Sedalgin Plus is a combined drug with analgesic, antipyretic and anti-inflammatory effect.
Sodium metamizole is a derivative of pyrazolone and has analgesic, antipyretic and mild anti-inflammatory effects, the mechanism of which is associated with inhibition of prostaglandin synthesis by inhibiting cyclooxygenase.
Caffeine has a stimulating effect on the central nervous system (CNS), mainly on the cerebral cortex, respiratory and vasomotor centers. It increases mental and physical performance, reduces sleepiness and fatigue.
Caffeine increases permeability of histohematic barriers and increases bioavailability of non-narcotic analgesics, thus strengthening the therapeutic effect.
Thiamine (vitamin B,) is involved in metabolism and helps to improve nerve-reflex
The pharmacokinetic properties of Sedalgin® Plus depend on the pharmacokinetics of its constituent components.
Assimilation: is rapidly and completely absorbed in the gastrointestinal tract (GIT), reaching maximum concentration (Cmax) in plasma an average of 60-90 minutes after administration.
Distribution:binds to plasma proteins.
Metabolism:is metabolized in the liver. By non-enzymatic hydrolysis, it is cleaved to 4-methylaminoantipyrine with further metabolism via active 4-aminoantipyrine to 4-acetylaminoantipyrine (main metabolite),
Elimation: methazole is excreted through the kidneys, with only 3% of the excreted amount remaining unchanged. About 90% of the major metabolite is excreted through the kidneys and 10% in the bile, with a half-life (T½) of about 10 hours.
absorption: is rapidly and completely absorbed in the gastrointestinal tract. Cmax in blood plasma is determined after 50-75 min.
Distribution:distributes rapidly to all tissues and organs, passes through the blood-brain and placental barriers, excreted in breast milk. Binding to plasma proteins is about 17%.
Metabolism: partially metabolized in liver.
Elimation: Extracted (including as metabolites) mainly by kidneys. T½ is 3-4 hours; in infants, when taken with breast milk, the T½ of caffeine reaches 80 hours.
absorption: is highly absorbed throughout the small intestine. Before absorption, thiamine hydrochloride is released from its bound state by digestive enzymes.
Distribution: The blood concentration of thiamine hydrochloride is relatively low. In plasma predominantly free thiamine is found, in erythrocytes and leukocytes its phosphorus esters. Half of the total amount is found in the transverse-striated muscles (including the myocardium) and about 40% in the internal organs.
Metabolism: Phosphorylation occurs in the liver. The most active phosphorus ester is thiamindiphosphate, which has coenzyme activity. It accumulates mainly in the liver, heart, brain, kidneys, spleen.
Elimation: through the intestines and kidneys.
Myositis, Arthritis and arthritis, Muscle pain (myalgia), Sciatica, Joint pain (arthralgia), Menstrual pain (algodysmenorrhea), Neuritis, Myalgia (muscle pain), Migraine, Neuralgia (nerve pain), Colds, Fever, Fever, Neuralgia, Radiculitis, Toothache, Lumbago, Headache, FluModerate or mild pain syndrome of various genesis: Headache (including migraine), toothache, neuralgia, muscle pain (myalgia), joint pain (arthralgia), radicular syndrome, menstrual pain (algodysmenorrhea). Fever syndrome in “colds” and other infectious-inflammatory diseases (if diagnosed).
1 tablet contains:
the active ingredients:
metamizole sodium 500 mg,
caffeine 50 mg,
thiamine hydrochloride 38.75 mg;
Microcrystalline cellulose 45.75 mg,
wheat starch 11.00 mg,
gelatin 4.00 mg,
colloidal silica 2.50 mg,
talc 12.00 mg,
magnesium stearate 6.00 mg.
How to take, the dosage
Sedalgin® Plus is taken orally. The tablets should be swallowed without chewing and with plenty of water.
The minimum dose sufficient to control pain and fever should be used.
If pain persists or increases in intensity, a physician should be consulted to determine the cause of the symptoms.
