LAXIPEG*ORAL POWDER 20SACHETS 9.7G

Laxipeg 9.7 g oral solution powder
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 short-term treatment of occasional constipation.

Consult your doctor if you do not feel better or if you feel worse after 7 days.

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 have acute abdominal pain of unknown origin, nausea or vomiting;
- if you have 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 the laxative fails to produce effects.
Consult your doctor before using the medicine, especially if you are elderly or in poor health.

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.

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 cause cardiac or neuromuscular disorders, especially if medicines for the heart (cardiac glycosides), medicines that increase urine production (diuretics) or medicines for inflammation (corticosteroids) are taken at the same time.

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

Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, a possible need to progressively increase the dosage), chronic constipation and loss of normal bowel functions (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 polyols, can be taken by diabetic patients or those on a galactose-free diet.

Children
In children, the medicine can only be used after consulting a doctor.

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

• In children, the following side effects may occur:

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

Uncommon (may affect up to 1 in 100 patients)
- vomiting;
- rectal irritation.

Very rare (may affect up to 1 in 10,000 patients)
- hypersensitivity.

Frequency unknown (frequency cannot be estimated from the available data)
- severe rapidly evolving allergic reaction (anaphylactic shock);
- swelling of tissues in general (angioedema);
- skin irritation (urticaria, rashes), itching.

• In adults, the following side effects may occur:

Common (may affect up to 1 in 10 patients)
- abdominal pain and/or distension;
- diarrhea;
- nausea.

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

Very rare (may affect up to 1 in 10,000 patients)
- hypersensitivity reactions that may manifest as itching, rash, urticaria, facial swelling (edema) and tissue swelling in general (angioedema), difficulty breathing (dyspnea), severe rapidly evolving allergic reaction (anaphylactic shock).

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.