Glycerin microenemas for adults adulax

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ADULAX Glycerin Micro-Enemas for Adults

Composition:

Active substance: glycerol;

1 applicator (7.5 ml) contains 6.14 ml of glycerol;

Excipient: purified water.

Pharmaceutical form. Rectal solution.

Main physicochemical properties: syrupy liquid, clear, colorless, with a characteristic odor, free from extraneous particles.

Pharmacotherapeutic group. Laxatives. Glycerol.

ATC code A06AX01.

Pharmacological properties.

Pharmacodynamics. The active substance of the medicinal product is glycerin, which, after rectal administration, produces a laxative effect due to its ability to lubricate fecal masses and promote fluid influx into them, thereby stimulating intestinal contractions.

Pharmacokinetics. Glycerin promotes bowel evacuation within a period of 15–30 minutes to 1 hour after administration of the micro-enema.

Clinical characteristics.

Indications.

For local relief of symptoms of short-term and episodic constipation.

Contraindications.

Hypersensitivity to glycerin.

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

Hemorrhagic proctocolitis.

Diarrhea.

Anorectal diseases.

Ulcerative colitis and inflammatory hemorrhoidal conditions.

Abdominal pain.

Intestinal obstruction.

Acute inflammatory bowel diseases.

Children under 12 years of age.

Interaction with other medicinal products and other forms of interaction.

No interactions have been reported.

If the patient is taking or has recently taken any medicinal product, they should consult a physician.

Special precautions for use

If blood appears in the feces, or if irritation, pain occurs, or if there is no improvement in bowel condition, treatment should be discontinued and a doctor should be consulted regarding further use of the medicinal product.

Adyulaks should not be used for longer than one week unless otherwise prescribed by a doctor.

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

Glycerol may intensify abdominal pain in patients suffering from irritable bowel syndrome. Such patients are advised to use the product with caution.

Avoid prolonged use of the medicinal product.

Use during pregnancy or breastfeeding

The product may be used only when, in the opinion of a physician, the benefit to the woman outweighs the potential risk to the fetus/child.

Ability to influence reaction rate while driving or operating machinery

Given the nature of the product and its action, no effect on reaction speed is expected.

Method of Administration and Dosage

The recommendations below should be followed unless otherwise instructed by a physician.

This medicinal product is intended for rectal use only.

Adults and children aged 12 years and older:

1 rectal applicator per day.

Elderly patients:

The recommended dose is the same as for adults.

Hepatic and/or renal impairment:

Dosage adjustment is not required.

Consult a physician if the effect of Adyulax glycerin micro-enemas for adults appears too strong or too weak.

Method of Administration

At the time of administration, remove the cap covering the tip of the cannula. Holding the cannula vertically with the tip pointing upwards, gently squeeze to release a few drops of the preparation to moisten the tip, facilitating insertion of the applicator into the rectum. After insertion into the rectum, express the contents of the applicator. Once emptied, withdraw the applicator while continuing to compress its walls. Each applicator is filled with an excess of product, which remains inside after use. Thus, the amount delivered into the rectum constitutes a full dose, and there is no need to completely empty the applicator, making it easier to use.

Each applicator contains 1 dose of the medicinal product and must be discarded after use.

If resistance is felt during insertion, administration should be stopped, as it may cause harm. Before continuing treatment, consult a physician to determine the cause of resistance.

Delay defecation as long as possible to allow the medicinal product to exert its effect.

Duration of Treatment

This product should not be used for longer than one week unless otherwise directed by a physician.

If symptoms worsen or persist after 7 days of use, consult a physician.

Children

This medicinal product is not intended for use in children under 12 years of age.

Overdose

Abuse or prolonged use of this product may lead to a condition known as "irritable bowel syndrome" (diarrhea or constipation). Therefore, if longer-term use is necessary, it should be used with caution under medical supervision.

In case of overdose or accidental ingestion, seek medical advice immediately.

Side effects.

Local discomfort, irritation, anal pain, and itching may occur. Hypersensitivity reactions are possible. Consult a physician if any of these or other side effects not listed in the instructions are observed.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

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

Packaging. Rectal solution, 6.14 mL/7.5 mL, 7.5 mL in applicators, 4 in a cardboard box.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

Kasen Recordati, S.L. / Casen Recordati, S.L.

Manufacturer's address and place of business.

Autovia de Logrono km 13,300, 50180 Utebo, Zaragoza, Spain / Autovia de Logrono km 13,300,
50180 Utebo, Zaragoza, Spain.

Date of last review.