Do not use for prolonged periods of time or increase the dose without a physician’s prescription. If the drug is used for a long time, a general blood count (number of blood cells) should be monitored.
A single dose for adults and adolescents over 15 years of age is 1 tablet. The maximum single dose is 2 tablets. Unless otherwise prescribed, a single dose may be taken 2 to 3 times a day. The maximum daily dose is 4 tablets.
When used as an analgesic, the duration of therapy is 1-5 days; when used as a antipyretic it is 1-3 days.
The dose should be reduced in elderly patients because excretion of sodium metabolites may be delayed.
Patients with impaired hepatic function
As the excretion rate of the drug is reduced in impaired hepatic function, repeated high doses of the drug should be avoided. No dose reduction is required if the drug is used for a short time.
Patients with impaired renal function
Patients with impaired general condition and decreased creatinine clearance should reduce the dose because excretion of sodium metabolites may be delayed.
In case of renal impairment the excretion rate of the drug is reduced, repeated administration of high doses of the drug should be avoided. No dose reduction is required if the drug is used for a short time.
Simultaneous use of Sedalgin® ® Plus with other medicinal products requires caution due to the content of sodium metamizole, which may affect the metabolism of the drug when used once and is an enzyme inducer when used for a long time.
Sedalgin® Plus may decrease serum concentrations of cyclosporin and may jeopardize tissue transplantation, so cyclosporine concentrations should be monitored when they are used together.
The concomitant use of Sedalgin® Plus withother non-narcotic analgesics, antipyretics and anti-inflammatory medications may result in mutual enhancement of toxic effects and also increases the risk of hypersensitivity reactions.
Tricyclic antidepressants, oral contraceptives and allopurinol impair the metabolism of sodium metamizole in the liver and increase its toxicity.
Barbiturates, phenylbutazone and other inducers of liver microsomal enzymes weaken the effects of sodium metamizole.
Neuroleptics, sedatives and tranquilizers enhance the analgesic effect of Sedalgin ® Plus. Severe hypothermia may develop when co-administered withchlorpromazine.
Sodium metamizole, by displacing oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin (drugs with high plasma protein binding) from plasma protein binding, increases their effects.
The simultaneous use of with myelotoxic drugs (e.g., gold salt preparations, anticancer drugs, chloramphenicol, etc.) manifestation of hematotoxicity of sodium methamisole is increased, there is a risk of white blood cell damage.
The addition of sodium methamisole to treatment with methotrexate may increase the hematotoxic effect of methotrexate, especially in elderly patients. Therefore, coadministration of these drugs should be avoided.
Tiamazole and sarcolysin when coadministered with sodium metamizole increase the risk of leukopenia.
Codeine, blockers H2-histamine receptors and propranolol increase the effects of sodium metamizole.
Treatment with sodium metamizole should not use radiographic contrast agents, colloidal blood substitutes and penicillin (increased risk of anaphylactic/anaphylactoid reactions).
When used together, sodium metamizole may decrease the effect of acetylsalicylic acid on platelet aggregation. Therefore, this combination should be used with caution when treating patients taking low doses of acetylsalicylic acid for cardioprotection (prevention of thrombosis).
Methamisole sodium may decrease the blood concentration of bupropion, which should be taken into account when using metamisole sodium and bupropion simultaneously.
The simultaneous use of sympathomimetics may cause central nervous system overstimulation.
When treating patients receiving cytostatic drugs, the drug should be taken only under the supervision of a physician.
The following conditions account for the increased risk of hypersensitivity reactions to sodium metamizole:
- bronchial asthma induced by taking analgesics;
- intolerance to analgesics in the form of urticaria or angioedema;
- chronic urticaria;
- alcohol intolerance (hypersensitivity to alcohol) against which, even when taking small amounts of some alcoholic beverages, patients experience sneezing, lacrimation and marked facial redness. Alcohol intolerance may indicate a previously unidentified bronchial asthma syndrome associated with analgesics (aspirin asthma);
- intolerance or hypersensitivity to dyes (e.g., tartrazine) or preservatives (e.g., benzoates);
- anaphylactic or other immunological reactions to other pyrazolones, pyrazolidines and other non-narcotic analgesics (see
If the patient has a history of a particularly high risk of anaphylactoid reactions, the drug should only be given after careful consideration of the risks and benefits. If it is decided to use the drug in such patients a strict medical monitoring of their condition will be necessary, and it is necessary to have means for immediate aid in case of developing anaphylactic/anaphylactoid reactions.
