Instructions for Sedalgin plus tablets blister No. 20
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, colloidal anhydrous silicon dioxide, talc, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round flat tablets of white or almost white color with a bevel and a notch on one side, 13 mm in diameter.
Pharmacotherapeutic group
Agents acting on the central nervous system. Other analgesics and antipyretics. ATC code N02B B52.
Pharmacological properties
Pharmacodynamics
Metamizole sodium is a pyrazolone derivative, belongs to the group of non-narcotic analgesics. It has a pronounced analgesic and antipyretic effect. It does not have a hypnotic effect, does not suppress the respiratory center, does not lead to euphoria and addiction. Metamizole exhibits analgesic effects of both the peripheral type, inhibiting the synthesis of endogenous algogens, and the central type, inhibiting the activity of nociceptive neurons in the dorsal roots of the spinal cord. An important role in the pharmacological effects of metamizole is played by its ability to inhibit the activity of cyclooxygenase-1 and especially cyclooxygenase-2, which causes a decrease in the synthesis of prostaglandins. Metamizole also exhibits a membrane-stabilizing effect.
Caffeine has a slight stimulating activity on the central nervous system (CNS). The main effect of caffeine is vasoconstriction, which affects certain types of headache and hypotension. It is believed that in some painful conditions it has a direct analgesic effect. Caffeine potentiates the effect of metamizole, promoting its penetration into the brain tissue. When combining caffeine with analgesics, a synergistic effect occurs.
Thiamine hydrochloride (vitamin B1) has many functions in the body's metabolism. It is a part of a number of enzymes and is the main part of the cocarboxylase molecule, which catalyzes the burning of pyruvic acid and facilitates the breakdown of carbohydrates. Through phosphorylation, thiamine is converted into its 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. By promoting 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 exhibits some analgesic effect.
Due to the presence of metamizole, which acts on enzymes responsible for drug metabolism, the pharmacokinetics of individual components used in the complex differ to some extent from the pharmacokinetics of the drugs when used alone.
Pharmacokinetics
The combined drug Sedalgin Plus is absorbed quickly, and its therapeutic effect manifests itself after 1 hour.
Indication
Symptomatic treatment of pain syndrome 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, polyneuropathies); dysmenorrhea.
Contraindication
Hypersensitivity to the active substances or to any excipients included in the composition of the medicinal product; hypersensitivity to pyrazolone or pyrazolidine derivatives (butadione, tribuzone, antipyrine) and xanthine; children under 12 years of age; elderly age; 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 arterial 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 with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after stopping the use of MAOIs.
Interaction with other medicinal products and other types of interactions
Ethanol enhances the analgesic effect of the drug, and caffeine reduces the effect of central nervous system depression. The simultaneous use of other hepatotoxic drugs and drugs that suppress hematopoiesis should be avoided. Due to the induction of liver enzymes, the activity of coumarin anticoagulants decreases. Tempidon enhances and prolongs its effect. The therapeutic effect is enhanced by tricyclic antidepressants, oral contraceptives, allopurinol as a result of enzyme inhibition and slowing down the biotransformation of the drug. Does not affect the effect of uterokinetic and uterotonic drugs. When used simultaneously with nonsteroidal anti-inflammatory drugs, it enhances their effect and toxicity in relation to the gastrointestinal tract and hematopoiesis.
The combination of the drug Sedalgin Plus with other drugs requires special attention, because metamizole, which is part of its composition, is an enzyme inducer.
When used simultaneously with other antipyretics, analgesics and anti-inflammatory drugs, the risk of allergic reactions and side effects increases.
Metamizole may reduce the antithrombotic effect of low-dose acetylsalicylic acid when used concomitantly. Therefore, metamizole should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.
With the concomitant use of the drug Sedalgin Plus and drugs that suppress bone marrow function (drugs containing gold salts, antitumor drugs, chloramphenicol, etc.), there is a possibility of damage to leukocytes.
