Composition of the medicinal product:
active ingredient: sodium picosulfate;
1 tablet contains sodium picosulfate, calculated as anhydrous substance, 7.5 mg;
Excipients: lactose monohydrate; potato starch; povidone; magnesium stearate.
Dosage form.
Pills.
Tablets are white or almost white in color with a biconvex surface.
Name and location of the manufacturer.
LLC "Pharmaceutical Company" Zdorovya ".
Ukraine, 61013, Kharkiv, Shevchenko St., 22.
Pharmacotherapeutic group.
Contact laxatives. Sodium picosulfate. ATS code A06A B08.
Slabilax-Zdorovye is a contact laxative of the triarylmethane group of local action, which after bacterial cleavage in the colon stimulates its mucous membrane, enhances peristalsis of the colon, promotes the accumulation of water and electrolytes in the lumen of the colon. The result is stimulation of defecation, reduction of the transit period and softening of feces.
After oral administration, sodium picosulfate reaches the colon without significant absorption. Therefore, there is no intrahepatic circulation. By bacterial cleavage in the intestine, the active laxative component bis-(n-hydroxyphenyl)-pyridyl-2-methane (BHRM) is formed. The onset of action occurs within 6 to 12 hours, which is associated with the release of the active substance of the drug.
After oral administration, only a small amount of the drug can be detected in the organs and systems of the body.
The laxative effect of the drug is not related to the level of the active substance in the blood plasma.
Indications for use.
Constipation or cases requiring easier defecation.
Contraindication.
Hypersensitivity to sodium picosulfate or to other components of the drug; intestinal obstruction; acute diseases of the abdominal cavity, including appendicitis; acute inflammatory bowel diseases, acute abdominal pain, accompanied by nausea and vomiting and may indicate acute diseases listed above; severe dehydration.
In the case of rare hereditary conditions that may cause hypersensitivity to the excipients of the drug (see section "Suitable precautions for use"), the use of sodium picosulfate is contraindicated.
Proper safety precautions during use.
As with other laxatives, the drug should not be taken daily or for a long time without establishing the cause of constipation. If daily use of laxatives is necessary, the cause of constipation should be determined. Prolonged and excessive use of laxatives can lead to electrolyte imbalance and hypokalemia, as well as cause addiction and constipation due to the "rebound" effect.
The drug contains lactose, so it should not be prescribed to patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Dizziness and/or syncope have been reported in patients taking sodium picosulfate. The available data on these cases suggest that the events are consistent with defecatory syncope (syncope associated with attempting to defecate) or with a vasovagal response to abdominal pain associated with constipation, and not necessarily with sodium picosulfate.
Special precautions.
Use during pregnancy or breastfeeding.
Long-term experience has not revealed any undesirable or harmful side effects of the drug when taken during pregnancy.
There is no data on the excretion of sodium picosulfate into breast milk.
Despite this, the drug, like all other medicines, can be used during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Children.
The use of the drug in this dosage form is not recommended for children under 10 years of age.
Method of administration and doses.
It is prescribed orally to adults and children over 10 years of age, 1 tablet (7.5 mg) in the evening before bedtime or in the morning. For severe and persistent constipation, adults are recommended to take 2 tablets (15 mg).
The duration of treatment is determined by the doctor individually and usually should not exceed 10 days.
Overdose.
Symptoms: intestinal colic, diarrhea, disturbances of water and electrolyte balance (hypokalemia, loss of other electrolytes and fluid), muscle weakness.
Ischemia of the colonic mucosa has been reported with the use of large doses of the drug, which significantly exceed those usually recommended for constipation. Sodium picosulfate, like other laxatives, with prolonged overdose leads to chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism and possible formation of kidney stones. With prolonged abuse of laxatives, there are reports of damage to the renal tubules, metabolic alkalosis, and muscle weakness as a result of hypokalemia.
Treatment: drug withdrawal, gastric lavage, symptomatic therapy aimed at normalizing water and electrolyte balance and maintaining vital functions, antispasmodics if indicated.
Side effects.
With short-term use of the drug, side effects are rarely observed. With long-term use of the drug in significantly increased doses, the following disorders are possible:
Skin: skin rashes, urticaria, itching;
from the side of water and electrolyte balance: loss of potassium, sodium and other electrolytes, possible development of dehydration;
from the digestive tract: dyspeptic phenomena, vomiting, nausea, abdominal cramps and pain, diarrhea, flatulence, pain in the stomach and anus, increased intestinal motility, which disappear when the dose of the drug is reduced;
from the immune system: allergic reactions, angioedema;
from the nervous system: headache, fatigue, drowsiness, convulsions.
Interaction with other drugs and other types of interactions.
With simultaneous use with diuretics and glucocorticoids, the risk of water and electrolyte disturbances, in particular hypokalemia, increases. It is possible to reduce the tolerance of cardiac glycosides. Broad-spectrum antibiotics can reduce the weakening effect of sodium picosulfate.
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.
Tablets of 7.5 mg No. 10 in blisters; No. 10 (10x1), No. 20 (10x2) in blisters in a box.
Vacation category.
Without a prescription.
