Enema

Leaflet attached to the packaging: information for the user

ENEMA, (32.2 mg + 139 mg)/ml, rectal solution

(Dinatrii phosphasdodecahydricus+ Natrii dihydrogenophosphas monohydricus)

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If within 5 minutes of administering the medicine, there is no improvement or the patient feels worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is ENEMA and what is it used for
• 2. Important information before using ENEMA
• 3. How to use ENEMA
• 4. Possible side effects
• 5. How to store ENEMA
• 6. Contents of the packaging and other information

1. What is ENEMA and what is it used for

ENEMA is a rectal solution. It works by cleansing the large intestine.
It prevents water absorption in the large intestine, causing softening of the stool mass. The increase in volume and softening of the stool mass lead to immediate stimulation of the bowel movement reflex.

Indications

ENEMA is used for: constipation, cleansing of the large intestine before diagnostic tests, before and after surgical procedures, cleansing of the intestine from contrast medium deposits after radiological examination, and cleansing of the intestine before and after childbirth.
If within 5 minutes of administering the medicine, there is no improvement or the patient feels worse, you should contact your doctor.

2. Important information before using ENEMA

When not to use ENEMA

• if the patient is allergic to disodium phosphate dodecahydrate and sodium dihydrogen phosphate monohydrate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has intestinal obstruction, anal stricture, ulcerative colitis, rectal bleeding,
• if the patient has: heart disease, high blood pressure, kidney disease, inflammation or symptoms of appendicitis,
• if the patient experiences: abdominal pain, nausea, and vomiting,
• in children under 3 years of age,
• in dehydrated patients.

Warnings and precautions

Before starting to use ENEMA, you should discuss it with your doctor, pharmacist, or nurse.
Due to the risk of electrolyte and acid-base balance disorders, such as hypernatremia (elevated sodium levels), hyperphosphatemia (elevated phosphate levels), hypokalemia (low potassium levels), hypocalcemia (low calcium levels), and acidosis, special caution should be exercised in cases of:

• patients with renal function disorders (the medicine can be used if the clinical benefits outweigh the risk of elevated phosphate ion levels in the blood),
• patients receiving diuretics or medications that may cause electrolyte and water balance disorders in the body,
• patients with a colostomy,
• weakened or elderly patients,
• patients with electrolyte disorders in the body (especially elevated phosphate levels in the blood) - in these patients, the medicine should be used with caution and it is recommended to monitor ion levels before and after administration of the medicine,
• patients with ascites, changes in the rectal mucosa (ulcers, fissures),
• if within 5 minutes of administration, there is no bowel movement, you should contact your doctor, as retention of the rectal solution may cause dehydration,
• in unconscious patients, patients with limited consciousness, and patients with heart disease, the medicine can only be administered in the presence of qualified personnel,
• if after using the rectal solution, bleeding or severe intestinal cramps occur, you should discontinue the medicine and consult your doctor. Before using the medicine, it is recommended to perform a blood ion level test. In cases of suspected electrolyte disorders and in patients who may experience elevated phosphate levels, the electrolyte level should be monitored before and after administration of the medicine. You should expect liquid stools after administration of the medicine. Additionally, it is necessary to consume a large amount of fluids after using the medicine to avoid dehydration. Repeated and prolonged use of ENEMA may lead to habituation.

Children and adolescents

The medicine can be used in children from 3 years of age only if prescribed by a doctor and under their supervision. In children under 5 years of age, the medicine should be used with special caution.

ENEMA and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In patients using calcium channel blockers, diuretics, lithium preparations, or other medicines that may affect ion levels in the blood, there may be changes in ion levels in the blood, such as hyperphosphatemia (elevated phosphate levels), hypokalemia (low potassium levels), hypocalcemia (low calcium levels), dehydration with elevated sodium levels (hypernatremia), or acidosis.
Due to the existing relationship between elevated sodium levels (hypernatremia) and decreased lithium levels in the blood, concurrent use of ENEMA and lithium preparations may result in decreased lithium levels in the blood, and thus decreased effectiveness of lithium preparations.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Due to the risk of electrolyte disorders, it is not recommended to use ENEMA during pregnancy and breastfeeding. An exception is a single application of the medicine to women before and after childbirth.
Due to the possibility of phosphate ions passing into breast milk, it is recommended to discard expressed milk for 24 hours after using the medicine.

Driving and using machines

The medicine does not affect the ability to drive and use machines
The medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).

