Descriptive sheet PediaPEG
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Description
Class IIa Medical Device (Directive 93/42/EEC).
It has a laxative effect that, through osmotic action, naturally regulates the intestines. It is neither absorbed nor fermented in the intestine, does not irritate the mucosa, and is eliminated unchanged in the stool.
PediaPEG is particularly indicated for chronic constipation and occasionally irregular bowel movements. Thanks to its affinity for water, PediaPEG softens stool, facilitating evacuation without causing cramps, abdominal pain, or urgency. Its effectiveness does not diminish over time.
Gluten and lactose free.
How to use
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 12 kg to 20 kg): 1 g of product per kg of body weight per day.
Over 11 years (or >20 kg): 10-30 g of product per day.
The dose may be increased or decreased depending on the individual's response to treatment. The most appropriate daily dosage for each age group should be determined based on the child's weight and the severity of constipation. In any case, it is advisable to consult a doctor for the most appropriate dosage. Use the product in pediatric children only after consulting a doctor. The maximum necessary dose does not normally exceed 30 g of product per day.
Based on the dosage, use the measuring cup with markings to measure 0.5 g (first mark), 1 g (second mark), and 2 g (level measuring spoon). Dissolve one level measuring spoon (equal to 2 g) in approximately 1/4 glass of water (about 25 ml). Drink the reconstituted solution. The daily dose can be divided into multiple administrations. The product can be reconstituted in advance in the appropriate volume of water and the solution stored in the refrigerator, covered, for up to 24 hours. It is recommended to take PediaPEG between meals.
Components
400 g of Macrogol 3350; excipients: silicon dioxide, flavouring, sodium saccharin.
Warnings
Do not take PediaPEG if you have intestinal stenosis, intestinal perforation, or inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). Do not take if you have intestinal obstruction.
The oral suspension must be prepared at the time of use. It is recommended not to take larger quantities than indicated, as higher doses may cause unexpected side effects. Do not use the product for more than 30 days. If symptoms persist, consult your doctor. Do not take if you are intolerant to the product. Do not take if you have a known hypersensitivity to the components or to polyethylene glycol. Do not use in children under 6 months. During treatment with PediaPEG, it is advisable to follow a suitable diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration. However, it is advisable to consult your doctor.
Overdose may cause severe pain, abdominal distension, diarrhea, and vomiting, which may result in electrolyte imbalance. If you experience any adverse reactions, contact your doctor immediately.
Gastrointestinal disturbances, rumbling, abdominal pain, nausea, and mild diarrhea (especially at first) may occur. Hypersensitivity and allergic reactions (skin rash, hives) may occur rarely. Consult your doctor or pharmacist if you experience any adverse reactions, even those other than those listed. If you forget to take a dose, do not take a double dose; instead, wait and take the next dose.
Keep out of reach of children. Do not use the device after the expiration date indicated on the packaging. Do not use if the packaging is damaged.
Conservation
Store in a cool, dry place, at a temperature not exceeding 25°C.
Shelf life in intact packaging: 36 months.
Validity after first opening: 1 month.
Format
400g jar.