Friflo enema

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FREEFLO® ENEMA

Composition:

Active substances: sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate;

One dose (118 ml) administered contains: sodium dihydrogen phosphate dihydrate 21.4 g, disodium hydrogen phosphate dodecahydrate 9.4 g;

Excipients: benzalkonium chloride, disodium edetate, purified water.

Pharmaceutical form. Rectal solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Laxatives. Enemas. Combinations. ATC code A06AG20.

Pharmacological properties.

Pharmacodynamics.

The medicinal product acts as a saline laxative when administered rectally. Accumulation of fluid in the lower part of the intestine causes distension and promotes intestinal peristalsis and motility, resulting in evacuation of the rectum, sigmoid colon, and part or all of the descending colon.

Pharmacokinetics.

Absorption in the colon is minimal; however, asymptomatic hyperphosphatemia, with phosphorus levels exceeding the normal range by 2–3 times, has been reported in approximately 25% of individuals with normal renal function following oral administration of bowel preparations containing sodium phosphate. Under normal conditions, the most intense absorption of phosphorus occurs in the small intestine, which rectally administered preparations do not reach.

Clinical characteristics.

Indications.

Episodic constipation.

Conditions requiring bowel cleansing, such as before and after surgical procedures on the colon, before and after childbirth, prior to proctoscopy, sigmoidoscopy or colonoscopy, as well as before radiological examination of the colon.

Contraindications.

• Hypersensitivity to the active substances or to any other component of the medicinal product.

• Conditions in which absorption capacity is increased or defecation capacity is reduced, for example when there is intestinal obstruction or reduced intestinal peristalsis:

  • suspicion of intestinal obstruction;
  • paralytic ileus;
  • anorectal stenosis;
  • atresia / stricture / incomplete opening of the anus;
  • rectal stricture;
  • colonic dilation (megacolon);
  • Hirschsprung’s disease;
  • ileostomy.

• Undiagnosed gastrointestinal pathology, for example:

  • symptoms indicating appendicitis, perforation/injury or intestinal obstruction; active inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis);
  • undiagnosed rectal bleeding.

• Congestive and symptomatic heart failure.

• Dehydration.

• Pediatric age.

• Moderate to severe renal impairment.

• Uncontrolled arterial hypertension.

Do not use concomitantly with other medicinal products containing sodium phosphate.

Interaction with other medicinal products and other forms of interaction.

Use with caution in patients taking calcium channel blockers, diuretics, lithium preparations, or other drugs that may cause dehydration or affect electrolyte levels, as there is a risk of developing hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremic dehydration, and acidosis.

Do not use concomitantly with other medicinal products containing sodium phosphate (see section "Contraindications").

Since hypernatremia is associated with low lithium levels, concomitant use of this medicinal product with lithium therapy may lead to decreased serum lithium levels and reduced efficacy.

Special precautions for use.

Do not use the medicinal product without a physician's prescription if nausea, vomiting, or abdominal pain is present.

In case of defecation following administration of this medicinal product, patients should drink plenty of fluids to prevent dehydration, especially in conditions that may lead to dehydration or when taking medicinal products that may reduce glomerular filtration rate, such as diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors, e.g.: enalapril, ramipril, lisinopril), angiotensin receptor blockers (ARBs, e.g.: losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan), or nonsteroidal anti-inflammatory drugs (NSAIDs).

Since the medicinal product contains sodium phosphates, there is a risk of increased serum concentrations of sodium and phosphate, and decreased concentrations of calcium and potassium, which may lead to hypernatremia, hyperphosphatemia, hypocalcemia, and hypokalemia, with clinical signs resembling tetany and renal failure.

Electrolyte imbalance is particularly dangerous in children suffering from megacolon or any other condition involving fluid retention due to enema use, and in patients with concomitant diseases.

For this reason, the medicinal product should be administered with caution to elderly or debilitated patients; patients receiving lithium therapy; patients with ascites, cardiac diseases, rectal mucosal lesions (ulcers, fissures), colostomy, those using diuretics or other medicinal products affecting electrolyte balance, drugs that may prolong the QT interval (e.g., amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide), or patients with pre-existing electrolyte imbalances such as hypocalcemia, hypokalemia, hyperphosphatemia, or hypernatremia. Use with caution in patients taking medications affecting renal perfusion, kidney function, or hydration status. In case of suspected electrolyte imbalance or in patients with a history of hypophosphatemia, electrolyte levels should be monitored before and after administration of the medicinal product.

The medicinal product should be used with caution in patients with impaired renal function and only if the benefit outweighs the risk of hyperphosphatemia.

Repeated and prolonged use of the medicinal product is not recommended, as it may lead to dependence. Administration of more than one enema within 24 hours may be harmful. Unless otherwise directed by a physician, the medicinal product should not be used for more than 6 consecutive days.

