Casenlax 10 g powder for oral solution in sachet
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASENLAX 10g powder for oral solution in sachet
Macrogol 4000
Read this 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 must not be given to other people, even if they have the same symptoms as you, since 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 10g powder for oral solution in sachet.
Casenlax is considered an osmotic laxative.
Casenlax is used for the symptomatic treatment of constipation in adults and children over 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 your condition worsens or does not improve.
This medicine contains Macrogol (PEG = Polyethylene glycol).
In the case of constipation, the maximum treatment period in children is 3 months.
2. What you need to know before taking Casenlax
Occasional constipation:
Occasional constipation may be related to a recent change in lifestyle. There are medications that can be used for short-term treatment. Consult your doctor if you have recently developed constipation not due to lifestyle changes, or if constipation is associated with pain, fever, or abdominal swelling.
Chronic constipation (long-term constipation):
Chronic constipation may be caused by:
- Intestinal disease requiring medical consultation.
- Intestinal dysfunction (imbalance) due to dietary habits and lifestyle.
Treatment includes, among others:
- Increasing dietary fiber intake (vegetables, wholemeal bread, fruit).
- Increasing fluid and fruit juice intake.
- Increasing physical activity (exercise, walking, etc.).
- Rehabilitation of the defecation reflex.
Do not take Casenlax:
- If you are allergic to Macrogol (PEG = polyethylene glycol) or to any of the other ingredients 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 gastrointestinal perforation.
- If you have or suspect intestinal obstruction (ileus).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Casenlax.
In case of diarrhoea, some patients may develop electrolyte disturbances (reduction of certain salts in the blood), particularly elderly people, those with liver or kidney problems, or those taking diuretics (medications that increase fluid elimination). If you belong to any of these groups and experience diarrhoea, your electrolyte levels should be checked via 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 children, to rule out organic causes of constipation. After 3 months of treatment, your doctor should reassess 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 medicine.
Pregnancy and breastfeeding
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 operating machinery
Casenlax has no influence on the ability to drive or operate machinery.
Casenlax contains sulphur dioxide
This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sulphur 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 sugar or polyols, and therefore can be prescribed to diabetic patients or patients on a galactose-free diet.
3. How to take Casenlax
Follow exactly the instructions given by your doctor or pharmacist for the administration of this medicine. If in doubt, please consult your doctor or pharmacist again.
Oral use.
The recommended dose is: 1 or 2 sachets per day, preferably taken as a single dose in the morning. 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 and may range from one sachet every two days (especially in children) up to a maximum of 2 sachets per day.
The effect of Casenlax occurs 24–48 hours after administration.
Dissolve the contents of the sachet in a glass of water (at least 125 ml) immediately before administration and drink the liquid.
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 trial data for treatment periods longer than 3 months.
Treatment should be discontinued gradually and restarted if constipation recurs.
If you take more Casenlax than you should
You may develop 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, telephone: 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 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 swelling (facial edema), angioedema (rapid swelling of the skin's deeper layers), urticaria, and anaphylactic shock. The frequency of these adverse effects has been reported as very rare (may affect up to 1 in 10,000 people) in the adult population, while in the pediatric population the frequency could not be established from the available data. If you notice any of the reactions described above, please stop taking this medicine immediately and contact your doctor without delay.
Adults
Generally, adverse effects are mild and transient and mainly affect 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
- Urgent need to go to the bathroom
- Fecal incontinence
Frequency not known (cannot be estimated from available data)
- Electrolyte disturbances: low levels of sodium and potassium in the blood (hyponatremia and hypokalemia)
- Dehydration due to severe diarrhea, especially in elderly patients
- Erythema
Children and adolescents
As in the adult population, adverse effects are generally mild and transient and mainly affect 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.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
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 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 10 g of macrogol 4000.
The other ingredients are sodium saccharin (E 954) and apple flavour (flavouring agents identical to natural substances, natural flavours, flavouring preparations, maltodextrin, gum arabic (E 414), sulphur dioxide (E 220), alpha-tocopherol (E 307). See Section 2 “Casenlax contains sulphur dioxide”.
Appearance of the product and contents of the pack
Casenlax is an almost white powder contained in a sachet for making a solution.
It is available in packs of 8, 10, 20, 30, 50, 60 or 100 sachets.
Only some 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
Belgium, Luxembourg: Transilax
Bulgaria: ?????????
Cyprus, Lithuania: Macrogol 4000 Casen Recordati
Denmark, Finland, France, Italy, Norway, Portugal, Spain, Sweden: Casenlax
Estonia, Latvia, Romania: Proctolax
Greece: Cleenlax forte
Ireland, United Kingdom (Northern Ireland): Peglax
Date of the most recent revision of this leaflet: 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/