Pergidal Children 3.6g Powder For Oral Solution 20 Sachets

Therapeutic indications

Treatment of constipation.

Dosage

The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Pergidal 7.3 g powder for oral solution is indicated in adults, the elderly and children over 12 years of age (adolescents), for whom the following dosage is recommended: 1-3 sachets per day. Pergidal Children 3.6 g powder for oral solution is indicated in children from the age of 6 months to 12 years:

Age	N ° sachets / day	Macrogol quantity
6 months - 1 year	1 sachet	3,644 g
14 years	1-2 sachets	3,644 g - 7,288 g
4 - 8 years	2-3 sachets	7,288 g - 10,932 g
8 - 12 years	3-4 sachets	10,932 g - 14,576 g

Take in the morning between meals. Sometimes it can take two days (or more) for the desired effect to be achieved. In relation to the response obtained in the individual patient, the doctor will modulate the dosage (within the authorized posology) and will establish the duration and methods of suspension of the treatment. Dissolve the powder for adults and children over 12 years of age in about 250 ml (more or less the content of two glasses or a cup) of water, and for children from 6 months to 12 years, depending on age, in 50-100 ml (more or less the content of 1 / 2-1 glass) of water. Do not add any other ingredients. It is best to drink the entire amount fairly quickly (within a few minutes) and avoid sipping it for a long time. A diet rich in liquids favors the effect of the medicine.

Overdose

Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced. See also the information in the paragraph “Special warnings and precautions for use” regarding the abuse of laxatives.

Contraindications

Hypersensitivity to the active substances or to any of the excipients. Laxatives should not be used by people with acute abdominal pain or of unknown origin, nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding. The presence of one or more of these symptoms or signs requires an adequate diagnostic investigation by the doctor in order to exclude one of the pathological conditions that contraindicate the use of laxatives (for example: intestinal obstruction, stenosis or perforation, paralytic ileus, severe inflammatory bowel diseases). Severe state of dehydration.

Side effects

Undesirable effects listed by frequency are reported, using the following convention: very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000), frequency not known (cannot be estimated from the available data). Gastrointestinal disorders Common: abdominal distension, nausea. Uncommon: abdominal pain, anal irritation, vomiting. Rare: severe diarrhea. Immune system disorders Very rare: hypersensitivity reactions. They can occur with: itching, rash, hives or edema (swelling, especially in the face or hands; swelling or itching of the lips or throat), difficulty in breathing. In such cases, stop taking the medicine and consult a doctor immediately.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the drug in pregnancy or breastfeeding. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.

Special warnings

Warnings The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In severe cases, the onset of dehydration or hypokalemia is possible, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Sunset yellow FCF (E 110) can cause allergic reactions. Precautions for use The treatment of chronic or recurrent constipation always requires the intervention of the physician for diagnosis, prescription of drugs and surveillance during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks or when the use of the laxative fails to produce effects. It is also advisable for elderly people or those in poor health to consult their doctor before using a laxative.

Expiry and Retention

Pergidal 7.3 g powder for oral solution No special storage conditions. Pergidal children 3.6 g powder for oral solution No special storage conditions.

Active principles

Pergidal 7.3 g powder for oral solution One sachet contains: Active ingredient: Macrogol 4000 7.287 g Pergidal children 3.6 g powder for oral solution One sachet contains: Active ingredient: macrogol 4000 3.644 g Excipients Sunset yellow color FCF (E110) For the full list of excipients, see section 6.1

Excipients

Pergidal 7.3 g powder for oral solution: • anhydrous sodium sulphate, • sodium bicarbonate, • sodium chloride, • potassium chloride, • simethicone, • acesulfame potassium, • mandarin flavor (dextrose, maltodextrin, gum arabic), • sunset yellow dye FCF (E110). Pergidal children 3.6 g powder for oral solution: • simethicone, • acesulfame potassium, • mandarin flavor (dextrose, maltodextrin, gum arabic), • sunset yellow FCF dye (E110).