CASENLAX 10 G ORAL SOLUTION IN SACHET
How to use CASENLAX 10 G ORAL SOLUTION IN SACHET
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
PROSPECTUS: INFORMATION FOR THE USER
Casenlax 10g oral solution in sachet
Macrogol 4000
Read this prospectus carefully before starting to take this medication, as it contains important information for you.
- Keep this prospectus, as you may need to read it again.
- If you have any doubts, consult your doctor, pharmacist, or nurse.
- 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects that do not appear in this prospectus. See section 4.
Contents of the prospectus:
- What Casenlax is and what it is used for
- What you need to know before starting to take Casenlax
- How to take Casenlax
- Possible adverse effects
- Storage of Casenlax
- Package contents and additional information
1. What Casenlax is and what it is used for
The name of this medication is Casenlax 10g oral solution in sachet.
Casenlax is considered an osmotic laxative.
Casenlax is used in the symptomatic treatment of constipation in adults and children over 8 years old. It should be used in conjunction with appropriate lifestyle changes and a suitable diet (see section 2).
You should consult your doctor if it worsens or does not improve.
This medication 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 starting to take 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 suffered from constipation not due to changes in your lifestyle or constipation associated with pain, fever, or abdominal inflammation.
Chronic constipation (long-term constipation):
Chronic constipation may be caused by: • Intestinal disease that requires consulting a doctor. • Intestinal dysfunction (imbalance) due to dietary habits and lifestyle.
Treatment includes, among others: • An increase in the proportion of fiber in the diet (vegetables, whole wheat bread, fruit).
- Increased water and fruit juice intake.
- Increased physical activity (exercise, walking...).
- Rehabilitation of the defecation reflex.
Do not take Casenlax:
- If you are allergic to Macrogol (PEG = polyethylene glycol) or to any of the other components of this medication (included in section 6).
- If you have a disease that affects 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 a gastrointestinal perforation.
- If you have or suspect you may have an intestinal obstruction.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Casenlax.
In the event of diarrhea, after treatment with Casenlax, you may be at risk of developing electrolyte disorders (decrease in certain salts in the blood). You are more likely to be at risk if you are an elderly person, or have liver or kidney problems, or are taking diuretics (medications that facilitate the elimination of fluids). If you are one of these people and experience diarrhea, you should visit your doctor to review your electrolyte levels with a blood test.
Children
Ask your doctor before administering this treatment to your child, to rule out that the constipation is caused by an organic problem. After 3 months of treatment, your doctor should evaluate your child's clinical condition.
Use of Casenlax with other medications
Casenlax may delay the absorption of other medications, making them less effective or ineffective, especially those with a narrow therapeutic index (e.g., antiepileptics, digoxin, and immunosuppressants). Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
Pregnancy and lactation
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.
Pregnancy
Casenlax can be taken during pregnancy.
Breastfeeding
Casenlax can be taken during breastfeeding.
Driving and using machines
Casenlax has no influence on the ability to drive and operate machinery.
Casenlax contains an insignificant amount of sugar or polyols, and therefore can be prescribed to diabetic patients or patients on a galactose-free diet.
Casenlax contains sodium benzoate
This medication contains 4 mg of sodium benzoate E211 in each sachet.
Casenlax contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".
3. How to take Casenlax
Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Oral route.
The recommended dose is: 1 or 2 sachets per day, preferably taken in a single dose in the morning. It is recommended to drink 125 ml of liquids (e.g., water) after each dose.
1 sachet contains 20 ml of oral solution and 10 g of macrogol 4000.
The daily dose should be adapted based on the clinical effects obtained and may range from 1 sachet every 2 days (especially in children) to a maximum of 2 sachets per day.
The effect of Casenlax occurs 24-48 hours after administration.
The 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 the lack of clinical trial data for more than 3 months of treatment.
Treatment should be gradually discontinued and resumed if constipation recurs.
If you take more Casenlax than you should
You may develop diarrhea, abdominal pain, and vomiting that disappear when treatment is temporarily interrupted or the dose is reduced.
If you experience significant diarrhea or vomiting, you should contact your doctor as soon as possible, as you may need treatment to prevent electrolyte loss due to fluid loss.
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 Casenlax
Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medications, this medication can cause adverse effects, although not everyone will experience them.
The most serious adverse effects are allergic reactions (hypersensitivity) that include pruritus (rash), eruption, facial edema (inflammation of the face), Quincke's edema (rapid inflammation of the inner layers of the skin), urticaria, and anaphylactic shock. The frequency of these adverse effects has been reported as very rare (may affect 1 in 10,000 people) in the adult population and with unknown frequency (cannot be estimated from available data) in the pediatric population. If you experience any of the reactions described above, please stop taking this medication and contact your doctor immediately.
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 disorders (low sodium and potassium levels in blood: hyponatremia and hypokalemia).
- Dehydration caused by 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 that usually disappear when the dose is reduced or treatment is temporarily interrupted.
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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Casenlax
Keep this medication out of the sight and reach of children.
This medication does not require special storage conditions.
Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
Do not use this medication if you observe any visible signs of deterioration.
Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package contents and additional information
Casenlax composition
The active ingredient is: Macrogol 4000.
Each sachet contains 10g of macrogol 4000.
The other components (excipients) are: Sodium benzoate (E-211), potassium sorbate, citric acid, sodium citrate, sucralose, and purified water.
Product appearance and package contents
Casenlax is a clear, colorless, odorless, and tasteless solution.
It is available in packages of 10, 20, 30, 50, or 100 sachets.
Only some package sizes may be marketed.
Marketing authorization holder and manufacturer
Casen Recordati, S.L.,
Autovía de Logroño, km 13.300
50180 UTEBO. Zaragoza (Spain)
This medication is authorized in the Member States of the European Economic Area under the following names:
Germany: Casenlax 10 g Lösung zum Einnehmen in Beuteln
Spain: Casenlax 10g solución oral en sobre
France: Casenlax 10g, solution buvable en sachet
Italy: Casenlax 10 g soluzione orale in bustina
Portugal: Casenlax 10g solução oral em saquetas
Date of the last revision of this prospectus: 11/2021
Other sources of information
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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