Casenglicol polvo para solucion oral

Package Insert: Information for the User

Casenglicol Powder for Oral Solution

macrogol 4000, anhydrous sodium sulfate, sodium hydrogen carbonate, sodium chloride, potassium chloride, sodium dihydrogen phosphate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Casenglicol and how is it used

2. What you need to know before starting to take Casenglicol

3. How to take Casenglicol

4. Possible adverse effects

5. Storage of Casenglicol

6. Contents of the package and additional information

Casenglicol belongs to a group of medications called osmotic laxatives.

Casenglicol is an intestinal evacuant indicated for adults for the prior preparation of colonoscopy, surgery, radiology, and other colorectal and genitourinary examinations.

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

Do not take Casenglicol

• If you are allergic to the active ingredients or 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 intestinal obstruction
• If you have 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 difficulties. In these cases, consult your doctor.
• Monitor the administration of Casenglicol, especially when administered 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 carried out more slowly or, if necessary, interrupted until the symptoms have reversed.
• If gastrointestinal obstruction or perforation is suspected, necessary diagnostic tests should be performed before administering Casenglicol.
• Casenglicol should be used with caution in patients with severe colitis or proctitis, and should be used with caution.
• Casenglicol should be used with caution in fragile patients, patients with significant kidney disease, or patients with known electrolyte balance disorders.
• If you experience sudden abdominal pain or rectal bleeding while taking Casenglicol for bowel preparation, contact your doctor or seek immediate medical attention.
• Avoid mixing Casenglicol with starch-based thickeners if you have swallowing difficulties. This may 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

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

Casenglicol accelerates intestinal transit, which may cause the administered medication to be poorly absorbed and eliminated through the gastrointestinal tract, potentially reducing its effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 operating machinery

Not described.

Casenglicol contains sodium and potassium

Consult your doctor or pharmacist if you need Casenglicol or more than 1 sachet per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

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 patients with potassium-poor diets.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

For intestinal evacuation with diagnostic or surgical purposes:

Adults

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

Dissolve the content of one sachet in1 literof water.

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

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

Patients 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).

Patients with hepatic insufficiency: no dose adjustment is required.

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

Use in children:

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

The solution is administered orally. It is recommended to administer200 to250 ml every 10-15 minutes, until the total volume has been ingested or the stool is clear.

No food should be taken during the 3 or 4 hours before administration of the solution and in no case should solid food be ingested 2 hours before using it.

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

Intestinal movement will occur approximately 1 hour after starting treatment.

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

Adults:The recommended dose is250-500 ml per dayof the solution reconstructed from a 17.6 g sachet in 250 ml of water or a 70.5 g sachet in a liter of water.

Patients 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).

Patients with hepatic insufficiency: no dose adjustment is required.

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

Use in children

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

Treatment duration:As with all laxatives, the use of Casenglicol should not be prolonged.

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

Administer Casenglicol as a single dose, when deep intestinal evacuation is required.

If you take more Casenglicol than you should

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

If you forgot to take Casenglicol

Do not take a double dose to compensate for the missed doses.

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

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

Theseadverse effects include:

Frequent (may affect up to 1 in 10 people)

• Nausea
• Feeling of abdominal fullness
• Abdominal cramps

Rare (may affect up to 1 in 100 people)

• Vomiting
• Abdominal cramps
• Anal irritation

These adverse reactions are transient and resolve quickly.

Unknown frequency (cannot be estimated from available data)

• Urticaria
• Dermatitis
• Rhinorrhea

These adverse reactions are caused by allergic reactions.

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 Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C

When not using this medication, the solution can be stored in the refrigerator (between 2°C and 8°C) and discard it 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 observe deterioration in the packaging.

Medications should not be disposed of through drains or trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Casenglicol

The active principles per 1 g, over 17.6 g, and over 70.5 g, are:

The other excipients are:

• Butylhydroxyanisole (E-320)
• Orange flavor
• Potassium acesulfame (E-950)
• Sucralose

Appearance of the product and contents of the packaging

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

Only some packaging sizes may be commercially available.

Marketing authorization holder andResponsible for manufacturing:

Casen Recordati, S.L.

Autovía de Logroño, Km 13,300

50180 Utebo, (Zaragoza)Spain

Last review date of this leaflet:February 2025

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