Mikrolaks rectal solution tube 5 ml with universal tip No. 4

Instructions for Mikrolaks rectal solution, tube 5 ml with universal tip No. 4

Composition

active ingredients: sodium citrate, sodium lauryl sulfoacetate 70%, sorbitol solution 70%, crystallizing;

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

excipients: sorbic acid, glycerin, purified water.

Dosage form

Rectal solution.

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

Pharmacotherapeutic group

Drugs affecting the digestive system and metabolism. Laxatives in enemas. ATX code A06AG11.

Pharmacological properties

Pharmacodynamics

Mikrolaks® has a chemical and mechanical effect. Sodium citrate displaces bound water contained in the stool. Due to the sorbitol of the crystallizing solution, the effect of sodium citrate on the displacement of water is enhanced. Sodium lauryl sulfoacetate is a non-toxic, non-irritating wetting agent. It facilitates the penetration of the rectal solution into the stool. This process helps to liquefy the stool and allows the patient suffering from constipation to perform the act of defecation within a few minutes, usually from 5 to 20 minutes. The process of displacing bound water by chemical and mechanical means is called peptization. The increase in the amount of water due to peptization and liquefaction helps to soften the stool and facilitate bowel movements.

Indication

Constipation (short-term use), as well as diseases that require easier defecation.

For bowel emptying during diagnostic and therapeutic procedures in the rectal area.

Contraindication

- Hypersensitivity to the active substances or to any of the excipients included in the preparation;

- intestinal obstruction;

- diagnosing hereditary fructose intolerance (intolerance to a certain type of sugar).

Interaction with other medicinal products and other types of interactions

Studies on the interaction of Mikrolaks® with other drugs have not been conducted.

Since Mikrolaks® contains sorbitol, it is not recommended to use it simultaneously with ion exchange resins used orally or rectally for the treatment of hyperkalemia, due to the risk of intestinal necrosis.

Application features

Sorbic acid may cause irritation of the mucous membrane.

If symptoms persist for a long time, you should consult a doctor and avoid long-term use of the drug.

If the contents of the tube are only partially used, the remaining rectal solution must be disposed of.

Use during pregnancy or breastfeeding

Studies in pregnant women have not been conducted. Since the drug, when used as recommended, is likely to have only minor systemic absorption, no harmful effects on the health of the fetus/newborn are expected when the drug is used during pregnancy and breastfeeding.

It is not known whether sodium citrate, sodium lauryl sulfoacetate and sorbitol pass into human breast milk. During breastfeeding, the use of the drug is recommended after consulting a doctor and assessing the risk/benefit to the child.

Ability to influence reaction speed when driving vehicles or other mechanisms

Unknown.

Method of administration and doses

The drug is used rectally.

A single dose of the drug should be administered 5-20 minutes before the desired effect.

Adults and children over 3 years of age should use the contents of 1 microenema tube with a tip (5 ml), inserting the microenema tip to its full length.

Newborns and children under 3 years of age should use the contents of 1 microenema tube with a tip (5 ml) and insert the microenema tip half way (see the marking on the tube tip).

Application instruction

Break off the seal on the tip of the tube.

Press lightly on the tube so that a drop of the drug lubricates the tip of the microenema tip to improve the insertion process. Insert the microenema tip to its full length (for children under 3 years old, half its length) into the rectum.

Squeeze the tube to completely squeeze out its contents. Remove the tip while continuing to squeeze the tube.

Children

Used for children from birth.

Overdose

No cases of overdose have been reported to date.

Adverse reactions

The frequency of adverse reactions is defined as follows: 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, frequency unknown - frequency cannot be estimated from the available data.

On the part of the immune system: frequency unknown - hypersensitivity reactions (e.g. urticaria).

Gastrointestinal tract: frequency unknown - abdominal pain, slight burning sensation in the anus, loose stools.

Expiration date

3 years.

Storage conditions

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

Packaging

5 ml of rectal solution in a tube with a tip. 4 or 12 tubes with tips in a cardboard box.

Vacation category

Without a prescription.

Producer

Famar Orleans/Famar Orleans.

Location of the manufacturer and its business address

5 avenue de Concyr, Orleans, 45071, France/5 avenue de Concyr, Orleans, 45071, France.

Applicant

McNeil Products Limited

Applicant's location

Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom

(Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom)

Applicant's representative

Johnson & Johnson Ukraine LLC

Location of the applicant's representative

02152, Kyiv, Pavla Tychyna Ave., 1B, Ukraine

+38 (044) 498 0888

+38 (044) 498 7392