Senadexin-forte

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SENADEXIN-FORTE (Senadexin-forte)

Composition:

Active substance: sennosides extract from senna leaves (calcium sennosides A and B);

One tablet contains sennosides extract from senna leaves (calcium sennosides A and B), calculated as 20% content of calcium sennosides A and B – 140 mg;

Excipients: lactose monohydrate; corn starch; vanillin; magnesium stearate; stearic acid; talc.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: intact, regular, round cylindrical tablets with flat upper and lower surfaces, beveled edges, a dividing line, light brown to dark brown in color with specks, and a vanilla odor.

Pharmacotherapeutic group.

Stimulant laxatives. Senna glycosides. ATC code A06AB06.

Pharmacological properties.

Pharmacodynamics. A prodrug of plant origin (senna leaf, also known as Alexandrian leaf or Cassia angustifolia leaf) that acts on the motility of the large intestine.

The pharmacological effect is due to anthra-glycosides (mainly sennosides A and B) as well as other glycosides. When administered orally, senna glycosides pass through the stomach and small intestine unchanged, without being absorbed. In the large intestine, anthra-glycosides are hydrolyzed by intestinal bacteria into pharmacologically active anthrones and anthranols, which stimulate intraluminal receptors of the colon, enhance peristalsis, and accelerate intestinal evacuation. Anthrones and anthranols inhibit absorption of water and electrolytes and promote diffusion of water into the intestinal lumen. As a result of the osmotic effect, the volume of fecal mass increases and intraluminal pressure rises, thereby stimulating peristalsis.

Laxative effect occurs within 6–12 hours. With prolonged use of the drug, the intensity of its action may decrease due to reduced potassium levels in the body.

Pharmacokinetics. The active substances—metabolites of senna anthra-glycosides—are practically not absorbed and are mainly excreted in feces, as well as in urine. They are also excreted in sweat, and a small amount passes into breast milk.

Clinical characteristics.

Indications.

Constipation due to intestinal atony of various etiologies.

Preparation for radiological examinations.

Contraindications.

Hypersensitivity to the active substance and/or to any of the excipients of the medicinal product. Nausea, vomiting, acute inflammatory gastrointestinal disorders (Crohn's disease, colitis, ulcerative colitis), undiagnosed gastrointestinal conditions that may indicate acute intestinal disease or require surgical intervention (diverticulitis, appendicitis, peritonitis, frequent diarrhea), intestinal obstruction / paralytic ileus, spastic constipation, incarcerated hernia, gastrointestinal or uterine bleeding, cystitis, epigastric pain of unknown origin, spastic abdominal pain, organic liver disorders, severe electrolyte imbalances (hypokalemia), rectal hemorrhage.

Interaction with other medicinal products and other forms of interaction.

To date, no cases of clinically significant drug interactions have been reported.

A possible reduction in serum levels of active substances may occur when concomitantly administered with quinidine sulfate (an antiarrhythmic agent) due to competitive properties with anthraquinone-containing laxatives. Concomitant use with cardiac glycosides may lead to cardiac arrhythmias due to hypokalemia. When used simultaneously with antiarrhythmic agents, diuretics, and corticosteroids, muscle weakness may develop. Prolonged use or use in high doses may impair the absorption of tetracyclines. The medicinal product may reduce the efficacy of drugs that are slowly absorbed in the gastrointestinal tract.

Also, medicinal products recently used by the patient should be taken into account.

Special precautions for use

The medicinal product is recommended for use only when bowel evacuation cannot be normalized through dietary changes; the minimum effective dose required to restore normal bowel function should be used.

Patients taking cardiac glycosides, antiarrhythmic agents, drugs that prolong the QT interval, diuretics, corticosteroids, or drugs based on licorice root should consult a physician before starting this medication.

If the cause of constipation is unknown or if there are complaints of other gastrointestinal disturbances (abdominal pain, nausea, vomiting), a physician must determine the cause of constipation before initiating laxative therapy, as these symptoms may indicate the presence or development of intestinal obstruction.

