Glycerol suppositories "farmina"

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLYCERIN SUPPOSITORIES "FARMINA"

Composition:

active substance: glycerol;

1 suppository contains glycerol 86% – 0.75 g or 1.5 g;

excipients: stearic acid, anhydrous sodium carbonate.

Pharmaceutical form. Suppositories.

Main physico-chemical properties: white or practically white, semi-transparent, hygroscopic suppositories.

Pharmacotherapeutic group. Laxatives. Glycerol. ATC code A06AX01.

Pharmacological properties.

Pharmacodynamics.

In its pure form, glycerol has an irritant effect, which disappears when water (30-50%), petrolatum, or lanolin is added. When administered into the rectum, suppositories exert a mild irritant effect on the mucous membrane and, via reflex pathways, stimulate defecation. When used as rectal suppositories, they facilitate the expulsion of fecal masses.

Clinical characteristics.

Indications.

Constipation of various etiologies (when oral administration of drugs is not possible).

Contraindications.

Hypersensitivity to the components of the drug. Intestinal obstruction, renal failure, appendicitis, bleeding, diarrhea, hemorrhoids in the stage of exacerbation, anal fissures, inflammatory diseases, tumors of the rectum, undiagnosed abdominal pain.

Special precautions.

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

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

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

Interaction with other medicinal products and other forms of interaction.

Glycerin suppositories may weaken the effect of other drugs administered rectally. A several-hour interval should be observed.

Special precautions for use.

Use during pregnancy or breastfeeding.

This medicinal product can be used during pregnancy only when the expected benefit for the mother outweighs the potential risk to the fetus.

It is unknown whether glycerol is excreted in breast milk; therefore, the physician may prescribe this medicinal product during breastfeeding only when the expected benefit for the mother outweighs the potential risk to the infant.

Ability to influence reaction rate while driving or operating machinery.

Has no effect.

Method of Administration and Dosage.

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

The suppository is inserted into the rectum and should be retained for at least 5 minutes, unless defecation occurs earlier. Residual parts of the suppositories are eliminated from the body along with fecal matter. If necessary, the dose may be increased to 2 suppositories per day.

For adults and children aged 5 years and older: 1 suppository (containing 1.5 g of glycerin) once daily. For children under 5 years: 1 suppository (containing 0.75 g of glycerin) once daily.

Children.

No restrictions.

Overdose.

In case of overdose, frequent bowel movements and loose stools may occur. These effects resolve spontaneously after discontinuation of the drug.

Side effects.

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

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

Shelf life.

2 years.

Storage conditions.

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

Packaging.

5 suppositories per blister; 1 or 2 blisters per cardboard box.

Availability.

Over-the-counter.

Manufacturer.

Farmina Ltd.

Manufacturer's address.

Lipska St. 44, 30-721 Kraków, Poland.