Neuroleptics and tranquilizers potentiate the analgesic effect of Sedalgin Plus. Concomitant use with chlorpromazine may lead to hypothermia.
Some antidepressants, oral contraceptives, allopurinol slow down the breakdown of metamizole and thus may increase the toxicity of Sedalgin Plus.
The drug reduces the concentration of cyclosporine A in the blood, so it can be dangerous in the presence of transplants.
Concomitant use with sympathomimetics may lead to central nervous system (CNS) excitation.
Caffeine can enhance the effect of ergotamine; reduce the effect of opioid analgesics, anxiolytics, hypnotics and sedatives. Caffeine is an antagonist of anesthetics and other drugs that depress the central nervous system, and a competitive antagonist of adenosine drugs. Enhances the absorption, action and toxicity of glycosides. When used with xanthine derivatives, psychostimulants - potentiates their effects. It is possible to increase the thyroid effect when caffeine is used simultaneously with thyroid-stimulating drugs. Cimetidine, isoniazid enhance the effect of caffeine. Caffeine reduces the concentration of lithium in the blood.
Application features
Do not exceed the recommended doses of the drug.
The drug should be used with caution in cases of impaired renal and/or hepatic function; in the presence of gastric and duodenal ulcer in the acute stage; in stomach diseases (achalasia, gastroesophageal reflux, pyloric stenosis), inflammatory bowel diseases, including nonspecific ulcerative colitis and Crohn's disease; in prostatic hyperplasia; in chronic bronchitis and bronchospasm in the presence of hyperthyroidism; in severe food or drug allergies and other atopic disorders, in cardiac arrhythmias, ischemic heart disease, severe arterial hypotension, cardiovascular failure, severe headache of unknown etiology, in a long-term alcoholic history.
Do not use the drug to relieve acute abdominal pain (until the cause is determined). Since metamizole sodium has anti-inflammatory and analgesic properties, the drug may mask signs of infection, symptoms of non-infectious diseases and complications with pain syndrome, which may complicate their diagnosis.
The drug may affect the psychophysical state of patients when used simultaneously with alcohol and medications that depress the central nervous system. Given this, alcohol consumption should be avoided when using the drug.
The drug can have an effect on the central nervous system, which can manifest as both excitation and inhibition of nervous activity, as well as on blood pressure and stimulate or inhibit cardiac activity.
Do not use simultaneously with other nonsteroidal anti-inflammatory drugs (NSAIDs) and metamizole.
When using analgesics every other day or more often, the appearance or intensification of an already existing headache after prolonged treatment with analgesics (more than 3 months) is possible. Headache caused by excessive use of analgesics should not be treated by increasing the dose. In such cases, treatment should be discontinued after consulting a doctor.
When using the drug, you should avoid excessive consumption of coffee, strong tea, other tonic drinks and medications containing caffeine. This may cause sleep problems, tremors, tension, irritability, and palpitations.
When used in children, constant medical supervision is required. It is necessary to monitor the qualitative and quantitative composition of peripheral blood.
When prescribing a longer course of treatment (more than 7 days), it is necessary to monitor the blood picture/monitor the qualitative and quantitative composition of peripheral blood (especially the leukocyte formula), kidney and liver function.
Patients should be warned before starting treatment that if unmotivated chills, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, asthenia, vaginitis or proctitis develop, the drug should be immediately discontinued. The drug should also be discontinued if rashes appear on the skin and mucous membranes. If these symptoms appear, you should immediately consult a doctor.
Excipients
This medicine contains wheat starch. This medicine can be used in patients with celiac disease. Patients with wheat allergy (other than celiac disease) should not use this medicine.
Impact on laboratory tests
Metabolites of metamizole sodium can change the color of urine to red, which is of no clinical significance.
Caffeine may affect the results of tests using adenosine or dipyridamole. Therefore, Sedalgin Plus should not be used for at least 12 hours before the tests.
