Laxipeg 97% Powder For Oral Solution 200g

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. • Perforation or risk of perforation of the digestive tract. • Paralytic ileus or suspected intestinal obstruction or symptomatic stricture. • 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 an adequate diagnostic investigation by the doctor in order to exclude one of the pathological conditions that contraindicate the use of laxatives. • Severe state of dehydration. Posology Children older than 8 years and weighing more than 20 kg. 2–4 heaped scoops per day (the scoop doses 2.5 g at the notch and 5 g when full). Do not exceed the maximum daily dosage of 20 g of macrogol. Children over 2 years of age and weighing less than 20 kg. The usual starting dose is 0.7 g / kg per day. Table for calculating the dose of Laxipeg in children up to 20 kg The indicated dose should be adjusted according to individual response. It is advisable to increase or decrease ½ or 1 scoop with respect to the dose indicated in the table. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. The daily dose can be taken in the morning, in the case of one measuring cup per day, or divided between morning and evening, in the case of more than one measuring cup per day, between meals. The effect occurs 24–48 hours after administration. In the absence of clinical data on dosing periods exceeding three months, the duration of treatment is limited to 3 months; in any case, the patient must follow the doctor's prescription. The content of one measuring cup (5 g) should be dissolved in at least half a glass of water (about 50 ml). Do not add any other ingredients. It is preferable to drink the entire quantity fairly quickly (within a few minutes) and avoid sipping it for a long time. A diet rich in liquids favors the effect of the medicine. The regularization of intestinal motility induced by the treatment must be maintained with a healthy lifestyle and proper nutrition. Warnings and precautions Warnings 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 adjunct to a healthy lifestyle and a correct diet, for example: • increase in the intake of fluids and vegetable fibers • appropriate physical activity and restoration of intestinal motility Before starting the treatment you must be excluded any organic disorder. At the end of the three months of treatment, a complete clinical evaluation of constipation should be conducted. The abuse of laxatives (frequent or prolonged use or with excessive doses), particularly those of contact or stimulants, can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In these cases, caution is recommended in patients prone to the development of electrolyte imbalances (eg in the elderly, in patients with hepatic insufficiency, renal insufficiency, heart failure). In these cases it is advisable to periodically check the levels of serum electrolytes. In the most severe cases, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Important information about some of the ingredients LAXIPEG, which does not contain any sugar or polyol, can be taken by diabetic patients or on a galactose-free diet. Precautions for use Very rare cases of hypersensitivity reactions (rash, urticaria, edema) and exceptional cases of anaphylactic shock have been reported with macrogol-containing medicinal products. In-depth diagnostics are necessary when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects. Interactions Laxatives can reduce the time spent 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. The use of licorice increases the risk of hypokalemia. Undesirable effects Pediatric population The undesirable effects listed in the following table have been reported in clinical trials involving 147 children aged 6 months to 15 years and from post-marketing data. Generally reported adverse reactions are mild in intensity and transient and have mainly affected the gastrointestinal tract: Adverse drug reactions are listed by frequency using the following frequency categories: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data). Gastrointestinal disorders Common [(≥ 1/100 to <1/10) Abdominal pain, Diarrhea *] Uncommon [(≥ 1/1000 to <1/100) Vomiting, Abdominal distension, Nausea] Rare (≥ 1/10000 to < 1/1000) None Very rare (<1/10000) None Immune system disorders - Hypersensitivity, anaphylactic shock, angioedema, urticaria, rash, pruritus * Diarrhea may cause perianal pain In addition, they have been reported in adults in clinical studies or post-marketing the following undesirable effects: Gastrointestinal disorders Common: abdominal distension, nausea Uncommon: urgency to evacuate, fecal incontinence, rectal irritation Metabolism and nutrition disorders Not known: Electrolyte imbalance (hyponatremia, hypokalaemia) and / or dehydration in particular in the elderly Immune system disorders Very rare: Hypersensitivity (pruritus, rash, face edema, angioedema, urticaria, dyspnoea, anaphylactic shock) Frequency not known: erythema. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Pregnancy and lactation There are no adequate and well-controlled studies on the use of the medicinal product in pregnancy or lactation. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant. Storage Store in the original packaging to protect the product from moisture. After opening, the contents of the bottle must be used within 90 days at the latest; the excess product must be thrown away.