GLYCEROL EUROV

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Glycerol Euro

Composition:

Active substance: glycerol;

1 suppository contains glycerol 1 g or 2 g;

Excipients: gelatin, purified water.

Pharmaceutical form. Rectal suppositories.

Main physico-chemical properties: candles made of gelatin mass, semi-transparent, yellow in color, homogeneous in appearance, odorless or with a slight characteristic odor.

Pharmacotherapeutic group.

Other laxatives. ATC code A06A X01.

Pharmacological properties.

Pharmacodynamics.

In its pure form, glycerin has an irritant effect, which disappears when water (30–50%), petrolatum, or lanolin is added. When used as rectal suppositories, it facilitates the expulsion 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 (when oral administration of drugs is not possible).

Contraindications.

Hypersensitivity to glycerin or to any component of the drug. Renal failure, irritable bowel syndrome, intestinal obstruction, appendicitis, bleeding, diarrhea, hemorrhoids in acute phase, anal fissures, inflammatory diseases, rectal tumors, undiagnosed abdominal pain, hemorrhagic proctocolitis.

Interaction with other medicinal products and other forms of interaction.

Glycerin suppositories may reduce the effect of other drugs administered rectally. An interval of several hours should be maintained.

Usage instructions.

It is not recommended to use the suppositories for treatment courses longer than 1 week.

Use with caution in patients with impaired kidney function, allergies, nausea, or vomiting.

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

Use during pregnancy or breastfeeding.

During pregnancy, the medication should be used only when the expected benefit to the mother outweighs the potential risk to the fetus.

It is unknown whether glycerin is excreted in breast milk; therefore, this medicinal product should be used only when, in the opinion of a physician, the expected benefit to the mother outweighs the potential risk to the infant.

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Administer 1 suppository once daily, 15–20 minutes after breakfast.

Insert the suppository into the rectum and retain it there for at least 5 minutes, unless defecation occurs earlier. Residual parts of the suppositories are eliminated from the body together with fecal matter. If necessary, the dose may be increased to 2 suppositories per day.

Single dose for adults and children aged 6 years and older: 1 suppository of 2 g or 2 suppositories of 1 g.

Single dose for children aged 2 to 6 years: 1 suppository of 1 g.

Treatment of constipation should not exceed 7 days.

Children.

For children aged 2 years and older, the drug should be administered at a dose of 1 g of glycerin.

Overdose.

Symptoms: frequent loose stools. Resolves spontaneously after discontinuation of the drug.

In case of overdose, discontinue the drug.

Side effects.

Some adverse effects and symptoms have been reported, which disappear after discontinuation of use, particularly rectal discomfort, irritation, burning sensation, colic, and spasms. In rare cases, it may cause hyperemia of the rectal mucosa, and in isolated cases – slight bleeding or mucus discharge.

Possible allergic reactions, pain, nausea, vomiting, gastrointestinal bleeding.

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

Shelf life. 3 years.

Storage conditions.

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

Packaging.

6 suppositories in a thermo-sealed blister made of white opaque PVC film; 1 or 2 blisters per pack.

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

Manufacturer.

Laboratorios Bassi - Industria Farmacéutica, S.A.

Manufacturer's address and place of business.

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