REGOLINT OS POLV 20BUST 9,7G

REGOLINT 9.7 G POWER FOR ORAL FUTURE

active ingredients

A bag contains: Active ingredient: macrogol 4000 g 9,736. For the full list of excipients see paragraph 6.1.

Excellent

Potax acesulphame, banana aroma.

Therapeutic indications

Short-term treatment of occasional constipation.

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, associated with symptomatic stenosis; drilling or risk of drilling of the digestive tract; ileo or suspect intestinal obstruction; acute or unknown abdominal pain; nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding; severe dehydration.

Population

Adults and children older than 8 years and weighing more than 20 kg 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 indicated dose must be adjusted according to the individual response. 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. The daily dose can be taken in one or two fractions, away from meals. In case you have to take a bag, the intake must take place in the morning. In case you have to take multiple sachets, you will need to split the doses 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 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. Use for longer periods requires the doctor’s prescription 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 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.

Warnings

Warnings Effective data 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 treatment organic diseases must be excluded. 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), may 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 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 the doctor as 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. Very rare cases of hypersensitivity rash, hives, edema, and edema have been reported with some macrogol medications, 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 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 studies that affected 600 adult patients 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.

Systemic organ classification	Adverse reactions
Gastrointestinal diseases
Town	Abdominal pain
	Addome extension
	Diarrea
	Nausea
Not common	Vote
	Evacuation
	Fetal incontinence
	Rectal irritation
Disorders of metabolism and nutrition
Notable	Electrolytic imbalance (hyponatremia, hypokaliemia)
	Dehydration (particularly in the elderly)
Immune system disorders
Very rare	Reactions of hypersensitivity (pruritus, rash, hives, edema, facial edema, angioedema, dispnea, anaphylactic shock)

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. As in the case of adults, the adverse reactions reported 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.

Systemic organ classification	Adverse reactions
Gastrointestinal diseases
Town	Abdominal pain
	Diarrhea
Not common	Vote
	Addome extension
	Nausea
	Rectal irritation
Immune system disorders
Notable	Hypersensitivity

* Diarrhea can cause perianal pain 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 with reduced 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. 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