PEDIAPAX POWDER 20 BAGS

Description
Medical device in powder for estemporaneous oral suspension useful in:
- Treatment of chronic constipation in children over 2 years old and weighing 10 kg or more.
- Treatment of fecal impaction in children from age 3, defined as refractory constipation with fecal load in the rectum and/or colon.

Method of use
Chronic constipation: the usual initial dose in children between 2 and 6 years old is half (1/2) a sachet per day, in children from 7 years old and up one (1) sachet per day, dissolved:
- In 125 ml of still water (about 1 glass) for the full sachet.
- In 62.5 ml of still water (about ½ glass) for the half sachet.
It is possible to dissolve the product in a liquid other than water (tea, milk, broth, or fruit juice).
The dose can be increased or decreased to allow regular evacuation of soft stools. If it is necessary to increase the dose, it is better to do so every 2 days. The maximum necessary dose normally does not exceed 2 sachets per day. In case of prolonged treatment, proceed with gradual discontinuation and resume if constipation reappears. Do not use the product for more than 30 consecutive days; if symptoms persist, consult a doctor.
PEDIAPAX can also be used in children under 2 years old, from 6 months: for this age group, to define a more precise dosage, a formulation with a dosing spoon is available.
Fecal impaction: diagnosis of fecal impaction/fecal load in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. A cycle of treatment with PEDIAPAX for fecal impaction should last from 3 up to a maximum of 6 consecutive days, in the following manner:

3-6 years:	2 PEDIAPAX sachets
7-10 years:	3 PEDIAPAX sachets
>10 years:	4 PEDIAPAX sachets

One sachet refers to the entire sachet of 13.125 g (2 half sachets). The daily number of sachets should be taken divided into doses of 6.563 g (½ sachet) dissolved in 62.5 ml of water (about half a glass), all consumed within 12 hours. It is possible to dissolve the product in a liquid other than water (tea, milk, broth, or fruit juice). The interval between doses is calculated based on the number of sachets to be taken within 12 hours, therefore:

N. sachets per day	N. of ½ sachets	1½ sachet every
2	4	3 hours
3	6	2 hours
4	8	1 hour and 30 min.

For dose customization, a dosage of 1-1.5 g/Kg/day can be considered (also using half the dose of PEDIAPAX). The indicated treatment scheme should be stopped once the occlusion has resolved. An indicator of resolution is passing a large amount of stool. After resolution, it is recommended to follow the child with an appropriate bowel treatment program to prevent the recurrence of fecal impaction (the dose to prevent recurrence is the same as for chronic constipation).
Note: it is possible to prepare a larger volume of ready-to-use solution, for example dissolving 6 sachets in 750 ml of water. In this case, the solution can be stored covered in the refrigerator for a maximum of 24 hours, then discarded.

Warnings
Keep the device and any resulting solution out of children’s reach; Do not use the device after the expiration date printed on the packaging and sachet; Do not use if the packaging is damaged; Each sachet is for single use and should be opened immediately before use: do not reuse partially used or opened sachets at unknown times, as this could pose a risk of product contamination. Do not exceed the recommended doses: overdose may cause severe pain, abdominal distension. Induced diarrhea with electrolyte disturbances caused by excessive evacuation may also occur. In case of suspected overdose, contact your pediatrician immediately. When PEDIAPAX is used in high doses to treat fecal impaction, it should be used with caution in patients with impaired swallowing reflexes, reflux esophagitis, or reduced consciousness levels. If you forget to take a dose, do not take a double dose to make up. During treatment with PEDIAPAX, a proper diet should be followed, accompanied by an oral rehydration solution (ORS) to prevent dehydration; a medical consultation is recommended.
Known side effects: gastrointestinal disturbances (abdominal pain, borborygmi, diarrhea, or stool loss), nausea, mild vomiting, abdominal distension, flatulence, perianal inflammation and irritation may appear, effects that normally improve with dose reduction. Very rarely, allergic reactions including anaphylaxis have been observed. Other allergy symptoms such as pruritus, urticaria, and dyspnea. If side effects persist, discontinue treatment and consult your pediatrician.
Contraindications and limitations of use: do not use below 2 years for chronic constipation and below 3 years for fecal impaction. For use below this age group, the bottle with dosing spoon is recommended. Use of the device is not recommended in case of: intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileus, severe inflammatory bowel diseases such as Crohn’s disease, ulcerative colitis, and toxic megacolon. Known hypersensitivity to PEG. Do not take the medical device during use of other oral devices or medicinal specialties: PEG’s osmotic power and increased gastrointestinal transit can negatively affect their effectiveness. Always consult your doctor before taking PEDIAPAX if other therapies are ongoing. Do not use if known gastric or intestinal lesions are present.
Disposal: expired or otherwise to be discarded device must be managed according to local waste management regulations. Never dispose of the product or its packaging in the environment.

Storage
Keep the intact packaging in a dry place, protected from light or heat sources: only remove and open sachets just before use. Store the device below 25°C.

Format
20 sachets of 13.125 g of powder for oral suspension.