Modelax^®-H (Solvent) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Contact Information

PROMOMED RUS LLC (Russia)

ATC Code

A06AG11 (Lauryl sulfate, including combination preparations)

Dosage Form

Modelax®-H

Rectal solution: 5 ml microclysters 2 or 4 pcs.

Dosage Form, Packaging, and Composition

Rectal solution almost white in color, opaque, viscous.

Excipients: sorbic acid – 1 mg, glycerol – 125 mg, purified water – up to 1 ml.

5 ml – single-use microclysters (tubes*) (2) – cardboard packs.
5 ml – single-use microclysters (tubes*) (4) – cardboard packs.

* polyethylene tubes with a universal or shortened tip and a break-off seal.
A mark in the form of a ring, indicating half the length, may be applied to the tip of the universal tube.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Modelax^®-H is a combined drug that has a laxative effect.

The effect occurs within 5-15 minutes. The drug contains sodium citrate (a peptizing agent that displaces bound water contained in the feces), sodium lauryl sulfoacetate (thins the intestinal contents), and sorbitol (enhances the laxative effect by stimulating the influx of water into the intestine).

The increase in water volume due to peptization and thinning helps to soften the feces and facilitates bowel movement.

Indications

• Constipation, including with encopresis;
• Preparation for endoscopic (rectoscopy) and radiological examination of the gastrointestinal tract.

ICD codes

Dosage Regimen

Adults and children over 3 years

Administer the entire contents of one microclyster (5 ml) rectally, inserting the tip to its full length (the length of the universal tip is 44.5 mm).

Newborns and children under 3 years

Administer the entire contents of one microclyster (5 ml) rectally, inserting the universal tip to half its length.

If complaints persist for a long time, it is necessary to consult a doctor.

For children under 3 years, it is also possible to use a microclyster with a shortened tip (the length of the shortened tip is 27 mm). In this case, it is necessary to administer the entire contents of one microclyster with a shortened tip rectally, inserting the tip to its full length.

Instructions for use

Break off the seal on the tip of the tube.

Gently squeeze the tube so that a drop of the drug lubricates the tip of the enema – this will facilitate the insertion process.

Insert the enema tip into the rectum.

Squeezing the tube, completely express its contents.

Remove the tip, while still gently squeezing the tube.

Adverse Reactions

Based on spontaneous reports of adverse events

Adverse reactions occurring during the use of the drug, which were identified during the post-registration period, were classified as follows: very common (>10%), common (>1%, but <10%), uncommon (>0.1%, but <1%), rare (>0.01%, but <0.1%), very rare ( <0.01%) and adverse reactions with unknown frequency of occurrence (frequency cannot be estimated from the available data).

Gastrointestinal disorders very rare – abdominal pain (including abdominal discomfort, abdominal pain, as well as upper abdominal pain); anorectal discomfort, loose stools.

Immune system disorders very rare – hypersensitivity reactions (e.g., urticaria).

If adverse reactions mentioned in the instructions occur, or they worsen, or any other adverse reactions not mentioned in the instructions develop, the patient must inform the doctor.

Contraindications

• Increased individual sensitivity to the components of the drug.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies in pregnant women have not been conducted. Since the drug is probably absorbed into the systemic circulation to an insignificant extent, no adverse effects on the fetus or breastfed infant are expected when used in accordance with the recommendations during pregnancy or lactation.

Special Precautions

If symptoms persist, prolonged use should be avoided and a doctor should be consulted.

If the medicine is spoiled or the expiration date has passed, it should not be poured into drains or thrown onto the street. It is necessary to place the medicine in a bag and put it in a trash container. These measures will help protect the environment.

Influence on the ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher, operator).

Overdose

No cases of overdose with the drug have been reported.

Drug Interactions

There is a risk of developing necrosis of the large intestine with simultaneous oral/rectal use of sodium polystyrene sulfonate and sorbitol, which is part of the drug.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.