Caffeine may cause a false increase in plasma uric acid, as determined by the Bittner method.
Caffeine may lead to a slight increase in the concentration of 5-hydroxyindoleacetic acid, vanillylmandelic acid and catecholamines in the urine, which may cause false-positive results in the diagnosis of pheochromocytoma and neuroblastoma.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment, caution should be exercised when driving vehicles and working with complex mechanisms due to the possibility of developing adverse reactions from the nervous system.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy, as its components may negatively affect the fetus (cause renal dysfunction and narrowing of the ductus arteriosus).
The drug is contraindicated during breastfeeding, as its components penetrate into breast milk.
Method of administration and doses
Sedalgin Plus tablets should be taken orally, after meals, with water.
Recommended dose for adults and children aged 16 and over:
1 tablet 3 times a day.
The maximum dose should not exceed 6 tablets per day.
Recommended dose for children aged 12 to 16 years:
½–1 tablet 3 times a day.
The maximum dose should not exceed 4 tablets per day.
The course of treatment with Sedalgin Plus is no longer than 3 days.
Children
Do not prescribe to children under 12 years of age.
Overdose
In case of accidental ingestion of a large number of tablets, the following clinical symptoms are observed: bullous-urticarial and petechial, sometimes morbilliform and typhoid rash; in some cases, anaphylactic shock occurs; hallucinations, tremor, Meniere-like phenomena, coma and tonic-clonic convulsions, nausea, vomiting, agitation, insomnia, headache, dizziness, tinnitus, palpitations, weakness, melena and hematemesis, in more severe cases - oliguria to anuria, epileptiform convulsions, agranulocytosis, aplastic or hemolytic anemia, hemorrhagic diathesis.
In case of an overdose of metamizole, hypothermia, a pronounced 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.
Large doses of caffeine can cause epigastric pain, effects on diuresis, rapid breathing, extrasystole, tachycardia or cardiac arrhythmia, and effects on the central nervous system (dizziness, insomnia, nervous excitement, irritability, affective state, anxiety, tremor, convulsions).
Treatment. General measures to reduce absorption: administration of agents that provoke vomiting, gastric lavage, use of activated charcoal, laxatives. Symptomatic treatment is carried out. There is no specific antidote.
Adverse reactions
The following adverse reactions may occur.
From the side of the central nervous system: insomnia, dizziness, increased excitability, anxiety, restlessness, mild tremor, visual impairment, headache, convulsions, increased reflexes, tachypnea. With prolonged uncontrolled use of high doses of the drug - habituation (weakening of the analgesic effect), dependence, with sudden withdrawal of the drug after prolonged use - increased effect on the central nervous system, increased fatigue, drowsiness, muscle tension, depression.
On the part of the immune system: hypersensitivity reactions, including rashes on the skin and mucous membranes; conjunctivitis, itching, redness, urticaria, angioedema, bronchospasm, anaphylactic shock, Lyell's syndrome, Stevens-Johnson syndrome, other allergic reactions.
Cardiovascular system: chest tightness, arrhythmias, tachycardia, palpitations (flutter), increase/decrease in blood pressure.
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.
On the part of the urinary system: development of acute renal failure, interstitial nephritis, oliguria, anuria, increased diuresis/increased frequency of urination, increased creatinine clearance, increased excretion of sodium and calcium, proteinuria, staining of urine in red.
Other: nasal congestion.
Effect on laboratory test results: hypo- or hyperglycemia; effect on laboratory tests (see section "Special instructions").
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after a medicinal product has been authorised is important. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report suspected adverse reactions through national reporting systems.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС in places inaccessible to children.
Packaging
10 tablets in a blister; 2 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
Balkanfarma-Dupnytsia JSC.
Location of the manufacturer and its business address
3 Samokovskoe Shose St., Dupnitsa, 2600, Bulgaria.
