Sedalgin Plus 20 tablets — Made in Bulgaria — Free Delivery

(Sedalgin Plus )
Sedalgin Plus 20 tablets — Made in Bulgaria — Free Delivery
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Balkanpharma-Dupnitsa AD Brand: Balkanpharma-Dupnitsa AD

Pharmacological properties

Pharmacodynamics. Metamizole sodium is a pyrazolone derivative, which belongs to the group of non-narcotic analgesics. it has a pronounced analgesic and antipyretic effect. does not show a hypnotic effect, does not depress the respiratory center, does not lead to euphoria and addiction. metamizole has an analgesic effect of both the peripheral type, suppressing the synthesis of endogenous algogens, and of the central type, suppressing 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 suppress the activity of tsog-1 and especially tsog-2, which leads to a decrease in the synthesis of prostaglandins. metamizole also has a membrane stabilizing effect.
Caffeine has little CNS stimulatory activity. The main effect of caffeine is vasoconstrictor, which affects certain types of headache and hypotension. It is believed to have a direct analgesic effect in some painful conditions. Caffeine potentiates the action of metamizole, promoting its penetration into the brain tissue. When combining caffeine with analgesics, a synergistic effect occurs.
Thiamine hydrochloride (vitamin B1) has multifaceted functions in the body's metabolism. It is 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. By phosphorylation, thiamine is converted into an active form - thiamine pyrophosphate, which as a coenzyme participates in the pentose phosphate cycle, decarboxylation of α-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. When used in high doses, it has some analgesic effect.
Due to the presence of metamizole, which acts on the enzymes responsible for the metabolism of preparations, the pharmacokinetics of the individual components used in the complex differs to some extent from the pharmacokinetics of preparations when used independently.
Pharmacokinetics. The combined preparation Sedalgin plus is rapidly absorbed, and its therapeutic effect is manifested after 1 hour.

Indications

Symptomatic treatment of pain syndrome with:
  • migraines, tension headaches;
  • inflammatory and degenerative diseases of the musculoskeletal system;
  • postoperative conditions;
  • diseases of the peripheral nervous system (radiculitis, plexitis, neuritis, neuralgia, polyneuritis, polyneuropathy);
  • dysmenorrhea.

Application

Sedalgin plus tablets are taken orally after meals with water.
Recommended dose for adults and children over the age of 16: 1 tablet 3 times a day.
The maximum dose should not exceed 6 tablets per day.
Recommended dose for children aged 12–16 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 more than 3 days.

Contraindications

Hypersensitivity to the active or auxiliary substances that make up the preparation; hypersensitivity to pyrazolone derivatives (butadione, tribuzon, antipyrine) and xanthine; children under 12 years of age, old age, pregnancy and lactation; ba; leukopenia; anemia; thrombocytopenia; cytostatic or infectious neutropenia, agranulocytosis, hepatic porphyria; congenital deficiency of glucose-6-phosphate dehydrogenase; marked increase in blood pressure, organic diseases of the cardiovascular system, including severe atherosclerosis, severe arterial disease, acute myocardial infarction; decompensated heart failure, paroxysmal tachycardia; glaucoma; severe renal and hepatic impairment; increased excitability, insomnia; suspicion of acute surgical pathology, allergic diseases, idiosyncrasy; do not use simultaneously with monoamine oxidase inhibitors (MAO) and within 2 weeks after stopping the use of MAO inhibitors.

