Senna leaves and fruits

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SENNA LEAVES AND FRUITS (SENNAEFOLIACUMFRUCTUS)

Composition:

Active substance: senna leaves and fruits;

1 pack contains: senna leaves and fruits – 50 g; 1 filter bag contains: senna leaves and fruits –
2 g.

Pharmaceutical form. Leaves and fruits.

Main physicochemical properties:

Crushed raw material: fragments of leaves, fruits, seeds, stems, rachis, fruit stalks of various shapes. Leaf color is grayish-green, brownish-green, yellowish-green; fruit color is green, greenish-brown, yellowish-brown, brown.

Coarse powder: fragments of leaves, fruits, seeds, stems, rachis, fruit stalks of various shapes, grayish-green, brownish-green, yellowish-green, green, greenish-brown, yellowish-brown, brown in color.

Pharmacotherapeutic group. Stimulant laxatives. ATC code A06AB06.

Pharmacological properties.

Pharmacodynamics.

Senna leaves and fruits contain flavonoids, anthraglycosides (sennoside A and B, rhein, aloe-emodin), organic acids, and resinous substances. This complex of biologically active substances produces a mild laxative effect. The laxative effect of senna leaf and fruit decoction manifests 6–10 hours after administration and is caused by anthraglycosides, which enhance the motor function of the large intestine.

Clinical characteristics.

Indications. Atony of the large intestine, chronic constipation.

Contraindications.

Hypersensitivity to the active substances of the drug. Metrorrhagia, paralytic intestinal obstruction, hemorrhoids, acute inflammatory bowel diseases (Crohn's disease, ulcerative colitis, appendicitis), peritonitis, peptic ulcer of the stomach and duodenum, gastrointestinal bleeding, anal fissures, spastic colitis, incarcerated hernia, pancreatitis, hepatitis, nephritis, cystitis, abdominal pain of unknown origin, severe disturbances of water-electrolyte balance, nausea, vomiting, diverticulitis, organic liver lesions.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with quinidine sulfate reduces serum levels of active ingredients; with cardiac glycosides – causes cardiac arrhythmia; with antiarrhythmic agents, diuretics and corticosteroids – causes muscle weakness.

Special precautions.

Before starting the medication, a physician must determine the cause of constipation in order to rule out intestinal obstruction. The drug should be used only if normal bowel movements cannot be achieved by dietary changes or by using agents that increase the volume of intestinal contents. To avoid habituation, it is advisable to alternate this medication with other laxatives and limit its use to 1 week.

Use during pregnancy or breastfeeding. Contraindicated.

Ability to affect reaction speed when driving or operating machinery. Does not affect.

Method of Administration and Dosage.

Place 2 tablespoons of leaves and fruits into an enameled container, pour 200 ml of hot boiled water, cover with a lid, and steep in a boiling water bath for 30 minutes. Allow to stand at room temperature until completely cooled, then strain, squeezing the residue. Adjust the volume of the decoction to 200 ml with boiled water.

Adults should take warm, ⅓–½ cup at bedtime or 1 tablespoon 1–3 times daily. Children aged 12–14 years: 1 tablespoon; 14–16 years: 2 tablespoons; 16–18 years: ¼ cup at bedtime. The decoction should be shaken before use.

Place 2 filter bags into a glass or enameled container, pour 200 ml of boiling water, cover, and let steep until completely cooled. Adults should take orally 1 cup at bedtime or ¼ cup 1–3 times daily. Children aged 12–14 years: ¼ cup; 14–16 years: ⅓ cup; 16–18 years: ½ cup at bedtime.

The prepared aqueous extract should be stored in the refrigerator (at 2–8°C) for no more than 2 days.

The duration of treatment is determined individually by a physician for each patient.

Children. The preparation should be used in children aged 12 years and older under a physician’s recommendation.

Overdose. In case of overdose, intestinal colic, dyspepsia, diarrhea, and disturbances in water-electrolyte balance may occur, requiring discontinuation of the preparation. Treatment is symptomatic. Prolonged (for several years) use of high doses of the preparation may lead to atrophy of the smooth musculature of the colon and disturbances in its innervation.

Side effects.

Allergic reactions (rash, itching, urticaria, localized or generalized exanthema). Gastrointestinal disturbances, colicky intestinal pain, flatulence, diarrhea, anorexia, changes in urine color, pseudomelanosis of the intestine, water-electrolyte imbalance (hypokalemia, hypocalcemia), albuminuria, hematuria, hyperaldosteronism, cardiac function disorders, increased fatigue, muscle weakness, cramps.

Shelf life. 3 years. Do not use after the expiry date.

Storage conditions. Store in the original packaging, in a place inaccessible to children, at a temperature not exceeding 30 °C.

Packaging. 50 g in packs with an inner pouch; 2 g in filter bags, 20 pcs.

Category of release. Over-the-counter.

Manufacturer/Applicant. JSC "Lektravy", Ukraine.

Manufacturer's location and address of place of business activity / Applicant's location.

Ukraine, 10001, Zhytomyr region, Zhytomyr, Kyivske shose, 21.