Microlax®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MIRCOLAX® (MICROLAX®)

Composition:

Active substances: sodium citrate, sodium lauryl sulfosuccinate 70%, sorbitol 70% solution, crystallizing;

1 ml of rectal solution contains: sodium citrate 90 mg, sodium lauryl sulfosuccinate 70% 12.9 mg, sorbitol 70% solution, crystallizing, 893 mg;

Excipients: sorbic acid, glycerin, purified water.

Pharmaceutical form. Rectal solution.

Main physicochemical characteristics: viscous, colorless, opalescent solution containing small air bubbles.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Laxatives in enemas. ATC code A06A G11.

Pharmacological properties.

Pharmacodynamics.

MicroLax® exerts a chemical and mechanical effect. Sodium citrate displaces bound water present in the fecal mass. Due to the crystallizing sorbitol solution, the action of sodium citrate in displacing water is enhanced. Sodium lauryl sulfosuccinate is a non-toxic, non-irritating wetting agent. It facilitates penetration of the rectal solution into the feces. This process promotes softening and liquefaction of the fecal mass, enabling the patient suffering from constipation to defecate within several minutes, usually between 5 and 20 minutes. The process of displacing bound water through chemical and mechanical pathways is called peptization. The increase in water content due to peptization and liquefaction contributes to softening of the fecal mass and facilitates intestinal evacuation.

Clinical characteristics.

Indications.

Constipation (short-term use), as well as conditions requiring facilitation of defecation.

For bowel evacuation prior to diagnostic or therapeutic procedures involving the rectal area.

Contraindications.

• Hypersensitivity to the active substances or to any of the excipients.
• Do not use in cases of intestinal obstruction or abdominal pain of unknown etiology.
• Diagnosis of hereditary fructose intolerance (intolerance to a specific type of sugar).
• Concomitant treatment with calcium or sodium polystyrene sulfonate cation-exchange resin (see section "Interaction with other medicinal products and other forms of interaction").

Interaction with other medicinal products and other forms of interaction.

Studies on drug interactions of MicroLax**®** with other medicinal products have not been conducted.

Since MicroLax**®** contains sorbitol, its simultaneous use with ion-exchange resins administered orally or rectally for the treatment of hyperkalemia is not recommended due to the risk of intestinal necrosis.

Special precautions for use

Sorbic acid may cause irritation of the mucous membrane.

If symptoms persist for a prolonged period, consult a physician. Avoid prolonged use of the drug.

If the tube content is used only partially, any remaining rectal solution must be discarded.

Use during pregnancy or breastfeeding

Studies involving pregnant women have not been conducted. Since the drug, when used according to recommendations, is most likely to have only minimal systemic absorption, harmful effects on the fetus/newborn during pregnancy and breastfeeding are not expected.

It is unknown whether sodium citrate, sodium lauryl sulfosuccinate, and sorbitol pass into human breast milk. During breastfeeding, the use of the drug is recommended only after consulting a physician and evaluating the risk/benefit ratio for the infant.

Ability to influence reaction rate while driving or operating machinery

Unknown.

Method of Administration and Dosage

The medication is administered rectally.

One dose should be administered 5–20 minutes prior to the desired effect.

Adults and children aged 3 years and older should use the contents of one tube of the microenema with a universal tip (5 mL), inserting the microenema tip fully.

Newborns and children under 3 years of age should use the contents of one tube of the microenema with a universal tip (5 mL), inserting the microenema tip halfway (see the mark on the tip of the tube).

Newborns and children under 3 years of age should use the contents of one tube of the microenema with a shortened tip (5 mL), inserting the microenema tip fully.

Instructions for Use

Break the seal on the tip of the tube.

Gently squeeze the tube so that a drop of the medication lubricates the tip of the microenema to facilitate insertion. Insert the universal microenema tip fully into the rectum (for children under 3 years, insert halfway). While squeezing the tube, completely expel its contents. Remove the tip while continuing to squeeze the tube.

For children under 3 years of age, a microenema with a shortened tip may also be used. In this case, the entire contents of one microenema tube should be administered rectally, inserting the tip fully.

Children

The medication can be used in children from birth.

Overdose

No cases of overdose have been reported to date.

Adverse reactions.

Adverse reactions identified during post-marketing use of sorbitol, sodium citrate, and sodium lauryl sulfosuccinate are listed in the table below. The frequency of adverse reactions is defined according to the following categories:

• Very common (≥ 1/10)
• Common (≥ 1/100 to < 1/10)
• Uncommon (≥ 1/1000 to < 1/100)
• Rare (≥ 1/10,000 to < 1/1000)
• Very rare (< 1/10,000)
• Not known (cannot be estimated from the available data).

Includes terms of preferred use: "Abdominal discomfort", "Abdominal pain", and "Upper abdominal pain".

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging.

Rectal solution, 5 ml.

5 ml of rectal solution in a tube with a single-use applicator tip (polyethylene tube with a shortened or universal tip with a seal on the tube tip).

4 or 12 tubes with shortened tips in a cardboard box labeled in Ukrainian.

4 or 12 tubes with universal tips in a cardboard box labeled in Ukrainian.

Category of supply. Over-the-counter.

Manufacturer.

DELPHARM ORLEANS, France / DELPHARM ORLEANS, France.

Manufacturer's location and address of its place of business.

5 avenue de Concyr, ORLEANS CEDEX 2, 45071, France / 5 avenue de Concyr, ORLEANS CEDEX 2, 45071, France.

Marketing Authorization Holder.

McNeil Products Limited / McNeil Products Limited.

Address of the Marketing Authorization Holder.

50-100 Holmers Farm Way, High Wycombe, HP12 4EG, England / 50-100 Holmers Farm Way, High Wycombe, HP12 4EG, England.

Representative of the Marketing Authorization Holder.

TOV "Johnson & Johnson Ukraine"

Address of the Representative of the Marketing Authorization Holder.

32/2 Ostrizkykh Knyaziv Street, Kyiv, 01010, Ukraine.

+38 (044) 498 0888

+38 (044) 498 7392