Side effects

Adverse reactions to the preparation may be noted:
  • from the side of the central nervous system: insomnia, dizziness, increased excitability, anxiety, anxiety, slight tremor, visual impairment, headache, seizures, increased reflexes, tachypnea. With prolonged uncontrolled use of the preparation in high doses, addiction (a decrease in the analgesic effect), dependence are possible, therefore, with a sudden withdrawal of the preparation after prolonged use, there is an increase in the effect on the central nervous system, increased fatigue, drowsiness, muscle tension, depression.
  • hypersensitivity reactions, including rash on the skin and mucous membranes; conjunctivitis, itching, redness, urticaria, angioedema, bronchospasm, anaphylactic shock, Lyell and Stevens-Johnson syndrome, other allergic reactions;
  • on the part of the cardiovascular system: a feeling of compression in the chest, arrhythmias, tachycardia, palpitation (flutter), increase / decrease in blood pressure;
  • on the part of the hematopoietic system: with prolonged use, transient leukopenia, granulocytopenia, agranulocytosis, hemolytic and aplastic anemia, purpura, thrombocytopenia are possible;
  • from the digestive and hepatobiliary systems: loss of appetite, nausea, gastrointestinal discomfort, vomiting, diarrhea, cholestasis, jaundice, liver dysfunction, hepatitis, exacerbation of gastritis and stomach ulcers;
  • from the urinary system: development of acute renal failure, interstitial nephritis, oliguria, anuria, increased diuresis / increased urinary frequency, increased creatinine clearance, increased sodium and calcium excretion, proteinuria, red staining of urine;
  • others: nasal congestion;
  • influence on the results of laboratory tests: hypo- or hyperglycemia; influence on laboratory tests (see SPECIAL INSTRUCTIONS).

Special instructions

The recommended dose of the preparation should not be exceeded.
Use with caution in case of impaired renal and / or liver function; in the presence of gastric and duodenal ulcers in the history of stomach diseases (achalasia, gastroesophageal reflux, stenosis of the pyloric stomach), inflammatory bowel diseases, including ulcerative colitis and Crohn's disease; with prostatic hyperplasia; with chronic bronchitis and bronchospasm in the presence of hyperthyroidism; in case of cardiac arrhythmias, ischemic heart disease, severe arterial hypotension, cardiovascular insufficiency, severe headache of unknown etiology, with a long alcohol history.
Do not use for acute abdominal pain (until the cause is clarified). Since metamizole sodium has anti-inflammatory and analgesic properties, the preparation can mask signs of infection, symptoms of non-infectious diseases and complications with pain syndrome, and can complicate their diagnosis.
The preparation can affect the psychophysical state of patients when used simultaneously with alcohol and preparations that depress the central nervous system. Considering this, when using the preparation, one should refrain from drinking alcoholic beverages.
The preparation can affect the central nervous system - both excitement and inhibition of nervous activity, as well as blood pressure, and stimulate or suppress the activity of the heart.
Do not use concomitantly with other NSAIDs and metamizole.
When using analgesics every other day or more, the appearance or increase in the severity of an existing headache may occur after prolonged treatment with analgesics (more than 3 months). Headache caused by overuse of analgesics should not be treated with dose escalation. In such cases, treatment should be discontinued after consulting a doctor.
When using the preparation, avoid excessive consumption of coffee, strong tea, other tonic drinks and medicines containing caffeine. It can cause sleep problems, tremors, tension, irritability, palpitations.
When used in children, constant medical supervision should be carried out. It is necessary to control the qualitative and quantitative composition of peripheral blood.
Regular long-term use of the preparation is not recommended due to the myelotoxicity of metamizole sodium salt.
When prescribing a longer course of treatment (more than 7 days), it is necessary to control the blood picture / qualitative and quantitative composition of peripheral blood (especially leukocyte count), 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 preparation should be immediately discontinued. Also, the use of the preparation must be discontinued when a rash appears on the skin and mucous membranes. If you experience these symptoms, you should see a doctor immediately.
Excipients. Sedalgin plus contains wheat starch, so the use of this preparation is dangerous for patients with celiac disease (gluten enteropathy).
Impact on laboratory research. Metamizole sodium metabolites can change the color of urine to red, which has no clinical significance.
Caffeine can interfere with test results using adenosine or dipyridamole. Therefore, Sedalgin plus should not be used for at least 12 hours before the tests.
Caffeine can cause a false increase in plasma uric acid levels as measured by the Bittner method.
Caffeine can cause mild increases in urinary 5-hydroxyindoleacetic acid (5-HIAA), vanillyl mandelic acid (VMA), and catecholamines, which can lead to false positive results for pheochromocytoma and neuroblastoma.
Use during pregnancy and lactation. The preparation is not used during pregnancy or lactation.
The ability to influence the reaction rate when driving or working with other mechanisms. During treatment, care should be taken when driving vehicles and working with mechanisms due to the possibility of adverse reactions from the nervous system.
Children. Not prescribed for children under 12 years of age.

