Pediapax Powder Against Constipation Children 400 g

Pedia _pax

MACROGOL 3350
pure, without electrolytes, without flavorings, without excipients

Gluten free

Useful for the treatment of constipation
and of fecal impaction in the pediatric age

For a more targeted management of the dosage
Ideal in the initial and final phase of the therapy of chronic constipation

Dosage recommended by the Guidelines
ESPGHAN / NASPGHAN 2014: 0.2-0.8 g / kg day

One teaspoon = 5 g of macrogol to dissolve
in half a glass of still water

• The dose can be increased or decreased
based on individual response.

1. IDENTIFICATION, COMPOSITION AND PURPOSE OF USE OF THE product
1.1 Description and indications for use
Pediapax is a powdered product 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, defined as refractory constipation with fecal load in the rectum and / or colon.
1.2 Composition
Each bottle contains 400 g of Macrogol 3350. The Pediapax product does not contain gluten .
1.3 Validity
36 months.
1.4 Mechanism of action
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 polymeric chains, by means of hydrogen bonds, the water molecules are retained, which hydrate the fecal mass by stimulating peristalsis. Pediapax is not absorbed from the intestine and is excreted unchanged.

2. METHOD OF USE
2.1 Chronic constipation
Unless otherwise prescribed by a doctor, it is advisable to use Pediapax in the following ways.

Weight kg)	Maximum daily dose registered mail
10-12 kg	2 tsp
13-20 kg	2 ½ tsp
21-25 kg	3 tsp
26-30 kg	4 tsp
> 30 kg	5 tsp

The dose can be increased or decreased depending on the individual response to treatment. The most correct daily dosage is to be decided on the basis of the weight of the child and the severity of constipation.
In any case, it is advisable to consult a doctor.
Use the product in pediatric children only after medical advice.
The maximum dose needed does not normally exceed 30 g of product per day.
Based on the dosage indicated above, take the quantity of product with the aid of the measuring cup with notches that allow you to dose 2.5 g (first notch) and 5 g (level measuring cup) of product.
Dissolve a level measuring spoon (equal to 5 g) in 62.5 ml of still water (about ½ glass).
It is possible to divide the daily dose into several administrations.
2.2 Fecaloma
The diagnosis of fecal impaction / fecal load in the rectum should 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 bodyweight per day.
Therefore, the posology for the treatment of fecaloma with Pediapax is as follows:

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

The daily dosage must be taken divided into doses of 5 g (level measuring cup) to be dissolved in about 62.5 ml of water (about half a glass) to be consumed entirely within 12 hours, for a correct intake of the product we recommend that you contact to the attending physician. The treatment must be stopped once the occlusion is resolved, but in any case it must 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 onset of a new fecal impaction (the dosage to prevent fecal impaction recurrence 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 kept covered in the refrigerator for up to 24 hours, and then discarded.

3. KNOWN SIDE EFFECTS
Gastro-intestinal disturbances (abdominal pain, borborygma, diarrhea or loose stools), as well as nausea, mild vomiting, abdominal distension, flatulence, inflammation and perianal irritation may appear especially in the initial phase of use, effects which normally improve by reducing the dose. Allergic reactions, including anaphylaxis, have been observed very rarely. Other symptoms of allergic reactions such as itching, hives and wheezing. If the side effects persist, suspend the treatment and contact your pediatrician for a consultation.

4. METHOD OF STORAGE
Store the unopened package in a dry place away from direct light or heat sources. Store the device below 25 ° C.

5. WARNINGS AND PRECAUTIONS
Keep the device and any solution obtained out of the reach of children.
Do not use the device after the expiry date stated on the package.
Do not use in case of damaged packaging.
Absolutely do not exceed the recommended doses: in case of overdose, intense pains, abdominal distension may occur.
Induced diarrhea can also occur, with electrolyte disturbances caused by possible excessive evacuation.
If overdose is suspected, contact your pediatrician immediately.
When Pediapax is used in high dosages to treat fecal impaction, it should be administered with caution to patients with impaired swallowing reflex, reflux esophagitis or reduced levels of consciousness. In case 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 adequate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration, it is however advisable to consult your doctor.

6. CONTRAINDICATIONS AND LIMITATIONS OF USE
Do not use under 2 years for the treatment of chronic constipation and under 3 years for the treatment of fecal impaction. The use of the device is not recommended in case of: intestinal perforation or 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 product while using other devices or oral medicinal specialties: the osmotic power of the PEG and the induced increase in gastrointestinal transit speed can 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.

7. INTERACTIONS WITH DRUGS AND FOOD SUPPLEMENTS
To date there are no known interactions with drugs but it is advisable that the intake of the product is spaced at least 2 hours from that of drugs administered orally since the osmotic power of the macrogol and the increase in the gastrointestinal transit speed induced can negatively affect on their effectiveness. However, consult your doctor before taking Pediapax in case of other therapies in progress.

8. DISPOSAL
The expired device or in any case to be eliminated must be managed in accordance with the waste management regulations of the Local Managing Authority. Never dispose of the product or its packaging in the environment.

Format
400 g bottle with 5 g measuring spoon with half dose notch.