Active ingredients: sodium dihydrogen phosphate dihydrate, dinitrium phosphate dodecahydrate.

100 ml of rectal solution contains: sodium dihydrogen phosphate dihydrate equivalent to sodium dihydrogen phosphate monohydrate 16 g; dinitrium phosphate dodecahydrate equivalent to dinitrium phosphate heptahydrate 6 g.

Excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water.

Rectal solution.

Basic physical and chemical properties: transparent colourless solution.

Pharmacotherapeutic group.

Agents affecting the digestive system and metabolism. Laxatives. Enemas.

ATX code A06A G20.

Pharmacodynamics.

The drug acts as a saline laxative when administered rectally. The accumulation of fluid in the lower intestine causes filling and promotes peristalsis and intestinal motility, causing emptying of only the rectum, sigmoid and part or all of the descending colon.

Pharmacokinetics.

Absorption in the colon is minimal, however, it has been reported that approximately 25% of individuals with normal renal function after oral administration of intestinal preparations containing sodium phosphate experienced asymptomatic hyperphosphatemia, which was 2-3 times higher than normal phosphorus levels. Under normal conditions, the strongest absorption of phosphorus is observed in the small intestine, which is not penetrated by rectally administered drugs.

Occasional constipation.

Cases requiring colon cleansing, e.g. before and after colon surgery, during and after childbirth, before proctoscopy, sigmoidoscopy or colonoscopy, as well as before X-ray examination of the large intestine.

• Hypersensitivity to the active substances or to any other substance included in the medicinal product;
• enlargement of the colon (megacolon);
• anorectal stenosis;
• narrowing or incomplete opening of the anus or rectum;
• Hirschsprung’s disease;
• suspected intestinal obstruction;
• suspected paralytic intestinal obstruction;
• suspected appendicitis; perforation/damage or obstruction of the intestine; active inflammatory disease of the large intestine (e.g. Crohn’s disease or ulcerative colitis);
• undiagnosed rectal bleeding;
• renal insufficiency;
• congestive heart failure;
• recent illness or feeling weak or thirsty;
• stomach pain (abdominal pain);
• dehydration and a condition where the ability to absorb or reduce the ability to defecate is increased;
• children’s age;
• simultaneous use with other medicinal products containing sodium phosphate.

Tell your doctor if you have recently taken any other prescription or non-prescription medications, including:

• medicines for high blood pressure or angina (calcium channel blockers);
• water pills (diuretics);
• certain medications used for psychiatric disorders (lithium);
• any other medications that may cause dehydration or affect the levels of electrolytes (potassium, sodium, phosphate, or water) in the body.

Use with caution in patients taking the above medications, as there is a risk of hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremic dehydration, and acidosis.

Since hypernatremia is associated with low lithium levels, concomitant use of the drug and lithium therapy may result in decreased serum lithium levels and reduced efficacy.

Do not use the drug in the presence of nausea, vomiting, or abdominal pain without a doctor’s prescription.

In the event of faeces as a result of taking this medicine, drink plenty of fluids to prevent dehydration, especially in diseases that may lead to dehydration or in the case of taking medicines that may reduce glomerular filtration rate, e.g, diuretics, angiotensin-converting enzyme inhibitors (ACEIs, e.g. enalapril, ramipril, lisinopril), angiotensin receptor blockers (ARBs, e.g. losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan) or non-steroidal anti-inflammatory drugs (NSAIDs).

As the drug contains sodium phosphates, there is a risk of increased sodium and phosphate concentrations and decreased serum calcium and potassium concentrations, which may lead to hypernatremia, hyperphosphatemia, hypocalcaemia and hypokalaemia with clinical signs similar to tetany and renal failure. Electrolyte imbalance is of particular concern for children suffering from megacolon or any other disease in which enema fluid retention is observed, and for patients with comorbidities. For this reason, the drug should be administered with caution to elderly or debilitated patients and patients with uncontrolled hypertension, ascites, heart disease, changes in the rectal mucosa (ulcers, cracks), colostomy, diuretics or other medicines that affect 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 previous electrolyte imbalance, as hypocalcaemia, hypokalaemia, hyperphosphaemia or hypernatraemia may occur. Use with caution in patients taking drugs that affect renal perfusion, renal function or hydration. In case of suspected electrolyte imbalance and a history of hypophosphatemia, electrolyte levels should be monitored before and after administration.

The drug should be used with caution in patients with impaired renal function, in whom the benefits of use outweigh the risk of hyperphosphatemia.

Repeated and prolonged use of the drug is not recommended as it may cause addiction. Administration of more than one enema within 24 hours may be harmful. Unless instructed by a doctor, the drug should not be used for more than one week.

