PEDIAPAX POWDER 20BAGS

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

How to use
Chronic constipation: the usual initial dose in children between 2 and 6 years is half (1/2) sachet per day, in children from 7 years onwards one (1) sachet per day, dissolved:
- In 125 ml of still water (about 1 glass) for the whole sachet.
- In 62.5 ml of still water (about 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 an increase in dose is necessary, it is better to do so every 2 days. The maximum necessary dose does not normally exceed 2 sachets per day. In the case of prolonged treatment, proceed with gradual discontinuation and a resumption of the same in case of recurrence of constipation. 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, in order to obtain a more precise definition of the dosage, the bottle formulation with measuring spoon is available.
Fecaloma: the diagnosis of fecaloma/fecal load in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. A treatment cycle for fecaloma with PEDIAPAX should last from 3 up to a maximum of 6 consecutive days, as follows:

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 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 over 12 hours. It is possible to dissolve the product in a liquid other than water (tea, milk, broth or fruit juice). The interval between one dose and the next is calculated based on the number of sachets to be taken in 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 a 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 scheme should be interrupted once the occlusion has been resolved. An indicator of such resolution is the passage of a large quantity of feces. After resolution, it is recommended to follow up with the child with an appropriate treatment program for the intestine, to prevent the onset of a new fecaloma (the dosage to prevent the recurrence of fecaloma 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 prepared solution out of reach of children; Do not use the device after the expiry date marked 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 pose a risk of contamination of the product. Do not exceed the recommended doses: in case of overdose, intense pain and abdominal distension may occur. Diarrhea induced 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 fecaloma, it must be administered with caution in patients with altered 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 appropriate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration; it is still advisable to consult the doctor.
Known side effects: gastrointestinal disturbances (abdominal pain, borborygmi, diarrhea or stool loss) may appear especially in the initial phase of use, as well as mild nausea, vomiting, abdominal distension, flatulence, inflammation and perianal irritation, effects that normally improve by reducing the dose. Very rarely allergic reactions, including anaphylaxis, have been observed. Other symptoms of allergic reactions such as itching, hives, and shortness of breath. If side effects persist, discontinue treatment and consult your pediatrician for advice.
Contraindications and limitations of use: do not use under 2 years for the treatment of chronic constipation and under 3 for the treatment of fecaloma. For use below this age group, the use of the bottle with 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, 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 while using 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 in the presence of any other ongoing therapies. Do not use in case 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 Body. Do not dispose of the product or its packaging in the environment under any circumstances.

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

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