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Senadexin (Tablets) Instructions for Use

ATC Code

A06AB06 (Sennosides A and B)

Active Substance

Senna (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Laxative drug that stimulates intestinal peristalsis

Pharmacotherapeutic Group

Drugs for the treatment of constipation; contact laxatives

Pharmacological Action

A laxative of plant origin. Senna leaves contain dianthrone glycosides (about 3%) – sennosides A, A1, B-G; a small amount of anthraquinone glycosides, including aloe-emodin and rhein 8-glycosides; about 10% mucilage; flavonoids, including kaempferol derivatives; naphthalene glycosides.

It stimulates peristalsis of the large intestine, causing a normal bowel movement 8-10 hours after administration. It acts selectively on the colon, restores normal bowel function, and does not affect digestion.

Indications

  • Constipation due to hypotension and sluggish peristalsis of the large intestine.
  • Regulation of bowel movements in hemorrhoids, proctitis, and anal fissures.
  • Spastic and atonic constipation of various etiologies.

ICD codes

ICD-10 code Indication
K59.0 Constipation
K60 Fissure and fistula of anus and rectum
K62.8 Other specified diseases of anus and rectum (including proctitis)
K64 Hemorrhoids and perianal venous thrombosis
ICD-11 code Indication
DB32.1 Slow-transit constipation
DB50.Z Fissure or fistula of anal region, unspecified
DB6Z Hemorrhoids or perianal venous diseases, unspecified
DB70.Z Infections of anal and rectal regions, unspecified
DB72.Z Some specified diseases of the anal canal, unspecified
DD91.1 Functional constipation
DE2Z Diseases of the digestive system, unspecified
EG61 Infections of the anus or perianal skin

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take orally in the evening after meals. The dose depends on the dosage form used.

For tablets, the specific dosage should be determined by a physician based on the patient’s condition and age. The effect typically occurs within 8-10 hours after administration.

Adverse Reactions

Possibleallergic reactions, abdominal pain, flatulence, and diarrhea.

With long-term use, the development of colitis and melanosis coli is possible. Prolonged use can lead to water-electrolyte imbalance and habituation, requiring dose escalation for effect.

Drug Interactions

Preparations reduce the absorption of tetracycline and other concurrently administered oral medications.

Concomitant use with thiazide diuretics, corticosteroids, or licorice root may increase the risk of hypokalemia. Monitor potassium levels with long-term concurrent use.

Contraindications

  • Hypersensitivity to senna or any component of the formulation.
  • Intestinal obstruction, abdominal pain of unknown origin, and acute inflammatory diseases of the abdominal organs.
  • Severe water-electrolyte imbalance, dehydration, and gastrointestinal bleeding.
  • Acute stage of proctitis, hemorrhoids, or strangulated hernia.
  • Spastic constipation, cystitis, and uterine bleeding.
  • Pregnancy, lactation, and childhood depending on the specific dosage form.

Overdose

Symptoms include severe abdominal pain, cramping, and profuse watery diarrhea, which may lead to fluid and electrolyte loss, hypokalemia, and dehydration.

Treatment is symptomatic and supportive. Ensure adequate fluid and electrolyte replacement. Discontinue use immediately. Do not administer anti-diarrheal medications.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Use with caution in liver diseases.

Use in Renal Impairment

Use with caution in kidney diseases.

Pediatric Use

Use in children of appropriate age categories is possible strictly according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the drug leaflets regarding contraindications for the use of specific senna dosage forms in children of different ages.

Special Precautions

With long-term use of senna preparations, habituation may develop, so it is advisable to alternate them with other laxatives.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Senadexin Tablets 0.07 g: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets from grayish-brown to brown in color with darker and lighter specks, round, flat-cylindrical in shape with a bevel and a score, with a faint characteristic odor.

1 tab.
Sum of calcium salts of sennosides A and B from senna leaves calculated on dry substance 20% (senadexin)* 0.07 g

* the pharmaceutical substance, the sum of calcium salts of sennosides A and B (senadexin), is obtained from the medicinal plant raw material senna leaves: collected during the flowering and fruiting phase, dried and threshed leaves of wild and cultivated perennial shrubs of Cassia acutifolia Del. (C. senna L.) and Cassia angustifolia Vahl., family Fabaceae.

Excipients: corn starch – 0.1373 g, lactose monohydrate – 0.034 g, talc – 0.0049 g, calcium stearate – 0.002 g, magnesium stearate – 0.0015 g, vanillin – 0.0003 g.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Marketing Authorization Holder

Pharmaceutical Company Zdorovye, LLC (Ukraine)

Manufactured By

Pharmaceutical Company Zdorovye, LLC (Ukraine)

Quality Control Release

PHARMACEUTICAL COMPANY ZDOROVYE, LLC (Ukraine)

Or

KIROV PHARMACEUTICAL FACTORY, JSC (Russia)

Dosage Form

Bottle OTC Icon Senadexin Tablets 70 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets from gray-brown to brown in color with specks of darker and lighter color, flat-cylindrical in shape, with a score and a bevel, with a vanillin odor.

1 tab.
Calcium sennosides (as 20% calcium salts of sennosides A and B from senna leaves) 70 mg

Excipients: lactose monohydrate, potato starch, corn starch, vanillin, magnesium stearate, methylparahydroxybenzoate (nipagin), stearic acid, talc, microcrystalline cellulose, croscarmellose sodium.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

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