LAXIPEG*ORAL POWDER FL 200G 97%

Laxipeg 97% powder for oral solution
Macrogol 4000

What it is and what it is used for
Laxipeg contains the active ingredient macrogol 4000, belonging to a group of medicines called osmotic laxatives that retain water in the intestine.

This medicine is indicated for the treatment of constipation in children.

Consult your doctor if you do not feel better or if you feel worse.

What you need to know before taking the medicine
Do not take Laxipeg:
- if you are allergic to macrogol 4000 or any of the other ingredients of this medicine (listed in section 6);
- if you experience acute abdominal pain of unknown origin, nausea, or vomiting;
- if you experience an increase or decrease in bowel movements (peristalsis) or rectal bleeding;
- if you suffer from an intestinal blockage (intestinal obstruction, symptomatic stenosis, paralytic ileus);
- if you suffer from or are at risk of a perforation of the digestive tract;
- if you suffer from a severe inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic megacolon;
- if you are severely dehydrated.

Warnings and precautions
Consult your doctor or pharmacist before taking Laxipeg.

The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of medicines, and monitoring during therapy.
Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks, or when the use of a laxative fails to produce effects.

Children
Data on the effectiveness of treatment in children under 2 years of age are limited.

The treatment of constipation with any medicine is only an adjunct to a healthy lifestyle and proper nutrition, for example:
• increased intake of fluids and vegetable fiber;
• appropriate physical activity and restoration of intestinal motility.

Before starting treatment, any organic disorder must be excluded. At the end of three months of treatment, a complete clinical evaluation of constipation should be performed.

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 nutrients.
In the most severe cases, dehydration or potassium deficiency (hypokalemia) may occur, which can lead to cardiac or neuromuscular disorders, especially if heart medications (cardiac glycosides), medications that increase urine production (diuretics) or anti-inflammatory medications (corticosteroids) are taken at the same time.

Pay particular attention during treatment with Laxipeg if you are prone to imbalances in blood salt levels (electrolyte imbalances), easily found in elderly people, or if you have kidney problems (renal insufficiency), liver problems (hepatic insufficiency) or heart problems (cardiac insufficiency). In these cases, you should regularly check your blood salt levels.

Laxative abuse, especially of contact laxatives (stimulant laxatives), can cause dependence (and therefore, a possible need to progressively increase the dosage), chronic constipation, and loss of normal intestinal function (intestinal atony).

Very rare cases of hypersensitivity reactions (rash, urticaria, edema) and exceptional cases of anaphylactic shock have been reported with macrogol-containing medicines.

Laxipeg, containing no sugar or polyol, can be taken by diabetic patients or those on a galactose-free diet.

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

• The following side effects may occur in children

Common (may affect up to 1 in 10 patients) - abdominal pain;
- diarrhea (diarrhea can cause perianal pain).

Uncommon (may affect up to 1 in 100 patients)
- vomiting;
- abdominal distension;
- nausea.

Not known (frequency cannot be estimated from the available data)
- hypersensitivity;
- severe allergic reaction with rapid onset (anaphylactic shock);
- swelling of the tissues in general (angioedema);
- skin irritation (urticaria, rash), itching.

• The following side effects may occur in adults

Common (may affect up to 1 in 10 patients)
- abdominal distension;
- nausea;

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

Very rare (may affect up to 1 in 10,000 patients)
- hypersensitivity reactions that may manifest as itching, skin rash, urticaria, swelling of the face (edema) and tissues in general (angioedema), difficulty breathing (dyspnea), severe allergic reaction with rapid onset (anaphylactic shock).

Not known (frequency cannot be estimated from the available data)
- electrolyte imbalance (sodium deficiency, potassium deficiency) and/or dehydration, especially in the elderly;
- skin redness (erythema).

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.