Glycerin microenemas glycik for babies

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Glycerin Micro-enemas Glycik for Babies (Glycerin micro-enemas Glycik for babies)

Composition:

Active substance: glycerol;

1 applicator (2.5 mL) contains glycerol 1.8 g;

Excipient: purified water.

Pharmaceutical form. Rectal solution.

Main physicochemical properties: colorless or almost colorless clear liquid.

Pharmacotherapeutic group. Laxatives. Glycerin. ATC code A06AG04.

Pharmacological properties.

Pharmacodynamics.

Glycerol, after rectal administration, exerts a laxative effect by stimulating intestinal peristalsis and reducing water absorption due to its osmotic and hygroscopic properties. Moreover, it may cause local stimulation associated with induced defecation.

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Clinical characteristics.

Indications.

For symptomatic treatment of constipation.

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

Contraindications.

Hypersensitivity to glycerin.

Papillomas.

Anal fissures.

Abdominal spasms, colic, nausea, vomiting, or other symptoms of appendicitis.

Ulcerative colitis and inflammatory hemorrhoidal conditions.

Hemorrhagic rectocolitis.

Diarrhea.

Intestinal obstruction.

Acute inflammatory diseases of the intestine.

Interaction with other medicinal products and other types of interactions.

No interactions with other medicinal products have been reported.

If the patient is taking or has recently taken any medicinal product, it is advisable to consult a physician, even if this medicinal product belongs to the over-the-counter group.

Special precautions for use

Do not use the medicinal product for longer than one week, except when medically indicated. Prolonged use should be avoided, as it may cause diarrhea. Use of the product may affect glucose control in patients with diabetes mellitus.

If blood appears in the stool, or if irritation, pain, or lack of improvement in bowel function occurs, treatment should be discontinued and a physician should be consulted regarding further use of the medicinal product.

The medicinal product may be used in patients with severe diseases, particularly cardiovascular disorders, only under medical supervision.

Glycerol may increase abdominal pain in patients suffering from irritable bowel syndrome. Such patients should use the product with caution.

Use during pregnancy or breastfeeding

The medicinal product is intended for use in children.

Ability to affect reaction speed when driving or operating machinery

The medicinal product is intended for use in children.

Method of Administration and Dosage

For children under 2 years of age, apply 1 applicator per day.

Defecation should occur within 5–30 minutes after administration of 1 microenema.

Method of Administration

For rectal use only.

At the chosen time for administration, remove the cap covering the applicator tip. Holding the applicator vertically with the tip pointing upward, gently squeeze it slightly to release a few drops of the solution to moisten the tip and facilitate insertion. After inserting into the rectum, squeeze the entire contents of the applicator into the rectum. While continuing to compress the applicator walls, remove it after emptying.

Each applicator contains a single dose of the medicinal product and must be discarded after use.

If resistance is felt during insertion, stop the procedure immediately, as it may cause injury. Before continuing administration, consult a physician to determine the cause of resistance.

After administration, retain the bowel movement as long as possible to allow the medicinal product to exert its effect.

Duration of Treatment

This medicinal product should not be used for longer than one week unless otherwise directed by a physician. If symptoms worsen or persist for more than 7 days, consult a physician.

Children

This product is indicated for children under 2 years of age. Rectally administered laxatives should be prescribed to children only in exceptional cases.

Overdose

Prolonged use of microenemas may cause inflammation of the intestine, abdominal pain, and diarrhea. Therefore, caution is advised and medical supervision is recommended in case of prolonged use.

Side effects.

Hypersensitivity reactions are possible.

Local discomfort, irritation, pain in the area of the anus, or itching may occur.

With prolonged use, a burning sensation in the anal area may develop, and in rare cases, inflammation of the rectum. Occasionally, abdominal spasms may occur.

Consult a doctor if any adverse reactions are observed, including those not listed in this instruction.

Shelf life. 5 years.

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

Packaging. 2.5 mL in an applicator in a foil pouch; 4 applicators in foil pouches in a cardboard box.

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

Manufacturer.

E.I. ZARBIS and Co., LP / E.I. ZARBIS & Co., LP.

Manufacturer's address and address of its business operation.

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