Solpadeine fast pills soluble N12
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Active ingredients
Caffeine + Paracetamol
Composition
1 tab. paracetamol 500 mg caffeine 65 mg. Excipients: sorbitol, sodium saccharinate, sodium bicarbonate, povidone, sodium lauryl sulfate, dimethicone, citric acid, sodium carbonate.
Pharmacological effect
Analgesic antipyretic combined composition, contains a combination of two active ingredients: paracetamol and caffeine. Has antipyretic and analgesic effect. Paracetamol blocks COX in the central nervous system, affecting the centers of pain and thermoregulation (cellular tissue peroxidase neutralizes the effect of paracetamol on COX in inflammatory tissues), which explains the almost complete absence of anti-inflammatory effect. The lack of influence on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on the water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa. Caffeine stimulates the psychomotor centers of the brain, has analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, increases physical and mental performance.
Pharmacokinetics
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract, the distribution in body fluids is relatively even. The binding of paracetamol to plasma proteins is minimal at therapeutic concentrations. Paracetamol is metabolized in the liver and excreted in the urine as glucuronide and sulfate metabolites - less than 5% is excreted unchanged. T1 / 2 when taking a therapeutic dose is 2-3 hours. Caffeine is quickly absorbed from the gastrointestinal tract and is distributed throughout the body. Caffeine is almost completely metabolized in the liver by oxidation and demethylation as metabolites, which are excreted in the urine. T1 / 2 is 4-9 hours.
Indications
- headache - migraine - toothache - neuralgia - muscular and rheumatic pain - painful menstruation - sore throat - to reduce fever and symptomatic treatment of colds and flu.
Contraindications
- hypersensitivity to the components of the drug - pronounced hepatic dysfunction - pronounced renal dysfunction - arterial hypertension - glaucoma - sleep disorders - epilepsy - children under 12 years old - sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (contains sorbitol). The drug should be used with caution in benign hyperbilirubinemia (includingGilbert's syndrome), viral hepatitis, alcoholic liver damage, deficiency of glucose-6-phosphate dehydrogenase, alcoholism.
Use during pregnancy and lactation
The drug Solpadeine Fast contains caffeine. When taking caffeine, there is a high risk of having a baby with a low body weight, the risk of spontaneous abortion. Once in the breast milk, caffeine can have a stimulating effect on the baby being breastfed. Solpadeine Fast should not use the drug during pregnancy and lactation (breastfeeding).
Dosage and administration
Tablets Solpadeine Fast before ingestion should be dissolved in at least 100 ml (half a cup) of water. Adults (including the elderly) and children over 12 years old are prescribed 1-2 tab. 3-4 times / day if necessary. The interval between doses of at least 4 hours. The maximum single dose - 2 tab., The maximum daily dose - 8 tab. The drug is not recommended for more than 5 days when prescribed as an anesthetic and more than 3 days as an antipyretic without the appointment and observation of a doctor. An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of a physician.
Side effects
In recommended doses, the drug is usually well tolerated. Determination of the frequency of side effects: very often (1/10), often (1/100 and less than 1/10), infrequently (1/1000 and less than 1/100), rarely (1/10 000 and less than 1/1000), very rarely (1/100 000 and less than 1/10 000). The following side effects were detected spontaneously during the post-registration use of the drug. Allergic reactions: very rarely - skin rash, angioedema (angioedema), Stevens-Johnson syndrome, anaphylaxis. On the part of the hematopoietic system: very rarely - leukopenia, thrombocytopenia, methemoglobinemia, agranulocytosis, hemolytic anemia. On the part of the respiratory system: very rarely - bronchospasm (in patients with hypersensitivity to acetylsalicylic acid and NSAIDs). On the part of the hepatobiliary system: very rarely - abnormal liver function. With prolonged use in high doses increases the likelihood of hepatotoxic action, nephrotoxic action and pancytopenia. Possible: dyspeptic phenomena (including nausea, epigastric pain), irritability, dizziness, sleep disturbances, tachycardia. With the consumption of sodium bicarbonate in high doses, the development of disorders on the side of the gastrointestinal tract, including belching, nausea; may also develop hypernatremia.With excessive use of caffeine-containing foods (including tea, coffee) while taking the drug may cause anxiety, anxiety, irritability, insomnia, headache, disorders of the digestive system, tachycardia, cardiac arrhythmia. If you experience any of these side effects, you should stop taking the drug and immediately consult a doctor.
