DOCUZALIA

INSTRUCTION

for medical use of the medicinal product

DOCUZALIA

(DOCUZALIA)

Composition:

active substance: docusate sodium;

1 capsule contains 100 mg of docusate sodium;

excipients: polyethylene glycol 400 (macrogol 400), propylene glycol, glycerol;

capsule shell: gelatin; glycerol; liquid sorbitol, partially dehydrated (E 420).

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules, oval, with a seam, transparent, light yellow-brown in colour. The capsule content is a clear, colourless or slightly yellowish, viscous liquid.

Pharmacotherapeutic group. Laxatives. Softeners, emollients. Docusate sodium.

ATC code A06A A02.

Pharmacological properties

Pharmacodynamics

Docusate sodium is an anionic wetting agent that acts as a faecal softener, reducing the surface tension of the fluid in the intestine and promoting its penetration into accumulated hard, dry faecal masses. Docusate sodium also acts on the intestinal mucosa, increasing the secretion of water and electrolytes into the intestinal lumen by increasing mucosal permeability, mediated by an increase in the level of intracellular cyclic adenosine monophosphate (cAMP) through competitive inhibition of cAMP phosphodiesterase.

Pharmacokinetics

Absorption

Docusate sodium exerts its pharmacological effects locally in the gastrointestinal tract. However, there are data indicating that docusate sodium is partially absorbed in the duodenum and jejunum of the small intestine.

Elimination

Docusate sodium is eliminated from the body via the biliary tract.

Clinical particulars

Indications

For use in the treatment of constipation:

– to prevent the formation of hard, dry faecal masses and to reduce straining during defecation in the presence of haemorrhoids and anal fissures;

– to soften hard, dry faecal masses in order to reduce straining during defecation.

For use as an adjunct for radiological examination of the abdominal organs.

Contraindications

Hypersensitivity to the active substance or to any of the components of the medicinal product.

Inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.), intestinal obstruction and conditions that may lead to the development of intestinal obstruction, nausea, vomiting, abdominal pain not associated with constipation.

Children under 12 years of age.

Interaction with other medicinal products and other forms of interaction

Docusate sodium may increase the intestinal absorption of other active substances when used concomitantly.

Combinations that are not recommended

• Mineral oils (paraffin oil).

Docusate sodium increases the intestinal absorption of mineral oils.

• Anthraquinone derivatives.

When used together with docusate sodium, anthraquinone derivatives should be prescribed in reduced doses because of the increase in their intestinal absorption.

• Medicinal products that may induce ventricular tachycardia of the torsades de pointes type:

• antiarrhythmic medicinal products: bepridil, class Ia antiarrhythmics (in particular quinidine), sotalol, amiodarone;
• other medicinal products: fenoxedil, lidoflazine, prenylamine, vincamine.

Before using a medicinal product that may induce ventricular tachycardia of the torsades de pointes type, hypokalaemia must be corrected, with monitoring of cardiac activity by electrocardiography (ECG), clinical observation and monitoring of serum electrolyte levels, in order to reduce the risk of ventricular cardiac rhythm disturbances, especially ventricular tachycardia of the torsades de pointes type.

Combinations requiring precautions and monitoring of blood potassium levels

• Digoxin.

Hypokalaemia increases the cardiotoxicity of digitalis glycosides. Before using digoxin, hypokalaemia must be corrected, with monitoring of cardiac activity by ECG, clinical observation and monitoring of serum electrolyte levels.

• Other medicinal products that lower serum potassium levels: amphotericin B (intravenous administration), corticosteroids (glucocorticoids and mineralocorticoids administered systemically), tetracosactide, hypokalaemic diuretics (alone or in combination).

Concomitant use with docusate sodium increases the risk of hypokalaemia. Serum potassium levels should be monitored and, if necessary, hypokalaemia corrected.

Special warnings and precautions for use

Before starting treatment with any laxative, organic bowel disorders must be excluded.

