PAXABEL 20 SACHETS OF POWDER FOR ORAL SOLUTION OF 10 G

Name
Paxabel 10 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 in the body.

Paxabel is used for the symptomatic treatment of constipation in adults and children aged 8 years and over.
This medicine comes in the form of a powder that dissolves in a glass of water (at least 50 ml) and is drunk. It usually works within 24-48 hours of 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 you are allergic (hypersensitive) to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6);
• if you have an existing illness, such as severe bowel 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 use this medicine if you suffer from any of the conditions listed above. If you are unsure, talk to your pharmacist or doctor before taking 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 you experience any of these symptoms, stop taking Paxabel and contact your doctor immediately.

This medicine can sometimes cause diarrhea. Check with your doctor or pharmacist before taking this medicine if:
- suffer from impaired liver or kidney function;
- are taking diuretics (water tablets) or are elderly because there is a risk of reduced 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 (stomach)

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

In adults:
Common (may affect up to 1 in 10 people)
• Abdominal pain (stomach ache)
• Abdominal swelling (stomach)
• Nausea (feeling sick) or vomiting
• Diarrhea

Uncommon (may affect up to 1 in 100 people)
• Vomit
• 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 weakness, tremors and an 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
• Symptoms of an allergic reaction, such as redness of the skin, rash, hives, swelling of the face and throat, difficulty breathing, weakness and collapse.

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.