CASENLAX 4 g ORAL SOLUTION POWDER IN SACHETS

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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this 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 you take Casenlax
3. How to take Casenlax
4. Possible side effects
5. Storage of Casenlax
6. Contents of the pack and further information

1. What is Casenlax and what is it 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 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 your doctor if it 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 you take Casenlax

Treatment of constipation with a laxative should be complementary to a healthy lifestyle and diet.

Do not take Casenlax

• If your child is allergic to macrogol (PEG = polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6).
• If your child has a disease that affects 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 that they have, or may be at risk of having a gastrointestinal perforation.
• If your child has or suspects that they 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, some patients may develop electrolyte disorders (decrease in sodium and other salts in the blood), mainly elderly people, those with liver or kidney problems, or those taking diuretics (medicines 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 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 immunosuppressants). Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 and use machines.

Casenlax contains sulfur dioxide.

This medicine can rarely cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfur dioxide.

Casenlax contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

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

3. How to take Casenlax

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Oral route.

The recommended dose is:

Children from 6 months to 1 year: 1 sachet per day.

Children from 1 to 4 years: 1 to 2 sachets per day.

Children from 4 to 8 years: 2 to 4 sachets per day.

Treatment should be administered in the morning in the case of 1 sachet per day, or divided between morning and evening in the case of higher doses. It is recommended to drink 125 ml of liquids (e.g., water) after each dose.

The daily dose should be adapted according to the clinical effects obtained.

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

Dissolve the contents of the sachet in a glass of water (at least 50 ml) immediately before administration and drink the liquid. The resulting solution will be clear and transparent like water.

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 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 disappears 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 salts (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 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects are allergic reactions (hypersensitivity) that include itching (hives), 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 frequency (cannot be estimated from the available data) in the pediatric population and as very rare frequency (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 medicine 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

Unknown frequency (cannot be estimated from the 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

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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaram.es). By reporting side 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.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Casenlax

The active substance is:

Macrogol 4000

Each sachet contains 4g of macrogol 4000

The other ingredients are:

Sodium saccharin (E954) and strawberry flavor (maltodextrin, triethyl citrate E1505, arabic gum E414, sulfur dioxide E220, and acetic acid E260). See section 2 "Casenlax contains sulfur dioxide".

Appearance of the product and pack contents

Casenlax is a almost white powder with a strawberry odor contained in a sachet to make a solution.

It is available in packs of 10, 20, 30, or 50 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Casen Recordati, S.L.

Autovía de Logroño, km 13.300

50180 UTEBO. Zaragoza (Spain)

This medicine is authorized in the EEA member states with the following names:

Germany: Laxbene Junior 4 g Pulver zur Herstellung einer Lösung zum Einnehmen, in Einzeldosis-Beuteln, für Kinder von 6 Monaten bis 8 Jahre

Denmark: Casenlax 4g pulver til oral opløsning i brev

Spain: Casenlax 4g polvo para solución oral

Finland: Casenlax 4g jauhe oraaliliuosta varten annospussi

Netherlands: Casenlax 4g poeder voor drank

Italy: Casenjunior 4 g polvere per soluzione orale in bustina monodose

Norway: Casenlax 4g pulver til mikstur oppløsning i dosepose

Portugal: Casenlax 4g pó para solução oral

Sweden: Casenlax 4g pulver till oral lösning i dospåse

Date of last revision of this leaflet: August 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/