Overdose
Symptoms caused by paracetamol: within 24 hours, pallor of the skin, nausea, vomiting, anorexia, stomach pain are possible; after 1-2 days, signs of liver damage may appear (tenderness in the area of the liver, increased activity of liver enzymes). Possible violation of carbohydrate metabolism and signs of metabolic acidosis. In adult patients, liver damage develops after taking more than 10 g of paracetamol. In the presence of factors that affect the toxicity of paracetamol for the liver, liver damage is possible after taking paracetamol in an amount of 5 g or more. In severe cases of overdose as a result of liver failure, encephalopathy, bleeding, hypoglycemia, swelling of the brain, or even death, can develop. Perhaps the development of acute renal failure with acute tubular necrosis, characteristic signs of which is pain in the lumbar region, hematuria, proteinuria, with severe liver damage may be absent. There are reports of cases of cardiac arrhythmias, pancreatitis. Treatment: in case of suspected overdose, even in the absence of pronounced first symptoms, it is necessary to stop the use of the drug and seek medical help immediately. For 1 hour after overdose, gastric lavage and enterosorbent administration (activated carbon, polyphepan) are recommended. The concentration of paracetamol in the blood plasma should be determined, but not earlier than 4 hours after the overdose (the earlier results are unreliable). The introduction of acetylcysteine within 24 h after overdose. The maximum protective effect is provided during the first 8 hours after the overdose, with time the effectiveness of the antidote drops sharply. If necessary, introduce acetylcysteine in / in. In the absence of vomiting, methionine may be used before the patient enters the hospital.The need for additional therapeutic measures (the further introduction of methionine, in / in the introduction of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after taking it. Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or a specialized department of liver diseases. Symptoms due to caffeine: epigastric pain, vomiting, frequent urination, tachycardia, arrhythmia, CNS stimulation (insomnia, anxiety, agitation, anxiety, increased neuro-reflex excitability, tremor and convulsions). However, it should be borne in mind that the appearance of clinically significant symptoms of caffeine overdose when taking this drug is always associated with severe liver damage in the background of paracetamol overdose. Treatment: no specific antidote. Treatment includes supportive measures, such as drinking plenty of fluids and maintaining vital signs. For 1 to 4 hours after an overdose, the intake of activated carbon is recommended. To reduce the effects of caffeine overdose on the functions of the central nervous system, the introduction of sedative IV preparations is recommended.
Interaction with other drugs
When taken regularly for a long time, the drug enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic administration of a single dose of the drug does not have a significant effect on the effect of indirect anticoagulants. The drug enhances the action of MAO inhibitors. Barbiturates, carbamazepine, phenytoin, primidone, ethanol, rifampicin, phenylbutazone, St. John's wort preparations, tricyclic antidepressants, and other microsomal oxidation inductors increase the production of hydroxylated active metabolites, causing the possibility of the development of severe damage to the liver in small overdose of the outfit. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic action. Under the influence of paracetamol, the time of chloramphenicol excretion is increased 5 times. Caffeine accelerates the absorption of ergotamine.The simultaneous intake of paracetamol and alcohol increases the risk of hepatotoxic effects and acute pancreatitis. Metoclopramide and domperidone increase, and Kolestiramin reduces the rate of absorption of paracetamol. The drug can reduce the effectiveness of uricosuric drugs.
special instructions
If while taking the drug improvement is not observed or the headache becomes permanent, you should consult a doctor. While taking the drug is not recommended excessive consumption of caffeine-containing foods (including tea, coffee), because This can lead to agitation, irritability, sleep disturbances, headaches, disorders of the gastrointestinal tract, tachycardia, cardiac arrhythmias. In the case of prolonged use in high doses, control of the blood picture is necessary. Glutathione deficiency due to eating disorders, cystic fibrosis, HIV infection, starvation, exhaustion causes the possibility of severe liver damage with small overdose of paracetamol (5 g or more). The drug should not be taken simultaneously with other paracetamol-containing drugs. In order to avoid toxic damage to the liver, paracetamol should not be combined with the intake of alcoholic beverages, as well as be taken by persons prone to chronic alcohol consumption. Patients suffering from atonic bronchial asthma, pollinosis, have an increased risk of developing allergic reactions. Patients observing salt-free or low-salt diet, when calculating the daily salt intake should consider the sodium content in the tablet (427 mg). When conducting tests for the determination of uric acid and blood glucose levels should inform the doctor about taking the drug. Solpadeine Fast can change the results of doping control tests of athletes. With the consumption of sodium bicarbonate in high doses, the development of disorders on the side of the gastrointestinal tract, including belching, nausea; may also develop hypernatremia. In such cases, it is necessary to control the water-electrolyte balance and apply the appropriate tactics of patient management.