SLABIGEL-ZDOROVYA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SLAGEL-ZDOROVYE (SLABIGEL-ZDOROVYE)

Composition:

Active ingredient: docusate sodium;

10 g of the preparation contains docusate sodium 0.12 g;

Excipients: sodium carmellose, glycerin, purified water.

Pharmaceutical form. Rectal gel.

Main physicochemical properties: opalescent liquid with the consistency of a liquid gel.

Pharmacotherapeutic group. Laxatives. Enemas.

ATC code A06A G10.

Pharmacological Properties.

Pharmacodynamics.

The product facilitates softening and easier passage of fecal matter and stimulates the defecation reflex.

Docusate sodium promotes water retention in the fecal mass, thereby increasing its volume. Onset of effect occurs within 5–20 minutes after administration.

The medicinal product acts locally in the rectum.

Pharmacokinetics.

Minimal absorption cannot be excluded even with rectal administration.

Clinical characteristics.

Indications.

Symptomatic treatment of occasional constipation, when an enema is required. Preparation for endoscopic examination of the rectum.

Contraindications.

Hypersensitivity to any of the components of the medicinal product.

Intestinal obstruction, haemorrhoids, anal fissures, anal bleeding, inflammatory bowel diseases, abdominal pain, nausea, vomiting, ulcerative colitis.

Interaction with other medicinal products and other forms of interaction.

Caution is necessary when using with medicinal products that cause hypokalaemia, which may promote the occurrence of cardiac arrhythmias (particularly torsades de pointes) and increase the toxicity of certain drugs, for example digoxin. Medicinal products that cause hypokalaemia include: potassium-depleting diuretics (alone or in combination), stimulant laxatives, glucocorticoids, tetracosactide, and intravenous amphotericin B.

Special precautions for use.

Prolonged and excessive use is not recommended, as it may lead to intestinal atony, dehydration, and hypokalemia (if no effect is observed after 1–2 administrations, the treatment strategy should be reconsidered). With prolonged use, there is a risk of developing dependence, requiring regular use of the laxative and increasing its dosage; upon discontinuation of the medication, severe constipation may occur.

Pharmacological treatment of constipation should only be an adjunct to hygienic and dietary management:

• Enrichment of the diet with dietary fiber and fluids;
• Recommendations regarding physical activity and retraining of defecation habits.

Use during pregnancy or breastfeeding.

Pregnancy.

There are no adequate data on the use of docusate enemas or oral docusate in pregnant women. Animal studies on oral administration of docusate are insufficient regarding effects on pregnancy and fetal embryonic development.

The potential risk for humans is unknown. Since minimal systemic absorption cannot be excluded following rectal administration, the drug should be used during pregnancy only if the expected benefit outweighs the potential risks.

Breastfeeding.

It is unknown whether docusate is excreted in human breast milk. Animal studies have demonstrated excretion of docusate and its metabolites into breast milk following systemic administration. The decision on whether to continue/cease breastfeeding or to continue/cease treatment with Slabigel-Zdorovya should be made taking into account the benefit of breastfeeding for the child and the benefit of treatment for the woman.

Ability to influence reaction rate when driving or operating machinery.

Does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

Administer rectally.

Insert the gel into the rectum using the tube-cannula (microenema). Remove the protective cap. Insert the tapered end of the tube-cannula into the rectum and squeeze out the entire contents of the tube. Remove the tube-cannula without releasing pressure.

If necessary, a drop of the gel can be used to lubricate the cannula.

Symptomatic treatment of constipation: 1 tube-cannula per day.

Preparation for endoscopic examination of the rectum: 1 tube-cannula 5–20 minutes before the scheduled time of defecation.

Children.

Do not use the medicinal product in children (under 18 years of age).

Overdose.

May lead to an intensification of adverse effects and to increased or excessive defecation, which may require symptomatic treatment.

Side effects.

With prolonged treatment, a burning sensation in the anal area may occur, and in exceptional cases — proctitis.

Undesirable effects are classified by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (<1/10,000); frequency not known (cannot be estimated based on available data).

Gastrointestinal disorders: very rare — proctitis; frequency not known — anal bleeding, diarrhea, burning sensation in the anal area.

Skin and subcutaneous tissue disorders: frequency not known — contact dermatitis.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 g of the drug in a tube-cannula, 1 or 6 tube-cannulas per box.

Availability category. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and location of business activity.

22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.