Senadexin-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SENADEXIN-ZDOROV'YA

Composition:

Active substance: 1 tablet contains calcium sennosides A and B 20% (Senna alexandrina leaf (Sennae alexandrina folium) dry extract (5:1) (extraction solvent: methanol)) 70 mg;

Excipients: lactose monohydrate; corn starch; vanillin; magnesium stearate; stearic acid; talc; microcrystalline cellulose; sodium croscarmellose.

Pharmaceutical form. Tablets.

Main physico-chemical properties: flat cylindrical tablets, with a score line and bevelled edge, from grey-brown to brown in colour with specks of darker and lighter shades, with a smell of vanillin.

Pharmacotherapeutic group. Stimulant laxatives. Senna glycosides. ATC code A06AB06.

Pharmacological Properties.

Pharmacodynamics. A plant-derived laxative that acts on the motility of the large intestine. The active component of the drug, senna, belongs to one of the groups of laxatives known as anthrones. In the large intestine, anthra-glycosides are metabolized by intestinal bacterial flora into pharmacologically active anthrones and anthranols, which stimulate peristalsis and accelerate intestinal evacuation by irritating the intramural receptors of the colon. Anthrones and anthranols inhibit the absorption of water and electrolytes and promote diffusion of water into the intestinal lumen. This leads to an increase in the volume of fecal mass and elevated intraluminal pressure, resulting in stimulation of peristalsis.

Laxative effect occurs within 6–12 hours. With prolonged use of the drug, the intensity of its effect 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 may pass into breast milk.

Clinical characteristics.

Indications. Constipation due to intestinal atony of various etiologies.

Preparation for radiographic examinations.

Contraindications. Increased individual sensitivity to the components of the drug and to other components of the drug, acute inflammatory diseases of the gastrointestinal tract (Crohn's disease, colitis, ulcerative colitis), nausea, vomiting, undiagnosed gastrointestinal disorders which may result from acute intestinal diseases and/or surgical interventions (diverticulitis, appendicitis, peritonitis, frequent diarrhea), intestinal obstruction/paralytic ileus, incarcerated hernia, organic liver lesions, epigastric pain of unknown origin, gastrointestinal and uterine bleeding, cystitis, spastic pain, severe disturbances of water-electrolyte balance (hypokalemia), rectal hemorrhages.

Interaction with other medicinal products and other forms of interactions.

Currently, there have been no reports of clinically significant drug interactions.

A possible reduction in serum levels of active substances may occur when concomitantly administered with quinidine sulfate (an antiarrhythmic agent) due to competing properties with anthraquinone laxatives. Concomitant use with cardiac glycosides may cause cardiac arrhythmia due to hypokalemia. Concomitant use of antiarrhythmic agents, diuretics, and corticosteroids may lead to muscle weakness. With prolonged use or use in high doses, the drug impairs absorption of tetracyclines. Reduces the effectiveness of drugs that are slowly absorbed in the gastrointestinal tract.

Special precautions for use.

The drug is recommended to be used only if normalization of intestinal bowel movements cannot be achieved by dietary changes; the minimum effective dose required to restore normal bowel function should be taken.

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

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

The drug is intended for episodic use; therefore, it should be used with caution and only after prior consultation with a physician if treatment exceeds 1 week, since prolonged use of stimulant laxatives may lead to increased intestinal atony.

The drug should not be taken within 2 hours after administration of other medicinal products or in doses exceeding the recommended ones.

Adults suffering from fecal incontinence should avoid prolonged skin contact with feces by frequently changing pads (liners) during treatment with this drug.

The drug should be used with caution in patients with liver or kidney disorders and in those with chronic inflammatory bowel diseases.

If a patient has known sugar intolerance, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding.

Although the use of the drug in pregnant women is not contraindicated, it is recommended 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 with this drug, as its components 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 rate while driving or operating machinery.

The drug generally does not impair the ability to drive vehicles or perform tasks requiring high attention, fast mental, or motor reactions. However, individual response to the drug should be assessed.

Dosage and Administration.

The drug should be taken orally, swallowed with a small amount of liquid, usually before bedtime or in the morning.

For adults and children aged 12 years and older, the recommended dose is 2 tablets 1–2 times daily. Maximum daily dose – 4 tablets.

For elderly patients, treatment should be initiated with a dose of 1 tablet.

Children.

Not recommended for children under 12 years of age.

Overdose.

In case of overdose, diarrhea may develop, leading to disturbances in water-electrolyte balance, intestinal colic, irritation of gastrointestinal organs, causing nausea, epigastric pain, cramps, worsening intestinal function, vascular collapse, and metabolic acidosis.

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

Adverse reactions.

The drug 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 system: in isolated cases, anorexia, abdominal pain, diarrhea may occur; with prolonged use/abuse – nausea, vomiting, flatulence, pseudomelanosis of the intestine, atony of the colon, digestive disturbances, colicky pain, weight loss.

Urinary system: change in urine color (red or brown depending on pH, which has no clinical significance); with prolonged use/abuse – proteinuria, hematuria.

Metabolism and nutritional disorders: prolonged use/abuse of laxatives may lead to electrolyte loss, primarily potassium, which may result in cardiac disturbances, collapse, fatigue, muscle weakness, cramps.

Immune system: allergic reactions may occur, including skin rashes, pruritus, urticaria, localized or generalized exanthema.

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; 1, 2 or 10 blisters in a cardboard box. 10 tablets in a blister.

Prescription status. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Manufacturer's address and place of business. 22 Shevchenka Street, Kharkiv, Kharkiv Region, 61013, Ukraine.