Name
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 the evacuation of feces by drawing water into the intestinal lumen (osmotic laxative).

This medicine is used to treat constipation in children aged 6 months to 12 years.


What you need to know before taking the medicine
Do not give Pergidal to your child
• if you are allergic to macrogol 4000 or any of the other ingredients of this medicine (listed in section 6);
• if you have sudden (sharp) abdominal pain of unknown origin;
• if you have nausea or vomiting;
• if you have a marked increase or reduction in intestinal motility (peristalsis);
• if you have bleeding from the rectum.
In all these cases, it is necessary for the doctor to carry out an adequate evaluation (diagnosis) in order 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 size of the colon (toxic megacolon) associated with narrowing of the intestinal lumen with obvious complications;
- perforation or risk of intestinal perforation;
- intestinal obstruction without an obvious cause (paralytic ileus), blockage (obstruction) or narrowing (stenosis) of the intestine;
- severe state of dehydration.


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

The doctor must exclude that the constipation is caused by specific problems (an organic disorder).

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

Take special care and consult your doctor:
• if your child experiences allergic reactions during treatment. Very rare cases of hypersensitivity reactions (skin rash, urticaria, oedema) and exceptionally anaphylactic shock have been reported with medicines containing macrogol (polyethylene glycol);
• if your child suffers from constant 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 is due to a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts for more than two weeks;
• if the use of the laxative fails to produce effects;
• if he is an elderly patient and/or his general health conditions are not good;
• if your child experiences persistent diarrhoea;
• if your child develops sudden abdominal pain or rectal bleeding while taking Pergidal for bowel preparation.

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

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

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

Excessive use of laxatives, especially those that increase intestinal contractions (contact laxatives, other than Pergidal), can cause dependence (hence the need to gradually 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 in diabetic patients or in patients on a galactose-free diet.

Health education notes
First of all, it must be kept 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 are constipated if they are unable to have a bowel movement every day.
This is a misconception 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 old
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 everybody gets them.

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

Uncommon (may affect up to 1 in 100 people):
- vomit;
- wind in the stomach (flatulence);
- nausea.

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

Frequency not known (frequency cannot be estimated from the available data):
- hypersensitivity reactions, which may manifest themselves with 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 people);
- abdominal pain and/or abdominal swelling;
- diarrhea;
- nausea.

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

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

Very rare (may affect up to 1 in 10,000 people):
- 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 appearance of swellings extending to the face, hands, feet, genitals, or even the 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 the side effects listed above occur, consult your doctor and, if necessary, stop taking 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.