Drug treatment of constipation should be only an adjunct to a healthy lifestyle and adherence to a diet, for example:

• increased intake of dietary fibre and fluids;
• adherence to the recommended level of physical activity and the development/restoration of the bowel-emptying reflex.

As with other laxatives, Docuzalia should not be used continuously. Prolonged use of the medicinal product may cause colonic atony, severe functional colopathy, melanosis of the colon and rectocolitis, and water–salt imbalance with hypokalaemia. With prolonged use there is a risk of developing dependence with a need for regular use of the laxative and an increase in its dose; on discontinuation of the medicinal product, severe constipation may develop.

If the need for a laxative arises every day, or if abdominal pain occurs, medical advice should be sought.

Paediatric population

When prescribing laxatives to children, the risk of disturbing the normal function of the bowel-emptying reflex should be taken into account.

Excipients

This medicinal product contains glycerol, which may cause headache, gastrointestinal irritation and diarrhoea.

This medicinal product contains propylene glycol, which may cause symptoms similar to those occurring with alcohol consumption.

Use during pregnancy or breastfeeding

Pregnancy

There are insufficient data on the safety of docusate sodium in pregnant women.

The results of animal studies do not allow a reliable assessment of the effect of docusate sodium on the course of pregnancy and embryonic development of the foetus. The potential risk to humans is unknown. Over the entire long period of widespread use of docusate sodium, no cases of congenital malformations have been reported. Nevertheless, for safety reasons docusate sodium should not be prescribed during the first trimester of pregnancy. In the second and third trimesters of pregnancy the medicinal product should be prescribed only when the expected benefit outweighs the possible risks.

Breastfeeding

The results of animal studies have shown that docusate sodium and its metabolites are excreted into breast milk following systemic administration. Therefore, docusate sodium should not be prescribed to breastfeeding women.

Fertility

Animal studies have not revealed any effect of docusate sodium on fertility.

Studies of the effect of docusate sodium on human fertility have not been conducted.

Effects on the ability to drive and operate machinery. No data available.

Method of administration and dosage

For oral use. The capsules should be swallowed whole with a glass of water. During treatment with the medicinal product, adequate hydration of the body must be ensured.

Adults and children aged 12 years and over

The maximum daily dose of the medicinal product is 500 mg. It is recommended to start treatment with high doses, for example 100 mg 3 times a day, which should be gradually reduced to the minimum effective dose depending on the severity of the clinical effect.

For radiological examination of the abdominal organs together with a barium mixture, docusate sodium should be taken at a dose of 400 mg.

Elderly patients

No dose adjustment of the medicinal product is required.

The recommended duration of treatment is no more than 7 days.

In severe cases the duration of treatment may be extended on the recommendation of a doctor, if the expected benefit of using the medicinal product outweighs the risks to the patient.

Children. The medicinal product is not intended for use in children under 12 years of age.

Overdose

Overdose of docusate sodium may cause diarrhoea, abdominal pain and symptoms of dehydration. Symptomatic treatment and restoration of water and electrolyte balance may be required.

Adverse reactions

The adverse reactions listed below are classified by system organ class (in accordance with MedDRA [Medical Dictionary for Regulatory Activities]) and by frequency of occurrence: very common (≥1/10); common (≥1/100–<1/10); uncommon (≥1/1000–<1/100); rare (≥1/10000–<1/1000); very rare (<1/10000); not known (cannot be estimated from the available data).

Gastrointestinal disorders: rare — diarrhoea, nausea, abdominal cramps.

Skin and subcutaneous tissue disorders: rare — skin rash; not known — pruritus.

Metabolism and nutrition disorders: hypokalaemia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are asked to report any suspected adverse reactions and any lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store in the original package at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Package. 10 capsules in a blister; 1 blister in a carton.

Dispensing category. Without prescription.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Location of the manufacturer and address of its place of business. 38 Kopylivska Street, Kyiv, 04073, Ukraine.

Date of last revision. 01.06.2026