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

How to use
Chronic constipation: the usual initial dose for children between 2 and 6 years of age is half (1/2) sachet per day, for children 7 years of age and older it is one (1) sachet per day, dissolved:
- In 125 ml of still water (approx. 1 glass) for the whole sachet.
- In 62.5 ml of still water (approx. ½ glass) for half a 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 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 if constipation reappears. Do not use the product for more than 30 consecutive days; if symptoms persist, consult your doctor.
PEDIAPAX can also be used for children under 2 years of age, starting from 6 months: for this age group, for a more precise definition of the dosage, the bottle formulation with a measuring spoon is available.
Fecal impaction: the diagnosis of fecal impaction/fecal load in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. A course 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 means the whole sachet of 13.125 g (2 half sachets). The daily number of sachets should 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. It is possible to dissolve the product in a liquid other than water (tea, milk, broth or fruit juice). The time interval between one intake and another is calculated based on the number of sachets to be taken within 12 hours, so:

No. 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 dosing, a dosage of 1-1.5 g/Kg/day can be considered (and therefore also use the half dose of PEDIAPAX). The indicated treatment regimen should be interrupted 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 follow an appropriate bowel treatment program to prevent the recurrence of 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 such use could lead to risks of product contamination. Do not exceed the recommended doses: in case of overdose, intense pain and abdominal distension may occur. Diarrhea may also occur, with electrolyte disturbances caused by excessive evacuation. In case of suspected overdose, contact your pediatrician immediately. When PEDIAPAX is used in high doses to treat fecal impaction, it should be administered with caution in patients with altered swallowing reflex, reflux esophagitis or reduced levels of consciousness. If you forget to take a dose, 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; it is always advisable to consult your doctor.
Known side effects: gastrointestinal disturbances (abdominal pain, borborygmi, diarrhea or fecal leakage) may occur, especially in the initial phase of use, as well as mild nausea, vomiting, abdominal distension, flatulence, perianal inflammation and irritation, effects that normally improve by reducing the dose. Allergic reactions, including anaphylaxis, have been observed very rarely. 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 for children under 2 years of age for the treatment of chronic constipation and under 3 years of age for the treatment of fecal impaction. For use below this age group, the bottle with a measuring spoon is recommended. The use of the device is not recommended in case of: perforation or intestinal obstruction due to structural or functional disorders of the intestinal wall, ileus, severe inflammatory diseases of the intestinal tract, 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 increase in gastrointestinal transit speed 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 case of known gastric or intestinal lesions.
Disposal: the expired device or any device to be disposed of must be managed according to the waste management regulations of the Local Management Body. Do not under any circumstances disperse the product or its packaging into the environment.

Storage
Store the intact package in a dry place away from direct light or 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.