Sene leaves

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SENNA LEAVES (SENNAE FOLIUM)

Composition:

Active ingredient: senna leaves;

1 packet contains senna leaves (Sennae folium) 100.0 g.

Pharmaceutical form. Leaves.

Main physicochemical properties: fragments of leaves of various shapes; grayish-green or brownish-green in color.

Pharmacotherapeutic group. Contact laxatives. ATC code A06AB06.

Pharmacological properties.

Pharmacodynamics. Senna leaves contain flavonoids, anthra-glycosides (sennosides A and B, rhein, aloe-emodin), organic acids, and resinous substances. This complex of biologically active substances provides a mild laxative effect.

Pharmacokinetics. The laxative effect of senna leaf decoction manifests 6–10 hours after administration and is caused by anthra-glycosides, which enhance the motor function of the large intestine.

Clinical characteristics.

Indications.

Colonic atony, chronic constipation.

Contraindications.

Hypersensitivity to biologically active substances of the medicinal product. 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.

Special safety precautions.

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

Interaction with other medicinal products and other types of interactions.

Concomitant use with quinidine sulfate reduces plasma levels of active substances; with cardiac glycosides – may cause cardiac arrhythmia; with antiarrhythmic agents, diuretics, and corticosteroids – may cause muscle weakness.

Special precautions for use.

The medicinal product "Senna leaves" is a traditional herbal medicinal product intended for use according to indications supported by long-standing use.

The patient should consult a physician if symptoms of the disease do not disappear during treatment with the medicinal product or if adverse reactions occur that are not listed in the instructions for medical use of the medicinal product.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of administration and dosage.

Use as a decoction: Place 1.5–2 teaspoons of "Senna leaves" into an enameled container, pour 200 ml (1 cup) of boiled room-temperature water, cover with a lid, and steep in a boiling water bath for 30 minutes. Allow to cool to room temperature, then strain and squeeze the remaining plant material into the obtained decoction. Adjust the volume of the resulting decoction to 200 ml with boiled water. Adults should take orally, warm, ½–⅓ cup at bedtime or 1 tablespoon 1–3 times daily. For children aged 12–14 years: 1 tablespoon; aged 14–16 years: 2 tablespoons; aged 16–18 years: ¼ cup at bedtime. The decoction should be shaken before use.

The duration of treatment is determined individually by a physician, taking into account the course of the disease, stability of the achieved therapeutic effect, and drug tolerance.

Children.

For children aged 12 years and older, the medicinal product should be used only as prescribed by a physician.

Overdose.

Treatment is symptomatic. Prolonged (up to several years) use of high doses may cause atrophy of the smooth musculature of the colon and disruption of its innervation. In case of overdose, colicky abdominal pain and dyspepsia may occur, requiring discontinuation of the drug and administration of astringent agents.

Side effects.

Allergic reactions (including rash, pruritus, urticaria, local and generalized exanthema). Gastrointestinal disturbances, diarrhea, colicky intestinal pain, flatulence, anorexia, change in urine color, intestinal pseudomelanosis, water-electrolyte imbalance (hypokalemia, hypocalcemia), albuminuria, hematuria, hyperaldosteronism, cardiac dysfunction, increased fatigue, muscle weakness, cramps.

Shelf life. 3 years.

Storage conditions.

Store in a dry, light-protected place at a temperature not exceeding 25 °C.

The prepared decoction should be stored in a cool place for no more than 2 days.

Keep out of reach of children.

Packaging.

100 g per box with an inner pouch.

Availability. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

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

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.