CASENLAX 500 MG/ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Casenlax 500 mg/ml Oral Solution

Macrogol 4000

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Casenlax and what is it used for
2. What you need to know before taking Casenlax
3. How to take Casenlax
4. Possible side effects
5. Storage of Casenlax
6. Package Contents and Additional Information

1. What is Casenlax and what is it used for

The name of this medication is Casenlax 500 mg/ml Oral Solution.

Casenlax belongs to a group of medications called osmotic laxatives. Osmotic laxatives are medications that allow the amount of water in the stool to increase, making it easier to pass.

Casenlax is indicated for the symptomatic treatment of constipation in children from 6 months to 8 years. It should be used in conjunction with appropriate lifestyle changes and a suitable diet (see section 2).

You should consult a doctor if your symptoms worsen or do 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 taking Casenlax

Treatment of constipation with a laxative should be accompanied by a healthy lifestyle and diet.

Do not take Casenlax

• If you are allergic to macrogol (PEG = polyethylene glycol) or any of the other components of this medication (listed 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 or are at risk of having an intestinal 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 (decreased levels of certain salts in the blood). You are more likely to be at risk if you are an elderly person, 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 check 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.

Using 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 using, have recently used, or may need to use any other medication.

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 medication.

Pregnancy

Casenlax can be taken during pregnancy.

Breastfeeding

Casenlax can be taken during breastfeeding.

Driving and Using Machines

Casenlax does not affect the ability to drive or operate machinery.

Casenlax contains an insignificant amount of sugars or polyolsand may be prescribed to diabetic patients or patients with a galactose-free diet.

Casenlax contains sodium benzoate

This medication contains 0.2 mg of sodium benzoate E 211 per ml.

Casenlax contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml; i.e., it is essentially "sodium-free".

3. How to take Casenlax

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Oral route.

The recommended dose is:

From 6 months to 1 year: 8 ml per day.

Between 1 and 4 years: 8 ml to 16 ml per day.

From 4 to 8 years: 16 ml to 32 ml per day.

Treatment should be administered in the morning in the case of a dose of 8 ml per day or divided between morning and evening in the case of higher doses. It is recommended to drink 125 ml of liquid (e.g., water) after each dose.

The daily dose should be adjusted based on the clinical effects obtained.

The effect of Casenlax occurs 24-48 hours after administration.

It is recommended to dose the oral solution using the syringe included 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 the lack of clinical trials 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

It may cause 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 loss of electrolytes 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). It is recommended to bring the package and package leaflet to the healthcare professional.

If you forget to take Casenlax

Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most serious side effects are allergic reactions (hypersensitivity) that include itching (pruritus), rash, 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 side effects has been described as unknown (cannot be estimated from 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 do not continue taking this medication and contact your doctor immediately.

Adults:

Side effects have generally been mild and transient and are mainly related to the gastrointestinal system. These side effects include:

Common (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 available data)

• Electrolyte disorders (low levels of sodium and potassium in the blood: hyponatremia, hypokalemia).
• Dehydration caused by severe diarrhea, especially in elderly patients.
• Erythema.

In children, side effects have generally been mild and transient and are mainly related to the gastrointestinal system. These side effects include:

Common (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 Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Casenlax

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

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Once the bottle is opened, the medication can be used for 2 months.

This medication does not require special storage conditions.

Do not use this medication if you notice any visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. If you are unsure, ask your pharmacist how to dispose of packages 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 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.

Product Appearance and Package Contents

Casenlax is a clear, colorless, odorless, and tasteless solution.

It is available in a 200 ml or 500 ml amber bottle with a syringe to facilitate dosing of the oral solution.

Marketing Authorization Holder and Manufacturer

Casen Recordati, S.L.

Autovía de Logroño, km. 13.300

50180 UTEBO. Zaragoza (Spain)

This medication is authorized in EEA member states under the following names:

Germany: Laxbene junior 500 mg/ml Lösung zum Einnehmen, für Kinder von 6 Monaten bis 8 Jahre

Spain: Casenlax 500 mg/ml solución oral

Italy: Casenjunior 500 mg/ml soluzione orale

Portugal: Casenlax 500 mg/ml solução oral

Date of the last revision of this package leaflet:May 2019

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/