Regulax^® (Chewable tablets) Instructions for Use

Marketing Authorization Holder

Krewel Meuselbach, GmbH (Germany)

ATC Code

A06AB06 (Sennosides A and B)

Active Substance

Senna (BP British Pharmacopoeia)

Dosage Form

Regulax®

Chewable cubes 710 mg+300 mg: 6, 12, or 18 pcs.

Dosage Form, Packaging, and Composition

1 pc. – sachets made of aluminum foil (6) – cardboard packs.
1 pc. – sachets made of aluminum foil (12) – cardboard packs.
1 pc. – sachets made of aluminum foil (18) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug that stimulates intestinal peristalsis

Pharmacotherapeutic Group

Laxative of plant origin

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, anal fissures; spastic and atonic constipation of various etiologies.

ICD codes

Dosage Regimen

Take orally in the evening after a meal.

Chew one to two chewable cubes thoroughly.

Do not exceed the maximum daily dose of two cubes.

Adjust the dose individually to achieve soft stool.

Start with the lowest effective dose.

The laxative effect typically occurs after 8 to 10 hours.

Use for a short duration only.

Discontinue use once normal bowel function is restored.

For long-term use, alternate with other laxative classes.

Consult a physician if constipation persists.

This product is not intended for chronic use without medical supervision.

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 phase, 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

Use is contraindicated 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, tolerance 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.