Sympathyl (Tablets) Instructions for Use

Marketing Authorization Holder

Laboratoire Innotech International (France)

Manufactured By

Innothera Chouzy (France)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Dosage Form

Sympathyl

Film-coated tablets: 40 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets are blue in color, round, and biconvex.

Excipients: microcrystalline cellulose – 122 mg, sodium carboxymethyl starch – 15 mg, micronized stearic acid – 3.65 mg.

Film coating composition: protective glaze – 2 mg (shellac – 1.554 mg, povidone – 223 mcg, glyceryl monoacetate – 223 mcg); colored powder – 13 mg (hypromellose – 7.15 mg, titanium dioxide (E171) – 3.704 mg, macrogol 6000 – 1.788 mg, indigo carmine (E132) – 344 mcg, azorubine (E122) – 13 mcg, yellow iron oxide (E172) – 1 mcg, talc traces).

20 pcs. – blisters (2) – cardboard packs.
20 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Sedative agent

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

It has a sedative effect, eliminates the state of anxiety and associated autonomic disorders, tachycardia, and corrects mild forms of sleep disorders.

The active substances of hawthorn – triterpene compounds and flavonoids have an antispasmodic effect, selectively dilating the vessels of the heart and brain, and reduce the excitability of the central nervous system and myocardium.

Eschscholzia has an anxiolytic, sedative effect, reduces the time to fall asleep and improves sleep quality in mild forms of dyssomnia. Eschscholzia alkaloids of the protopine group increase in vitro the binding of GABA to its sensitive brain receptors.

Magnesium improves the regulation of transmembrane exchange of Na⁺ and K⁺, is a Ca²⁺ antagonist, reduces the ability to conduct excitation through neuromuscular synapses, to contract smooth and striated muscles; it also has a neurosedative, antispasmodic, and anxiolytic effect.

Pharmacokinetics

Magnesium oxide is converted into magnesium chloride in the stomach, which is absorbed in the small intestine by passive absorption, which does not exceed 50%.

It is excreted mainly in the urine and penetrates into breast milk.

The study of the pharmacokinetics of other components is difficult.

Indications

Emotional stress, stress, accompanied by increased excitability, restlessness, irritability, anxiety, fear, increased fatigue, palpitations; sleep disorders (mild forms).

ICD codes

Dosage Regimen

Administer orally, before meals, with a full glass of water.

Take 2 tablets twice daily, in the morning and in the evening.

Adhere to a regular schedule for consistent therapeutic effect.

Do not exceed the recommended daily dose of 4 tablets.

For sleep disorders, take the evening dose approximately 30-60 minutes before bedtime.

The duration of use is not specified; follow the prescribing physician’s guidance.

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

Adverse Reactions

Diarrhea, pain in the epigastric region.

Contraindications

Hypersensitivity; severe chronic renal failure (creatinine clearance less than 30 ml/min); childhood; lactation period.

With caution: pregnancy.

Use in Pregnancy and Lactation

Contraindicated during lactation.

With caution: pregnancy.

Use in Renal Impairment

Contraindicated in severe chronic renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

Contraindicated in childhood.

Special Precautions

There is no reliable data on the teratogenic effect of the drug. In clinical settings, analysis of a significant number of pregnancies that occurred while taking eschscholzia, hawthorn, and magnesium did not reveal any toxic effects on the fetus; however, there are insufficient observations to completely exclude the risk.

Drug Interactions

It reduces the renal excretion of quinidine (due to urine alkalinization) and increases its concentration in blood plasma (risk of overdose development).

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

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.