LAXIPEG OS POLV FL 200G 97%

LAXIPEG 97% POLVER FOR ORAL FUTURE

active ingredients

100 g of powder contain: Active ingredient: macrogol 4000: 97.36 g. Excipient with known effects: 275 mg of Propilene Glycol For the full list of excipients, see paragraph 6.1.

Excellent

Potaxic acesulphame, banana aroma containing glycol propylene, ceroso maize maltodextrin, modified corn starch.

Therapeutic indications

Treatment of the constipation of the child.

Contraindications

• Hypersensitivity to the active ingredient Macrogol (Politilenglicole) or to any of the excipients listed in the paragraph 6.1. • Severe inflammatory diseases of the intestine (such as ulcerative colitis, Crohn's disease) or toxic megacolons. • Perforation or risk of drilling of the digestive tract. • Paralytic ileo or suspects intestinal obstruction or symptomatic stenosis. • Acute abdominal 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 adequate diagnostic examination by the doctor in order to exclude one of the pathological conditions that contraindicate the use of laxatives. • Severe dehydration.

Population

Population Pediatric population Children over 8 years and weighing more than 20 kg: 2-4 scoops per day (measurino dosa 2,5 g al tacca 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. Laxipeg dose calculation table in children up to 20 kg

Body weight (kg)	Daily dose	n. of measles
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. Method of administration: The daily dose can be taken in the morning, in case of a scoop a day, or fractionated between morning and evening, in case it is higher than the scoop a day, away from meals. The effect occurs after 24-48 hours from administration. In the absence of clinical data on periods of administration over three months, the duration of treatment is limited to 3 months. The content of a scoop (5 g) is dissolved in at least half a glass of water (about 50 ml). Do not add other substances. 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 thrown.

Warnings

Data on the effectiveness of treatment in children under 2 years of age are limited. Treatment of stypsis with any medicinal product is only a coadjuvant of a healthy lifestyle and proper nutrition, for example: • increased intake of liquids and vegetable fibers; • appropriate physical activity and restoration of intestinal motility. Before starting the treatment must be excluded any organic disorder. At the end of the three months of treatment, a comprehensive clinical assessment should be carried out on the stypsis. 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 these cases, caution is recommended in patients prone to the development of electrolytic imbalances (e.g. 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. 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. 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). Important information about some excipients: LAXIPEG, by not containing any sugar or polyol, it may be taken by diabetic patients or subject to a galactose-free regime. Very rare cases of hypersensitivity reactions (skin rash, hives, edema) and exceptional cases of anaphylactic shock with drugs containing macrogol have been reported. 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. Important information about some excipients: This medicine contains 13.75 mg of glycol propylene per misurino colmo (5 g) equivalent to 2.75 mg/g.

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. The use of licorice increases the risk of hypopotassiemia.

Effects

Pediatric population: 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. Generally the reported adverse reactions are mild and transient and have mainly affected the gastrointestinal apparatus: 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   Undesirable effects   Town(≥ 1/100, Not common(≥ 1/1000, Rare (≥ 1/10000, Very rare ( Notable Gastrointestinal diseases Abdominal pain, Diarrhea* Vomito, Abdominal Distension, Nausea       Immune system disorders         Hypersensitivity, anaphylactic shock, angioedema, hives, rash, itching * Diarrhea can cause perianal pain In addition, the following side effects were reported in clinical studies or post-marketing: Gastrointestinal diseases. Common: abdominal distension, nausea; Not common: urgency of evacuation, fecal incontinence, rectal irritation. Disorders of metabolism and nutrition. Notable: Electrolytic imbalance (iponatriemia, hypokaliemia) and/or dehydration in particular in the elderly. Immune system disorders. Very rare: Hypersensitivity (pruritus, rash, facial edema, angioedema, hive, dispnea, anaphylactic shock); Frequency not known: erythema. Reporting of suspicious 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Overdose causes diarrhea that disappears with temporary termination of treatment or with reduced dose. The excessive loss of liquids caused by diarrhea or vomiting may require corrections of the electrolytic imbalance. Excessive doses can cause abdominal pain and vomiting. 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 macrogol solution volumes (from 4 to 11 liters) for colon washing, both for preparation before colonoscopy and for the 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. Data on the effect of Laxipeg on animal and human fertility are not available.

Source: Farmadati