Enema Casen 139 mg/ml + 32 mg/ml rectal solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enema Casen 139 mg/mL and 32 mg/mL rectal solution

sodium dihydrogen phosphate anhydrous / disodium hydrogen phosphate anhydrous

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Enema Casen is and what it is used for
2. Before you use Enema Casen
3. How to use Enema Casen
4. Possible adverse effects
5. How to store Enema Casen
6. Contents of the pack and other information

1. What Enema Casen is and what it is used for

Enema Casen belongs to a group of medicines called rectal laxatives.

Enema Casen is indicated in cases where bowel evacuation is required, such as:

• Pre- and post-surgery.
• Labour and postpartum.
• Prior to proctoscopy and sigmoidoscopy (examination of the intestine using endoscopic techniques with a probe).
• Prior to radiological examinations.
• Fecal impaction.

You should consult a doctor if your condition worsens or does not improve after 6 days.

2. What you need to know before using Enema Casen

Do not use Enema Casen

• If you are allergic to anhydrous monosodium phosphate, anhydrous disodium hydrogen phosphate, or any of the other ingredients of this medicine (listed in section 6).
• In children under 2 years of age.
• If intestinal obstruction is suspected.
• If you have megacolon (dilation of the colon), ileostomy (artificial anus), anorectal stenosis (narrowing of the rectum), inability to produce normal bowel movements (paralytic ileus), or imperforate anus.
• Congenital obstruction of the colon (Hirschsprung's disease).
• If you have severe or moderate renal impairment.
• If you have symptomatic heart failure.
• If you have symptoms of appendicitis, intestinal perforation, or active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
• If you have undiagnosed rectal bleeding.
• If you have uncontrolled high blood pressure (hypertension).
• If you are dehydrated.

If you are unsure about any of these conditions or your specific situation, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before using Enema Casen:

• If you do not have a bowel movement within 10 minutes after administration (evacuation usually occurs about 5 minutes after administration), it is recommended to consult your doctor, who may perform necessary tests to minimize the risk of developing severe hyperphosphatemia.
• If you are elderly, weak, have ascites (fluid accumulation in the abdomen), anal ulcers or fissures, or suffer from kidney or heart disease.
• If you have undergone colostomy surgery (major colon surgery), you must consult your doctor.
• If you have pre-existing electrolyte imbalances (abnormal levels of mineral salts in the body), as hypocalcemia (low blood calcium levels), hypokalemia (low blood potassium levels), hyperphosphatemia (high blood phosphate levels), hypernatremia (high blood sodium levels), dehydration, or acidosis may occur.
• If electrolyte disturbances are suspected, your doctor will perform a blood test to determine the levels of these substances before administering Enema Casen.
• If you experience nausea, vomiting, or abdominal pain, follow your doctor's instructions.
• Repeated and prolonged use of Enema Casen is not recommended, as it may lead to dependence. Do not use if symptoms worsen or persist without consulting your doctor.
• Enema Casen should not be used for more than 6 consecutive days unless directed by a doctor.
• Enema Casen must be administered according to the instructions for use and handling. Administration should be stopped if resistance is encountered, as forcing it may cause injury.
• If you experience rectal bleeding after enema administration, do not administer another enema and consult your doctor immediately.
• Consult your doctor if signs of irritation occur.

This medicine should not be used as a routine treatment for constipation.

Use of Enema Casen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that your doctor knows if you are taking:

• Medicines for high blood pressure (hypertension), such as angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, ramipril, lisinopril) and angiotensin receptor blockers (e.g., losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan),
• Medicines for angina (calcium channel blockers),
• Medicines to empty the bladder (diuretics),
• Medicines for behavioral disorders (lithium),
• Medicines that may alter the balance of water or electrolytes (potassium, sodium, phosphate, calcium) in the blood,
• Medicines for bowel cleansing (sodium phosphate),
• Medicines that affect heart rhythm (prolong the QT interval), such as amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or ibuprofen.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are breastfeeding, you should express and discard your breast milk for at least 24 hours following administration of Enema Casen.

