Santoperalgin (Tablets) Instructions for Use

Marketing Authorization Holder

Khimpharm, JSC (Kazakhstan)

ATC Code

N02BB72 (Metamizole sodium in combination with psycholeptics)

Dosage Form

Santoperalgin

Tablets 10 or 20 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Combined analgesic agent (opioid analgesic agent + NSAID + non-narcotic analgesic agent + psychostimulant agent + barbiturate)

Pharmacological Action

A combined medicinal product that has analgesic, antipyretic, vasodilating, and antimigraine action. It relieves symptoms of the common cold and influenza.

Paracetamol is an analgesic-antipyretic. It has analgesic, antipyretic, and weak anti-inflammatory effects. The mechanism of action is associated with the inhibition of prostaglandin synthesis and a predominant effect on the thermoregulation center in the hypothalamus.

Metamizole sodium is an analgesic-antipyretic, a pyrazolone derivative. It has analgesic, antipyretic, and antispasmodic effects on the smooth muscles of the urinary and biliary tracts.

Codeine has a central antitussive effect (by suppressing the excitability of the cough center), as well as an analgesic effect, due to the excitation of opiate receptors in various parts of the CNS, leading to the stimulation of the antinociceptive system and a change in the emotional perception of pain. It depresses respiration less than morphine and less frequently causes miosis, nausea, vomiting, and constipation (activation of opioid receptors in the intestine causes relaxation of smooth muscles, decreased peristalsis, and spasm of all sphincters). It enhances the effect of analgesics.

Caffeine stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, and increases physical and mental performance.

Phenobarbital is an antiepileptic agent that has sedative, hypnotic, antispasmodic, and muscle relaxant effects.

Indications

Pain syndrome (mild to moderate intensity): arthralgia; myalgia; neuralgia; sciatica; migraine; toothache and headache; dysmenorrhea; pain from injuries, burns; febrile syndrome (including in acute respiratory viral infections).

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of water.

Adhere to the shortest possible duration of treatment and the lowest effective dose.

For adults and adolescents over 12 years of age, take one tablet as a single dose.

If pain or fever persists, a second tablet may be taken after 4-6 hours.

Do not exceed three tablets within a 24-hour period.

The total duration of self-treatment without medical consultation should not exceed three to five days as an analgesic and three days as an antipyretic.

For postoperative pain, use only as a single dose under direct medical supervision.

Adjust dosage carefully in elderly or debilitated patients; consider a reduced initial dose.

Discontinue use immediately and consult a physician if symptoms persist or worsen.

Avoid concomitant use with other products containing paracetamol, codeine, or non-steroidal anti-inflammatory drugs (NSAIDs).

Adverse Reactions

From the nervous system: dizziness, drowsiness, decreased speed of psychomotor reactions,

From the cardiovascular system: palpitations, tachycardia,

From the digestive system: nausea, vomiting, constipation;

From laboratory parameters: leukopenia, granulocytopenia, agranulocytosis.

Other: allergic reactions (rash, itching, urticaria),

With long-term uncontrolled use in high doses – tolerance (weakening of the analgesic effect), drug dependence (Codeine); impaired liver and/or kidney function.

Contraindications

Hypersensitivity; severe hepatic and/or renal failure; glucose-6-phosphate dehydrogenase deficiency; anemia; leukopenia; bronchial asthma; conditions accompanied by respiratory depression; intracranial hypertension; acute myocardial infarction; arrhythmias; alcohol intoxication; glaucoma; pregnancy; lactation period; children under 12 years of age.

With caution

Peptic ulcer of the stomach and duodenum (in the acute stage), arterial hypertension, elderly patients.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Pediatric Use

Contraindicated in children under 12 years of age.

Geriatric Use

With caution in elderly patients.

Special Precautions

With long-term (more than 1 week) treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

May change the results of doping control tests in athletes.

Makes diagnosis difficult in “acute abdomen”.

Patients suffering from atopic bronchial asthma and hay fever have an increased risk of developing allergic reactions.

During treatment, one should refrain from consuming ethanol and exercise caution when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use of agents that depress the CNS (including sedatives and anxiolytics), an increase in the severity of the sedative effect and the depressant effect on the respiratory center is likely.

Enhances the effect of ethanol on the psychomotor reaction.

Metamizole reduces the concentration of cyclosporine. By displacing oral hypoglycemic agents, indirect anticoagulants, corticosteroids, and indomethacin from protein binding, it increases their activity.

Tricyclic antidepressants, oral contraceptives, and allopurinol impair the metabolism of metamizole in the liver and increase its toxicity.

Barbiturates, phenylbutazone, and other inducers of microsomal liver enzymes weaken the effect of metamizole.

Simultaneous use of the drug with other non-narcotic analgesics may lead to increased toxic effects.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.