Predisposed patients may develop anaphylactic shock, so patients with bronchial asthma or atopy should be given sodium metamizole with caution.
Serious skin reactions
.Life-threatening skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been described with sodium methamisole. If symptoms of SSD or TEN (such as a progressive skin rash, often with blisters or mucous membrane lesions) occur, treatment should be stopped immediately. Treatment with the drug should never be repeated.
Cutaneous reactions should be closely monitored, especially during the first weeks of treatment.
Agranulocytosis developing during treatment with metamizole is of immune-allergic origin and lasts at least one week. Such a reaction occurs very rarely and can be severe, life-threatening and even fatal. This reaction is not dose-dependent and can occur at any time during treatment.
The drug should be discontinued and the doctor immediately consulted if the following subjective or objective symptoms occur, possibly associated with neutropenia: fever, chills, sore throat, mouth ulcers. In case of neutropenia (neutrophil count < 1500 in mm3), the treatment should be stopped immediately, a detailed general blood test should be performed urgently and the blood count should be continued until the blood count returns to normal values.
If pancytopenia develops, treatment should be stopped immediately and gross blood counts monitored until normal.
You should seek medical attention immediately if subjective or objective symptoms occur during treatment with the drug that suggest abnormal blood changes (e.g., general malaise, infections, persistent fever, bruising, bleeding, pallor).
Isolated hypotensive reactions
The use of sodium metamizole may cause isolated hypotensive reactions. These reactions probably depend on the dose of the drug and occur more frequently after parenteral administration.
Acute abdominal pain
It is unacceptable to use Sedalgin® Plus to relieve acute abdominal pain (until the cause is known).
Hepatic and renal disorders
In patients with hepatic or renal disorders, Cedalgin
sup>® Plus should only be used after consulting a physician because these patients have a reduced rate of excretion of the drug.
Influence on laboratory results
In patients treated with sodium metamizole, changes in the results of laboratory tests performed using Trinder reaction and similar reactions (e.g., analysis of creatinine, triglycerides, HDL cholesterol and uric acid serum concentrations) have been recorded.
Caffeine may interfere with adenosine or dipyridamole test results, so do not take Sedalgin® Plus less than 12 hours before the test.
The wheat starch in Cedalgin® Plus contains a small amount of gluten (considered gluten-free) and is not likely to cause problems in patients with celiac disease. One tablet contains no more than 0.01 micrograms of gluten. Patients with wheat allergies (other than celiac disease) should not take this medication.
Influence on driving and operating ability
There is no evidence that Sedalgin® Plus, when used in the recommended doses, has adverse effects on concentration and reaction time.
However, with high-dose therapy, consideration should be given to the possibility of impaired concentration and reaction time, which may pose a risk in situations where these abilities are particularly important (e.g., driving or operating a moving machine), especially with concomitant alcohol use.
- High sensitivity to sodium metamizole, caffeine, thiamine and/or excipients as well as other pyrazolones (phenazole, propiphenazole, isopropylaminophenazole) or pyrazolidones (phenylbutazone, oxyphenbutazole), including, for example, a history of agranulocytosis when using one of the drugs.
- Disorders of medullary hematopoiesis (e.g., after treatment with cytostatics) or diseases of the hematopoietic environment.
- An history of bronchospasm or other anaphylactic reactions (e.g., urticaria, rhinitis, angioedema) when using analgesic drugs such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen.)
- Acute intermittent hepatic porphyria (risk of exacerbations of porphyria).
- Congenital deficiency of 6-phosphate dehydrogenase (risk of hemolysis).
- Breastfeeding period.
- Childhood (under 15 years).
