Name
Paxabel 4 g, powder for oral solution in sachet
Macrogol 4000


What is it and what is it for?
Paxabel contains the active ingredient Macrogol 4000, which belongs to a class of medications called osmotic laxatives. It works by adding water to the stool, which helps overcome problems caused by very slow bowel movements. Paxabel is not absorbed into the bloodstream or metabolized by the body.

Paxabel is used for the symptomatic treatment of constipation in children aged 6 months to 8 years. This medicine comes in a powder form that dissolves in a glass of water and is drunk.
The effect of PAXABEL appears within 24-48 hours following its administration.

Treatment of constipation with any medicinal product should be considered an adjuvant to an appropriate lifestyle and a healthy diet.


What you need to know before taking the medicine
Do not use Paxabel:
• if your child is allergic (hypersensitive) to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6)
• if your child has an existing illness, such as a serious intestinal disease:
- inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, abnormal dilation of the intestine);
- perforation or risk of intestinal perforation;
- ileus or suspected intestinal obstruction;
- abdominal pain from undetermined causes.

Do not give this medicine to your child if he or she has any of the conditions listed above. If you are unsure, consult your pharmacist or doctor before administering this medicine.


Warnings and precautions
Allergic reactions such as rash and swelling of the face or throat (angioedema) have been reported in adults after taking products containing macrogol (polyethylene glycol). Isolated cases of serious allergic reactions characterized by weakness, collapse, or difficulty breathing and general malaise have been reported.

If your child shows any of these symptoms, contact your doctor immediately.

An organic disorder must be ruled out before starting treatment. Talk to your pharmacist or doctor before administering this medicine.

This medicine can sometimes cause diarrhoea. Consult your doctor or pharmacist before giving this medicine if your child:
- suffer from impaired liver or kidney function;
- are taking diuretics (water tablets) because there is a risk of a reduction in sodium (salt) or potassium in the blood.

Before taking PAXABEL, talk to your doctor or pharmacist if you know you have a swallowing disorder.

If you have difficulty swallowing, avoid mixing Paxabel with starch-based food thickeners. This can result in a watery liquid that could enter the lungs and cause pneumonia if swallowed incorrectly.


Possible side effects
Like all medicines, Paxabel can cause side effects, although not everybody gets them.
Side effects are usually mild and temporary and include:

In children:
Common (may affect up to 1 in 10 people)
• Abdominal pain (stomach ache);
• Diarrhea that may cause cramps in the rectum (anus).

Uncommon (may affect up to 1 in 100 people)
• Nausea (feeling sick) or vomiting;
• Abdominal swelling (swelling).

Not known (frequency cannot be estimated from the available data)
• Allergic (hypersensitivity) reactions (skin rash, hives, swelling of the face and throat, difficulty breathing, weakness or collapse).

Additional side effects have been observed in adults:

Uncommon (may affect up to 1 in 100 people)
• Urgency to go to the bathroom;
• Fecal incontinence.

Not known (frequency cannot be estimated from the available data)
• Low levels of potassium in the blood which can cause muscle weakness, tremors and altered heart rhythm;
• Low sodium levels which can cause tiredness and confusion, muscle spasms, convulsions and coma;
• Dehydration caused by severe diarrhea especially in the elderly;
• Redness of the skin.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.