GLYCERIN MICROENEMAS FOR CHILDREN PEDOLAX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Glycerin Microenemas for Children Pedolax

Composition:

Active substance: glycerol;

1 applicator (4 ml) contains glycerol 3.28 ml;

Excipients: purified water.

Pharmaceutical form. Rectal solution.

Main physicochemical characteristics:

syrup-like liquid, transparent, colourless, with a characteristic odour, free from foreign particles.

Pharmacotherapeutic group. Laxatives. Glycerol.

ATC code A06AX01.

Pharmacological properties.

Pharmacodynamics. The active substance of the medicinal product is glycerin, which exerts a laxative effect after rectal administration due to its ability to lubricate fecal masses and facilitate the influx of fluid into them, thereby stimulating intestinal contractions.

Pharmacokinetics. Glycerin promotes bowel evacuation within 15–30 minutes to 1 hour after administration of the micro-enema.

Clinical characteristics.

Indications.

For local relief of symptoms of short-term and episodic constipation.

Contraindications.

Hypersensitivity to glycerin.

Abdominal spasms, colic, nausea, vomiting, or other symptoms of appendicitis.

Hemorrhagic proctocolitis.

Diarrhea.

Anorectal disorders.

Ulcerative colitis and inflammatory hemorrhoidal conditions.

Abdominal pain.

Intestinal obstruction.

Acute inflammatory bowel diseases.

Children under 2 years of age.

Interaction with other medicinal products and other forms of interaction.

Not reported.

If the patient is taking or has recently taken any medicinal product, it is advisable to consult a physician, even if that medicinal product belongs to the over-the-counter group.

Special precautions for use

"Pedolax Glycerin Microenemas for Children" should not be used for longer than one week, except when medically indicated.

If blood appears in the stool, or if irritation, pain, or lack of improvement in bowel condition occurs, treatment should be discontinued and a doctor should be consulted regarding further use of the medicinal product.

This medicinal product must not be used in children under 2 years of age.

Patients with severe diseases, particularly cardiovascular disorders, should use this medicinal product only under medical supervision.

Glycerol may increase abdominal pain in patients suffering from irritable bowel syndrome. Such patients should use the product with caution.

Avoid prolonged use of the medicinal product.

Use during pregnancy or breastfeeding

The medicinal product is intended for use in children.

Ability to affect reaction speed when driving or operating machinery

No such effects have been reported. Given the nature and action of the product, such effects are not expected.

Method of Administration and Dosage

The recommendations provided below should be followed unless otherwise instructed by a physician.

"Pedolax Glycerin Microenemas for Children" are intended for rectal use only.

Children under 2 years of age

Not to be used.

Children aged 2 to 12 years

1 applicator per day.

Children aged 12 years and older

Not to be used.

Adults and elderly patients

Not to be used.

Hepatic and/or renal impairment

Dosage adjustment is not required.

Consult a doctor if the effect of "Pedolax Glycerin Microenemas for Children" appears too strong or too weak.

Method of Administration

At the chosen time for administration, remove the cap covering the tip of the cannula. Holding the cannula vertically with the tip pointing upwards, gently squeeze the applicator slightly to release a few drops of the preparation to moisten the tip of the cannula, facilitating insertion into the rectum. After insertion into the rectum, express the contents of the applicator. Once empty, remove it while continuing to compress the walls of the applicator. Each applicator is filled with an excess of solution, which remains in the applicator after use. Thus, the amount of solution administered corresponds to the full dose, and there is no need to completely empty the applicator, which facilitates ease of use.

Each applicator contains one dose of the medicinal product and should be discarded after use.

If resistance is felt during insertion, administration should be stopped, as it may cause harm. Therefore, before continuing use, consult a doctor to determine the cause of resistance.

Delay defecation as long as possible to allow the medicinal product to exert its effect.

Duration of Treatment

This medicinal product should not be used for longer than one week unless otherwise prescribed by a physician. If symptoms worsen or persist for more than 7 days, consult a doctor.

Children — intended for use in children aged 2 to 12 years.

Overdose

Abuse or prolonged use of the medicinal product may lead to a so-called "irritable colon syndrome" (diarrhea or constipation). Therefore, caution and medical supervision are advised in cases of prolonged use.

In case of overdose or accidental ingestion, seek immediate medical assistance, providing the name of the product and the amount ingested.

Adverse reactions.

Local discomfort, irritation, pain in the area of the anal opening, or itching may occur. Consult a physician if any of these or other adverse reactions not listed in the instructions have been observed. Hypersensitivity reactions are possible.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after the medicinal product has been registered is important. It allows ongoing monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical personnel, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging. Rectal solution, 3.28 mL/4 mL, 4 mL in applicators, pack of 4 in a cardboard box.

Availability category. Over-the-counter (without prescription).

Manufacturer.

Casen Recordati, S.L. /
Casen Recordati, S.L.

Manufacturer's address and place of business.

Autovia de Logrono km 13,300
50180 Utebo, Zaragoza, Spain /
Autovia de Logrono km 13,300
50180 Utebo, Zaragoza, Spain.