Casenlax 4 g powder for oral solution in sachets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Casenlax 4 g, powder for oral solution in sachets
Macrogol 4000.
Read all of this 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 other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- 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 4g powder for oral solution in sachet.
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 intestinal transit.
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 an adequate diet (see section 2).
You should consult your doctor if symptoms worsen or do 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 starting Casenlax
The treatment of constipation with a laxative should be an adjunct to a healthy lifestyle and diet.
Do not take Casenlax
- If your child is allergic to macrogol (PEG = polyethylene glycol) or to any of the other ingredients of this medicine (listed in section 6).
- If your child has a disease affecting the intestine or colon (such as ulcerative colitis, Crohn's disease).
- If your child has abdominal pain of unknown cause.
- If your child has, suspects having, or is at risk of gastrointestinal perforation.
- If your child has or suspects having intestinal obstruction.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting Casenlax.
In case of diarrhea following treatment with Casenlax, some patients may develop electrolyte disturbances (low levels of sodium and other salts in the blood), particularly elderly patients, those with liver or kidney problems, or those taking diuretics (medicines that increase fluid elimination). If you belong to any of these groups and experience diarrhea, 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 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 doctor should evaluate your child's clinical condition.
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 are planning 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 using machines
Casenlax does not affect the ability to drive or operate machinery.
Casenlax contains sulfur dioxide.
This medicine may rarely cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sulfur dioxide.
Casenlax contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per sachet; hence, it is essentially "sodium-free".
Casenlax contains a negligible amount of sugars or polyols and may be prescribed to diabetic patients or patients on a galactose-free diet.
3. How to take Casenlax
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Oral use.
Recommended dose:
Children 6 months to 1 year: 1 sachet per day.
Children 1 to 4 years: 1 to 2 sachets per day.
Children 4 to 8 years: 2 to 4 sachets per day.
Treatment should be taken in the morning if one sachet per day is prescribed, 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 achieved.
The effect of Casenlax occurs 24–48 hours after administration.
Dissolve the contents of the sachet in a glass of water (at least 50 ml) immediately before use and drink the solution. The resulting solution will be clear and transparent like water.
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 trials beyond 3 months of treatment.
Treatment should be gradually discontinued and restarted if constipation recurs.
If you take more Casenlax than you should
This may cause diarrhea, abdominal pain, and vomiting, which resolve when treatment is temporarily interrupted or the dose is reduced.
If you experience severe diarrhea or vomiting, you should 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).
If you forget to take Casenlax
Do not take a double dose to make up for forgotten 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), angioedema (rapid swelling of the skin's inner layers), urticaria, and anaphylactic shock. The frequency of these adverse effects has been described as not known (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 experience any of the reactions described above, please stop taking this medicine immediately and contact your doctor without delay.
Adults: Adverse effects have generally been mild, transient, and 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 disturbances (low blood levels of sodium and potassium: hyponatremia, hypokalemia)
- Dehydration, caused by severe diarrhea, especially in elderly patients
- Erythema
Children: Adverse effects have generally been mild, transient, and 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 can 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If 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 pack and other information
Composition of Casenlax
The active substance is:
Macrogol 4000
Each sachet contains 4 g of macrogol 4000.
The other components are: Sodium saccharin (E 954) and strawberry flavour (flavouring substances, natural flavours, potato maltodextrin, triethyl citrate (E 1505), gum arabic (E 414), sulphur dioxide (E 220) and acetic acid (E 260)). See section 2 "Casenlax contains sulphur dioxide".
Appearance of the product and contents of the pack
Casenlax is an almost white powder with a strawberry odour contained in a sachet for making a solution.
It is available in packs of 10, 20, 30 or 50 sachets.
Not all pack sizes may be marketed.
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
Bulgaria: ?????????
Belgium, Luxembourg: Transilax
Cyprus: Macrogol 4000 Casen Recordati
Denmark, Spain, Finland, Portugal, Norway, Sweden: Casenlax
Estonia, Latvia, Romania: Proctolax
Greece: Cleenlax
Lithuania: Macrogol 4000 Recordati
Italy: Casenjunior
Date of the most recent review of this leaflet: February 2026
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/