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 3 years of age, defined as refractory constipation with fecal load in the rectum and/or colon.
The efficacy of the device is due to the characteristics of polyethylene glycol (PEG), a high molecular weight polymer, metabolically inert, not degraded by the intestinal bacterial flora; water molecules are retained on the long linear polymer chains by hydrogen bonds, which hydrate the fecal mass, 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
The product can be dissolved in a liquid other than water (tea, milk, broth or fruit juice).
Chronic constipation: unless otherwise prescribed by a doctor, it is advisable to use PEDIAPAX as follows.

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 (or >20 kg)	10-30 g of product per day

The dose can be increased or decreased depending on the individual response to treatment. The most correct daily dosage should be decided based on the child's weight and the severity of the constipation. In any case, it is advisable to consult a doctor. Use the product in pediatric age children only after medical advice.
The maximum necessary 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 a doctor. Based on the dosage indicated above, take the quantity of product using the measuring spoon with notches that allow dosing 2.5 g (first notch) and 5 g (level spoon) of product. Dissolve one level spoonful (equal to 5 g) in 62.5 ml of still water (about ½ glass) or other liquid. The daily dose can be divided into several administrations. 2.2 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. The dosage recommended by ESPGHAN and NASPGHAN guidelines is 1-1.5 g per kg body weight per day.
Therefore, the dosage for the treatment of fecal impaction with PEDIAPAX is as follows:

Weight (kg)	Maximum daily dose recommended
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 divided into 5 g doses (level spoonful) to be dissolved in approximately 62.5 ml of still water (about half a glass) or other liquid, to be consumed entirely within 12 hours. For correct product intake, 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. An indicator of this 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 - 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 a maximum of 24 hours, and then discarded.

Warnings
Gastrointestinal disorders (abdominal pain, borborygmus, 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 for advice.
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 packaging; Do not use if the packaging is damaged; Do not exceed the recommended doses: in case of overdose, severe 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 impaired 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 prevent dehydration. However, it is advisable to consult a doctor. Do not use below 6 months for the treatment of chronic constipation and below 3 years for the treatment of fecal impaction. 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, ileum, 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 during the use of other devices or oral medicinal specialties: the osmotic power of PEG and the increased rate 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 case of known gastric or intestinal lesions.

Storage
Store the intact package in a dry place away from direct light or heat sources.
Store the device below 25°C.
Validity of intact packaging: 36 months.


Format
400 g bottle of powder for oral suspension.