Leaflet: information for the user

Casenlax 500 mg/ml oral solution

Macrogol 4000

Read 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, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What Casenlax is and what it is used for

2.What you need to know before you start taking Casenlax

3.How to take Casenlax

4.Possible side effects

5.Storage of Casenlax

6.Contents of the pack and additional information

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 an increase in the amount of water in the feces, thereby facilitating transit.

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

Consult a doctor if symptoms worsen or do not improve.

This medication contains Macrogol (PEG = Polyethylene Glycol).

In case of constipation, the maximum treatment period in children is 3 months.

The treatment of constipation with a laxative should be supplementary to 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 intestinal perforation.

•If you have or suspect you may have intestinal obstruction.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Casenlax.

In case of diarrhea, after treatment with Casenlax, you may be at risk of developing electrolyte disorders (decrease of certain salts in the blood). It is more likely that you are at risk if you are an elderly person, or have liver or kidney problems, or are taking diuretics (medicines that facilitate the elimination of liquids). If you are any 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 constipation is caused by an organic problem. After 3 months of treatment, your doctor should evaluate your child's clinical status.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 operating machinery

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

Casenlax contains a negligible amount of sugars or polyolsand can be prescribed to diabetic patients or patients on 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; it is essentially "sodium-free".

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

Oral administration.

The recommended dose is:

6 months to 1 year: 8 ml per day.

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

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

The treatment should be administered in the morning in the case of a 8 ml per day dose, or divided between the morning and night 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 adjusted according to the clinical effects obtained.

The effect of Casenlax is produced within 24-48 hours of administration.

It is recommended to dose the oral solution using the syringe included in the package.

The improvement of 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 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 experience 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 due to fluid loss, you may need treatment to prevent electrolyte loss.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested). It is recommended to bring the package and the leaflet to the healthcare professional.

If you forgot to take Casenlax

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The most serious side effects are allergic reactions (hypersensitivity) that include itching (hives), rash, facial edema (inflammation of the face), Quincke edema (rapid inflammation of the inner layers of the skin), urticaria, and anaphylactic shock. The frequency of these side effects has been described asunknown frequency (cannot be estimated from available data)in the pediatric populationand 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:

The side effects have been generally milder and of transient nature and are primarily related to the gastrointestinal system. These side effects include:

Frequent (may affect up to 1 in 10 people)

•Abdominal pain.

•Abdominal distension.

•Diarrhea.

•Nausea.

Rare (may affect up to 1 in 100 people)

•Vomiting.

•Urgency to defecate.

•Fecal incontinence.

Unknown frequency (cannot be estimated from available data)

•Electrolyte disturbances (low sodium and potassium levels in the blood: hyponatremia, hypokalemia).

•Dehydration, caused by severe diarrhea, especially in elderly patients.

•Erythema.

In children, the side effects have been generally milder and of transient nature and are primarily related to the gastrointestinal system. These side effects include:

Frequent (may affect up to 1 in 10 people)

•Abdominal pain.

•Diarrhea (may cause perianal pain).

Rare (may affect up to 1 in 100 people)

•Vomiting.

•Swelling.

•Nausea.

Overdoses may cause diarrhea, abdominal pain, and vomiting that generally disappear when the dose is reduced or the treatment is temporarily interrupted.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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.

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 drains or trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Casenlax

The active principle 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.

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and Responsible for the manufacture

Casen Recordati, S.L.

Autovía de Logroño, km. 13.300

50180 UTEBO. Zaragoza (Spain)

This medicinal product is authorized in the Member States of the EEA with the following names:

Germany: Laxbene junior 500 mg/ml Solution for oral administration, for children from 6 months to 8 years

Spain: Casenlax 500 mg/ml oral solution

Italy: Casenjunior 500 mg/ml oral solution

Portugal: Casenlax 500 mg/ml oral solution

Date of the last review of this leaflet:May 2019

Other sources of information

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/