REGOLINT*OS POWDER 200G 973.6MG/G

Regolint 973.6 mg/g powder for oral solution
Macrogol 4000

What it is and what it is used for
REGOLINT contains the active ingredient macrogol 4000, which belongs to a group of medicines called osmotic laxatives. These work by drawing water into the intestines, facilitating the formation of soft stools.

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

Consult your doctor if the condition does not resolve or worsens after a few days.

What you need to know before taking the medicine
Do not use REGOLINT if:
- you are allergic to macrogol 4000 or any of the other ingredients of this medicine (listed in section 6);
- you suffer from severe inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease) or toxic megacolon;
- you experience acute or unexplained abdominal pain;
- you show a marked increase or decrease in bowel activity (peristalsis), nausea or vomiting, rectal bleeding;
- you have an obstruction (ileus) or suspected obstruction, a narrowing (stenosis) or a perforation, or risk of perforation of the intestine;
- you are in a condition characterized by excessive fluid loss (severe dehydration).

Warnings and precautions
Consult your doctor or pharmacist before using REGOLINT.

Before starting treatment, consult your doctor, who must ensure that your constipation is not due to other diseases. If you suffer from chronic or recurrent constipation, consult your doctor, who will advise you on an appropriate therapy and monitor your condition.

Also consult your doctor if the need for a laxative arises from any of the following conditions:
- your bowel habits (frequency and characteristics of bowel movements) have suddenly changed for more than 2 weeks;
- the laxative is not effective.

If you suffer from constipation, first correct your eating habits and adopt a healthy lifestyle, following a balanced diet rich in water and fiber and engaging in physical activity.

Stop treatment immediately and inform your doctor if you experience allergic reactions such as skin irritation (rash, hives), swelling of the face, lips, throat and/or tongue (edema), and severe allergic reactions (anaphylactic shock).

Do not use laxative medicines if you suffer from acute or unexplained abdominal pain, nausea or vomiting, marked accentuation or reduction of peristalsis, or rectal bleeding. In these cases, consult your doctor, who will determine if you suffer from conditions where laxative use is contraindicated (for example: intestinal obstruction or suspected obstruction, intestinal stenosis or perforation, paralytic ileus, severe inflammatory bowel diseases).

After approximately 3 months of treatment, it is recommended to consult a doctor, as specific checks are necessary and an appropriate therapy needs to be established.

If you take laxatives frequently, for a long time, or in high doses, you may experience persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients. In more severe cases, excessive fluid loss (dehydration) may occur, accompanied by low potassium levels in the blood (hypokalemia), which can cause problems with heart, nerve, and muscle function (cardiac or neuromuscular dysfunctions). These effects can occur especially if you are simultaneously taking medicines that increase the strength of heart contraction (cardiac glycosides), facilitate urine elimination (diuretics), or for the treatment of allergies and inflammations (corticosteroids).

Use caution and inform your doctor if:
- you suffer from liver problems (hepatic insufficiency);
- you suffer from kidney problems (renal insufficiency);
- you have heart problems (heart failure);
- you are elderly.
In these cases, the doctor should periodically check the levels of salts in the blood (serum electrolytes).

If you take laxatives excessively or incorrectly (abuse), especially certain types of laxatives (stimulant laxatives), you may develop dependence (possible need to progressively increase the dose of medicine), chronic constipation, and loss of normal bowel function (intestinal atony).

Children under 2 years of age
No information is available on the effectiveness of this medicine in children under 2 years of age.

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

The side effects that may occur are generally mild and temporary, and mainly affect the gastrointestinal tract. In case of hypersensitivity reactions, stop taking the medicine and consult a doctor immediately:

Common (may affect up to 1 in 10 people)
- abdominal pain;
- diarrhea, which can cause pain in the area near the anus (perianal).

Uncommon (may affect up to 1 in 100 people)
- vomiting;
- abdominal bloating (abdominal distension);
- nausea;
- irritation of the last part of the intestine (rectal irritation).

Frequency unknown (frequency cannot be estimated from the available data)
- allergic reactions (hypersensitivity).

In addition, the following side effects have been reported in adults:

Common (may affect up to 1 in 10 people)
- abdominal bloating (abdominal distension);
- nausea.

Uncommon (may affect up to 1 in 100 people)
- urgency to defecate;
- difficulty holding back stool expulsion (fecal incontinence).

Very rare (may affect up to 1 in 10,000 people)
- allergic reactions (hypersensitivity) such as itching, skin irritation (rashes, hives), swelling due to fluid accumulation (edema) localized especially to the face, lips and throat or hands (edema, facial edema, angioedema), difficulty breathing (dyspnea), severe allergic reaction that can lead to death (anaphylactic shock).

Frequency unknown (frequency cannot be estimated from the available data)
- alteration of body salt levels, such as reduction of sodium and potassium levels in the blood (hyponatremia, hypokalemia);
- excessive fluid loss (dehydration), especially in elderly people.

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.