Interactions

Ethanol enhances the analgesic effect of the preparation, and caffeine reduces the effect of inhibiting the central nervous system. the simultaneous use of other hepatotoxic preparations and agents that inhibit hematopoiesis should be avoided. due to the induction of liver enzymes, the activity of coumarin anticoagulants decreases. tempidone enhances and lengthens its action. the therapeutic effect is enhanced by tricyclic antidepressants, oral contraceptives, allopurinol as a result of enzyme inhibition and slowing down of the biotransformation of the preparation. the preparation does not affect the effect of uterokinetic and uterotonic preparations. when used simultaneously with NSAIDs, it enhances their effect and toxicity in relation to the gastrointestinal tract and hematopoiesis.
The combination of Sedalgin plus with other preparations requires special attention, since metamizole, which is part of the preparation, is an enzyme inducer. When used simultaneously with other antipyretic, analgesic and anti-inflammatory preparations, the risk of developing allergic reactions and side effects increases. With the combined use of Sedalgin plus and preparations that inhibit the function of the bone marrow, there is a possibility of damage to white blood cells. Antipsychotics and tranquilizers potentiate the analgesic effect of Sedalgin plus. Concomitant use with chlorpromazine can lead to hypothermia.
Some antidepressants, oral contraceptives, allopurinol slow down the breakdown of metamizole and thus may increase the toxicity of the preparation.
The preparation reduces the concentration of cyclosporin A in the blood, therefore it can be dangerous in the presence of transplants.
Simultaneous use with sympathomimetics can lead to excitation of the central nervous system.
Caffeine can enhance the effects of ergotamine; reduce the effect of opioid analgesics, anxiolytics, hypnotics and sedatives. Caffeine is an antagonist of anesthetics and other preparations that depress the central nervous system, and a competitive antagonist of adenosine preparations. Enhances absorption, action and toxicity of glycosides. When used with xanthine derivatives, psychostimulants - potentiation of their effects. An increase in the thyroid effect is possible with the simultaneous use of caffeine with thyroid-stimulating agents. Cimetidine, isoniazid enhance the effect of caffeine. Caffeine lowers the concentration of lithium in the blood.

Overdose

If a large number of tablets are accidentally taken, the following clinical symptoms are noted: bullous-urticarial and petechial, sometimes morbillous and typhoid rash; in some cases, anaphylactic shock, hallucinations, tremors, less-like phenomena, coma and tonic-clonic seizures, nausea, vomiting, agitation, insomnia, headache, dizziness, tinnitus, palpitations, weakness, melena and hematemesis, in more severe cases cases - oliguria, up to anuria, epileptoform convulsions, agranulocytosis, aplastic and hemolytic anemia, hemorrhagic diathesis.
In case of an overdose of metamizole, hypothermia, a marked decrease in blood pressure, dysphagia, shortness of breath, gastralgia / gastritis, weakness, drowsiness, delirium, hemorrhagic syndrome, acute renal and hepatic failure, paralysis of the respiratory muscles are also possible.
High doses of caffeine can cause pain in the epigastric region, the effect on diuresis, rapid breathing, extrasystole, tachycardia or cardiac arrhythmia, the effect on the central nervous system (dizziness, insomnia, nervous agitation, irritability, emotional state, anxiety, tremor, convulsions).
Treatment. General measures to reduce absorption: the introduction of preparations that provoke vomiting, gastric lavage, intake of activated charcoal, laxatives. Symptomatic treatment is carried out. There is no specific antidote.

Storage conditions

In its original packaging at a temperature not exceeding 25 ° c.

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