Before using the medicinal product, read the instructions for medical use carefully, especially the rules for administration (see section "Dosage and administration"). Do not insert the nozzle of the bottle into the rectum unless it has been previously lubricated with vaseline oil. Patients should be advised to stop administration immediately if resistance is felt, as forceful insertion may cause local injury. Rectal bleeding after administration of the medicinal product may indicate a serious condition. In such cases, further use of the medicinal product should be discontinued immediately and medical advice should be sought.

Defecation usually occurs approximately 5 minutes after administration of the medicinal product; therefore, retention of the enema for longer than 5 minutes is not recommended. If defecation does not occur after administration or if retention lasts longer than 10 minutes, serious adverse effects may occur. In such cases, further use of the medicinal product should be discontinued and medical advice should be sought. The physician will decide whether laboratory tests are needed to detect possible electrolyte abnormalities and to minimize the risk of severe hyperphosphatemia.

This medicinal product contains 80 mg of benzalkonium chloride per dose (118 mL), which may cause irritation and can provoke skin reactions.

"Free-Flow Enema" is a solution for rectal administration.

DO NOT SWALLOW.

Use during pregnancy or breastfeeding.

Pregnancy.

There are no adequate data on the risk of congenital malformations or other fetal toxic effects associated with the use of "Free-Flow Enema" during pregnancy.

The medicinal product should be used only under medical supervision during or after labor.

Breastfeeding.

Sodium phosphate may pass into breast milk. It is recommended to express and discard breast milk for 24 hours after enema administration and not to use it for infant feeding.

Effect on ability to drive or operate machinery.

The medicinal product "Free-Flow Enema" has no direct effect on the ability to drive or operate machinery. However, due to the nature of the product, patients should remain near a toilet after administration.

Method of administration and dosage.

The following recommendations should be followed unless otherwise directed by a physician.

Adults and elderly patients.

Administer 1 bottle (administered dose — 118 mL) no more than once daily, or as prescribed by a physician.

Patients with renal impairment.

Do not use in patients with clinically significant renal dysfunction.

The product should be used with caution in patients with impaired renal function and only if the expected benefit outweighs the risk of hyperphosphatemia (see section "Special precautions").

Patients with hepatic impairment.

No dose adjustment is required for patients with hepatic impairment.

Administration instructions for enema.

1. Prior to administration, remove the protective induction seal located under the tip of the bottle.
2. Remove the protective cap from the bottle tip.
3. Lubricate the bottle tip with a small amount of petroleum jelly.
4. Lie on the left side with both knees bent.
5. Gently insert the bottle tip into the rectum with steady pressure, directing it toward the navel.
6. Squeeze the bottle until almost all of its contents have been delivered into the rectum.

Stop administration immediately if resistance is felt. Forcible administration may cause injury.

1. Carefully withdraw the tip from the rectum. Some leakage of liquid from the bottle may occur.
2. Remain in the same position until a strong urge to defecate is felt (usually within 2–5 minutes).
3. After use, place the bottle back into the cardboard packaging for disposal.

If no urge to defecate occurs within the specified time, consult a physician.

This product should be used only for short-term relief in cases of occasional constipation.

Children.

Do not use in pediatric practice.

Overdose.

Fatal cases have been reported when sodium phosphate enemas were used in excessive doses or over prolonged periods in children or in patients with bowel obstruction.

In cases of overdose or prolonged use, hyperphosphatemia, hypocalcemia, hypernatremia, hypernatremic dehydration, hypokalemia, hypovolemia, acidosis, and tetany may occur.

Recovery from toxic effects is usually achieved through rehydration. Treatment of electrolyte imbalances may require immediate medical intervention, including appropriate electrolyte and fluid replacement therapy.

Adverse Reactions

The medicinal product is generally well tolerated when used according to the indications. However, rare adverse events possibly related to the use of the medicinal product "Freefloo enema" have been reported. In some cases, adverse events may occur due to incorrect use of the enema.

The adverse reactions observed during the use of the medicinal product are listed below by system organ classes and frequency of occurrence: very common (> 1/10), common (> 1/100 and < 1/10), uncommon (> 1/1000 and < 1/100), rare (> 1/10000 and < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated based on available data).

Immune system disorders.

Very rare: hypersensitivity reactions (e.g., urticaria).

Skin and subcutaneous tissue disorders.

Very rare: blisters, pruritus, burning sensation.

Metabolism and nutrition disorders.

Very rare: dehydration, hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremia, metabolic acidosis.

Frequency not known: tetany.

Gastrointestinal disorders.

Very rare: nausea, vomiting, abdominal pain, abdominal distension, diarrhea, gastrointestinal pain, anal discomfort, proctalgia.

General disorders and administration site conditions.

Very rare: rectal irritation, pain, burning sensation, chills.

Investigations.

Frequency not known: transient increase in blood phosphorus levels.

If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Reporting of suspected adverse reactions.

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

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach and sight of children.

Packaging.

133 ml in a bottle with induction seal, nozzle, and cap. One bottle per cardboard box.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

Kusum Healthcare Pvt Ltd /
Kusum Healthcare Pvt Ltd.

Manufacturer's address and site of operations.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India /
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.