Sene leaves
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SENNA LEAVES (sennae folium)
Composition:
Active substance: senna leaves (sennae folium);
One pack contains senna leaves (sennae folium) 50 g or 100 g;
One filter bag contains senna leaves (sennae folium) 2 g.
Pharmaceutical form. Leaves.
Main physicochemical properties: fragments of leaves of various shapes passing through a sieve with 7 mm diameter openings. Color is grayish-green or brownish-green. Taste is slightly bitter with a sensation of sliminess; odor is weak and characteristic (for 100 g or 50 g packs).
Powdery mass, a mixture of particles of light green, grayish-green, or brownish-green color. Taste is slightly bitter with a sensation of sliminess; odor is weak and characteristic (for filter bags).
Pharmacotherapeutic group.
Laxatives. ATC code A06AB06.
Pharmacological properties.
The biologically active substances of the drug exert a laxative effect, which manifests 6–10 hours after administration and is caused by anthraglycosides that enhance peristalsis of the large intestine.
Clinical characteristics.
Indications.
Colonic atony, chronic constipation.
Contraindications.
Hypersensitivity to the biologically 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 water-electrolyte imbalance, nausea, vomiting, diverticulitis, organic liver lesions.
Interaction with other medicinal products and other forms of interaction.
Concomitant use with quinidine sulfate reduces the level of active substances in blood serum; with cardiac glycosides it causes cardiac arrhythmia; with antiarrhythmic agents, diuretics and corticosteroids it 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 medication should be used only if bowel regularity cannot be achieved through dietary changes or use of agents that increase stool bulk. To avoid dependence, it is advisable to alternate this medication with other laxatives and limit duration of use to 1 week.
Use during pregnancy or breastfeeding.
Contraindicated.
Ability to affect reaction speed when driving or operating machinery.
No effect.
Method of Administration and Dosage.
Raw material: Place 1.5-2 teaspoons of leaves 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 and squeeze out the remaining liquid into the decoction. Adjust the decoction volume to 200 ml by adding boiled water. Adults should take warm, 1/3–½ cup at bedtime or 1 tablespoon 1–3 times daily. For children aged 12 years and older: 1–2 tablespoons up to ¼ cup at bedtime.
Powder: Place 2 filter bags into a glass or enameled container, pour 200 ml (1 cup) of boiling water, cover with a lid, and let steep for 30 minutes. Adults should take warm, 1/3–½ cup at bedtime or 1 tablespoon 1–3 times daily. For children aged 12 years and older: 1–2 tablespoons up to ¼ cup at bedtime.
Shake the decoction before use.
The duration of treatment is determined individually by a physician.
Children.
The drug may be used in children aged 12 years and older as prescribed by a physician.
Overdose.
In case of overdose, intestinal colic, dyspepsia, diarrhea, and electrolyte imbalance may occur, requiring discontinuation of the drug.
Treatment: symptomatic therapy. Prolonged (up to several years) use of high doses may lead to atrophy of the smooth musculature of the colon and impaired innervation.
Side effects.
Allergic reactions (including rash, itching, urticaria, local or generalized exanthema). Digestive disturbances, colicky intestinal pain, flatulence, diarrhea, anorexia, change in urine color, pseudomelanosis of the intestine, water-electrolyte imbalance (hypokalemia, hypocalcemia), albuminuria, hematuria, hyperaldosteronism, cardiac dysfunction, increased fatigue, muscle weakness, convulsions. Prolonged (up to several years) use of large doses of senna leaf decoction may cause atrophy of the smooth musculature of the large intestine and impairment of its innervation.
Shelf life. 3 years.
Storage conditions.
Store in original packaging at a temperature not exceeding 25 °C.
The prepared decoction should be stored at a temperature between 8 °C and 15 °C for no more than 2 days.
Keep out of reach of children.
Packaging.
50 g, 100 g in packs with an inner pouch; 2 g in filter bags; 20 filter bags per cardboard pack.
Prescription status.
Over-the-counter.
Manufacturer.
JSC "Lubnipharm".
Manufacturer's address and place of business.
16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.
INSTRUCTIONS
for medical use of medicinal product
SENNA LEAVES
(sennae folium)
Composition:
Active substance: senna leaves (sennae folium);
1 pack contains senna leaves (sennae folium) 50 g or 100 g;
1 filter bag contains senna leaves (sennae folium) 2 g.
