PEDIAPAX POWDER 400 G

Description
Medical device in powder form for extemporaneous oral suspension useful in:
- treatment of chronic constipation in children aged 6 months and over;
- 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 effectiveness 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; on the long linear polymer chains, through hydrogen bonds, water molecules are retained, which hydrate the fecal mass by stimulating peristalsis. PEDIAPAX is not absorbed at the intestinal level and is expelled in an unchanged form.

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 12kg to 20kg)	1 g of product per kg of body weight per day
Above 11 years old (or >20 kg)	10-30 g of product per day

The dose may be increased or decreased depending on the individual response to treatment. The most appropriate daily dosage is to be decided based on the child's weight and the severity of constipation. In any case, it is advisable to seek the advice of a doctor. Use the product in children of pediatric age only after medical advice.
The maximum dose required 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, take the quantity of product using the measuring cup with notches that allow you to dose 2.5 g (first notch) and 5 g (level measuring cup) of product. Dissolve one level measuring cup (equal to 5 g) in 62.5 ml of still water (about ½ glass) or other liquid. It is possible to divide the daily dose into several administrations. 2.2 Fecaloma The diagnosis of fecaloma/fecal load 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 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 must be taken divided into doses of 5 g (level scoop) 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 intake of the product we recommend consulting your doctor. Treatment must be interrupted once the obstruction is resolved, but in any case it must last a maximum of 6 consecutive days. An indicator of such resolution is the passage of a large quantity of feces. After resolution, it is recommended that the child follow an appropriate treatment program for the intestine, to prevent the onset of a 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 a maximum of 24 hours, and then discarded.

Warnings
Gastrointestinal disturbances (abdominal pain, rumbling, diarrhea or loose stools) may appear especially in the initial phase of use, in addition to nausea, mild vomiting, abdominal distension, flatulence, inflammation and perianal irritation, effects that usually improve by reducing the dose. Allergic reactions, including anaphylaxis, have been observed very rarely.
Other symptoms of allergic reaction such as itching, hives and dyspnea. If side effects persist, stop treatment and contact 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 package; Do not use if the package is damaged; Do not exceed the recommended doses: in case of overdose, severe pain and abdominal distension may occur. Induced diarrhea may also occur, with electrolyte disturbances caused by possible 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 an altered 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 under 6 months for the treatment of chronic constipation and under 3 years for the treatment of fecal impaction. Taking the device is not recommended in case of: intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileum, serious 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 increase in gastrointestinal transit speed induced may negatively affect their effectiveness. In any case, consult your doctor before taking PEDIAPAX in case of other therapies in progress. Do not use in case of known gastric or intestinal lesions.

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


Format
400 g bottle of powder for oral suspension.