Instructions for Senade tablets 13.5 mg blister No. 500
Composition
active ingredients: calcium sennosides A and B;
1 tablet contains calcium sennosides 15% 90.0 mg (with sennosides A and B content of 13.5 mg);
excipients: lactose monohydrate; corn starch; microcrystalline cellulose; talc; magnesium stearate; sodium lauryl sulfate; sodium carboxymethylcellulose
Dosage form
Pills.
Main physicochemical properties: brown to dark brown, flat, round tablets with beveled edges, with the CIPLA monogram on one side and a break line in the center on the other.
Pharmacotherapeutic group
Contact laxatives. Senna glycosides.
ATX code A06A B06.
Pharmacological properties
Pharmacodynamics.
A laxative of plant origin that acts on the motility of the large intestine.
The pharmacological action is due to anthraglycosides (mainly sennosides A and B), as well as other glycosides. When used internally, senna glycosides pass through the stomach and small intestine unchanged, without being absorbed. In the large intestine, anthraglycosides are broken down by intestinal bacteria into pharmacologically active anthrones and anthranols, which, irritating the interoreceptors of the large intestine, increase peristalsis and accelerate bowel emptying. Anthrones and anthranols prevent the absorption of water and electrolytes, promote the diffusion of water into the intestinal lumen. As a result of the osmotic effect, there is an increase in fecal masses, an increase in filling pressure, which contributes to the stimulation of peristalsis.
Pharmacokinetics.
After taking the drug, the effect occurs after 6–12 hours. Defecation normalizes after a few 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 of them penetrates into breast milk.
Indication
Constipation caused by intestinal atony of various etiologies.
Contraindication
Increased individual sensitivity to the active substance and/or to other components of the drug; nausea, vomiting; acute inflammatory diseases of the gastrointestinal tract (Crohn's disease, colitis, ulcerative colitis); undiagnosed diseases of the digestive system, which may be the result of acute intestinal diseases and/or surgical interventions (diverticulitis, appendicitis, peritonitis, frequent diarrhea), spastic constipation, strangulated hernia, organic liver lesions, intestinal obstruction/paralytic intestinal obstruction, epigastric pain of unknown origin, gastrointestinal and uterine bleeding, cystitis, spastic pain, rectal hemorrhages, severe disturbances of water-salt balance (hypokalemia).
Interaction with other medicinal products and other types of interactions
To date, no cases of clinically significant drug interactions have been reported.
A decrease in the level of active substances in the blood serum is possible with simultaneous use of quinidine sulfate (an antiarrhythmic drug) due to competing properties with anthraquinone laxatives. Simultaneous use with cardiac glycosides due to hypokalemia can cause cardiac arrhythmia. With simultaneous use of antiarrhythmic drugs, diuretics and corticosteroids, muscle weakness develops. With prolonged use or use in high doses, the drug disrupts the absorption of tetracyclines. Reduces the effectiveness of drugs that are slowly absorbed in the digestive tract.
It is also necessary to consider the medications that the patient has taken recently.
Application features
The drug is recommended for use only if normalization of bowel movements cannot be achieved by changing the diet; the minimum effective dose necessary to restore normal bowel function should be taken.
Patients taking cardiac glycosides, antiarrhythmics, drugs that increase the QT interval, diuretics, corticosteroids, or licorice root preparations should consult a doctor before using the drug.
If the cause of constipation is unknown or there are complaints from the digestive tract (abdominal pain, nausea and vomiting), then before starting to take laxatives, it is necessary for the doctor to establish the cause of constipation, as these symptoms may be signs of an incipient or already existing intestinal obstruction.
The drug is intended for occasional use, so the drug should be taken with caution and after prior consultation with a doctor if its use lasts more than one week, since prolonged use of laxatives that stimulate intestinal activity may lead to increased intestinal atony.
The drug should not be used within 2 hours of taking other medications or in doses exceeding the recommended ones.
Adults suffering from fecal incontinence should avoid prolonged skin contact with feces by changing pads (napkins) when taking the drug.
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 is not contraindicated in pregnant women, it is recommended to use it only under the supervision of a doctor. Studies have not revealed any danger to the fetus. There is no evidence of teratogenicity of the drug.
Use of the drug by pregnant women may cause a higher likelihood of side effects (abdominal pain, diarrhea).
It is recommended to stop breastfeeding during treatment with the drug, as the components of the drug may penetrate into breast milk and cause frequent loose stools in the child. At the same time, with proper dosage, the occurrence of undesirable effects in the child is unlikely.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug usually does not affect the ability to drive vehicles and perform work that requires increased attention, speed of mental and motor reactions. However, it is necessary to check the individual reaction to the drug.
Method of administration and doses
The drug should be taken orally with a small amount of liquid, usually in the evening before bedtime or in the morning.
Adults and children over 12 years of age are recommended to take 2 tablets 1–2 times a day.
The maximum daily dose is 4 tablets.
The lowest effective dose of the drug necessary to restore normal bowel function should be taken.
The drug is intended for short-term treatment.
Elderly patients should start treatment with a dose of 1 tablet.
Children
The drug is not recommended for use in children under 12 years of age.
Overdose
Overdose may cause diarrhea, which may be accompanied in some cases by severe intestinal irritation, causing water-salt balance disorders, loss of water and electrolytes, intestinal colic, irritation of the digestive tract, causing nausea, epigastric pain, cramps, deterioration of intestinal function, vascular collapse and metabolic acidosis. Electrolytes, in particular potassium, should be monitored. This is important for elderly patients. Continuous administration of higher doses may lead to toxic hepatitis. Overdose may cause colicky abdominal pain, dyspepsia, requiring discontinuation of the drug. The use of large doses may cause atrophy of the smooth muscles of the colon and disruption of its innervation.
Treatment is symptomatic, including gastric lavage. If there is a risk of severe diarrhea, rehydration (taking plenty of water) is recommended.
Adverse reactions
The drug is usually well tolerated, but side effects are rare, which are usually reversible and quickly disappear after stopping the drug or reducing its dose.
On the part of the gastrointestinal tract: in rare cases, anorexia, complaints of spastic abdominal pain, diarrhea are possible; with prolonged use - nausea, vomiting, flatulence, intestinal pseudomelanosis, colonic atony, indigestion, colic, weight loss. With prolonged use/abuse of laxatives, pigment deposits in the intestinal mucosa (pseudomelanosis) may occur, which is safe and, as a rule, disappears after discontinuation of the drug.
On the part of the kidneys and urinary system: change in urine color (red or brown depending on the pH, which has no clinical significance); with prolonged use/abuse - proteinuria, hematuria, hyperaldosteronism, hypocalcemia.
Metabolism and metabolism: prolonged use of laxatives can lead to loss of electrolytes, mainly potassium, which can cause cardiac dysfunction, especially when used simultaneously with cardiac glycosides, diuretics and adrenal cortex hormones; feeling of fatigue, muscle weakness, cramps, collapse.
On the part of the immune system: allergic reactions may occur (including skin rashes, itching, urticaria, local or generalized exanthema).
In case of any reaction, you should consult a doctor regarding further use of the drug.
Expiration date
3 years.
Storage conditions
Store out of the reach of children in the original packaging (blister) at a temperature not exceeding 25 ºС.
Packaging
20 tablets in a blister. 25 blisters with instructions for medical use of the drug in a cardboard box.
Vacation category
Without a prescription.
Producer
Meditab Specialties Limited.
Location of the manufacturer and address of its place of business
Plot No. 352, Kundaim Indl. Estate, Kundaim – Goa, India.
