Casenlax 500 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Casenlax 500 mg/ml oral solution
Macrogol 4000
Read the entire leaflet carefully before you start taking 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, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Casenlax is and what it is used for
- What you need to know before taking Casenlax
- How to take Casenlax
- Possible side effects
- How to store Casenlax
- Contents of the pack and other information
1. What Casenlax is and what it is used for
The name of this medicine is Casenlax 500 mg/ml oral solution.
Casenlax belongs to a group of medicines called osmotic laxatives. Osmotic laxatives are medicines that increase the amount of water in the stools, thereby facilitating bowel movement.
Casenlax is indicated for the symptomatic treatment of constipation in children from 6 months to 8 years of age. It should be used in conjunction with appropriate lifestyle changes and a suitable diet (see section 2).
You should consult a doctor if your condition worsens or does not improve.
This medicine contains Macrogol (PEG = Polyethylene glycol).
In cases of constipation, the maximum treatment period in children is 3 months.
2. What you need to know before taking Casenlax
The treatment of constipation with a laxative should be an adjunct to a healthy lifestyle and diet.
Do not take Casenlax
- If you are allergic to macrogol (PEG = polyethylene glycol) or to any of the other components of this medicine (listed in section 6).
- If you have a disease affecting the intestine or colon (such as ulcerative colitis, Crohn's disease).
- If you have abdominal pain of unknown cause.
- If you have or suspect you may have gastrointestinal perforation or are at risk of intestinal perforation.
- If you have or suspect you may have intestinal obstruction.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Casenlax.
If you develop diarrhoea after treatment with Casenlax, you may be at risk of developing electrolyte disturbances (reduction in certain salts in the blood). This risk is higher if you are elderly, have liver or kidney problems, or are taking diuretics (medications that increase fluid elimination). If you belong to any of these groups and experience diarrhoea, you should see your doctor to check your electrolyte levels with a blood test.
Avoid mixing Casenlax with starch-based thickeners if you have swallowing difficulties. This may result in an aqueous liquid that could enter your lungs and cause pneumonia if you are unable to swallow properly.
If you need to thicken liquids to swallow them safely, Casenlax may counteract the thickening effect.
Children
Ask your doctor before giving this treatment to your child, to rule out constipation caused by an organic condition. After 3 months of treatment, your child's clinical condition should be evaluated by the doctor.
Use of Casenlax with other medicines
Casenlax may delay the absorption of other medicines, making them less effective or ineffective, especially those with a narrow therapeutic index (e.g., antiepileptics, digoxin, and immunosuppressive agents). Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 medicine.
Pregnancy
Casenlax may be taken during pregnancy.
Breastfeeding
Casenlax may be taken during breastfeeding.
Driving and use of machines
Casenlax does not affect the ability to drive or operate machinery.
Casenlax contains a negligible amount of sugars or polyols and may be prescribed to diabetic patients or patients on a galactose-free diet.
Casenlax contains sodium benzoate
This medicine contains 0.2 mg of sodium benzoate E 211 per ml.
Casenlax contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per ml; therefore, it is essentially “sodium-free”.
3. How to take Casenlax
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Oral use.
Recommended dosage:
From 6 months to 1 year: 8 ml per day.
From 1 to 4 years: 8 ml to 16 ml per day.
From 4 to 8 years: 16 ml to 32 ml per day.
The treatment should be administered in the morning when the daily dose is 8 ml, or divided between morning and evening for higher doses. It is recommended to drink 125 ml of liquid (e.g., water) after each dose.
The daily dose should be adjusted according to the clinical effects observed.
The effect of Casenlax occurs within 24–48 hours after administration.
It is recommended to measure the oral solution using the syringe provided in the package.
Improvement in intestinal transit after administration of Casenlax will be maintained by following a healthy lifestyle and diet.
Use in children and adolescents
In children, treatment should not exceed 3 months due to lack of clinical data beyond 3 months of treatment.
Treatment should be gradually discontinued and restarted if constipation recurs.
If you take more Casenlax than you should
Diarrhea, abdominal pain, and vomiting may occur, which resolve when treatment is temporarily interrupted or the dose is reduced.
If you experience severe diarrhea or vomiting, contact your doctor as soon as possible, as fluid loss may require treatment to prevent loss of salts (electrolytes).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medicine and the amount ingested). It is advisable to take the container and package leaflet to the healthcare professional.
If you forget to take Casenlax
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most serious adverse effects are allergic reactions (hypersensitivity), including pruritus (rash), rash, facial edema (swelling of the face), Quincke's edema (rapid swelling of the inner layers of the skin), urticaria, and anaphylactic shock. The frequency of these adverse effects has been described as unknown frequency (cannot be estimated from the available data) in the pediatric population and as very rare (may affect up to 1 in 10,000 patients) in adults. If you notice any of the reactions described above, please stop taking this medicine and contact your doctor immediately.
Adults:
Adverse effects have generally been mild and transient, and are mainly related to the gastrointestinal system. These adverse effects include:
Frequent (may affect up to 1 in 10 people)
- Abdominal pain.
- Abdominal distension.
- Diarrhea.
- Nausea.
Uncommon (may affect up to 1 in 100 people)
- Vomiting.
- Urgency to defecate.
- Fecal incontinence.
Frequency not known (cannot be estimated from the available data)
- Electrolyte disorders (low blood levels of sodium and potassium: hyponatremia, hypokalemia).
- Dehydration, caused by severe diarrhea, especially in elderly patients.
- Erythema.
In children, adverse effects have generally been mild and transient, and are mainly related to the gastrointestinal system. These adverse effects include:
Frequent (may affect up to 1 in 10 people)
- Abdominal pain.
- Diarrhea (may cause perianal pain).
Uncommon (may affect up to 1 in 100 people)
- Vomiting.
- Bloating.
- Nausea.
Excessive doses may cause diarrhea, abdominal pain, and vomiting, which usually resolve when the dose is reduced or treatment is temporarily discontinued.
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 via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Casenlax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.
After opening the bottle, the medicine can be used for 2 months.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Casenlax
The active substance is:
Macrogol 4000
Each ml contains 500 mg of macrogol 4000.
The other components (excipients) are: Sodium benzoate (E 211), potassium sorbate, citric acid, sodium citrate, sucralose and purified water.
Nature of the product and contents of the container
Casenlax is a transparent, colourless solution, odourless and tasteless.
It is available in amber-coloured bottles of 200 ml or 500 ml, with an oral dosing syringe to facilitate administration.
Marketing Authorisation Holder and Manufacturer
Casen Recordati, S.L.
Autovía de Logroño, km. 13.300
50180 UTEBO. Zaragoza (Spain)
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Laxbene junior
Spain, Portugal: Casenlax
Italy: Casenjunior
Date of the most recent review of this summary: February 2026
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/