Enemafosfo^® (Solvent) Instructions for Use

Marketing Authorization Holder

Melon, LLC (Russia)

Manufactured By

Vertex, JSC (Russia)

ATC Code

A06AG01 (Sodium phosphate)

Active Substances

Sodium dihydrogen phosphate (BP British Pharmacopoeia)

Sodium hydrogen phosphate (Grouping name)

Dosage Form

Enemafosfo®

Rectal solution 7.2 g+19.2 g/120 ml: bottle 1 pc. complete with cannula

Dosage Form, Packaging, and Composition

Rectal solution transparent, colorless.

Excipients : sodium benzoate – 0.48 g, concentrated phosphoric acid – to pH 5.0-5.8, purified water – to 120 ml.

120 ml – single-use bottles (1) complete with cannula – cardboard packs.

Clinical-Pharmacological Group

Laxative drug with osmotic properties

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Saline laxative.

The action is based on increasing fluid retention 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 orally or rectally using the appropriate dosage forms.

For rectal administration, use the entire contents of one 120 ml bottle.

Lie on your left side with knees bent.

Gently insert the provided cannula into the rectum.

Squeeze the bottle to administer the solution.

For oral administration, dilute the entire contents of one bottle in at least 120 ml of cool water.

Stir until completely dissolved and drink immediately.

Follow administration with a full glass of additional water.

For pre-procedural bowel cleansing, use according to a specific medical schedule.

Typically administer the evening before the procedure and repeat on the morning of the procedure.

Do not take other oral medications within one hour of administration.

Maintain adequate fluid intake before, during, and after use.

Do not use for more than one week without medical consultation.

Discontinue use and consult a physician if no bowel movement occurs within 6 hours after oral intake.

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

Can be used 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, a doctor should be consulted 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.