Enemaxal^® (Solvent) Instructions for Use

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

ATC Code

A06AG01 (Sodium phosphate)

Active Substances

Sodium hydrogen phosphate (Group)

Sodium dihydrogen phosphate (BP)

Dosage Form

Enemaxal®

Rectal solution 0.08 g+0.181 g/1 ml: bottle-enema 120 ml

Dosage Form, Packaging, and Composition

Rectal solution transparent, colorless.

Excipients : sodium benzoate – 0.004 g, phosphoric acid – to pH 5.0-5.8, water – to 1 ml.

120 ml – single-use bottle-enemas* (1) – cardboard packs.

* with or without a rectal applicator.

Clinical-Pharmacological Group

Laxative drug with osmotic properties

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Saline laxative.

The action is based on increasing the retention of fluid in the intestine through osmotic processes.

The accumulation of fluid in the intestine leads to increased peristalsis and subsequent bowel emptying.

The effect develops within 5-7 minutes after administration.

Pharmacokinetics

Sodium phosphate is poorly absorbed in the intestine; however, absorption of sodium and phosphate ions does occur and is dose-dependent.

Indications

Constipation; preparation for endoscopic examination of the rectum; preparation for X-ray examination of the abdominal organs; preparation for surgical operations on the abdominal organs, childbirth.

ICD codes

Dosage Regimen

Administer Enemaxal^®rectally using the provided single-use bottle-enema.

For constipation in adults, use the entire 120 ml contents of one bottle-enema as a single dose.

For pre-procedural bowel cleansing prior to endoscopic or X-ray examination, surgery, or childbirth, use the entire 120 ml contents of one bottle-enema as directed by a physician.

Do not use orally. The rectal solution is for rectal use only.

Ensure the patient is positioned comfortably, typically lying on their left side with knees bent.

Gently insert the rectal applicator tip into the anus and slowly squeeze the bottle to empty the entire contents into the rectum.

Dispose of the used bottle-enema after a single application; do not reuse.

The laxative effect typically develops within 5 to 7 minutes after administration.

This product is contraindicated in patients under 18 years of age.

Maintain adequate fluid intake during use. Monitor electrolyte levels before and after use, especially in at-risk patients.

Adverse Reactions

Possible allergic reactions, nausea, vomiting, abdominal pain, local irritant effect (irritation around the anus).

Contraindications

Intestinal obstruction, intestinal perforation, acute inflammatory and/or ulcerative lesions of the distal intestines, acute hemorrhoids, anal fissures, age under 18 years, hypersensitivity to the active substances.

Use in Pregnancy and Lactation

Use is possible for preparation for childbirth according to indications when the potential benefit outweighs the risk of use. Use during breastfeeding is not recommended.

Use in Renal Impairment

The drug is contraindicated for use in renal impairment.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

When using this product, patients should maintain adequate fluid intake.

Electrolyte levels should be monitored before and after use.

If no bowel movement occurs within 6 hours after oral administration, the patient should be asked to stop taking this product and consult a doctor, as dehydration may develop.

Drug Interactions

When used rectally, consultation with a doctor is necessary if the patient is taking anticoagulants, digitalis preparations, ciprofloxacin, etidronate, sodium polystyrene sulfonate, or tetracycline antibiotics.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.