- Particular hypotension (systolic blood pressure below 100 mmHg.), hemodynamic instability (myocardial infarction, multiple trauma, onset of shock), decreased circulating blood volume, onset of heart failure, high fever (increased risk of a sharp drop in blood pressure).
- In diseases in which a significant decrease in blood pressure may pose an increased risk (patients with severe coronary heart disease and pronounced stenosis of the cerebral arteries).
- In alcoholism.
- In patients at increased risk of severe anaphylactic/anaphylactoid reactions with:
- bronchial asthma, especially in combination with concomitant polyposis rhinosinusitis;
- chronic urticaria and other types of atopy (allergic diseases in the development of which a significant role belongs to hereditary predisposition to sensitization: polinosis, allergic rhinitis, etc.п.
- intolerance of alcohol (reaction even to small amounts of certain alcoholic beverages, with symptoms such as itching, lacrimation and marked redness of the face);
- intolerance of dyes (eg tartrazine) or preservatives (eg benzoates).
- In severe hepatic and renal dysfunction (low doses are recommended due to the possibility of delayed excretion of sodium metamizole).
Adverse reactions are categorized according to the World Health Organization (WHO) Classification: very common (≥1/10); common (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); frequency unknown (cannot be determined based on available data).
Blood and lymphatic system disorders
Frequency unknown: Transient leukopenia, agranulocytosis, hemolytic anemia, purpura, thrombocytopenia.
Immune system disorders
Frequency unknown: anaphylactic shock or other anaphylactic reactions.
Nervous system disorders
Frequency unknown: insomnia, vertigo, increased excitability.
Hfrequency unknown: Tachycardia, palpitations.
Relatory system, chest and mediastinum disorders Frequency unknown: bronchospasm.
Frequency unknown: Loss of appetite, nausea, vomiting, cholestasis, jaundice.
Skin and subcutaneous tissue disorders
Hfrequency unknown: rash, itching.
All side effects should be reported to the treating physician.
The following symptoms may occur in overdose: Nausea, vomiting, abdominal pain, decreased renal function/acute renal failure with oliguria (e.g. due to the development of interstitial nephritis), more rarely symptoms from the central nervous system (agitation, insomnia, headache, dizziness), tinnitus, melena, hematoma, and cardiac rhythm disturbances (tachycardia). In more severe cases, oliguria to anuria, epileptopharyngeal seizures, coma, seizures, agranulocytosis, aplastic or hemolytic anemia, hemorrhagic diathesis.
After administration of very high doses of the drug, excretion through the kidneys of the non-toxic metabolite sodium metamizole (rubazonic acid) may cause red staining of urine.
In recent administration, primary detoxification measures aimed at limiting further absorption of the drug may be taken (use of vomiting agents, gastric lavage, activated charcoal, laxatives). There is no specific antidote. The major metabolite of metamizole (4-N-methylaminoantipyrine) is excreted by hemodialysis, hemofiltration, hemoperfusion or plasma filtration. Symptomatic treatment is used if necessary. If seizure syndrome develops, intravenous administration of diazepam and fast-acting barbiturates.
Data related to methamisole
There are no data on the adverse effects of methamisole on the fetus: In rats and rabbits, methamisole had no teratogenic effects, and toxic effects on the fetus were observed only at high doses toxic to the mother. Nevertheless, clinical data on the use of Sedalgin® Plus during pregnancy are insufficient.
Methamisole penetrates the placenta.
The use of Sedalgin® Plus during pregnancy is contraindicated. This is because although methamisole is a weak inhibitor of prostaglandin synthesis, the possibility of premature closure of the arterial (botallic) duct and complications in the perinatal period associated with impaired platelet aggregation of the mother and the newborn cannot be completely excluded.
Methamizole metabolites penetrate into breast milk. Breast-feeding is not allowed during treatment with Sedalgin® Plus and for 48 hours after the last dose of the drug.
|Conditions of storage|
In a dry, light-protected place at a temperature not exceeding 25 ° C. Keep out of reach of children!
Balkanpharma – Troyan AD, Bulgaria
Balkanpharma – Troyan AD
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