PATIENT INFORMATION LEAFLET

Casenlax 10g oral solution in sachet

Macrogol 4000

1.What is Casenlax and what it is used for

2.What you need to know before starting to take 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 10g oral solution in a sachet.

Casenlax is considered an osmotic laxative.

Casenlax is used for the symptomatic treatment of constipation in adults and children over 8 years old. It should be used along with appropriate lifestyle changes and an adequate 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.

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 experienced 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 bread, fruit).

• Increased water intake and fruit juice.

• Increased physical activity (exercise, walking...).
• Rehabilitation of the defecation reflex.

Do not take Casenlax:

• If you are allergic to Macrogol (PEG = polyethylene glycol) or any of the other components of this medication (including 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 case of diarrhea, after treatment with Casenlax, you may be at risk of developing electrolyte disorders (decrease of 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 (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 the 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 taking, have recently taken, or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 has no influence on the ability to drive and operate machinery.

Casenlax contains a negligible amount of sugar or polyols, and therefore can be prescribed to diabetic patients or patients following 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; this is, essentially "sodium-free".

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

Oral administration.

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 (for example, water) after each dose.

1 sachet contains 20 ml of oral solution and 10 g of macrogol 4000.

The daily dose should be adjusted according to the clinical effects obtained and may range from one sachet every two days (especially in children) to a maximum of 2 sachets per day.

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

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 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 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 can 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 reported as very rare (may affect 1 in 10,000 people) in the adult population and 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 medicine and contact your doctor immediately.

Adults

Generally, side effects are mild and transient, and mainly affect 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.
• Urgent need to use the bathroom.
• Fecal incontinence.

Unknown frequency (cannot be estimated from available data)

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

Children and adolescents

Like in the adult population, side effects are generally mild and transient and mainly affect 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.

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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish 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.

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

Composition of Casenlax

The active principle 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.

Appearance of the product and contents of the packaging

Casenlax is a transparent, colourless, odourless and tasteless solution.

It is available in packaging of 10, 20, 30, 50 or 100 sachets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorisation and responsible person for the manufacture

Casen Recordati, S.L.,

Autovía de Logroño, km 13.300

50180 UTEBO. Zaragoza (Spain)

This medicinal product is authorised in the Member States of the European Economic Area with the following names:

Germany: Casenlax 10 g Solution for Oral Use in Sachets

Spain:Casenlax 10g oral solution in sachets

France:Casenlax 10g, oral solution in sachets

Italy: Casenlax10 goral solution in sachets

Portugal:Casenlax 10g oral solution in sachets

Date of the last review of this leaflet: 11/2021

Other sources of information

The 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/