REGOLINT OS POLV200G 973,6MG/G

REGOLINT 973,6 MG/G POLVER FOR ORAL FUTURE

active ingredients

100 g powder contain: Active ingredient: macrogol 4000 g 97.36. For the full list of excipients see paragraph 6.1.

Excellent

Potax acesulphame, banana aroma.

Therapeutic indications

Treatment of the constipation of the child.

Contraindications

Hypersensitivity to macrogol (polyethyleneglycol) or to any of the excipients; severe inflammatory diseases of the intestine (such as ulcerative colitis, Crohn disease) or toxic megacolons; drilling or risk of perforation of the digestive tract; ileo or suspect intestinal obstruction, or symptomatic stenosis; acute or unknown abdominal pain; nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding. Severe dehydration.

Population

Children over 8 years and weighing more than 20 kg 2–4 misurini colmi per day (the measurino dosa 2,5 g to the notch and 5 g when filled). Do not exceed the maximum daily dosage of 20 g macrogol. Children over 2 years and weighing less than 20 kg The usual initial dose is 0.7 g/kg per day. Table for calculating Regolint dose in children up to 20 kg

Body weight (kg)	Daily dose	no measures
6–9	5 g	1
10–12	7.5 g	1 1⁄2
13–16	10 g	2
17–20	12.5 g	2 1⁄2

The indicated dose must be adjusted according to the individual response. Increases or reductions of 1⁄2 or 1 scoop compared to the dose shown in the table are recommended. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. The daily dose can be taken in one or two fractions, away from meals. In the case of a single administration per day, the intake must take place in the morning. In case you have to take more doses, it will be necessary to divide them between morning and evening. The effect of REGOLINT in 24–48 hours after its administration. Sometimes it may take two days (or more) before obtaining the desired effect. In children, in the absence of clinical data on periods of administration greater than three months, the duration of treatment is limited to 3 months; in any case, the patient must comply with the doctor's prescription. The content of a scoop (5 g) is dissolved in at least half a glass of water (about 60 ml). Do not add other ingredients. It is preferable to drink the whole quantity quickly enough (in a few minutes) avoiding sipping it for a long time. A fluid-rich diet promotes the effect of the medicine. Regularization of intestinal motility induced by treatment should be maintained with a healthy lifestyle and proper nutrition.

Conservation

Store in the original packaging to protect the medicine from moisture. After opening the bottle content must be used up to 90 days; the surplus product must be eliminated.

Warnings

Warnings Data on the effectiveness of treatment in children under 2 years of age are limited. Treatment of stypsis with any medicine is only a coadjuvant of a healthy lifestyle and proper nutrition, for example: increased intake of liquids and plant fibers appropriate physical activity and restoration of intestinal motility. Before starting the treatment must be excluded any organic disorder. Laxatives should not be used by subjects with acute or unknown abdominal pain, nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding. The presence of one or more of these symptoms or signs requires adequate diagnostic examination by the doctor in order to exclude one of the pathological conditions that contraindicate the use of laxatives (e.g. obstruction or suspected intestinal obstruction, stenosis or intestinal perforation, paralytic ileum, severe inflammatory diseases of the intestine). After a 3-month treatment cycle, full clinical supervision of constipation must be performed. The abuse of laxatives (frequent or prolonged use or excessive doses), especially those of contact or stimulants, can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. Caution should be placed in the elderly, in patients with liver failure, kidney failure, heart failure. It is appropriate in these cases to periodically check the levels of serum electrolytes. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). REGOLINT, not containing any sugar or polyol, may be taken by diabetic patients or subject to a galactose-free regime. Precautions for use Diagnostic insights are necessary when the need for laxative comes from a sudden change of previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of laxative fails to produce effects. Very rare cases of hypersensitivity reactions (skin rash, hives, edema) have been reported with some medicines containing macrogol, including exceptional cases of anaphylactic shock. In these cases, stop taking the medicine and immediately consult a doctor.

Interactions

Laxatives can reduce the time of stay in the intestine and therefore the absorption of other drugs administered simultaneously by mouth. Avoid ingesting laxatives and other drugs at the same time: after taking a medicine let spend a range of at least two hours before taking laxative. You should use caution when Regolint is used with medications with a narrow therapeutic index (e.g. antiepileptics and immunosuppressants). The use of licorice increases the risk of hypopotassiemia.

Effects

The side effects listed in the following table were reported during clinical studies that affected 147 children aged between 6 months and 15 years, and post-marketing data. The reported adverse reactions are usually mild and transient, and mainly affect the gastrointestinal apparatus. In case of hypersensitivity reactions stop taking the medicine and consult a doctor immediately. The adverse reactions of the drug are listed according to the frequency using the following frequency classes: very common (≥ 1/10), common (≥ 1/100, Systemic organ classification Adverse reactions Gastrointestinal diseases Town Abdominal pain Diarrhea Not common Vote Addome extension Nausea Rectal irritation Immune system disorders Notable Reactions of hypersensitivity * Diarrhea can cause perianal pain In addition, the following side effects were reported in clinical studies or post-marketing data: Gastrointestinal diseases Common: abdomen distension, nausea Not common: urgency of evacuation, fecal incontinence Disorders of metabolism and nutrition Notable: electrolytic imbalance (hyponatremia, hypokaliemia), dehydration (particularly in the elderly) Immune system disorders Very rare: hypersensitivity (pruritus, rash, hives, edema, facial edema, angioedema, dispnea, anaphylactic shock) Reporting of suspected adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Overdose causes diarrhea that disappears with temporary termination of treatment or reduction of dose. An excessive loss of liquids caused by diarrhea or vomiting may require the correction of electrolytic imbalance. Excessive doses can cause abdominal pain. Intake cases have been reported for administrations of large volumes of polyethyleneglycol and electrolytes. Children with neurological damage that suffer from hormonal dysfunction are particularly at risk of aspiration. Inflammation and perianal pain have been reported in conjunction with high volumes of macrogol solutions (from 4 to 11 litres) for colon washing, both for preparation before colonoscopy and for removal of fecal stagnation in case of hencopresis. See also the paragraph "Special warnings and precautions for use" about the abuse of laxatives.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicinal product must be used only in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or for the infant.

Source: Farmadati