Ezekol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EZECOL (ezecol)

Composition:

Active substances: 1 sachet contains: macrogol 3350 – 13,125.0 mg, sodium chloride – 350.7 mg, sodium bicarbonate – 178.5 mg, potassium chloride – 46.6 mg;

Excipients: acesulfame potassium, lemon flavor (DC 210 PH).

Pharmaceutical form. Oral powder for solution.

Main physicochemical properties: white crystalline powder with a characteristic odor in a single-dose sachet.

Pharmacotherapeutic group. Agents affecting the digestive tract and metabolism. For constipation. Osmotic laxatives. Macrogol, combinations. ATC code A06AD65.

Pharmacological properties.

Pharmacodynamics.

Macrogol exerts an osmotic effect on the intestine, causing a laxative effect. Macrogol increases the volume of intestinal contents, which, via neuro-muscular pathways, stimulates enhanced colonic motility. The physiological action consists in enhancing propulsive activity of the colon, softening fecal matter, and facilitating defecation. The electrolytes of macrogol and serum diffuse through the intestinal barrier (mucosa) and secrete water into the intestinal lumen without causing excess accumulation or loss of sodium, potassium, or water.

Research data indicate that the dose required to establish normal bowel movements decreases over time. For most patients, 1 to 2 sachets per day are sufficient; however, the dose should be adjusted according to individual sensitivity.

Pharmacokinetics.

Macrogol 3350 remains in the intestine unchanged. It is practically not absorbed from the gastrointestinal tract. Any absorbed macrogol 3350 is excreted in the urine.

Clinical characteristics.

Indications.

For the treatment of chronic constipation.

The medicinal product is effective in resolving coprostasis, defined as refractory constipation with fecal loading of the colon and rectum.

Contraindications.

Perforation or obstruction of the intestine due to structural or functional abnormalities of the intestinal wall, intestinal obstruction, severe inflammatory bowel diseases such as Crohn's disease, ulcerative colitis, and toxic megacolon.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Macrogol increases the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. Absorption of other medicinal products may be temporarily reduced during administration of Ezecol. There have been isolated reports of reduced efficacy of certain medicinal products, for example antiepileptic drugs, when taken concomitantly with Ezecol.

Special precautions for use.

This medicinal product contains 46.6 mg/packet of potassium. Caution should be exercised when administering to patients with impaired renal function or those on a potassium-controlled diet. The diagnosis of coprostasis/fecal impaction of the rectum must be confirmed by physical or radiological examination of the abdominal cavity and rectum.

Mild adverse reactions may occur during administration of Ezekol. If patients develop any symptoms indicating fluid/electrolyte imbalance (e.g., edema, dyspnea, increased fatigue, dehydration, heart failure), Ezekol should be discontinued immediately, electrolyte levels should be checked, and any abnormalities corrected.

Use during pregnancy or breastfeeding.

Pregnancy.

There is limited data on use in pregnant women. Animal studies have shown indirect reproductive toxicity. Clinically, no effects during pregnancy in women have been observed, as macrogol 3350 is poorly absorbed.

Ezekol may be prescribed during pregnancy based on a risk/benefit assessment.

Breastfeeding.

Systemic effects of macrogol 3350 in breastfeeding women are negligible; therefore, Ezekol may be prescribed during breastfeeding.

Fertility. Ezekol did not impair fertility in animal studies. There are no data on effects on fertility in humans.

Ability to affect reaction speed when driving or operating machinery.

Due to the pharmacokinetic and pharmacodynamic properties of Ezekol, it has no influence on the ability to drive or operate machinery.

Dosage and Administration

Chronic constipation.

The treatment course usually does not exceed 2 weeks; if necessary, the course may be repeated.

Prolonged use of Ezecol, as with all laxatives, is not recommended. However, extended treatment duration may be required in patients with severe chronic or resistant constipation, including patients with scleroderma, Parkinson's disease, or those taking medications that cause constipation, such as opioids and M-cholinergic blockers.

Adults, including elderly patients, and children aged 12 years and older: 1–3 sachets per day in divided doses, depending on individual sensitivity.

In cases of prolonged use, the dose may be reduced to 1 or 2 sachets per day.

Fecal impaction

The treatment course for fecal impaction with Ezecol usually does not exceed 3 days.

Adults, including elderly patients, and children aged 12 years and older: 8 sachets per day, to be taken within 6 hours.

Patients with cardiovascular disorders: for treatment of fecal impaction, the dose should be divided so that no more than 2 sachets are taken within one hour.

Patients with renal impairment: dosage adjustment is not required for treatment of constipation or fecal impaction.

Preparation for use

Dissolve the contents of one sachet in 125 mL of water.

For administration in fecal impaction: dissolve 8 sachets in 1 L of water.

Children.

Use in children under 12 years of age is contraindicated.

Overdose.

Severe abdominal pain or bloating, which can be relieved by nasogastric aspiration.

In case of significant fluid loss due to diarrhea or vomiting, correction of fluid and electrolyte balance is required.

Side effects.

Gastrointestinal reactions are the most commonly observed. These reactions may occur due to increased gastrointestinal content as well as enhanced motility resulting from the pharmacological effect of Ezecol. Dose reduction usually results in mild diarrhea.

The frequency of adverse reactions is unknown, as it is difficult to assess based on available data.

Immune system disorders: Allergic reactions, including anaphylactic shock, angioedema (Quincke's edema), dyspnea, rash, erythema, urticaria, and pruritus.

Metabolism and nutrition disorders: Electrolyte imbalance, particularly hyperkalemia and hypokalemia.

Nervous system disorders: Headache.

Gastrointestinal disorders: Abdominal pain, diarrhea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, rectal discomfort.

General disorders: Peripheral edema.

Shelf life: 3 years.

Reconstituted solution: 6 hours.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30°C.

Keep out of reach of children.

The reconstituted solution should be stored tightly closed at a temperature between 2°C and 8°C.

Packaging.

13.72 g of oral powder in sachets labeled in Ukrainian.

20 sachets per cardboard box.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

STRAIDS PHARMA SCIENCE LIMITED

Strides Pharma Science Limited

Address.

No. 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bengaluru, Karnataka 562106, India

Marketing Authorization Holder.

Strides CIS Limited

Address.

Julia House, 3 Thermistocles Dervis Street, CY-1066, Nicosia, Cyprus