PATIENT INFORMATION LEAFLET

Casen Enema 139 mg/mL and 32 mg/mL Rectal Solution

sodium dihydrogen phosphate anhydrous/hydrogen phosphate disodium anhydrous

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

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

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

2. Before using Enema Casen

3. How to use Enema Casen

4. Possible side effects

5. Storage of Enema Casen

6.Contents of the pack and additional information

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

Enema Casen is indicated in cases where intestinal evacuation is necessary, such as:

• Pre- and post-surgery.
• Childbirth and postpartum.
• Before rectoscopy and sigmoidoscopy (intestinal exploration using endoscopic techniques with a probe).
• Before radiological examinations
• Fecal impaction.

Consult a doctor if symptoms worsen or do not improve after 6 days

No use Enema Casen

• If you are allergic todihidrogenofosfato de sodio anhidro, al hidrogenofosfato de disodio anhidroor any of the other components of this medication (listed in section 6).
• Children under 2 years old.
• Suspected intestinal obstruction.
• If you have megacolon (colon dilation), ileostomía (artificial anus), anorectal stenosis (rectal narrowing), inability to produce normal intestinal movements (paralytic ileus) or imperforate anus.
• Congenital colon obstruction (Hirschsprung's disease).
• Severe or moderate renal insufficiency.
• Symptomatic heart failure.
• If you have symptoms of appendicitis, intestinal perforation or active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
• Undiagnosed rectal bleeding.
• Uncontrolled high blood pressure.
• Dehydration.

In case of doubt about any of these situations or your particular situation, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before using Enema Casen:

• If, after 10 minutes of enema administration, you are unable to evacuate (evacuation occurs approximately 5 minutes after administration), it is recommended to consult your doctor to perform the necessary tests to minimize the risk of severe hyperphosphatemia.
• Older patients, weak, ascites (fluid accumulation in the abdomen), ulcers or anal fissures, or patients with kidney or heart disease.
• Patients who have undergone colostomy (major colon surgery) should consult their doctor.
• If you have pre-existing electrolyte imbalances (alteration of mineral salt levels in the body) as it may cause hypocalcemia (low calcium levels in blood), hypokalemia (low potassium levels in blood), hyperphosphatemia (high phosphorus levels in blood), hypernatremia (high sodium levels in blood), dehydration and acidosis.
• In case of suspected electrolyte disorders, your doctor will perform a blood test to determine the levels of these substances before administering Enema Casen.
• If you have nausea, vomiting or abdominal pain, follow your doctor's instructions.
• Do not recommend repeated and prolonged use of Enema Casen as it may cause habituation. Do not use if symptoms worsen or persist without consulting a doctor.
• Do not use Enema Casen for more than 6 consecutive days, unless indicated by a doctor.
• Enema Casen should be administered following the instructions for use and handling. You should interrupt administration if you encounter resistance, as forcing its administration may cause injuries.
• If you bleed from the rectum after enema administration, do not administer another enema and consult your doctor immediately.
• Consult your doctor if irritation symptoms occur.

This medication should not be used as a habitual treatment for constipation.

Use of Enema Casen with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

It is especially important for your doctor to know if you are taking:

• Medications for the treatment of high blood pressure (hypertension), such as angiotensin-converting enzyme inhibitors (e.g. enalapril, ramipril, lisinopril) and angiotensin receptor antagonists (e.g. losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan),
• Medications to treat angina (calcium channel blockers),
• Medications to empty the bladder (diuretics),
• Medications for behavioral disorders (lithium),
• Medications that may alter the balance of water or electrolytes (potassium, sodium, phosphate, calcium) in the blood,
• Medications for intestinal cleansing (sodium phosphate),
• Medications that alter heart rhythm (prolong 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 lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are breastfeeding, you should express and discard milk for at least 24 hours after Enema Casen administration.

Driving and operating machinery

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

Enema Casen contains benzalkonium chloride

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

Benzalkonium chloride may cause local irritation.

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

Enema Casen is a rectal medication. It should be administered at room temperature. For self-administration of Enema Casen, it is recommended that the patient recline on the left side and with both legs folded over the chest (Figure 1) or recline with the left leg extended and the right leg folded over the chest (Figure 2).

Figura 1 Figura 2

When Enema Casen is to be administered to the patient by another person, the recommended positions may be either those described for self-administration, or the one shown in Figure3.

Figura 3

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

In the indicated positions, carefully insert the cannula into the rectum to avoid damaging the wall of the rectum and squeeze the container, gently and continuously, until the required amount of liquid is introduced. It is advisable for the patient to maintain this position until they feel strong urges to defecate.

Generally,2 to5 minutes are sufficient to achieve the desired effect. If the product is not expelled within this time, see section 4: "Possible adverse effects".

In general, the following dose is recommended:

Children

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

• Children from2 to15 years:The recommended dose is a single dose of 5 mL/kg, or up to a maximum of 140mL.The maximum duration of treatment will be 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 a day, for a maximum of 6 consecutive days.

Seniors

The recommended dosage regimen is the same as for adults.

Patients with altered liver function

No dose adjustment is necessary in this case.

Patients with altered kidney function

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

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

If you use more Enema Casen than you should

Consult your doctor or pharmacist immediately or the toxicology information service. Tfno. 91 562 04 20.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following are the adverse effects of Enema Casen 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 (elevated phosphorus in the blood), dehydration,

- hypocalcemia (decreased calcium in the blood), hypokalemia (decreased potassium in the blood), hypernatremia (elevated sodium in the blood), metabolic acidosis (accumulation of acids in bodily fluids), nausea, vomiting, abdominal pain, abdominal distension (swollen abdomen), diarrhea, gastrointestinal pain, anal pain and discomfort, itching, blisters, prickling, rectal irritation, and chills.

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

- Transient elevation of phosphorus in the blood.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Norequires special storage conditions, however, in rare occasions some inorganic flocculations may appear in the solution which in no way affect the integrity of the preparation.

Keep out of reach and sight of children.

Do not useEnema Casenafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer needat the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Enema Casen

• The active principles aredihydrogen phosphate of anhydrous sodium and hydrogen phosphate of anhydrous disodium. Each mL of rectal solution contains 139 mg of dihydrogen phosphate of anhydrous sodium and 32 mg of hydrogen phosphate of anhydrous disodium.
• The other components are benzalkonium chloride, disodium EDTA andpurified water.

Appearance of the product and contents of the packaging

Enema Casen is presented in the form of a colorless and odorless rectal solution, in flexible plastic containers of 250, 140 and 80 mL, hermetically closed, with an antireturn valve and a prelubricated latex-free rectal cannula.

Holder of the marketing authorization and responsible for manufacturing

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza).

Last review date of this leaflet: October 2017

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es