chloride film or PA / Al / PVC film and varnished aluminum printed foil.
1, 2 or 3 blister strip packagings together with instructions for medical use are placed in a pack of cardboard.
Indications
Medium and mild pain syndrome of various origins in adults and children over 15 years of age:
headache
migraine
toothache
neuralgia
arthralgia
myalgia
algomenorrhea (pain).
Feverish syndrome in adults: with acute respiratory infections, flu.
Use during pregnancy and lactation
Taking the drug is contraindicated during pregnancy and during breastfeeding, as the safety of this combination in pregnant and lactating women has not been studied.
If you need to use the drug during lactation, you should stop breastfeeding.
Special instructions
General
This medication should not be taken simultaneously with medicines containing ASA or paracetamol.
Like other treatments for migraine, patients who have not previously been diagnosed with migraine or those who have atypical symptoms of migraine before starting treatment for suspected migraines should be careful to rule out other potentially serious neurological disorders.
If vomiting occurs in patients with> 20% of migraine attacks or> 50% of the attacks they require bed rest, the drug should not be used.
If migraine does not stop after taking the first two tablets, you should seek medical help.
The drug should not be used if more than 10 headache attacks per month have occurred in the patient 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 attention. Caution should be exercised in patients with risk factors for dehydration, such as vomiting, diarrhea, either 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
in acetylsalicylic acid, 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 an increase in 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 coagulation, without the supervision of a doctor (see section “Interaction with other drugs”). Patients with blood clotting disorders should be closely monitored. Caution should be exercised during metro or menorrhagia.
If a patient develops bleeding or ulceration of the gastrointestinal tract while taking the drug, you must immediately cancel it. At any time during treatment with any NSAIDs, potentially fatal bleeding, ulceration and perforation of the gastrointestinal tract can occur with or without a history of severe gastrointestinal complications.
These complications are usually more severe in older patients. Alcohol, glucocorticosteroids, and NSAIDs may increase the risk of gastrointestinal bleeding (see the Interaction with Other Medicines section). The drug can contribute to the development of bronchospasm and the occurrence of exacerbation of bronchial asthma (including bronchial asthma due to intolerance to analgesics) or other hypersensitivity reactions.
Risk factors include asthma, seasonal allergic rhinitis, nasal polyposis, chronic obstructive pulmonary disease, chronic respiratory infections (especially those associated with symptoms characteristic of allergic rhinitis). Such phenomena can also occur in patients with allergic reactions (for example, skin, including itching and urticaria) to other substances. In such patients, extreme caution is recommended.
Children under 18 years of age should not be prescribed medicines 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 are hyperpyrexia, prolonged vomiting, metabolic acidosis, disorders of the nervous system and psyche, hepatomegaly and impaired liver function, acute encephalopathy, respiratory failure, convulsions, coma.
ASA may 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 paracetamol
, caution should be exercised when administering 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 (e.g. rifampicin, isoniazid, chloramphenicol, hypnotics and anticonvulsants, including phenobarbital, phenytoin and carbamazepine). Patients with a history of alcoholism are at particular risk for liver damage (see the Interaction with Other Medicines section).
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 of 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 its caffeine content
, the drug should be used with caution in patients with gout, hyperthyroidism, and arrhythmia.
When using the drug, you should limit the intake of products containing caffeine, since excessive intake of caffeine can lead to nervousness, irritability, insomnia and, in some cases, increased heart rate.
Impact on the ability to drive vehicles, mechanisms
Research on the impact on the ability to drive vehicles and work with mechanisms has not been conducted. If you experience adverse reactions such as dizziness or drowsiness, you should refrain from these activities and inform your doctor.
Composition
Active ingredients:
acetylsalicylic acid – 250.0 mg,
paracetamol – 250.0 mg,
caffeine (anhydrous caffeine) – 65.0 mg.
Excipients:
microcrystalline cellulose (microcrystalline cellulose 101) – 66.01 mg,
hyprolose (low-substituted hydroxypropyl cellulose) – 21.50 mg,
talcum – 10.00 mg,
hyprolysis (hydroxypropyl cellulose) – 7.30 mg (silicon dioxide aerosil) – 3.40 mg,
stearic acid – 2.50 mg,
calcium stearate – 1.29 mg.