Pharmaceutical form. Leaves.
Main physicochemical properties: pieces of leaflets of various shapes passing through a sieve with 7 mm diameter openings. Color is grayish-green or brownish-green. Taste is slightly bitter with a mucilaginous sensation; odor is weak and characteristic (for packs of 50 g or 100 g).
Powdered mass, a mixture of particles of light green, grayish-green or brownish-green color. Taste is slightly bitter with a mucilaginous sensation; odor is weak and characteristic (for filter bags).
Pharmacotherapeutic group.
Laxatives. ATC code A06AB06.
Pharmacological properties.
Biologically active substances of the drug exert a laxative effect, which manifests 6–10 hours after administration and is due to anthraglycosides that enhance peristalsis of the large intestine.
Clinical characteristics.
Indications.
Atony of the large intestine, chronic constipation.
Contraindications.
Hypersensitivity to biologically active components 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 water-electrolyte imbalance, nausea, vomiting, diverticulitis, organic liver lesions.
Interaction with other medicinal products and other types of interactions.
Concomitant use with sulfated quinidine reduces serum levels of active substances; with cardiac glycosides may cause cardiac arrhythmia; with antiarrhythmic agents, diuretics, and corticosteroids may cause muscle weakness.
Special precautions.
Prior to initiating treatment, a physician must determine the cause of constipation to exclude intestinal obstruction. The drug is recommended only when normalization of bowel movements cannot be achieved by dietary changes or use of agents that increase intestinal content volume. To avoid dependence, the drug should be alternated with other laxatives and treatment duration should be limited to 1 week.
Use during pregnancy or breastfeeding.
Contraindicated.
Ability to affect reaction rate when operating vehicles or machinery.
Does not affect.
Method of administration and dosage.
Whole raw material: Place 1.5–2 teaspoons of leaves into an enameled container, add 200 ml of hot boiled water, cover with lid, and steep on a boiling water bath for 30 minutes. Allow to cool to room temperature, then strain and squeeze the residue into the decoction. Adjust the volume of the decoction to 200 ml with boiled water. Adults should take 1/3–½ cup warm at bedtime or 1 tablespoon 1–3 times daily. Children aged 12 years and older: from 1–2 tablespoons up to ¼ cup at bedtime.
Powder: Place 2 filter bags into a glass or enameled container, pour 200 ml (1 cup) of boiling water, cover and let steep for 30 minutes. Adults should take 1/3–½ cup warm at bedtime or 1 tablespoon 1–3 times daily.
Children aged 12 years and older: from 1–2 tablespoons up to ¼ cup at bedtime.
Shake the decoction before use.
The duration of treatment is determined individually by a physician.
Children.
For children aged 12 years and older, use only as directed by a physician.
Overdose.
In case of overdose, intestinal colic, dyspepsia, diarrhea, and water-salt imbalance may occur, requiring discontinuation of the drug.
Treatment: symptomatic therapy. Prolonged (up to several years) use of high doses of the drug may lead to atrophy of the smooth musculature of the large intestine and impairment of its innervation.
Side effects.
Allergic reactions (including rash, itching, urticaria, local or generalized exanthema). Digestive disturbances, colicky intestinal pain, flatulence, diarrhea, anorexia, change in urine color, pseudomelanosis of the intestine, water-electrolyte imbalance (hypokalemia, hypocalcemia), albuminuria, hematuria, hyperaldosteronism, cardiac dysfunction, increased fatigue, muscle weakness, convulsions.
Prolonged (up to several years) use of large doses of senna leaf decoction may cause atrophy of the smooth musculature of the large intestine and impairment of its innervation.
Shelf life. 3 years.
Storage conditions.
Store in original packaging at a temperature not exceeding 25 °C.
The prepared decoction should be stored at a temperature between 8 °C and 15 °C for no more than 2 days.
Keep out of reach of children.
Packaging.
50 g, 100 g in packs with an inner pouch; 2 g in filter bags; 20 filter bags per cardboard pack.
Prescription status.
Over-the-counter.
Manufacturer.
JSC "Lubnipharm".
Manufacturer's address and place of business.
16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.
Date of last revision.