Driving and use of machines

Enema Casen will not affect your ability to drive or operate machinery.

Enema Casen contains benzalkonium chloride

This medicine contains 0.6 mg of benzalkonium chloride per milliliter of rectal solution.

Benzalkonium chloride may cause local irritation.

3. How to use Enema Casen

Follow exactly the administration instructions for Enema Casen provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Enema Casen is a rectally administered medication. It should be administered at room temperature. For self-administration of Enema Casen, it is recommended that the patient lies on their left side with both knees bent towards the chest (Figure 1), or lying with the left leg straight and the right leg bent towards the chest (Figure 2).

Figure 1 Figure 2

When Enema Casen is to be administered by another person, the recommended positions may be either those described for self-administration, or the one shown in Figure 3.

Figure 3

Remove the blue protective sheath from the pre-lubricated cannula.

In the recommended positions, carefully insert the cannula into the rectum to avoid damaging its wall, and gently and steadily squeeze the container until the required amount of liquid has been administered. The patient should maintain this position until they feel a strong urge to defecate.

Generally, 2 to 5 minutes are sufficient to achieve the desired effect. If the product is not expelled within this time, refer to section 4: "Possible adverse effects".

The following doses are generally recommended:

Children

• Infants and children under 2 years: Do not administer Enema Casen to children under two years of age; its use is contraindicated.

• Children from 2 to 15 years: The recommended dose is a single dose of 5 mL/kg, up to a maximum of 140 mL. The maximum duration of treatment is one enema per day for no more than 6 consecutive days.

Adults

The recommended dose is a single enema of 140 mL or 250 mL. It may be administered once daily for a maximum of 6 consecutive days.

Elderly

The recommended dosing regimen is the same as for adults.

Patients with impaired liver function

In this case, dose adjustment is not necessary.

Patients with impaired kidney function

This medication must not be administered to patients with moderate or severe renal insufficiency.

It should be administered with caution to patients with mild renal insufficiency and only under medical prescription.

If you use more Enema Casen than you should

Contact your doctor, pharmacist, or the Toxicology Information Service immediately at phone number 91 562 04 20.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects of Enema Casen are described below according to their frequency:

Very rare adverse effects (may affect up to 1 in 10,000 people):

• allergic reaction,

• tetany (painful muscle spasms in the limbs), hyperphosphatemia (increased blood phosphorus), dehydration,

• hypocalcemia (decreased blood calcium), hypokalemia (decreased blood potassium), hypernatremia (increased blood sodium), metabolic acidosis (accumulation of acids in body fluids), nausea, vomiting, abdominal pain, abdominal distension (swollen abdomen), diarrhea, gastrointestinal pain, anal pain and discomfort, stinging, blistering, itching, rectal irritation, and chills.

Very common adverse effects (may affect more than 1 in 10 people):

• Transient increase in blood phosphorus.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enema Casen

No special storage conditions are required. However, in rare instances, some inorganic flocculations may appear in the solution, which in no way affect the integrity of the preparation.

Keep out of the reach and sight of children.

Do not use Enema Casen after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Enema Casen

• The active substances are anhydrous sodium dihydrogen phosphate and anhydrous disodium hydrogen phosphate. Each mL of rectal solution contains 139 mg of anhydrous sodium dihydrogen phosphate and 32 mg of anhydrous disodium hydrogen phosphate.
• The other components are benzalkonium chloride, disodium edetate, and purified water.

Appearance of the product and contents of the container

Enema Casen is presented as a colorless, odorless rectal solution in 250 mL, 140 mL, and 80 mL sealed containers made of flexible plastic, fitted with a non-return valve and a pre-lubricated, latex-free rectal cannula.

Marketing Authorization Holder and Manufacturer

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza), Spain.

Date of the most recent revision of this leaflet: October 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es