Shell:
Opadry 20A28380 WHITE – 13.5 mg [hypromellose (hydroxypropyl methylcellulose 2910) – 4.556 mg, hyprolysis (hydroxypropyl cellulose) – 4.556 mg, talc – 2.700 mg, titanium dioxide – 1.688 mg].
Dosage and administration
The drug is used orally during or after meals.
For relief of pain in adults and children over 15 years of age: 1 tablet every 4-6 hours.
At the first sign of migraine, 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 headache and other types of pain usually occurs quickly – after 15 minutes, with migraines, relief usually occurs after 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 headache and migraine, 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 old). In elderly patients, especially with low body weight, caution should be exercised.
Patients with hepatic and renal failure. 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 exacerbate renal or hepatic failure. In this regard, the drug is contraindicated in patients with severe hepatic or renal failure, and with hepatic and renal failure of mild to moderate degree it should be used with caution.
Overdose of
Acetylsalicylic acid.
For mild intoxications – dizziness, tinnitus, deafness, excessive sweating, nausea, vomiting, headache, and confusion. Occurs at a plasma concentration of 150-300 μg / ml.
Treatment – dose reduction or withdrawal of therapy.
At concentrations above 300 mcg / ml, more severe intoxication occurs, manifested by hyperventilation, fever, anxiety, ketoacidosis, respiratory alkalosis and metabolic acidosis. Inhibition of the central nervous system can lead to coma, cardiovascular collapse and respiratory failure may also occur. The greatest risk of chronic intoxication is observed in children and the elderly when taken for several days more than 100 mg / kg / day.
Treatment – If more than 120 mg / kg of salicylates are suspected of being administered over the last hour, activated charcoal is administered orally. 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 μg / ml (350 μg / ml for children under 5 years of age), intravenous administration of sodium bicarbonate effectively removes salicylates from plasma. If the plasma concentration exceeds 700 mcg / ml (lower concentrations in children and the elderly) or in severe metabolic acidosis, hemodialysis or hemoperfusion is the treatment of choice.
Overdose of paracetamol. In case of an overdose, intoxication is possible, 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, in which fulminant hepatitis, liver failure, and cholestatic can develop hepatitis, cytolytic hepatitis, in the above cases – sometimes fatal. The clinical picture of acute overdose develops within 24 hours after taking paracetamol. Symptoms: gastrointestinal upset (nausea, vomiting, decreased appetite, 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 liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after administration of paracetamol, an increase in the activity of microsomal liver enzymes, lactate dehydrogenase, a concentration of bilirubin and a decrease in the content of prothrombin are noted. Clinical symptoms of liver damage occur 2 days after an overdose of the drug and 5 g or more, or children over 140 mg / kg, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after administration of paracetamol, an increase in the activity of microsomal liver enzymes, lactate dehydrogenase, a concentration of bilirubin and a decrease in the content of prothrombin are noted. Clinical symptoms of liver damage occur 2 days after an overdose of the drug and 5 g or more, or children over 140 mg / kg, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after administration of paracetamol, an increase in the activity of microsomal liver enzymes, lactate dehydrogenase, a concentration of bilirubin and a decrease in the content of prothrombin are noted. Clinical symptoms of liver damage occur 2 days after an overdose of the drug and bilirubin concentrations and a decrease in prothrombin content. Clinical symptoms of liver damage occur 2 days after an overdose of the drug and bilirubin concentrations and a decrease in prothrombin content. Clinical symptoms of liver damage occur 2 days after an overdose of the drug andreach a maximum of 4-6 days.
Treatment – Immediate hospitalization. The quantitative determination of paracetamol in plasma before treatment as early as possible after overdose. The introduction of SH-group donors and precursors of glutathione synthesis – methionine and acetylcysteine – is most effective in the first 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous (iv) administration 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 carried out 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 include gastralgia, agitation, delirium, anxiety, nervousness, anxiety, insomnia, mental agitation, muscle twitching, confusion, cramps, dehydration, rapid urination, hyperthermia, headache, increased tactile or pain sensitivity, nausea and vomiting with blood), tinnitus. With severe overdose, hyperglycemia may occur. Cardiological disorders are manifested by tachycardia and arrhythmia.
Treatment – dose reduction or withdrawal of caffeine.
Storage conditions
Store in the original package, in a dry place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Expiration
2 years.
Dosage form
tablets
