CASENLAX 10 g ORAL SOLUTION POWDER IN SACHET

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CASENLAX10g powder for oral solution in sachet

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 signs of illness are the same as yours.
• If you get 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 pack:

1. What Casenlax is and what it is 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 other information

1. What Casenlax is and what it is used for

The name of this medicine is Casenlax 10g powder for oral solution in sachet.

Casenlax is considered an osmotic laxative.

Casenlax is used for the symptomatic treatment of constipation in adults and children over 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

Occasional constipation:

Occasional constipation may be related to a recent change in lifestyle. There are medicines that can be used for short-term treatment. Consult your doctor if you have recently suffered from 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 wheat bread, fruit).

• Increase in water and fruit juice intake.
• Increase in 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 medicine (included 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, 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 review your electrolyte levels with a blood test.

Children

Ask your doctor before administering this treatment to your children, to rule out that 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 taking, have recently taken, or may need to take any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Casenlax can be taken during pregnancy.

Breastfeeding

Casenlax can be taken during breastfeeding.

Driving and using machines

Casenlax has no influence on the ability or skill to handle machinery.

Casenlax contains sulfur dioxide

This medicine may 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; this is, essentially "sodium-free".

Casenlax contains an insignificant amount of sugar or polyols, and therefore can be prescribed to diabetic patients or patients on 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: 1 or 2 sachets per day, preferably taken in a single dose in the morning. 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 and may range from one sachet every two days (especially in children) to a maximum of 2 sachets per day.

The effect of Casenlax occurs 24-48 hours after 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 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 trial data for more than 3 months of treatment.

Treatment should be gradually discontinued and resumed if constipation occurs again.

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 suffer from significant diarrhea or vomiting, you should contact your doctor as soon as possible, as you may need treatment to prevent loss of 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 reported as very rare (may affect 1 in 10,000 people) in the adult population, and in the pediatric population, the frequency could not be 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:

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.
• Urgent need to go to the bathroom.
• Fecal incontinence.

Frequency not known (cannot be estimated from the 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

As in the adult population, side effects are generally mild and transient and mainly affect 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, even if it is 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.

This medicine does not require special storage conditions.

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 shown.

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 other information

Composition of Casenlax

The active substance 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 pack

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

It is available in packs of 10, 20, 30, 50, 60, or 100 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 Member States of the European Economic Area under the following names:

Germany: Laxbene 10g powder for oral solution, sachet, for children from 8 years and adults.

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

Spain: Casenlax 10g powder for oral solution

Finland: Casenlax 10g powder for oral solution, sachet

France: Casenlax 10g powder for oral 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 10g powder for mixture, solution in dose sachet

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 sachet

Date of last revision of this leaflet: August 2018

Other sources of information

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/