LAXIPEG OS POLV 20BUST 9,7G

LAXIPEG 9.7 G POWER FOR ORAL FUTURE

active ingredients

Laxipeg 9,7 g powder for oral solution A bag contains: Active ingredient: macrogol 4000 g 9,736. Excipient with known effects: 27,5 mg of Propilene glycol. For the full list of excipients, see paragraph 6.1.

Excellent

Potax acesulphame, banana aroma containing: glycol propylene, cerous corn maltodextrin, modified corn starch.

Therapeutic indications

Short-term treatment of occasional constipation.

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 disease) or toxic megacolons • Perforation or risk of perforation 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. . Adults and children older than 8 years and weighing more than 20 kg. . Oral use. . From 1 to 2 sachets per day, preferably taken in a single dose in the morning. Each sachet should be dissolved in a glass of water before taking. The daily dose must be adapted according to the clinical effect obtained and may vary from a bag to alternate days (especially in children) up to 2 sachets per day. Do not exceed the maximum daily dosage of 20 g macrogol. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Method of administration: The daily dose can be taken in one or two fractions, away from meals. The effect occurs after 24-48 hours from administration. In this case, the treatment should be kept in mind, however, that laxatives should be used as often as possible and not more than seven days. The use for longer periods is defined by the doctor after adequate evaluation of the individual case. In children, in the absence of clinical data on periods of administration greater than three months, treatment should not exceed three months. Dissolve the contents of a sachet in at least 125 ml (equal to a glass) of water. 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.

Warnings

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. Laxative abuse (frequent or prolonged use or excessive doses) 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. In children the medicine can only be used after consulting the doctor. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. You should also consult your doctor before using the medicine. Important information about some excipients: This medicine contains 27,5 mg of glycol propylene per sachet 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

The adverse reactions of the drug are listed according to the frequency using the following frequency classes: very common (≥ 1/10); common (≥ 1/100, Adults: The side effects listed in the following table were reported during clinical trials (600 adult patients) and post-marketing data. The reported adverse reactions are generally mild and transient and have mainly affected the gastrointestinal apparatus:

Systemic organ classification	Undesirable effects
	Town (≥ 1/100,	Not common (≥ 1/1000,	Rare (≥ 1/10000,	Very rare (	Notable
Gastrointestinal diseases	Abdominal pain and/or distension, Diarrhea, Nausea	Vomito, Evacuation Urgence, Fecal Incontinence, Rectal Irritation,
Disorders of metabolism and nutrition					Electrolytic imbalance (hyponatriemia, hypokaliemia) and/or dehydration in particular in the elderly
Immune system disorders				Hypersensitivity (pruritus, rash, facial edema, angioedema, hives, dispnea, anaphylactic shock)	Eritema

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:

Systemic organ classification			Undesirable effects
	Town(≥ 1/100,	Not common(≥ 1/1000,	Rare(≥ 1/10000,	Very rare(	Notable
Gastrointestinal diseases	Abdominal pain, Abdominal distension, Nausea, Diarrhea*	Vomito, Rectal Irritation,
Immune system disorders				Hypersensitivity	Anaphylactic Shock, Angioedema, Orticaria, Rash, Prurito

* Diarrhea can cause perianal pain 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. 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