LAXIPEG "97% POWDER FOR ORAL SOLUTION" 200 G BOTTLE"

Name
Laxipeg 97% powder for oral solution
Macrogol 4000


What is it and what is it used for?
Laxipeg contains the active substance macrogol 4000, which belongs 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.

Talk to 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 increased or reduced bowel movements (peristalsis) or rectal bleeding;
- if you suffer from intestinal blockage (intestinal obstruction, symptomatic stenosis, paralytic ileus);
- if you suffer or are at risk of perforation of the digestive tract;
- if you suffer from severe inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic megacolon;
- if he is severely dehydrated.


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

Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications, 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 lasts for more than two weeks or when the use of the laxative fails to produce effects.

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

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

Before starting treatment, any organic disorder must be ruled out. A complete clinical evaluation for constipation should be conducted after three months of treatment.

Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in loss of water, mineral salts (especially potassium) and other essential nutrients.
In more severe cases, dehydration or potassium deficiency (hypokalemia) may occur, which can lead to cardiac or neuromuscular problems, especially if you are taking heart medications (cardiac glycosides), medications that increase urine production (diuretics), or medications for inflammation (corticosteroids) at the same time.

Take special care during treatment with Laxipeg if you are prone to salt imbalances in your blood (electrolyte imbalances), which are common in elderly people, or if you have kidney (renal insufficiency), liver (hepatic insufficiency), or heart (cardiac insufficiency) problems. In these cases, you should regularly check your salt levels in your blood.

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

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

Laxipeg, containing no sugar or polyol, can be taken by diabetic patients or those undergoing 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 people) - abdominal pain;
- diarrhea (diarrhea can cause perianal pain).

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

Frequency not known (frequency cannot be estimated from the available data)
- hypersensitivity;
- severe, rapidly evolving allergic reaction (anaphylactic shock);
- swelling of the tissues in general (angioedema);
- skin irritation (hives, 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 people)
- urgent evacuation;
- fecal incontinence;
- rectal irritation.

Very rare (may affect up to 1 in 10,000 people)
- hypersensitivity reactions which may manifest themselves with itching, skin rash, hives, swelling of the face (edema) and of the tissues in general (angioedema), difficulty breathing (dyspnoea), severe allergic reaction with rapid progression (anaphylactic shock).

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

Reporting of side effects
If you experience 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.