Sedalgyn Plus (metamizole, caffeine, thiamine) tablets №10

Description

Sedalgyn Plus (metamizole, caffeine, thiamine) tablets №10

Composition

active ingredients: metamizole sodium, caffeine, thiamine hydrochloride;

1 tablet contains metamizole sodium 500 mg, caffeine 50 mg, thiamine hydrochloride 38.75 mg;

excipients: microcrystalline cellulose, wheat starch, gelatin, anhydrous colloidal silicon dioxide, talc, magnesium stearate.

Dosage form

Tablets.

Basic physical and chemical properties: flat round tablets of white or almost white color with a chamfer and a notch on one side, 13 mm in diameter.

Pharmacological group

Agents acting on the central nervous system. Other analgesics and antipyretics.
ATX code N02B B52.

Pharmacological properties

Metamizole sodium – a derivative of pyrazolone, belongs to the group of non-narcotic analgesics. It has a clear analgesic and antipyretic effect. Does not show a soporific effect, does not depress the respiratory center, does not lead to euphoria and addiction. Metamizole has an analgesic effect of both peripheral type, inhibiting the synthesis of endogenous algogens, and the central type, inhibiting the activity of nociceptive neurons in the posterior roots of the spinal cord. An important role for the pharmacological effects of metamizole is its ability to inhibit the activity of cyclooxygenase-1 and especially cyclooxygenase-2, which causes a decrease in prostaglandin synthesis. Metamizole also has a membrane-stabilizing effect.

Caffeine has little stimulating activity against the central nervous system (CNS). The main effect of caffeine is vasoconstrictor, which affects certain types of headaches and hypotension. It is believed that in some painful conditions it has a direct analgesic effect. Caffeine potentiates the action of metamizole, promoting its penetration into brain tissue. When combining caffeine with analgesics there is a synergistic effect.

Thiamine hydrochloride (vitamin B1) has multifaceted functions in the body’s metabolism. It is part of a number of enzymes and is a major part of the cocarboxylase molecule, which catalyzes the combustion of pyruvic acid and facilitates the breakdown of carbohydrates. Through phosphorylation, thiamine is converted into the active form – thiamine pyrophosphate, which as a coenzyme participates in the pentose phosphate cycle, decarboxylation of alpha-keto acids and the formation of acetyl-coenzyme-A in the Krebs cycle. In the nervous system, about 90% of thiamine is contained in the mitochondria of axons, and 10% is included in the membranes of axons. Contributing to the decarboxylation of pyruvic acid, it has a positive effect on the elimination of inflammatory processes in the nervous system. Thiamine facilitates the synthesis of the mediator acetylcholine and inhibits the enzyme that breaks it down – cholinesterase, thus improving the conduction of nerve impulses. Used in high doses, it has some analgesic effect.
Due to the presence of metamizole, which acts on the enzymes responsible for drug metabolism, the pharmacokinetics of the individual components used in the complex, to some extent differs from the pharmacokinetics of drugs when used alone.

Indication for the use of Sedalgyn Plus

Symptomatic treatment of pain in:

• migraine, tension headache;
• inflammatory and degenerative diseases of the musculoskeletal system;
• postoperative conditions;
• diseases of the peripheral nervous system (radiculitis, plexitis, neuritis, neuralgia, polyneuritis, polyneuropathy);
• dysmenorrhea.

Contraindication

Hypersensitivity to the active substances or to any of the excipients; hypersensitivity to pyrazolone or pyrazolidine derivatives (butadione, tribuzon, antipyrine) and xanthine; children under 12 years; old age; period of pregnancy or breastfeeding; bronchial asthma; leukopenia; anemia; thrombocytopenia; cytostatic or infectious neutropenia, agranulocytosis, hepatic porphyria; congenital deficiency of glucose-6-phosphate dehydrogenase; pronounced increase in blood pressure, organic diseases of the cardiovascular system, including severe atherosclerosis, severe hypertension, acute myocardial infarction; uncompensated heart failure, paroxysmal tachycardia; glaucoma; severe renal and hepatic failure; increased excitability, insomnia; suspicion of acute surgical pathology; allergic diseases, idiosyncrasy. Do not use together with monoamine oxidase (MAO) inhibitors and for 2 weeks after discontinuation of MAO inhibitors.

