PROSPECTO: INFORMATION FOR THE USER

CASENLAX10g powder for oral solution in sachet

Macrogol 4000

1.What is Casenlax and what is it used for

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 isCasenlax10g powder for oral solution in a sachet.

Casenlaxis considered an osmotic laxative.

Casenlaxis usedin the symptomatic treatment of constipation in adults and children over 8 years old. 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 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 and fruit juice intake.

• 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 (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.
• if you have or suspect you may have an intestinal obstruction (ileus).

Warnings and Precautions

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

In case of diarrhea, some patients may develop electrolyte disorders (decrease in certain salts in the blood), mainly elderly people, those with liver or kidney problems, or those taking diuretics (medications that facilitate the elimination of liquids). If you are any of these people, and experience diarrhea, you should check your electrolyte levels with a blood test.

Children

Ask your doctor before administering this treatment to your children, to rule out that the constipation is caused by an organic problem. After 3 months of treatment, your doctor should evaluate the clinical status of your child.

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 or skill to operate machinery.

Casenlax contains sulfur dioxide

This medication 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 sugar or polyols, and can therefore be prescribed to diabetic patients or patients following 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: 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.

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.

Dissolve the contents of the sachet in a glass of water (at least 125 ml) immediately before administration and drink the liquid.

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 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 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 can 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 reported as very rare (may affect 1 in 10,000 people) in the adult population and in the pediatric population, the frequency has not been established from the available data. If you notice any of the reactions described above, please do not continue 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.

Less frequent (may affect up to 1 in 100 people)

• Vomiting.
• Urgent need to go to 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).

Less frequent (may affect up to 1 in 100 people)

• Vomiting.
• Swelling.
• Nausea.

Excessive doses may cause diarrhea, abdominal pain, and vomiting that usually disappears 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 leaflet. You can also report them directly through theSpanish 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.

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration datethat appears on the packagingafter 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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will helpprotectthe environment.

Composition of Casenlax

The active ingredient is Macrogol 4000. Each sachet contains 10g of macrogol 4000.

The other components are sodium saccharin (E-954) and apple flavor (natural flavor, maltodextrin, gum arabic (E-414), sulfur dioxide (E-220), alpha-tocopherol (E-307). See Section 2 “Casenlax contains sulfur dioxide”.

Appearance of the product and contents of the packaging

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

It is available in packaging of 10, 20, 30, 50, 60 or 100 sachets.

Only some sizes of packaging 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 European Economic Area with the following names:

Germany: Laxbene 10g powder for the preparation of a solution for oral intake, in sachets, for children from 8 years and adults.

Denmark: Casenlax 10g powder for oral solution, brief.

Spain: Casenlax 10g powder for oral solution

Finland: Casenlax 10g powder for oral solution, sachet

France: Casenlax 10g powder for drinkable solution

Netherlands: Casenlax 10g powder for drink

Ireland: Peglax 10g powder for oral solution in sachet

Italy: Casenlax 10g powder for oral solution in sachets

Norway: Casenlax 10 g powder for mixing, solution in dose pouch

Portugal: Casenlax 10g powder for oral solution

United Kingdom: Peglax 10g powder for oral solution in sachet

Sweden: Casenlax 10g powder for oral solution in dose pouch

Last review date of this leaflet: August 2018

Other sources of information

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/