Instructions Enema-Sella disposable enema rectal solution 22 g bottle 120 ml
Warehouse
active ingredients: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate.
100 ml of rectal solution contains: sodium dihydrogen phosphate dihydrate equivalent to sodium dihydrogen phosphate monohydrate 16 g; disodium phosphate dodecahydrate equivalent to disodium phosphate heptahydrate 6 g;
excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate
(E 216), purified water.
Dosage form
Rectal solution.
Main physicochemical properties: transparent colorless solution.
Pharmacotherapeutic group
Drugs that affect the digestive system and metabolism. Laxatives. Enemas.
ATX code A06A G20.
Pharmacological properties
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 colon, and part or all of the descending colon.
Pharmacokinetics
Absorption in the colon is minimal, but it has been reported that approximately 25% of individuals with normal renal function have asymptomatic hyperphosphatemia, which exceeds the normal phosphorus level by 2 to 3 times, after oral administration of enteral preparations containing sodium phosphate. Under normal conditions, the greatest absorption of phosphorus occurs in the small intestine, which is not penetrated by rectally administered preparations.
Indication
Episodic constipation.
Cases requiring colon cleansing, such as before and after colon surgery, during and after childbirth, before proctoscopy, sigmoidoscopy or colonoscopy, and before X-ray examination of the colon.
Contraindication
-Hypersensitivity to the active substances or to any other substance included in the composition of 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 ileus;
-suspected: appendicitis; intestinal perforation/injury or obstruction; active inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis);
-undiagnosed rectal bleeding;
-renal failure;
- congestive heart failure;
-recent illness or feeling weak or thirsty;
-stomach pain (abdominal pain);
-dehydration and a condition where the ability to absorb increases or the ability to defecate decreases;
-childhood;
- simultaneous use with other drugs containing sodium phosphate.
Interaction with other medicinal products and other types of interactions
It is necessary to inform the doctor if the patient has recently used any other prescription or non-prescription medicines, including:
medicines to treat high blood pressure or angina (calcium channel blockers); diuretics; some medicines used for mental disorders (lithium); any other medicines 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 developing hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremic dehydration, and acidosis.
Since hypernatremia is associated with low lithium levels, concomitant use of the drug and lithium therapy may cause a decrease in serum lithium levels and reduced efficacy.
Application features
Do not use the drug if you have nausea, vomiting, or abdominal pain without a doctor's prescription.
Since the product contains sodium phosphates, there is a risk of increased serum sodium and phosphate concentrations and decreased serum calcium and potassium concentrations, which may lead to hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia with clinical signs similar to tetany and renal failure. Electrolyte imbalance is of particular concern in children with megacolon or any other condition in which there is fluid retention, and in patients with comorbidities. For this reason, the drug should be prescribed with caution in elderly or debilitated patients and in patients with uncontrolled arterial hypertension, ascites, heart disease, changes in the rectal mucosa (ulcers, fissures), colostomy, who use diuretics or other drugs 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 in patients with a history of electrolyte imbalance, as hypocalcemia, hypokalemia, hyperphosphatemia or hypernatremia may occur. Use with caution in patients taking drugs that affect renal perfusion, renal function or hydration. If electrolyte imbalance is suspected and patients have a history of hypophosphatemia, electrolyte levels should be monitored before and after administration of the drug.
The drug should be used with caution in patients with impaired renal function, in whom the benefit of use outweighs the risk of hyperphosphatemia.
Repeated and prolonged use of the drug is not recommended, as it may cause addiction. Administering more than one enema within 24 hours may be harmful. Unless directed by a doctor, the drug should not be used for more than one week.
Before using the drug, you should read the instructions for use and the rules for administering the drug. Patients should be warned to stop the administration if resistance is felt, as the effort during administration may cause local damage. Rectal bleeding after using the drug may indicate a serious condition. In this case, you should stop further use of the drug and consult a doctor.
Usually, defecation occurs approximately 5 minutes after administration of the drug, so holding the enema for more than 5 minutes is not recommended. If after administration of the drug, defecation does not occur or if the retention time lasts more than 10 minutes, serious side effects may occur. In this case, further use of the drug should be discontinued and a doctor should be consulted, who will decide on the appointment of laboratory tests in order to identify possible abnormalities in electrolyte levels and minimize the risk of developing severe hyperphosphatemia.
The drug contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), therefore it may cause allergic reactions (possibly delayed).
Enema-Sella disposable enema is a solution for rectal use. DO NOT SWALLOW.
Use during pregnancy or breastfeeding
There is insufficient data to assess the potential risk of embryonic defects or embryotoxic effects caused by the use of the drug, therefore the drug should not be used during pregnancy or suspected pregnancy.
The drug can be used only as prescribed by a doctor during or after childbirth.
Since the active substances contained in the drug may pass into breast milk, it is recommended to express breast milk and not use it for feeding for 24 hours after using the enema.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Method of administration and doses
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 bottle no more than 1 time per day or as prescribed by a doctor.
Procedure for administering an enema:
1. The patient should remove the protective plastic cover and put on the tip.
2. Lie on your 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 bottle until all its contents pass into the intestines.
Stop the injection if any resistance is felt. Forced injection may cause harm.
Note: It is not necessary to leave the vial 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 vial.
6. Remain in this position until you feel a strong urge to have a bowel movement, which usually occurs within 2-5 minutes.
7. After use, place the bottle back into the cardboard packaging for disposal.
You should be prepared for the urge to have a bowel movement within 5 minutes of taking the medicine. This is normal and indicates that the medicine is working. It is advisable to stay near a toilet until the effect of the medicine wears off.
If there is no urge to defecate within the specified time, you should consult a doctor. Until this time, the drug should not be used any longer.
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. After this, you should drink clear liquids, preferably water, to quench your thirst after a clinical procedure or as directed by your doctor.
Children
Do not use in pediatric practice.
Overdose
Given that the drug is almost not absorbed, overdose can only be accidental.
With overdose or prolonged use, hyperphosphatemia, hypocalcemia, hypernatremia, hypernatremic dehydration, acidosis and tetany may occur.
Recovery from toxic effects is usually achieved by rehydration. In severe cases, correction of electrolyte changes should be achieved by administering calcium and magnesium salts (10% calcium gluconate) with simultaneous enhancement of exogenous phosphorus excretion, and dialysis.
If more than the recommended dose has been used or if the medicine has been accidentally swallowed (drank), you should inform your doctor immediately. If possible, take the bottle or carton with you to show the doctor.
Adverse reactions
Adverse reactions are listed below using the following frequency classification: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data):
Very rarely (< 1/10,000) the following cases have been observed:
Immune system disorders: hypersensitivity reactions (e.g. urticaria).
Skin and subcutaneous tissue disorders: blisters, itching, burning.
Metabolic disorders: dehydration, hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremia, metabolic acidosis.
Gastrointestinal: nausea, vomiting, abdominal pain, abdominal spasm, diarrhea, gastrointestinal pain, anal discomfort, proctalgia.
General disorders and administration site conditions: anal irritation, pain, burning, chills.
If any adverse reactions occur, treatment should be discontinued and a doctor should be consulted.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
120 ml of the drug in a bottle, 1 bottle with a plastic cap and cannula in a cardboard box.
Vacation category
Without a prescription.
Producer
CHEMICAL AND PHARMACEUTICAL LABORATORY "A. SELLA" SRL
Location of the manufacturer and its business address
Via Vicenza, 67-36015 Schio (VI), Italy.
