Casenlax 4 g polvo para solucion oral en sobres

Label: information for the user

Casenlax 4 g, powder for oral solution in sachets

Macrogol 4000.

1.What Casenlax is and for what it is used

2.What you need to know before starting to take Casenlax

3.How to take Casenlax

4.Possible adverse effects

5.Storage of Casenlax

6.Contents of the package and additional information

The name of this medication is Casenlax 4g powder for oral solution in a sachet.

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.It should be used in conjunction with appropriate lifestyle changes and an adequate diet (see section 2).

You should consult your doctorif it worsensor if it does not improve.

This medication contains Macrogol (PEG = Polyethylene Glycol).

In the 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 your child is allergic to macrogol (PEG = polyethylene glycol) or any of the other components of this medication (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 or suspects they have a gastrointestinal perforation.
• If your child has or suspects they may have an intestinal obstruction.

Warnings and precautions

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

In case 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 liquids). 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 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 or 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 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 sulfur dioxide.

This medication rarely may produce severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains sulfur dioxide.

Casenlax contains sodium

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

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

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:

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

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

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

The treatment should be administered in the morning in the case of 1 sachet per day, or divided between 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 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 of intestinal transit after the 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

You may experience 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 the loss of electrolytes due to fluid 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).

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 pruritus (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 (cannot be estimated from available data)in the pediatric populationand 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 medicine and contact your doctor immediately.

Adults:lthe side effects have been generally milder and of a 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 levels of sodium and potassium in the blood: hyponatremia, hypokalemia)
• Dehydration, caused by severe diarrhea, especially in elderly patients.
• Erythema

Children:the side effects have been generally milder and of a 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 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.

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 in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Casenlax

The active principle is:

Macrogol 4000

Each sachet contains 4g of macrogol 4000

The other components are:

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

Appearance of the product and contents of the packaging

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

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

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

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 4 g Powder for the preparation of a solution for oral administration, in single-dose sachets, for children from 6 months to 8 years

Denmark: Casenlax 4g powder for oral solution in sachets

Spain: Casenlax 4g powder for oral solution

Finland: Casenlax 4g powder for oral solution in a dose sachet

Netherlands: Casenlax 4g powder for drink

Italy: Casenjunior 4 g powder for oral solution in a single-dose sachet

Norway: Casenlax 4g powder for mixing oral solution in dose sachet

Portugal: Casenlax 4g powder for oral solution

Sweden: Casenlax 4g powder for oral solution in a dose sachet

Last review date of this leaflet: August 2020

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