Regolint 9.7 g 20 sachets powder for oral solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Short-term treatment of occasional constipation.

CONTRAINDICATIONS

Hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients; severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, associated with symptomatic stricture; perforation or risk of perforation of the digestive tract; ileus or suspected intestinal obstruction; acute abdominal pain or pain of unknown origin; nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding; severe state of dehydration.

WARNINGS AND PRECAUTIONS FOR USE

Warnings Efficacy data 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 correct nutrition, for example: increased intake of liquids and vegetable fibres, appropriate physical activity and restoration of intestinal motility. Before starting treatment, organic diseases must be excluded. Laxatives should not be used by subjects with acute abdominal pain or pain of unknown origin, nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding. The presence of one or more of these symptoms or signs requires an adequate diagnostic investigation by the doctor in order to exclude one of the pathological conditions that contraindicate the use of laxatives (for example: obstruction or suspected intestinal obstruction, intestinal stenosis or perforation, paralytic ileus, serious inflammatory diseases of the intestine). After a 3-month course of treatment, full clinical supervision of constipation should be performed. The 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 nutritional factors. In more severe cases, the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunction, especially in case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Caution should be exercised in the elderly, in patients with hepatic insufficiency, renal insufficiency, heart failure. In these cases it is advisable to periodically check serum electrolyte levels. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). REGOLINT, not containing any sugar or polyol, can be taken by diabetic patients or those undergoing a galactose-free regime. Precautions for use In children the medicine can only be used after consulting a doctor. The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during the course of therapy. Consult your doctor when the need for the laxative arises from a sudden change in previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine. Very rare cases of hypersensitivity reactions (rash, urticaria, edema) have been reported with some macrogol-containing medicinal products, including exceptional cases of anaphylactic shock. In these cases, stop taking the medicine and consult a doctor immediately.

INTERACTIONS

Laxatives can reduce the residence time in the intestine and therefore the absorption of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least two hours before taking the laxative. Caution should be used when Regolint is used with drugs with a narrow therapeutic index (e.g. antiepileptics and immunosuppressive agents). The use of licorice increases the risk of hypokalemia.

SIDE EFFECTS

Adverse drug reactions are listed by frequency using the following frequency classes: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000) and not known (frequency cannot be estimated). based on available data). Adults: The side effects listed in the following table were reported during clinical trials involving 600 adult patients and from post-marketing data. The reported adverse reactions are usually mild in intensity and transient, and mainly affect the gastrointestinal system. In case of hypersensitivity reactions, stop taking the medicine and consult a doctor immediately.

Systemic organ classification | Adverse reactions

Gastrointestinal disorders

Municipality | Abdominal pain

Distension of the abdomen

Diarrhoea

Nausea

Uncommon | Vomiting

Evacuation urgency

Fecal incontinence

Rectal irritation

Metabolism and nutrition disorders

Not known | Electrolyte imbalance (hyponatremia, hypokalemia)

Dehydration (particularly in the elderly)

Immune system disorders

Very rare | Hypersensitivity reactions (pruritus, rash, urticaria, edema, face edema, angioedema, dyspnoea, anaphylactic shock)

Pediatric population: The side effects listed in the table below were reported during clinical trials involving 147 children aged 6 months to 15 years, and from post-marketing data. As in the case of adults, the reported adverse reactions are usually mild in intensity and transient, and mainly affect the gastrointestinal system. In case of hypersensitivity reactions, stop taking the medicine and consult a doctor immediately.

Systemic organ classification | Adverse reactions

Gastrointestinal disorders

Municipality | Adverse reactions: Abdominal pain

Adverse reactions: Diarrhoea*

Uncommon | Adverse reactions: Vomiting

Adverse reactions: Distension of the abdomen

Adverse reactions: Nausea

Adverse reactions: Rectal irritation

Immune system disorders

Not known | Adverse reactions: Hypersensitivity

* Diarrhea can cause perianal pain Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.