The medicinal product is intended for episodic use. Therefore, if treatment exceeds 1 week, caution and prior consultation with a physician are required, since prolonged use of stimulant laxatives may exacerbate intestinal atony.

The product should not be administered within 2 hours after taking other medicinal products or in doses exceeding those recommended.

Adults suffering from fecal incontinence should avoid prolonged contact of the skin with feces by changing absorbent pads (linens) regularly during treatment with this product.

The product should be used with caution in patients with liver or kidney disease, as well as in those with chronic inflammatory bowel diseases.

The medicinal product contains lactose, which should be taken into account in patients with rare hereditary forms of lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding

Although the use of this medicinal product is not contraindicated in pregnant women, it is recommended to use it only under medical supervision. Use during pregnancy is associated with a higher likelihood of adverse effects (abdominal pain, diarrhea).

Breastfeeding should be discontinued during treatment, as components of the medicinal product may pass into breast milk and cause frequent loose stools in the infant. However, with appropriate dosing, the occurrence of adverse effects in the infant is unlikely.

Ability to affect reaction speed when driving or operating machinery

The medicinal product generally does not affect the ability to drive vehicles or operate machinery, or to perform tasks requiring increased attention and rapid mental or motor reactions. However, individual response to the drug should be assessed.

Dosage and Administration.

The medicinal product is taken orally, swallowing with a small amount of liquid, usually before bedtime or in the morning.

Adults and children aged 12 years and older are recommended to take 1 tablet 1–2 times daily. The maximum daily dose is 2 tablets.

Elderly patients should start treatment with a dose of 1/2 tablet.

The product is intended for short-term treatment.

Children.

Not recommended for use in children under 12 years of age.

Overdose.

In case of overdose, diarrhea may develop, which in some cases can be accompanied by severe irritation of the intestine, leading to disturbances in water-electrolyte balance, loss of water and electrolytes, intestinal colic, irritation of gastrointestinal organs, nausea, epigastric pain, seizures, vascular collapse, and metabolic acidosis. Electrolyte levels, particularly potassium, should be monitored. This is especially important for elderly patients. Prolonged intake of higher doses may lead to toxic hepatitis. Overdose may cause colicky abdominal pain and dyspepsia, requiring discontinuation of the medicinal product. The use of large doses may cause atrophy of the smooth musculature of the colon and impaired innervation.

Treatment is symptomatic and includes gastric lavage. If there is a risk of severe diarrhea, rehydration (ingestion of large amounts of water) is recommended.

Adverse reactions.

The medicinal product is usually well tolerated, but rare adverse effects may occur, which are generally reversible and quickly resolve after discontinuation of the drug or dose reduction.

Gastrointestinal disorders: in isolated cases anorexia, complaints of spasmodic abdominal pain, diarrhea may occur; with prolonged use – nausea, vomiting, flatulence, pseudomelanosis of the intestine, atony of the large intestine, digestive disturbances, colics, weight loss. With prolonged use/abuse of laxatives, pigment deposition in the intestinal mucosa (pseudomelanosis) may occur, which is benign and usually resolves after discontinuation of the drug.

Renal and urinary system disorders: change in urine color (red or brown depending on pH, clinically insignificant); with prolonged use/abuse – proteinuria, hematuria, hyperaldosteronism, hypocalcemia.

Metabolism and nutrition disorders: prolonged use of laxatives may lead to electrolyte loss, primarily potassium, which may cause cardiac disturbances, especially when used concomitantly with cardiac glycosides, diuretics, and adrenocortical hormones, as well as fatigue, muscle weakness, cramps, collapse.

Immune system disorders: allergic reactions (including skin rashes, pruritus, urticaria, localized or generalized exanthema).

In case of any adverse reaction, consult a physician regarding further use of the medicinal product.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets in a blister pack, 2 blisters or 10 blisters per carton.

Prescription status.

Over-the-counter: tablets № 10, № 20 (10×2).

By prescription only: tablets № 100 (10×10).

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and place of business.

16 Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.