PAXABEL*ORAL POWDER 20SACHETS 4G

Paxabel 4 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 metabolised by the body.

Paxabel is used for the symptomatic treatment of constipation in children aged between 6 months and 8 years. This medicine consists of a powder to be dissolved in a glass of water and drunk. The effect of PAXABEL occurs within 24-48 hours after its administration.

The treatment of constipation with any medicinal product should be considered an adjunct 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 components of this medicine (listed in section 6).
- if your child has an existing severe bowel disease, such as:
• 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 of unknown cause

Do not give this medicine to your child if they suffer from any of the conditions listed above. If you are unsure, ask your pharmacist or doctor before administering 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 macrogol (polyethylene glycol) containing products. Isolated cases of severe allergic reactions characterised by weakness, collapse or respiratory difficulties and general malaise have been reported.

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

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

This medicine can sometimes cause diarrhoea, consult your doctor or pharmacist before administering the medicine if your child:
- suffers from impaired liver or kidney function
- is taking diuretics (water pills) 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 and starch-based food thickeners. This can result in a watery liquid that could enter the lungs and cause pneumonia if you are unable to swallow properly.

Possible side effects
Like all medicines, Paxabel can cause side effects, although not everyone experiences 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)
• Diarrhoea which 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 (hypersensitivity) reactions (skin rash, hives, swelling of the face and throat, difficulty breathing, weakness or collapse).

In adults, additional side effects have been observed:
Uncommon (may affect up to 1 in 100 people)
• Urge to go to the toilet
• Faecal incontinence

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.