Sedal-M^® (Tablets) Instructions for Use

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

Manufactured By

Sopharma, JSC (Bulgaria)

ATC Code

N02BB72 (Metamizole sodium in combination with psycholeptics)

Dosage Form

Sedal-M®

Tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat, with a smooth surface, with a bevel and a score line.

Excipients : lactose monohydrate – 37.8 mg, corn starch – 20 mg, sodium starch glycolate (type A) – 20 mg, povidone K25 – 30 mg, magnesium stearate – 7 mg, talc – 10 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – 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

Combined medicinal product with analgesic, antipyretic, vasodilating, and antimigraine action. Relieves symptoms of cold and flu.

Paracetamol is an analgesic-antipyretic. It has analgesic, antipyretic, and weak anti-inflammatory effects. The mechanism of action is associated with 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 stimulation of the antinociceptive system and a change in the emotional perception of pain. Compared to morphine, it depresses respiration to a lesser extent 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 with sedative, hypnotic, antispasmodic, and muscle relaxant effects.

Indications

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

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of water.

Adhere strictly to the maximum daily dose of 4 tablets.

For adults and adolescents over 12 years, take 1 tablet per dose.

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

Do not exceed 4 doses (4 tablets) in 24 hours.

Limit treatment duration to 3-5 days for pain and 2-3 days for fever.

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

For postoperative pain, use only as a single dose unless directed otherwise.

Adjust dosage in elderly or debilitated patients; initiate therapy at the lowest effective dose.

Do not crush or chew the tablets.

Avoid concomitant use with other products containing paracetamol, codeine, or sedatives.

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 it difficult to establish a diagnosis 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 an increase in toxic effects.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.