Before using the medicine, read the instructions for use and the rules for administration of the medicine. Patients should be warned to discontinue administration if they feel resistance, as forceful administration may cause local damage. Rectal bleeding after administration may indicate a serious condition. In this case, discontinue further use of the drug and consult a physician.

Voiding usually occurs approximately 5 minutes after administration of the drug, so holding the enema for more than 5 minutes is not recommended. If you do not have a bowel movement after using the medicine or if the retention time is longer than 10 minutes, serious side effects may occur. In this case, you should discontinue further use of the drug and consult a physician who will decide on the appointment of laboratory tests to identify possible electrolyte abnormalities and minimise the risk of severe hyperphosphatemia.

The drug contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), so it may cause allergic reactions (possibly delayed).

Enema-Sella single use enema is a solution for rectal use. DO NOT SWALLOW.

There are insufficient data to assess the potential risk of embryonic defects or embryotoxic effects caused by the use of the drug, so the drug should not be used during pregnancy or suspected pregnancy.

The drug should be used only as prescribed by a doctor during or after childbirth.

Since the active substances contained in the drug can pass into breast milk, it is recommended to express breast milk within 24 hours after the enema application and not to use it for feeding.

Ability to influence the reaction rate when driving vehicles or using other mechanisms.

Unknown.

The drug is intended for rectal use only.

The following recommendations should be followed unless otherwise instructed by your doctor.

Adults, including elderly patients:

1 vial no more than 1 time per day or as prescribed by your doctor.

The procedure for administering an enema:

1. The patient should remove the protective cap.
2. Lie on the left side with both legs bent at the knees.
3. With constant pressure, carefully insert the tip of the vial into the rectum so that it is directed towards the navel.
4. Squeeze the vial until all its contents are passed into the intestine.

Discontinue insertion if you feel any resistance. Forced insertion may cause harm.

Note: It is not necessary to leave the bottle completely empty. The vial contains more solution than is necessary to achieve the desired effect, so a small amount of liquid is acceptable.

5. Carefully remove the tip from the rectum. Some liquid may leak from the bottle.
6. Remain in this position until you feel a strong urge to have a bowel movement, which usually occurs within 2-5 minutes.

1. After use, return the bottle to the carton for disposal.

If rectal bleeding is observed, consult a doctor immediately.

You should be prepared for the urge to have a bowel movement within 5 minutes after taking the medicine. This is normal and indicates that the medicine is working. It is advisable to stay near the toilet until the effect of the medicine wears off.

If there is no urge to defecate within this time, you should consult your doctor. Until then, you should not use the medicine again.

You should drink plenty of clear liquids, such as water, clear soups, herbal teas, black tea or black coffee, or drinks such as fruit juices without pulp (but not red or purple juices) to prevent dehydration. In general, you should drink 250 ml every hour until the effect of the drug wears off. Thereafter, you should drink clear liquids, preferably water, to quench your thirst after the clinical procedure or as directed by your doctor.

Children. Do not use in paediatric practice.

Given that the drug is almost not absorbed, an overdose can only be accidental.

In case of overdose or prolonged use, hyperphosphatemia, hypocalcaemia, hypernatremia, hypernatremic dehydration, acidosis and tetany may occur.

Recovery from toxic effects is usually achieved by rehydration. In severe cases, calcium and magnesium salts (10% calcium gluconate) should be administered to correct electrolyte changes, while increasing the excretion of exogenous phosphorus, and dialysis should be performed.

If more than the required amount of the drug has been used or if the drug has been swallowed (drunk) by accident, inform your doctor immediately. If possible, take the bottle or carton with you to show the doctor.

The adverse effects are listed below using the following frequency classification: very common (≥ 1/10), common (≥ 1/100 to 1/10), uncommon (≥ 1/1000 to 1/100), rare (≥ 1/10,000 to 1/1000), very rare (1/10,000), unknown (cannot be estimated from available data):

Very rarely (< 1/10 000) such cases have been observed:

From the immune system: hypersensitivity reactions (eg urticaria).

From the skin and subcutaneous tissue: blisters, itching, burning.

Metabolic disorders: dehydration, hyperphosphatemia, hypocalcaemia, hypokalaemia, hypernatremia, metabolic acidosis.

Gastrointestinal tract: nausea, vomiting, abdominal pain, abdominal cramp, diarrhoea, gastrointestinal pain, anal discomfort, proctalgia.

General disorders and conditions at the injection site: irritation of the anus, pain, burning, chills.

If any adverse reactions occur, discontinue treatment and consult a physician.

5 years.

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

Keep out of the reach of children.

120 ml of the drug in a vial, 1 vial with a cannula with a cap in a cardboard package.

Without a prescription.