Description
Medical device in powder form for extemporaneous oral suspension useful in:
- treatment of chronic constipation in children from 6 months of age;
- treatment of fecal impaction in children from the age of 3 years, defined as refractory constipation with fecal loading in the rectum and/or colon.
The device's effectiveness is due to the properties of polyethylene glycol (PEG), a high molecular weight, metabolically inert polymer that is not degraded by intestinal bacterial flora. Hydrogen bonds retain water molecules on the long, linear polymer chains, hydrating the fecal mass and stimulating peristalsis. PEDIAPAX is not absorbed in the intestine and is expelled unchanged.

Components
Each bottle contains 400 g of Makropur (purified Macrogol 3350).

Gluten- free and lactose- free.

How to use
It is possible to dissolve the product in a liquid other than water (tea, milk, broth or fruit juice).
Chronic constipation: unless otherwise prescribed by your doctor, it is advisable to use PEDIAPAX according to the following methods.

From 6 months to 2 years (up to 12 kg)	0.8 g of product per kg of body weight per day
From 2 to 11 years (from 12 kg to 20 kg)	1 g of product per kg of body weight per day
Over 11 years old (or >20 kg)	10-30 g of product per day

The dose may be increased or decreased depending on the individual's response to treatment. The most appropriate daily dosage should be determined based on the child's weight and the severity of constipation. In any case, it is advisable to consult a doctor. Use the product in pediatric patients only after consulting a doctor.
The maximum required dose does not normally exceed 30 g of product per day. Do not use the product for more than 30 consecutive days. If symptoms persist, consult your doctor. Based on the dosage indicated above, remove the required amount of product using the measuring cup with markings that allow you to measure 2.5 g (first marking) and 5 g (level measuring cup) of product. Dissolve one level measuring cup (equal to 5 g) in 62.5 ml of still water (approximately ½ glass) or other liquid. The daily dose can be divided into multiple administrations. 2.2 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. The dosage recommended by the ESPGHAN and NASPGHAN guidelines is 1-1.5 g per kg of body weight per day.
Therefore, the dosage for the treatment of fecal impaction with PEDIAPAX is as follows:

Weight (kg)	Maximum daily dose registered mail
14-17 kg	4 teaspoons
18-22 kg	5 teaspoons
23-27 kg	6 teaspoons + half
28-34 kg	8 teaspoons
35-39 kg	9 teaspoons
>40 kg	10 teaspoons + half

The daily dosage should be taken in divided doses of 5 g (level scoop) dissolved in approximately 62.5 ml of still water (about half a glass) or other liquid, to be consumed entirely within 12 hours. For proper administration, we recommend consulting your doctor. Treatment should be discontinued once the obstruction is resolved, but in any case, it should last a maximum of 6 consecutive days. One 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 movement program to prevent the onset of new fecal impaction (the dosage to prevent the recurrence of fecal impaction is that for patients with chronic constipation - Ref. § 2.1). NOTE: It is possible to prepare a larger volume of ready-to-use solution. In this case, the solution can be stored covered in the refrigerator for up to 24 hours, and then discarded.

Warnings
Gastrointestinal disturbances (abdominal pain, rumbling, diarrhea, or loose stools) may occur, especially during the initial phase of use, as well as nausea, mild vomiting, abdominal distension, flatulence, and perianal inflammation and irritation. These effects usually improve with dose reduction. Allergic reactions, including anaphylaxis, have been observed very rarely.
Other symptoms of an allergic reaction, such as itching, hives, and shortness of breath, may occur. If side effects persist, discontinue treatment and consult your pediatrician.
Keep the device and any resulting solution out of the reach of children; Do not use the device after the expiration date printed on the package; Do not use if the package is damaged; Do not exceed the recommended dose: an overdose may cause severe pain and abdominal distension. Induced diarrhea may also occur, with electrolyte disturbances caused by excessive bowel movements. If you suspect an overdose, contact your pediatrician immediately. When PEDIAPAX is used in high doses to treat fecal impaction, it should be administered with caution to patients with impaired swallowing reflex, reflux esophagitis, or reduced levels of consciousness. If you forget to take a dose, DO NOT TAKE A DOUBLE DOSE to catch up. During treatment with PEDIAPAX, it is advisable to follow an appropriate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration. However, it is advisable to consult your doctor. Do not use in children under 6 months of age for the treatment of chronic constipation or in children under 3 years of age for the treatment of fecal impaction. Use of the device is not recommended in cases of: intestinal perforation or 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 devices or oral medicinal products: the osmotic power of PEG and the increased gastrointestinal transit speed it induced may negatively affect their efficacy. In any case, consult your doctor before taking PEDIAPAX if you are currently undergoing other therapies. Do not use if you have known gastric or intestinal lesions.

Conservation
Store the intact package in a dry place, away from direct light or heat.
Store the device below 25°C.
Shelf life when packaging is intact: 36 months.


Format
400 g bottle of powder for oral suspension.