Herbion^® Laksana (Tablets) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

A06AB06 (Sennosides A and B)

Active Substance

Senna (BP British Pharmacopoeia)

Dosage Form

Herbion® Laksana

Film-coated tablets, 15 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets dark brown in color, round, with a bevel.

Excipients : lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, glycerol, colloidal anhydrous silica, magnesium stearate.

Shell composition hypromellose, propylene glycol, talc, titanium dioxide (E171), iron oxide brown (E172).

Extraction solvent methanol 60% (raw material ratio 25-45:1).

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

Clinical-Pharmacological Group

Laxative drug that stimulates intestinal peristalsis

Pharmacotherapeutic Group

Laxative

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 caused by hypotension and sluggish peristalsis of the large intestine. Regulation of bowel movements in hemorrhoids, proctitis, anal fissures; spastic and atonic constipation of various etiologies.

ICD codes

Dosage Regimen

Take orally once daily in the evening after the last meal.

Swallow the tablet whole with a full glass of water.

For adults and children over 12 years, the typical dose is one to two tablets (15 mg to 30 mg of sennosides).

Initiate therapy with the lower dose of one tablet.

Increase to two tablets only if a single tablet does not produce a satisfactory effect.

Do not exceed the maximum daily dose of four tablets (60 mg of sennosides).

The onset of action typically occurs within 8 to 10 hours after ingestion.

Use the lowest effective dose for the shortest duration necessary to establish normal bowel function.

Limit continuous use to a maximum of one to two weeks.

Prolonged use requires medical supervision due to the risk of electrolyte imbalance and laxative dependence.

Discontinue use if abdominal pain, diarrhea, or watery stools occur.

Consult a physician if constipation persists despite one week of treatment.

This product is generally not recommended for children under 12 years of age unless directed by a physician.

Adverse Reactions

Possible allergic reactions, abdominal pain, flatulence, diarrhea; with long-term use – colitis.

Contraindications

Hypersensitivity to senna; intestinal obstruction, abdominal pain of unknown origin, water-electrolyte imbalance, acute inflammatory diseases of the abdominal organs, proctitis and hemorrhoids in the acute stage, strangulated hernia, gastrointestinal bleeding, uterine bleeding, cystitis, spastic colitis, spastic constipation; pregnancy, breastfeeding period; childhood – depending on the dosage form.

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 senna 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.

Drug Interactions

Senna preparations reduce the absorption of tetracycline.

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.