3. How to use ENEMA

This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse. If you are unsure, you should consult your doctor, pharmacist, or nurse.
The solution should only be administered as a rectal enema.
Adults: 120-150 ml.
Children: with a body weight below 14 kg - 30 ml, with a body weight between 14 and 27 kg - 60 ml, with a body weight between 28 and 40 kg - 90 ml.
In dehydrated patients, the enema volume should be reduced, as the medicine may cause further dehydration.
Repeating enemas at short intervals should be avoided.
The medicine should not be used more than once a day or as advised by your doctor.
The medicine is administered rectally by injecting the appropriate volume of the solution in the evening on the day preceding the examination or surgical procedure and on the day of the operation. The rectal enema on the day preceding the operation can be repeated if complete cleansing is not achieved. The rectal solution should be at room temperature.
After using the medicine, the patient should be given an additional dose of fluids orally.
Laxatives should not be used for more than one week.
To administer the enema, you should replace the cap with the applicator cap, which is located in the individual carton (does not apply to the preparation intended for closed healthcare facilities). Remove the protective cap and insert the special tip into the rectum, directing it towards the navel. Slowly press the bottle until its contents are introduced into the rectum. The packaging contains an excess of the solution, so it is not necessary to empty the bottle completely. After administering the enema, you should wait in the chosen position until the urge to defecate occurs (2-5 minutes) and then defecate.
There are three positions that allow for the administration of the enema. The first position (Sims) and the second position (knee-chest) require the assistance of another person. The third position allows for self-administration of the enema.

Using a higher dose of ENEMA than recommended

The medicine is available in a single-dose packaging, which excludes the possibility of overdose. However, in patients who should not use the medicine and in particularly sensitive patients, there may be disturbances in electrolyte and acid-base balance, acidosis, and dehydration. There may also be disturbances in the functioning of the circulatory and respiratory systems. If the above symptoms occur, you should contact your doctor.
There have been reports of fatal cases related to electrolyte and water balance disorders due to the use of this type of product in excessive doses, administration to children, or patients with constipation.

Missing a dose of ENEMA

You should not use a double dose to make up for a missed dose of the medicine.

Stopping the use of ENEMA

If you have any further doubts about the use of the medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, ENEMA can cause side effects, although not everybody gets them.
The frequency of side effects cannot be determined based on available data.
Metabolic and nutritional disorders
Elevated phosphate ion levels in the blood (hyperphosphatemia), decreased potassium levels in the blood (hypokalemia), and accumulation of excessive amounts of acidic substances or decreased amounts of alkaline substances in the blood (metabolic acidosis).
Transient decreased calcium ion levels (hypocalcemia) and transient elevated sodium levels (hypernatremia), resulting in dehydration. However, ENEMA has a reduced phosphate content, which reduces the risk of electrolyte disorders. Additionally, ENEMA is a medicine used sporadically, and any potential electrolyte and water balance disorders are usually transient.
General disorders and administration site conditions
Irritation of the rectal mucosa, chills, blisters, stinging, rectal itching, pain.
Gastrointestinal disorders
Nausea, vomiting, abdominal pain, bloating, diarrhea .
Frequent use may lead to disturbances in the functioning of the large intestine.
Immune system disorders
Allergic reactions, e.g., hives, itching.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store ENEMA

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use the medicine after the expiration date stated on the packaging after: Expiration Date (EXP). The expiration date is the last day of the specified month. Lot means batch number.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What ENEMA contains

• The active substances of the medicine are: disodium phosphate dodecahydrate (Dinatrii phosphasdodecahydricus) and sodium dihydrogen phosphate monohydrate (Natrii dihydrogenophosphasmonohydricus). 1 ml of the solution contains 32.2 mg of disodium phosphate and 139 mg of sodium dihydrogen phosphate, calculated as anhydrous substances.
• The other ingredients (excipients) are: methyl parahydroxybenzoate, purified water

What ENEMA looks like and what the packaging contains

A bottle with a cap containing 150 ml of liquid and an interchangeable applicator cap that allows for easy expression of the contents, placed in a cardboard box.
For closed healthcare facilities:
A bottle containing 150 ml of liquid, capped with a cap that has an integrated applicator allowing for easy expression of the contents - packaged in 50 units per collective carton.

Marketing authorization holder and manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
phone: +48 89 648 00 78
(logo of the marketing authorization holder)
The content of the patient leaflet is available in a format suitable for the blind and visually impaired at the free phone number 800 706 848.

Date of the last update of the leaflet: