GLYCERIN SUPPOSITORIES GLYCIK FOR BABIES

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Glycerine Suppositories Glycik for Babies (Glycerine suppositories Glycik for babies)

Composition:

Active substance: glycerol;

1 suppository contains glycerol 0.6 g;

Excipients: gelatin, purified water.

Pharmaceutical form. Rectal suppositories.

Main physicochemical properties: suppositories from yellow to brownish-yellow in color, torpedo-shaped, odorless.

Pharmacotherapeutic group. Laxatives. Other laxatives.

ATC code A06AX01.

Pharmacological Properties

Pharmacodynamics

Pure glycerin has an irritant effect, which disappears when water (30–50%), vaseline, or lanolin is added. When administered into the rectum, suppositories exert a mild irritant effect on the mucous membrane and reflexively stimulate defecation.

When used as rectal suppositories, glycerin facilitates the elimination of fecal masses.

The effect of the medicinal product occurs within 5–30 minutes.

Pharmacokinetics

After rectal administration, absorption is weak and residence in the body is short-term.

Glycerin practically does not enter the systemic circulation and does not cause systemic adverse effects.

Clinical characteristics.

Indications.

For symptomatic treatment of constipation.

For rapid cleansing of the rectum (preparation for endoscopic examinations of the rectum).

Contraindications.

Hypersensitivity to the components of the medicinal product. Renal insufficiency, irritable bowel syndrome, intestinal obstruction, appendicitis, bleeding, diarrhea, hemorrhoids in the stage of exacerbation, rectal tumors, colic, abdominal pain, hemorrhagic proctocolitis, anal fissures.

Interaction with other medicinal products and other types of interactions.

Glycerin suppositories may weaken 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 more than 3 days.

Do not use without consulting a doctor in case of impaired kidney function, allergy, nausea, or vomiting. Hands should be thoroughly washed before and after using suppositories.

The use of the medicinal product may affect glucose level control in patients with diabetes mellitus. If symptoms do not resolve within 3 days or if the condition worsens, medical advice should be sought.

Use during pregnancy or breastfeeding.

The medicinal product is intended for use in children.

Ability to affect reaction rate when driving vehicles or operating machinery.

The medicinal product is intended for use in children.

Method of administration and dosage.

Route of administration.

For rectal use only. It is recommended to store suppositories in the refrigerator for half an hour prior to use. Remove the plastic cap. Moisten the suppository with water and insert it into the rectum. Retain the suppository in the rectum for at least 10 minutes to achieve full effect. Defecation should occur within 5–30 minutes after administration.

Treatment of constipation should not exceed 3 days.

Children.

For use in children under 2 years of age.

Overdose.

Excessive use of suppositories may cause inflammation of the intestine, abdominal pain, and diarrhea.

Side effects.

Some adverse events and symptoms have been reported, which disappear after discontinuation of the product, including: rectal discomfort, irritation, burning sensation, colicky pain, and spasms. In rare cases, the medicinal product may cause hyperemia of the rectal mucosa, and in isolated cases — slight bleeding or mucus discharge. Allergic reactions, pain, nausea, and vomiting are possible. With prolonged use, irritation and unpleasant sensations in the rectum have been observed; sometimes catarrhal proctitis may occur.

Shelf life. 5 years.

Storage conditions. Store at a temperature not exceeding 25 ºC. Keep out of reach of children.

Packaging. 5 suppositories per strip. 1 strip per cardboard box.

Supply category. Over-the-counter.

Manufacturer.

E.I. ZARBIS & Cо., LP.

Manufacturer's address and address of its business operation.

Thivon 35, Megara Attiki, 19100, Greece / Thivon 35, Megara Attiki, 19100, Greece.