Sedalgin Plus, tablets 10 pcs

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
conduction.

Indications

Composition

1 tablet contains:

acting ingredients:

metamizole sodium 500 mg,

caffeine 50 mg,

Thiamine hydrochloride 38.75 mg;

excipients:

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, 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.

The drug should not be used for a long time or the dose should be increased without a physician’s prescription. If prolonged use, it is necessary to monitor the general blood count (number of blood cells).

The single dose for adults and adolescents older than 15 years is 1 tablet. The maximum single dose is 2 tablets. Unless otherwise prescribed, a single dose may be taken 2-3 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 an antipyretic, it is 1-3 days.

Elderly patients

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.

Because in patients with impaired renal function 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.

Interaction

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.

Cedalgin® 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 drugs 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 increase the analgesic effect of Sedalgin ® Plus. Severe hypothermia may develop when co-administered withchlorpromazine.

Sodium metamizole displaces oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin (drugs with high plasma protein binding) by increasing their effects.

In concomitant use with myelotoxic drugs (e.g., gold salt preparations, anticancer drugs, chloramphenicol, etc.) the manifestation of hematotoxicity of sodium metamizole is increased, there is a risk of damage to white blood cells.

The addition of sodium methamisole to treatment with methotrexate may increase the hematotoxic effects of methotrexate, especially in elderly patients. Therefore, coadministration of these drugs should be avoided.

Tiamazole and sarcolysin when co-administered with sodium metamizole increase the risk of leukopenia.

Codeine, blockers H2-histamine receptors and propranolol increase the effects of sodium metamizole.

When treating with sodium metamizole, do 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).

Sodium metamizole may decrease the blood concentration of bupropion, which should be taken into account when using metamizole sodium and bupropion concomitantly.

The concomitant use of sympathomimetics may cause central nervous system overstimulation.

Special Instructions

When treating patients receiving cytostatic drugs, the drug should be taken only under the supervision of a physician.

Anaphylactic/anaphylactoid reactions

The following conditions cause an increased risk of hypersensitivity reactions to sodium metamizole:

Contraindications

With caution

Side effects

Unwanted 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.

Cardiac disorders

Hfrequency unknown: Tachycardia, palpitations.

Relatory system, chest and mediastinum disorders Frequency unknown: bronchospasm.

Gastrointestinal disorders

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.

Overdose

Symptoms

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 of 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.

The non-toxic metabolite of sodium metamizole (rubazonic acid) may cause red staining of the urine after very high doses of the drug are administered.

Treatment

In recent administration of the drug, primary detoxification measures aimed at limiting further absorption of the drug (use of vomiting agents, gastric lavage, activated charcoal, laxatives) may be taken. 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 a seizure syndrome develops, intravenous diazepam and fast-acting barbiturates are administered.

Pregnancy use

Data related to metamizole

Pregnancy

There are no data on the adverse effects of metamizole 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.

Breastfeeding period

Methamisole metabolites penetrate into breast milk. Do not breastfeed during treatment with Sedalgin ® Plus and for 48 hours after the last dose of the drug.