Glycerin suppositories glycik for adults

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Glycerine suppositories Glycik for adults

Composition:

Active ingredient: glycerol;

1 suppository contains glycerol 2.4 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. Glycerol. ATC code A06AX01.

Pharmacological properties.

Pharmacodynamics.

Glycerol is a laxative medicinal product that induces rapid defecation and acts within 5–30 minutes after administration.

Glycerol stimulates intestinal peristalsis and reduces water absorption due to its osmotic and hygroscopic properties. Moreover, it may cause local stimulation associated with induced defecation.

Pharmacokinetics.

Not established.

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 failure, irritable bowel syndrome, intestinal obstruction, appendicitis, nausea, vomiting or other symptoms of appendicitis, bleeding, diarrhea, hemorrhoids in the acute stage, rectal tumors, undiagnosed abdominal pain, abdominal spasms, ulcerative colitis, acute inflammatory bowel diseases, colic, papillomas, hemorrhagic rectocolitis, anal fissures.

Interaction with other medicinal products and other types of interactions.

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 observed.

Special precautions for use

Prolonged use of the medicinal product should be avoided. Suppositories should not be used for more than 1 week. If symptoms do not resolve or the condition worsens within 1 week, medical advice should be sought.

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

Use during pregnancy or breastfeeding

This medicinal product is not recommended during the first trimester of pregnancy. During other periods of pregnancy, the product should be used only when the expected benefit to the pregnant woman outweighs the potential risk to the fetus.

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

Ability to affect reaction speed while driving or operating machinery

No effect.

Method of Administration and Dosage.

For rectal use only.

Remove the plastic cap. Moisten the suppository with water and insert it into the rectum. Hold the suppository in the rectum for at least 10 minutes to achieve full effect.

Apply 1 suppository per day. If defecation does not occur within 5–30 minutes after administration, administer another suppository after 1 hour.

Children.

Do not use in pediatric practice.

Overdose.

Overdose may cause inflammation of the intestine, abdominal pain, and diarrhea. These symptoms resolve after discontinuation of the drug.

Side effects.

Some adverse events and symptoms have been reported, which disappear after discontinuation of the product, including: rectal discomfort, irritation, burning sensation, colic, 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.

Shelf life.

5 years.

Storage conditions.

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

Packaging.

5 suppositories per strip; 2 strips per cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

E.I. ZARBIS & Co., LP.

Manufacturer's address and place of business.

Thivon 35, Megara Attiki, 19100, Greece.