PERGIDAL*OS POW 20SACH 7.3G

Pergidal 7.3 g powder for oral solution
Macrogol 4000

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

This medicinal product is used to treat constipation in adults, the elderly and children over 12 years of age (adolescents).

What you need to know before taking the medicinal product
Do not take Pergidal
• if you are allergic to macrogol 4000 or any of the other ingredients of this medicinal product (listed in section 6);
• if you have sudden (acute) abdominal pain of unknown origin;
• if you have nausea or vomiting;
• if you have a marked increase or decrease in intestinal motility (peristalsis);
• if you have bleeding from the rectum.
In all these cases, the doctor must carry out an adequate assessment (diagnosis) in order to rule out any conditions that make the use of this medicinal product unsuitable, 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 dehydration.

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

In children over 12 years of age (adolescents), the doctor must rule out that constipation is due to specific problems (an organic disorder).

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

Pay particular attention and contact your doctor:
• if you experience allergic reactions during treatment. Very rare cases of hypersensitivity reactions (skin rashes, urticaria, oedema) and exceptionally anaphylactic shock have been reported with macrogol (polyethylene glycol) containing medicines;
• if you constantly suffer 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 condition is not good;
• if you experience persistent diarrhoea;
• if you experience sudden abdominal pain or rectal bleeding while taking Pergidal for bowel preparation.

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

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

Abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhoea 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 you also take medicines for the treatment of cardiac arrhythmias (cardiac glycosides), medicines that increase the elimination of urine (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 should be borne in mind that, in most cases, a balanced diet rich in water and fibre (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, however, 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.

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

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

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

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

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

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

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

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

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

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

Should any of the above side effects occur, consult your doctor and, if necessary, stop taking the medicinal product.
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.