Name
CASENLAX 10 g powder for oral solution in sachet
Macrogol 4000


What it is and what it is used for
The name of this medicine is Casenlax 10 g powder for oral solution in sachet.

Casenlax is considered an osmotic laxative.

Casenlax is indicated for the symptomatic treatment of constipation in adults and children aged 8 years and above. It should be used with appropriate lifestyle modifications and dietary measures (see section 2).

Talk to your doctor if you do not feel better or if you feel worse.

This medicine contains Macrogol (PEG = polyethylene glycol).

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


What you need to know before taking the medicine
Do not take Casenlax
- if you are allergic to Macrogol (PEG = polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6);
- if you have any bowel or colon disease (such as ulcerative colitis, Crohn's disease);
- if you have abdominal pain of unknown cause;
- if you have or suspect you have gastrointestinal perforation;
- if you have or suspect intestinal obstruction.


Warnings and precautions
Talk to your doctor or pharmacist before taking Casenlax.

If you develop diarrhoea while taking Casenlax you may be at risk of developing electrolyte imbalances (a decrease in certain salts in the blood). You are more likely to be at risk if you are elderly or have liver or kidney problems or are taking diuretics (water tablets). If you are one of these people and develop diarrhoea you should see a doctor to check your electrolyte levels with a blood test.

Children
Consult your doctor before administering this treatment to your child, in order to exclude any organic cause of constipation. After 3 months of treatment, your doctor will need to evaluate your child's clinical condition.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects are allergic (hypersensitivity) reactions including pruritus (itchy rash), rash, facial oedema (swelling of the face), Quincke's oedema (rapid swelling of the deep layers of the skin), urticaria (hives) and anaphylactic shock. Their frequency has been reported as very rare (may affect up to 1 in 10,000 people) in the adult population and as not known (frequency cannot be estimated from the available data) in the paediatric population. If you notice any of the reactions listed above, stop taking the medicine immediately and seek urgent medical advice.

Adults :
In general, adverse reactions were mild and transient and mainly involved the gastrointestinal system. These adverse reactions 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)
• vomit;
• urgent need to defecate;
• fecal incontinence.

Not known (frequency cannot be estimated from the available data)
• electrolyte disturbances (low blood levels of sodium and potassium: hyponatremia, hypokalemia);
• dehydration caused by severe diarrhea especially in elderly patients;
• erythema.

Children/adolescents :
As in the adult population, adverse reactions were mild and transient and mainly involved the gastrointestinal system. These adverse reactions 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)
• vomit;
• swelling;
• nausea.

Excessive doses may cause diarrhoea, abdominal pain and vomiting which usually disappear when the dose is reduced or treatment is temporarily stopped.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.