PEDIAPAX POWDER 20 SACHETS 13.125 G

Description
Medical device in powder form 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 the age of 3 years, defined as refractory constipation with fecal loading in the rectum and/or colon.

How to use
Chronic constipation : the usual starting dose in children between 2 and 6 years is half (1/2) sachet per day, in children aged 7 years and over 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 the half 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 for regular, soft stools. If the dose needs to be increased, it is best to do so every 2 days. The maximum required dose does not normally exceed 2 sachets per day. For prolonged treatment, gradually discontinue use and resume if constipation recurs. Do not use the product for more than 30 consecutive days. If symptoms persist, consult your doctor.
PEDIAPAX can also be used on children under 2 years of age, starting from 6 months: for this age group, in order to define the dosage more precisely, the bottle formulation equipped with a measuring spoon is available.
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. A treatment course for fecal impaction with PEDIAPAX should last from 3 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 is a full 13.125 g sachet (two half sachets). The daily number of sachets should be taken divided into 6.563 g doses (1/2 sachet) to be dissolved in 62.5 ml of water (about half a glass), all consumed within 12 hours. The product can be dissolved in a liquid other than water (tea, milk, broth, or fruit juice). The time interval between doses is calculated based on the number of sachets to be taken in 12 hours, therefore:

No. of sachets per day	No. of ½ sachets	1 ½ sachets each
2	4	3 hours
3	6	2 hours
4	8	1 hour and 30 minutes.

For personalized dosage, a dosage of 1-1.5 g/kg/day can be considered (and therefore a half dose of PEDIAPAX can also be used). The indicated treatment regimen should be discontinued once the obstruction has resolved. 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 management program to prevent the onset of new fecal impaction (the dosage to prevent recurrence of fecal impaction is the same as 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 up to 24 hours, then discarded.

Warnings
Keep the device and any resulting solution out of the reach of children; Do not use the device after the expiration date shown on the packaging and sachet; Do not use if the packaging is damaged; Each sachet is for single use only and should be opened only immediately before use: do not reuse partially used sachets or sachets opened at an unknown time, as this could pose a risk of product contamination. Do not exceed the recommended dose; 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.
Known side effects : Gastrointestinal disturbances (abdominal pain, rumbling, diarrhea, or loose stools) may occur, especially during the initial use phase, as well as nausea, mild vomiting, abdominal distension, flatulence, and perianal inflammation and irritation. These effects usually improve by reducing the dose. Allergic reactions, including anaphylaxis, have been observed very rarely. Other symptoms of allergic reactions include itching, hives, and dyspnea. If side effects persist, discontinue treatment and consult your pediatrician.
Contraindications and limitations of use : Do not use in children under 2 years of age for the treatment of chronic constipation and in children under 3 years of age for the treatment of fecal impaction. For use in children under this age group, the use of the bottle with a measuring spoon is recommended. 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 induced increase in gastrointestinal transit speed 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.
Disposal : The expired or otherwise discarded device must be managed in accordance with the waste management regulations of the Local Management Authority. Do not dispose of the product or its packaging in the environment under any circumstances.

Conservation
Store the unopened package in a dry place away from direct light or heat. Remove and open the pouches only immediately before use. Store the device below 25°C.

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