Senade

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SENADE® (SENADE)

Composition:

Active substances: calcium sennosides A and B;

1 tablet contains 90.0 mg calcium sennosides 15% (containing 13.5 mg sennosides A and B);

Excipients: lactose monohydrate; corn starch; microcrystalline cellulose; talc; magnesium stearate; sodium lauryl sulfate; sodium carboxymethylcellulose.

Pharmaceutical form. Tablets.

Main physicochemical properties: flat, round tablets with bevelled edges, varying in colour from brown to dark brown; on one side – monogram CIPLA, on the other – a central break line.

Pharmacotherapeutic group. Stimulant laxatives. Senna glycosides.

ATC code A06AB06.

Pharmacological properties.

Pharmacodynamics.

A prodrug of plant origin that acts on the motility of the large intestine.

The pharmacological effect is due to anthraglycosides (mainly sennosides A and B), as well as other glycosides. After oral administration, senna glycosides pass through the stomach and small intestine unchanged, without being absorbed. In the large intestine, anthraglycosides 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 the absorption of water and electrolytes and promote diffusion of water into the intestinal lumen. As a result of the osmotic effect, fecal mass increases and intraluminal pressure rises, thereby promoting peristaltic stimulation.

Pharmacokinetics.

After administration, the effect occurs within 6–12 hours. Bowel movements normalize after several days of regular use.

The active substances—metabolites of senna anthraglycosides—are practically not absorbed, are mainly excreted in feces and partially in urine; a small amount passes into breast milk.

Clinical characteristics.

Indications.

Constipation caused by intestinal atony of various etiologies.

Contraindications.

Hypersensitivity to the active substance and/or to other components of the drug; nausea, vomiting; acute inflammatory gastrointestinal disorders (Crohn's disease, colitis, ulcerative colitis); undiagnosed gastrointestinal conditions that may result from acute intestinal disorders and/or surgical interventions (diverticulitis, appendicitis, peritonitis, frequent diarrhea); spastic constipation, incarcerated hernia, organic liver disease, intestinal obstruction/paralytic ileus, epigastric pain of unknown origin, gastrointestinal and uterine bleeding, cystitis, spastic pain, rectal hemorrhages, severe disturbances of fluid and electrolyte balance (hypokalemia).

Interaction with other medicinal products and other forms of interaction.

Currently, 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 arrhythmia due to hypokalemia. Concomitant use of antiarrhythmic agents, diuretics, and corticosteroids may result in muscle weakness. Prolonged use or use in high doses may impair the absorption of tetracyclines. Reduces the effectiveness of drugs that are slowly absorbed in the gastrointestinal tract.

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

Special precautions for use.

The drug should be used only if normalization of 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 symptoms (abdominal pain, nausea, vomiting), a physician should 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, caution should be exercised and medical advice sought if use exceeds one week, as prolonged use of stimulant laxatives may lead to increased intestinal atony.

The drug should not be taken within 2 hours after other medicinal products or in doses exceeding those recommended.

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

The drug should be used with caution in patients with liver or kidney disease, or with chronic inflammatory bowel diseases.

The drug 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 the drug in pregnant women is not contraindicated, it is recommended to use it only under medical supervision. Studies have not revealed any risk to the fetus. There is no evidence of teratogenic effects of the drug.

Use of the drug during pregnancy may increase the likelihood of adverse effects (abdominal pain, diarrhea).

Breastfeeding is recommended to 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 speed when driving or operating machinery.

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

Method of administration and dosage.

The medication should be taken orally, swallowing with a small amount of liquid, usually in the evening 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.

The lowest effective dose required to restore normal bowel function should be used.

The medication is intended for short-term treatment only.

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

Children. The medication is not recommended for 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 fluid and electrolyte balance, loss of water and electrolytes, intestinal colic, irritation of the gastrointestinal tract organs, causing nausea, epigastric pain, cramps, worsening of intestinal function, vascular collapse, and metabolic acidosis. Electrolytes, particularly potassium, should be monitored. This is especially important for elderly patients. Chronic intake of higher doses may lead to toxic hepatitis. Overdose may also cause colicky abdominal pain and dyspepsia, requiring discontinuation of the medication. Prolonged use of high doses may result in 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 drug is generally well tolerated, but rarely adverse effects may occur, which are usually reversible and quickly resolve after discontinuation or dose reduction of the drug.

Gastrointestinal disorders: in isolated cases, anorexia, 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 deposits in the intestinal mucosa (pseudomelanosis) may be observed, which are benign and usually disappear after discontinuation of the drug.

Renal and urinary disorders: change in urine color (red or brown depending on pH, which has no clinical significance); 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; fatigue, muscle weakness, cramps, collapse.

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

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

Shelf life. 3 years.

Storage conditions. Store in a place inaccessible to children, in the original packaging (blister), at a temperature not exceeding 25 °C.

Packaging. 20 tablets in a blister. 25 blisters with instructions for medical use in a cardboard box.

Availability. Over-the-counter.

Manufacturer.

Mediteb Specialities Limited.

Manufacturer's address and place of business.

Plot No. 352, Kunderim Industrial Estate, Kunderim – Goa, India.