CASENGLICOL POWDER FOR ORAL SOLUTION

Introduction

Leaflet: Information for the user

Casenglicol powder for oral solution

macrogol 4000, sodium sulfate anhydrous, sodium hydrogen carbonate, sodium chloride,

potassium chloride, sodium dihydrogen phosphate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Casenglicol and what is it used for
2. What you need to know before taking Casenglicol
3. How to take Casenglicol
4. Possible side effects
5. Storage of Casenglicol
6. Package contents and additional information

1. What is Casenglicol and what is it used for

Casenglicol belongs to a group of medications called osmotic laxatives.

Casenglicol is an intestinal evacuant indicated in adults for pre-colonoscopy, surgery, radiology, and other colorectal and genitourinary examinations.

It is sometimes used for the treatment of chronic constipation of non-organic cause in adults that has been previously treated, without satisfactory results, with a high-water content diet and increased daily physical exercise.

2. What you need to know before taking Casenglicol

Do not take Casenglicol

• If you are allergic to the active substances or to any of the other components of this medication (listed in section 6)
• If you have a gastric or intestinal ulcer
• If you have gastric retention
• If you have a chronic intestinal disease, ileus, or megacolon
• If you have an intestinal obstruction
• If you have an intestinal perforation

Warnings and precautions

Consult your doctor or pharmacist before starting to take Casenglicol.

• Use with caution in patients with altered nausea reflex and patients prone to regurgitation or aspiration, and in patients with swallowing problems. In these cases, consult your doctor.
• The administration of Casenglicol should be monitored, especially when performed through a nasogastric tube, to avoid regurgitation or aspiration of the solution, especially in patients with damaged swallowing reflex, gastroesophageal reflux, or in a state of semi-consciousness or unconsciousness.
• If abdominal pain occurs. In such cases, administration will be performed more slowly or even interrupted until symptoms reverse.
• If gastrointestinal obstruction or perforation is suspected, diagnostic tests should be performed before administering Casenglicol.
• When administering Casenglicol to patients with severe colitis or proctitis, it should be used with caution.
• Casenglicol should be used with caution in fragile patients, patients with significant renal disease, or with known hydroelectrolytic balance disorders.
• If you experience sudden abdominal pain or rectal bleeding while taking Casenglicol for intestinal preparation, contact your doctor or go to a doctor immediately.
• Avoid mixing Casenglicol with starch-based thickeners if you have swallowing problems. This can result in a watery liquid that could enter your lungs and cause pneumonia if you cannot swallow it properly.

Children

Do not administer to children.

Other medications and Casenglicol

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Casenglicol works by accelerating intestinal transit, which can cause medication administered during its use to not be absorbed properly and be eliminated through the gastrointestinal tract, potentially reducing its effect.

Pregnancy, breastfeeding, and fertility

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

There is no experience with the use of Casenglicol during pregnancy or breastfeeding, and it should only be used if your doctor considers it essential.

Driving and using machines

Not described.

Casenglicol contains sodium and potassium

Consult your doctor or pharmacist if you need Casenglicol or more than 1 sachet per day for an extended period, especially if you have been recommended a low-salt diet (sodium).

This medication contains 10.58 mmol (or 413.7 mg) of potassium per liter of solution, which should be taken into account in patients with renal insufficiency or in patients with low-potassium diets.

3. How to take Casenglicol

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Casenglicol will be taken by dissolving the contents of each 17.6g sachet in 250ml of drinking water or each 70.5g sachet in 1 liter of drinking water. The solution should be consumed within 4 hours.

The recommended dose is:

For intestinal evacuation for diagnostic or surgical purposes:

Adults

70.5g sachets: the complete dose is 4 sachets of 70.5g.

Dissolve the contents of one sachet in 1 liter of water.

17.6g sachets: the complete dose is 16 sachets of 17.6g.

Dissolve the contents of one sachet in 250ml of water.

Patient with renal insufficiency: no dose adjustment is required in renal insufficiency. This medication should be administered with caution in patients with renal insufficiency (see section 2).

Patient with hepatic insufficiency: no dose adjustment is necessary.

Elderly patients: the dosage regimen is the same as for adults.

Use in children:

No data available. Therefore, this medication should not be administered to children.

The solution is normally administered orally. It is recommended to administer at a rate of 200 to 250ml every 10-15 minutes, until the entire volume has been ingested or the stool is clear.

No food should be taken during the 3 or 4 hours prior to administration of the solution, and in no case should solid food be ingested 2 hours prior to its use.

In patients unable to drink the solution, a nasogastric tube can be used at a rate of 20-30ml per minute.

Bowel movement will occur approximately 1 hour after starting treatment.

For the treatment of chronic constipation of non-organic cause:

Adults: the recommended dose is 250-500ml per day of the reconstituted solution from a 17.6g sachet in 250ml of water or a 70.5g sachet in 1 liter of water.

Patient with renal insufficiency: no dose adjustment is required in renal insufficiency. This medication should be administered with caution in patients with renal insufficiency (see section 2).

Patient with hepatic insufficiency: no dose adjustment is necessary.

Elderly patients: the dosage regimen is the same as for adults.

Use in children

No data available. Therefore, this medication should not be administered to children.

Treatment duration: as with all laxatives, prolonged use of Casenglicol is not recommended.

Do not use Casenglicol for more than six days without consulting your doctor.

Administer on an isolated basis, when deep intestinal evacuation is needed.

If you take more Casenglicol than you should

If you take more Casenglicol than you should, you may experience excessive diarrhea, which can lead to dehydration. Drink plenty of fluids. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Casenglicol

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

These side effects include:

Frequent (may affect up to 1 in 10 people)

• Nausea
• Feeling of abdominal fullness
• Abdominal cramps

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Abdominal cramps
• Anal irritation

These adverse reactions are transient and resolve quickly.

Frequency not known (cannot be estimated from available data)

• Urticaria
• Dermatitis
• Rhinorrhea

These adverse reactions are caused by allergic reactions.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Casenglicol

Keep this medication out of sight and reach of children.

Do not store above 30°C

When not in use, the solution can be stored in the refrigerator (between 2°C and 8°C) and discarded 48 hours after preparation.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Casenglicol if you notice damage to the packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Casenglicol composition

The active substances per 1g, per 17.6g sachet, and per 70.5g sachet are:

The other excipients are:

• Butylhydroxyanisole (E-320)
• Orange flavor
• Acesulfame potassium (E-950)
• Sucralose

Appearance of the product and package contents

Casenglicol is presented in the form of single-dose sachets containing powder for oral solution in different package sizes: packages of 4 sachets of 70.5g, 100 sachets of 70.5g, 16 sachets of 17.6g, or 500 sachets of 17.6g.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer:

Casen Recordati, S.L.

Autovía de Logroño, Km 13,300

50180 Utebo, (Zaragoza) Spain

Date of the last revision of this leaflet:February 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/