Sennales-Ruseuro (Tablets) Instructions for Use

Marketing Authorization Holder

Nabros Pharma, Pvt. Ltd. (India)

ATC Code

A06AB06 (Sennosides A and B)

Active Substance

Sennosides A and B (Grouping name)

Dosage Form

Sennales-Ruseuro

Tablets 13.5 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, flat, with beveled edges and a score on one side, brown in color, with the presence of inclusions of a darker color allowed.

Excipients: sodium carboxymethyl starch, starch, colloidal silicon dioxide, croscarmellose, lactose, talc.

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

Clinical-Pharmacological Group

Laxative drug that stimulates intestinal peristalsis

Pharmacotherapeutic Group

Laxative of plant origin

Pharmacological Action

A laxative of plant origin. It has a laxative effect that occurs after 8-10 hours. The laxative effect is due to the effect on the receptors of the large intestine, which enhances peristalsis.

Indications

Constipation caused by hypotension and sluggish peristalsis of the large intestine; regulation of stool in hemorrhoids, proctitis, anal fissures.

ICD codes

Dosage Regimen

Take orally, typically as a single daily dose in the evening before bedtime.

Swallow the tablet whole with a sufficient amount of water.

For adults and children 12 years and older, the usual dose is 1-2 tablets (13.5-27 mg).

For children 6 to 11 years old, the usual dose is 1 tablet (13.5 mg).

Do not exceed the maximum daily dose of 4 tablets (54 mg).

Adjust the dose individually to achieve soft stool; use the lowest effective dose.

The laxative effect usually occurs within 8-10 hours after administration.

Limit use for short-term treatment; do not use continuously for more than 2 weeks without medical consultation.

If constipation persists or you need to use a laxative regularly, consult a doctor to determine the underlying cause.

Adverse Reactions

From the digestive system: cramping abdominal pain, flatulence are possible; with long-term use, especially in high doses, melanin deposition in the intestinal mucosa, nausea, vomiting, diarrhea are possible.

From the metabolism: with long-term use, especially in high doses, disturbances in water-electrolyte balance, melanin deposition in the intestinal mucosa are possible.

From the urinary system: with long-term use, especially in high doses, albuminuria, hematuria, discoloration of urine are possible.

From the nervous system: with long-term use, especially in high doses, convulsions, fatigue, confusion are possible.

Dermatological reactions: with long-term use, especially in high doses, skin rash is possible.

From the cardiovascular system: with long-term use, especially in high doses, vascular collapse is possible.

Contraindications

Hypersensitivity to the active substance, spastic constipation, intestinal obstruction, abdominal pain of unclear origin, strangulated hernia, acute inflammatory diseases of the abdominal cavity, peritonitis, gastrointestinal and uterine bleeding, cystitis, disturbances of water-electrolyte balance; children under 6 years of age.

With caution

Liver and/or kidney diseases, pregnancy, breastfeeding period, conditions after abdominal surgery.

Use in Pregnancy and Lactation

Use with caution during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in liver diseases.

Use in Renal Impairment

Use with caution in kidney diseases.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

It is not recommended to use this remedy for more than 2 weeks.

After administration, urine may turn yellow-brown or red-lilac in color.

Drug Interactions

With long-term use in high doses, an enhancement of the effect of cardiac glycosides and an influence on the effect of antiarrhythmic drugs is possible due to the potential development of hypokalemia.

With simultaneous use with thiazide diuretics, corticosteroids, licorice root preparations, the risk of developing hypokalemia increases.

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.