Description
Medical device in powder form for extemporaneous oral suspension useful in:
- Treatment of chronic constipation in children older than 2 years and weighing 10 kg or more.
- Treatment of fecal impaction in children aged 3 years and above, defined as refractory constipation with fecal loading in the rectum and/or colon.

Instructions for use
Chronic constipation: the usual initial dose for children aged 2 to 6 years is half (1/2) a sachet per day, for children aged 7 years and above, one (1) sachet per day, dissolved:
- In 125 ml of still water (approx. 1 glass) for the full sachet.
- In 62.5 ml of still water (approx. ½ glass) for half a sachet.
The product can be dissolved in a liquid other than water (tea, milk, broth or fruit juice).
The dose can be increased or decreased to allow for regular bowel movements of soft stools. If it is necessary to increase the dose, it is best to do so every 2 days. The maximum necessary dose normally does not exceed 2 sachets per day. In the case of prolonged treatment, proceed with gradual discontinuation and resumption of treatment 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 of age, starting from 6 months: for this age group, for a more precise dosage definition, the bottle formulation with a measuring spoon is available.
Fecal impaction: the diagnosis of fecal impaction/fecal loading in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. A cycle of treatment for fecal impaction with PEDIAPAX should last from 3 to a maximum of 6 consecutive days, in the following manner:

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

A sachet refers to the full 13.125 g sachet (2 half sachets). The daily number of sachets must be taken divided into doses of 6.563 g (1/2 sachet) to be dissolved in 62.5 ml of water (about half a glass), all consumed within 12 hours. The product can be dissolved in a liquid other than water (tea, milk, broth or fruit juice). The interval between one intake and the next is calculated based on the number of sachets to be taken within 12 hours, so:

No. of sachets per day	No. of ½ sachets	1 ½ sachet every
2	4	3 hours
3	6	2 hours
4	8	1 hour and 30 min.

For personalized dosage, a dosage of 1-1.5 g/Kg/day can be considered (and therefore also use half the dose of PEDIAPAX). The indicated treatment regimen should be discontinued once the obstruction has resolved. An indicator of such resolution is the passage of a large amount of stool. After resolution, it is recommended that the child follows an appropriate bowel treatment program to prevent the onset of a new fecal impaction (the dosage to prevent recurrence of fecal impaction is that for patients with chronic constipation).
Note: it is possible to prepare a larger volume of ready-to-use solution, for example by 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, and then discarded.

Warnings
Keep the device and any solution obtained out of the reach of children; Do not use the device after the expiry date shown on the package and on the sachet; Do not use if the package is damaged; Each sachet is for single use and must be opened only immediately before use: do not reuse partially used or opened sachets at unknown times, as this method of use could lead to risks of product contamination. Absolutely do not exceed the recommended doses: in case of overdose, severe pain and abdominal distension may occur. Diarrhea may also occur, with electrolytic disturbances caused by excessive evacuation. In case of suspected overdose, contact your pediatrician immediately. When PEDIAPAX is used in high dosages to treat fecal impaction, it must be administered with caution in patients with impaired swallowing reflex, reflux esophagitis or reduced levels of consciousness. If a dose is forgotten, do not take a double dose to make up for it. During treatment with PEDIAPAX, it is advisable to follow an adequate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration; however, it is advisable to consult a doctor.
Known side effects: gastrointestinal disorders (abdominal pain, borborygmi, diarrhea or fecal leakage) may appear, especially during the initial phase of use, in addition to nausea, mild vomiting, abdominal distension, flatulence, perianal inflammation and irritation, effects that normally improve by reducing the dose. Allergic reactions, including anaphylaxis, have been very rarely observed. Other symptoms of allergic reactions include itching, urticaria and dyspnea. If side effects persist, discontinue treatment and consult your pediatrician.
Contraindications and limitations of use: do not use below 2 years of age for the treatment of chronic constipation and below 3 years of age for the treatment of fecal impaction. For use below this age range, the bottle with measuring spoon is recommended. The use of the device is not recommended in cases of: perforation or intestinal 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 while using other oral devices or medicinal specialties: the osmotic power of PEG and the increased speed of gastrointestinal transit induced can negatively affect their effectiveness. In any case, consult your doctor before taking PEDIAPAX if you are undergoing other therapies. Do not use in the presence of known gastric or intestinal lesions.
Disposal: the expired or otherwise to be disposed of device must be managed according to the waste management regulations of the Local Managing Authority. In no case should the product or its packaging be dispersed into the environment.

Storage
Store the intact package in a dry place away from light or direct heat sources: extract and open the sachets only just before use. Store the device below 25°C.

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