Method of application and dosage

Sedalgyn Plus tablets should be taken orally, after meals, with water.

• Recommended dose for adults and children over 16 years of age:
  1 tablet 3 times a day.
  The maximum dose should not exceed 6 tablets per day.
• Recommended dose for children 12 to 16 years of age:
  ½-1 tablet 3 times a day.
  The maximum dose should not exceed 4 tablets per day.

The course of treatment with Sedalgyn Plus is no longer than 3 days.

Children

Do not administer to children under 12 years of age.

Overdose

At casual reception of a large number of Sedalgyn Plus tablets the following clinical symptoms are observed: bullous-urticarial and petechial, sometimes measles and typhoid rash; in some cases there is an anaphylactic shock; hallucinations, tremor, menisci, coma and tonic-clonic convulsions, nausea, vomiting, agitation, insomnia, headache, dizziness, tinnitus, palpitations, weakness, melena and hematemesis, in more severe cases – oliguria to anupuria, epiphora convulsions, agranulocytosis, aplastic or hemolytic anemia, hemorrhagic diathesis.

Hypothermia, marked decrease in blood pressure, dysphagia, shortness of breath, gastralgia / gastritis, weakness, drowsiness, delirium, hemorrhagic syndrome, acute renal and hepatic failure, and paralysis of the respiratory muscles are also possible with metamizole overdose.

Large doses of caffeine can cause epigastric pain, effects on diuresis, rapid breathing, extrasystole, tachycardia or cardiac arrhythmia, effects on the central nervous system (dizziness, insomnia, nervous excitement, irritability, affect, anxiety, tremor, convulsions).

Treatment. General measures to reduce absorption: the introduction of agents that provoke vomiting, gastric lavage, the use of activated charcoal, laxatives. Symptomatic treatment is performed. There is no specific antidote.

Side effects

The following side effects may occur:

• From the central nervous system: insomnia, dizziness, irritability, anxiety, restlessness, mild tremor, visual disturbances, headache, seizures, increased reflexes, tachypnea. With long-term uncontrolled use of high doses of the drug – addiction (weakening of the analgesic effect), dependence, with sudden withdrawal of the drug after prolonged use – increased impact on the central nervous system, fatigue, drowsiness, muscle tension, depression.
• From the immune system: hypersensitivity reactions, including rashes on the skin and mucous membranes; conjunctivitis, pruritus, redness, urticaria, angioneurotic edema, bronchospasm, anaphylactic shock, Lyell’s syndrome, Stevens-Johnson syndrome, and other allergic reactions.
• From the cardiovascular system: chest tightness, arrhythmia, tachycardia, palpitations (flutter), increase / decrease in blood pressure.
• From the hematopoietic system: temporary leukopenia; granulocytopenia, agranulocytosis, hemolytic and aplastic anemia, purpura, thrombocytopenia.
• From the digestive and hepatobiliary system: loss of appetite, nausea, gastrointestinal discomfort, vomiting, diarrhea, cholestasis, jaundice, liver dysfunction, hepatitis, exacerbation of gastritis and gastric ulcer.
• From the urinary system: development of acute renal failure, interstitial nephritis, oliguria, anuria, increased diuresis / increased urination, increased creatinine clearance, increased sodium and calcium excretion, proteinuria, red urine.
• Others: nasal congestion.
• Influence on the results of laboratory tests: hypo- or hyperglycemia; influence on laboratory researches.
• Reports of suspected adverse reactions
  Reporting suspected adverse reactions after drug registration is important. This makes it possible to continue monitoring the benefit / risk balance of the medicinal product. Healthcare professionals should report suspected adverse reactions through national reporting systems.