Pediapax
Single-use class IIa medical device CE0426. For the treatment of constipation and faecal impaction in children, based on pure Macrogol 3350, electrolyte-free and flavour-free, in divisible sachets of 13.125 g of powder for oral suspension.
Treatment of chronic constipation in children over 2 years of age weighing more than 10 kg.
Treatment of faecal impaction in children from 3 years of age, defined as refractory constipation with faecal loading of the rectum and/or colon.
Ingredients Each sachet contains: pure macrogol 3350.
Directions for use Chronic constipation:
2-6 years - half dose 6.563 g to be dissolved in half a glass of water.
from 7 years - full dose 1 sachet of 13.125 g to be dissolved in a glass of water.
Treatment of faecal impaction from 3 years of age:
One course of treatment of faecal impaction with pediapax for up to 7 days:
| daily dosing schedule |
| Day | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
| Number of sachets | 2 | 3 | 4 | 5 | 6 | 6 | 6 |
A sachet means the whole 13.125 g sachet (2 half-sachets). The daily number of sachets must be taken divided into doses of 6.563 g (½ sachet) dissolved in 62.5 ml of water (about half a glass), all taken within 12 hours.
The interval between one dose and the next is calculated according to the number of sachets to be taken in the 12 hours, as follows:
| Number of sachets | Number of half-sachets | one half-sachet every |
| 2 | 4 | 3 hours |
| 3 | 6 | 2 hours |
| 4 | 8 | 1 hour 30 min. |
| 5 | 10 | 1 hour 15 min. (approx.) |
| 6 | 12 | 1 hour |
Note: a larger volume of ready-to-use solution can be prepared, 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.
Side effects Gastrointestinal disturbances may occur, especially at the start of use (abdominal pain, borborygmi, diarrhoea or faecal leakage), as well as nausea, mild vomiting, abdominal distension, flatulence, perineal inflammation and irritation; these effects normally improve on reducing the dose. Allergic reactions, including anaphylaxis, have been observed very rarely. Other symptoms of allergic reaction include itching, urticaria and dyspnoea. If side effects persist, stop treatment and consult your paediatrician.
Storage Store the intact pack in a dry place away from direct light or heat sources: remove and open the sachets only just before use. Store the device below 25 °C.
Warnings and precautions Keep the device and any prepared solution out of the reach of children. Do not use after the expiry date shown on the pack and on the sachet. Do not use if the pack is damaged. Each sachet is single-use and must be opened only immediately before use: do not use partially used sachets or sachets opened at an unknown time, as this could entail a risk of product contamination. Never exceed the recommended doses: in case of overdose, intense pain and abdominal distension may occur, as well as induced diarrhoea with electrolyte disturbances caused by excessive evacuation. If overdose is suspected, contact your paediatrician immediately. When the product is used at high doses to treat faecal impaction, it must be administered with caution in patients with an impaired swallowing reflex, reflux oesophagitis or reduced levels of consciousness. If you forget to take a dose, do not take a double dose to make up for it.
Contraindications and limitations of use Do not use under 2 years of age for the treatment of chronic constipation and under 3 years of age for the treatment of faecal impaction. Use of the device is not recommended in case 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 oral devices or medicinal products: the osmotic power of PEG and the induced increase in gastrointestinal transit speed may adversely affect their efficacy. In any case, consult your doctor before taking Pediapax if you are undergoing other treatments. Do not use in the presence of known gastric or intestinal lesions.
Pack size Pack of 20 divisible sachets of 13.125 g.
