Instructions for Senadexin 70 mg No. 10
Composition
active ingredient: 1 tablet contains the amount of senna leaf extract (calcium sennosides A and B) calculated as 20% content of calcium sennosides A and B – 70 mg;
excipients: lactose monohydrate; corn starch; vanillin; magnesium stearate; stearic acid; talc.
Dosage form
Pills.
Main physicochemical properties: solid regular round cylinders, the upper and lower surfaces of which are flat, the edges of the surfaces are beveled, there is a dividing line, from light brown to dark brown with specks, with the smell of vanillin.
Pharmacotherapeutic group
Contact laxatives. Senna glycosides. ATX code A06A B06.
Pharmacological properties
Pharmacodynamics.
A laxative of plant origin (senna leaf or Alexandrian leaf, or cassia leaf) 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 administered orally, 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, by 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, the volume of fecal masses increases, the filling pressure increases, which helps stimulate peristalsis.
The laxative effect is manifested after 6-12 hours. With prolonged use of the drug, the intensity of its action may decrease due to a decrease in the potassium content in the body.
Pharmacokinetics.
The active substances – metabolites of senna anthraglycosides – are practically not absorbed, are mainly excreted with feces and urine. They are also excreted with sweat, and a small amount of them enters breast milk.
Indication
Constipation caused by intestinal atony of various etiologies.
Preparation for X-ray examinations.
Contraindication
Hypersensitivity to the components of the drug. Nausea, vomiting, acute inflammatory diseases of the digestive tract (Crohn's disease, colitis), undiagnosed diseases of the digestive tract, which may be the result of acute intestinal diseases or surgical interventions (diverticulitis, appendicitis, peritonitis, frequent diarrhea), intestinal obstruction, spastic constipation, strangulated hernia, gastrointestinal and uterine bleeding, cystitis, epigastric pain of unknown origin, spastic pain, organic liver lesions, severe disorders of water-salt balance (hypokalemia), rectal hemorrhages.
Special safety precautions
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, therefore, take the drug with caution and after prior consultation with a doctor if the drug is used for more than 1 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 should be used with caution in patients with liver or kidney disease, or chronic inflammatory bowel disease.
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.
Interaction with other medicinal products and other types of interactions
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.
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 the supervision of a doctor. The use of the drug in pregnant women is associated with a higher likelihood of developing 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 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.
Elderly patients should start treatment with a dose of 1 tablet.
Children.
Not recommended for use in children under 12 years of age.
Overdose
Overdose may cause diarrhea, which causes water-salt imbalance, intestinal colic, irritation of the digestive tract, causing nausea, epigastric pain, cramps, deterioration of intestinal function, vascular collapse, and metabolic acidosis.
Treatment: symptomatic, including gastric lavage. If there is a risk of severe diarrhea, rehydration (drinking 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 digestive tract: in rare cases, anorexia, abdominal pain, diarrhea are possible; with prolonged use/abuse - nausea, vomiting, flatulence, intestinal pseudomelanosis, colonic atony, indigestion, colic, weight loss.
On the part of the urinary system: change in urine color (red or brown depending on the pH, which has no clinical significance); with prolonged use/abuse - proteinuria, hematuria.
Metabolism and metabolism: prolonged use/abuse of laxatives can lead to loss of electrolytes, mainly potassium, which can cause cardiac disorders, fatigue, muscle weakness, cramps, collapse.
On the part of the immune system: allergic reactions may occur (skin rash, itching, urticaria, local or generalized exanthema).
Expiration date
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 blisters;
10 tablets in a blister, 10 blisters in a pack.
Vacation category
Without a prescription: No. 10 tablets.
Prescription: tablets No. 100 (10×10).
Producer
JSC "Lubnypharm".
Location of the manufacturer and its address, place of business.
Ukraine, 37500, Poltava region, Lubny, Barvinkova st., 16.
