PERGIDAL*BB OS POWDER 20 SACHETS 3.6G

Pergidal children 3.6 g powder for oral solution
Macrogol 4000

What it is and what it is used for
The active ingredient of Pergidal is macrogol 4000, a substance that facilitates bowel movements by drawing water into the intestinal lumen (osmotic laxative).

This medicine is used in the treatment of constipation in children from 6 months to 12 years of age.

What you need to know before taking the medicine
Do not give Pergidal to your child
• if they are allergic to macrogol 4000 or any of the other ingredients of this medicine (listed in paragraph 6);
• if they have sudden (acute) abdominal pain of unknown origin;
• if they have nausea or vomiting;
• if they have a marked increase or decrease in intestinal motility (peristalsis);
• if they have rectal bleeding.
In all these cases, the doctor must carry out an adequate assessment (diagnosis) to exclude one of the conditions that make the use of this medicine inappropriate, for example:
- severe inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease);
- abnormal colon size (toxic megacolon) associated with narrowing of the intestinal lumen with evident complications;
- intestinal perforation or risk of perforation;
- intestinal obstruction without an evident cause (paralytic ileus), blockage (obstruction) or narrowing (stenosis) of the intestine;
- severe dehydration.

Warnings and precautions
Talk to your doctor or pharmacist before giving Pergidal to your child.

The doctor must rule out that the constipation is due to specific problems (an organic disorder).

The treatment of constipation with any medicine is only a support to a healthy lifestyle and a correct diet, for example: a diet rich in liquids and fiber, appropriate physical activity and the restoration of intestinal reflexes.

Pay particular attention and contact your doctor:
• if your child experiences allergic reactions during treatment. Very rare cases of hypersensitivity reaction (skin rashes, urticaria, edema) and exceptionally anaphylactic shock have been reported with medicines containing macrogol (polyethylene glycol);
• if your child constantly suffers from constipation. Continuous treatment of constipation always requires the intervention of a doctor for diagnosis, prescription of medicines and monitoring during therapy;
• if the use of this medicine results from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks;
• if the use of the laxative fails to produce effects;
• if you are an elderly patient and/or your general health conditions are not good;
• if your child experiences persistent diarrhea;
• if your child experiences sudden abdominal pain or rectal bleeding while taking Pergidal for bowel preparation.

In case of diarrhea, if there is a predisposition to alterations in water-salt balance, for example in elderly patients, if liver or kidney function is impaired or if medicines that increase urine elimination (diuretics) are taken, the doctor will evaluate whether to consider checking blood minerals.

Contact your doctor after three months of treatment for a complete clinical review of your child.

The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with excessive loss of water, mineral salts (especially potassium) and other essential nutrients. In the most severe cases, imbalances can occur that can cause heart problems or problems with the transmission of signals from the brain to the muscles (neuromuscular). These phenomena can occur especially if your child also takes medicines for the treatment of cardiac arrhythmias (cardiac glycosides), medicines that increase urine elimination (diuretics) or anti-inflammatory medicines (corticosteroids).

Excessive use of laxatives, especially those that increase intestinal contractions (contact laxatives, different from Pergidal), can cause dependence (therefore the need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).

Pergidal does not contain significant amounts of sugars or polyols and can be prescribed to diabetic patients or patients on a galactose-free diet.

Health education notes
First of all, it must be borne in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit) can permanently solve the problem of constipation.
Many people think they suffer from constipation if they cannot have a bowel movement every day.
This is a mistaken belief, as this situation is completely normal for a large number of individuals.
Consider, instead, that constipation occurs when bowel movements are reduced compared to one's personal habits and are associated with the emission of hard stools.
Contact your doctor if episodes of constipation occur repeatedly.

Children under 2 years of age
Data on the efficacy of this medicine in children under 2 years of age are limited.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

• Side effects in children:
Common (may affect up to 1 in 10 patients):
- abdominal pain;
- diarrhea (which may cause perianal irritation).

Uncommon (may affect up to 1 in 100 patients):
- vomiting;
- gas in the abdomen (flatulence);
- nausea.

Rare (may affect up to 1 in 1,000 patients):
- severe diarrhea.

Frequency not known (frequency cannot be estimated from the available data):
- hypersensitivity reactions, which may manifest as itching, skin rashes, hives or localized swelling, especially of the face or hands, swelling or tingling of the lips or throat (edema);
- difficulty breathing.

• Side effects in adults:
Common (may affect up to 1 in 10 patients);
- abdominal pain and/or abdominal bloating;
- diarrhea;
- nausea.

Uncommon (may affect up to 1 in 100 patients):
- vomiting;
- urgency to defecate;
- fecal incontinence;
- anal irritation.

Rare (may affect up to 1 in 1,000 patients):
- severe diarrhea.

Very rare (may affect up to 1 in 10,000 patients):
- hypersensitivity reactions, which may manifest as itching, skin rashes, hives or localized swelling, especially of the face or hands, swelling or tingling of the lips or throat (edema);
- Quincke's edema, a condition characterized by the rapid onset of extensive swelling of the face, hands, feet, genital organs, or even mucous membranes;
- difficulty breathing, anaphylactic shock.

Frequency not known (frequency cannot be estimated from the available data):
- sodium deficiency (hyponatremia);
- potassium deficiency (hypokalemia);
- dehydration, especially in elderly patients.

If you experience any of the side effects listed above, consult your doctor and, if necessary, discontinue the medicine.
Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.