PAXABEL*ORAL POWDER 20 SACHETS 10G

Paxabel 10 g, powder for oral solution in sachet
Macrogol 4000

What it is and what it is used for
Paxabel contains the active ingredient Macrogol 4000, which belongs to a class of medicines called osmotic laxatives. It works by adding water to the stool, which helps to 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 over 8 years of age.

This medicine consists of a powder to be dissolved in a glass of water (at least 50 ml) and drunk. It usually takes effect within 24-48 hours after administration.

The treatment of constipation with any medicinal product should be considered an adjunct to an appropriate lifestyle and a healthy dietary regimen.

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 paragraph 6);
- if you have an existing disease, such as a severe 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 use this medicine if you suffer from any of the conditions listed above. If you are unsure, ask your pharmacist or doctor before taking the medicine.

Warnings and precautions
Cases of allergic reactions such as skin rash and swelling of the face or throat (angioedema) have been reported in adults after taking products containing macrogol (polyethylene glycol). Isolated cases of severe 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 the medicine if:
- you suffer from impaired liver or kidney function;
- you are taking diuretics (water pills) or are elderly because there is a risk of a reduction in sodium (salt) or potassium in the blood.
Before taking PAXABEL, consult your doctor or pharmacist if you know you have a swallowing disorder.
If you have difficulty swallowing, avoid mixing Paxabel and starch-based food thickeners. This can result in a watery liquid that could enter your lungs and cause pneumonia if you are unable to swallow properly.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone 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 can cause rectal (anal) cramps

Uncommon (may affect up to 1 in 100 people)
• Nausea (feeling sick) or vomiting
• Abdominal bloating (in the stomach)

Not known (frequency cannot be estimated from the available data)
• Allergic reactions (hypersensitivity) (skin 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 bloating (in the stomach)
• Nausea (feeling sick) or vomiting
• Diarrhea

Uncommon (may affect up to 1 in 100 people)
• Vomiting
• Urge to go to the bathroom
• Fecal incontinence

Not known (frequency cannot be estimated from the available data)
• Low potassium levels in the blood that can cause weakness, tremors, and altered heart rhythm
• Low sodium levels that can cause fatigue and confusion, muscle spasms, seizures, and coma
• Dehydration caused by severe diarrhea, especially in the elderly
• Symptoms of an allergic reaction, such as skin redness, rash, hives, swelling of the face and throat, difficulty breathing, weakness, and collapse.

Reporting of side effects
If you get any side effects, including those 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.