GLYCEROL EURO

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLYCEROL EURO (GLYCEROL EURO)

Composition:

Active substance: glycerol;

1 suppository contains glycerol 686 mg;

Excipients: gelatin, purified water.

Pharmaceutical form. Suppositories.

Main physicochemical characteristics: suppositories made of gelatinous mass, semi-transparent, yellow in color, with a homogeneous content, odorless or with a slight characteristic odor.

Pharmacotherapeutic group.

Laxatives. Other laxatives. ATC code A06AX01.

Pharmacological properties.

Pharmacodynamics.

In its pure form, glycerin has an irritating effect, which disappears when water (30–50%), vaseline, or lanolin is added. When used as rectal suppositories, it facilitates the elimination of fecal masses. Upon insertion into the rectum, glycerin suppositories exert a mild irritant effect on the mucosa and, via a reflex pathway, initiate the defecation process.

Clinical characteristics.

Indications.

Symptomatic treatment of constipation of various etiologies in children from 3 months to 1 year of age (when oral administration of medications is not possible).

Contraindications.

Hypersensitivity to glycerin or to any component of the medicinal product. Renal insufficiency; irritable bowel syndrome, intestinal obstruction; appendicitis, nausea, vomiting or other symptoms of appendicitis; bleeding, diarrhea, acute hemorrhoids, anal fissures; abdominal spasms, ulcerative colitis, acute inflammatory bowel diseases, colic; papillomas, rectal tumors; undiagnosed abdominal pain; hemorrhagic rectocolitis.

Interaction with other medicinal products and other forms of interaction.

Glycerin may interact with other medicinal products. Glycerin suppositories may reduce the effect of other medicinal products administered rectally. A several-hour interval should be maintained.

Special precautions for use.

It is not recommended to use suppositories for a treatment course longer than 3 days.

Do not use without consulting a physician in case of kidney function disorders, allergies, nausea, or vomiting.

Hands should be thoroughly washed before and after administration of suppositories.

Use during pregnancy or breastfeeding.

The medicinal product is intended for pediatric use.

Ability to influence reaction rate when driving or operating machinery.

The medicinal product is intended for pediatric use.

Method of Administration and Dosage.

Children.

Administer 1 suppository once daily.

The suppository should be inserted into the rectum and retained for at least 5 minutes, unless bowel evacuation occurs earlier. Residual suppository material is expelled from the body together with fecal matter.

Treatment of constipation should not exceed 3 days.

Children. For use in children aged from 3 months to 1 year.

Overdose.

Symptoms: frequent loose stools. Overdose may cause inflammation of the intestine, abdominal pain, and diarrhea. Symptoms resolve spontaneously after discontinuation of the drug.

In case of overdose, discontinue use of the medicinal product.

Side effects.

Some adverse effects and symptoms have been reported, which resolve after discontinuation of the product, particularly rectal discomfort, irritation, burning, colic, and spasms. In rare cases, the medicinal product may cause hyperemia of the rectal mucosa, and in isolated cases, minor bleeding or mucus discharge.

Allergic reactions, pain, nausea, vomiting, and gastrointestinal bleeding are possible.

With prolonged use, irritation and unpleasant sensations in the rectum have been observed; occasionally, catarrhal proctitis may occur.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

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

Packaging.

6 suppositories in a thermo-sealed strip made of white opaque PVC film; 1 or 2 strips in a cardboard box.

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

Manufacturer.

Laboratorios Bassi - Industria Farmacéutica, S.A.

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

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16, Mortágua, 3450-232, Portugal.