Regolint 9, 7 g 20 sachets powder for oral solution

Regolint 9.7 g 20 sachets powder for oral solution is an osmotic laxative based on macrogol 4000 , specifically formulated for the short-term treatment of occasional constipation in adults and children over 8 years of age. Each sachet contains 9.7 g of macrogol 4000, an active ingredient that acts by attracting water into the intestine, thus promoting the softening of the stool and facilitating intestinal regularity in a natural and delicate way. The powder, with a pleasant banana aroma, is free of sugars and polyols, making it suitable for those who follow particular diets, such as diabetic patients or those who require a galactose-free diet.

Regolint is indicated for those who suffer from occasional constipation and want a rapid and predictable effect , generally visible within 24-48 hours of taking it. Its formulation in single-dose sachets to dissolve in water guarantees ease of use and a precise dosage, adaptable to individual needs. The product is ideal for adults and children over 20 kg in weight, offering an effective solution to restore intestinal regularity without irritating the mucosa or causing dependence. Thanks to its osmotic action, Regolint promotes physiological evacuation and contributes to intestinal well-being, making it a reliable choice for those looking for a safe, well-tolerated and easy-to-take laxative .

ACTIVE INGREDIENTS

Active ingredients contained in Regolint 9.7 g 20 sachets powder for oral solution - What is the active ingredient of Regolint 9.7 g 20 sachets powder for oral solution?

One sachet contains : Active ingredient : macrogol 4000 g 9.736. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Regolint 9.7 g 20 sachets powder for oral solution - What does Regolint 9.7 g 20 sachets powder for oral solution contain?

Acesulfame potassium, banana flavor.

DIRECTIONS

Therapeutic indications Regolint 9.7 g 20 sachets powder for oral solution - Why is Regolint 9.7 g 20 sachets powder for oral solution used? What is it used for?

Short-term treatment of occasional constipation.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Regolint 9.7 g 20 sachets powder for oral solution - When should Regolint 9.7 g 20 sachets powder for oral solution not be used?

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, associated with symptomatic stenosis; perforation or risk of perforation of the digestive tract; ileus or suspected intestinal obstruction; acute abdominal pain or pain of unknown origin; nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding; severe state of dehydration.

DOSAGE

Quantity and method of taking Regolint 9.7 g 20 sachets powder for oral solution - How do you take Regolint 9.7 g 20 sachets powder for oral solution?

Adults and children over 8 years of age and weighing more than 20 kg The daily dose must be adjusted according to the clinical effect obtained and can vary from one sachet every other day (especially in children) up to 2 sachets per day. Do not exceed the maximum daily dosage of 20 g of macrogol. The indicated dose must be adjusted according to individual response. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. The daily dose can be taken in one or two fractions, away from meals. If one sachet must be taken, it must be taken in the morning. If more than one sachet must be taken, the doses must be divided between morning and evening. The effect of REGOLINT occurs within 24–48 hours of its administration. Sometimes two days (or more) may be necessary before obtaining the desired effect. Continue treatment in this case, keeping in mind, however, that laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. In children, in the absence of clinical data on periods of administration longer than three months, treatment should not exceed three months. Dissolve the contents of one sachet in at least 125 ml (equal to a glass) of water. Do not add other ingredients. It is preferable to drink the entire quantity fairly quickly (within a few minutes) avoiding 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 should be maintained with a healthy lifestyle and a correct diet.

CONSERVATION

Storage Regolint 9.7 g 20 sachets powder for oral solution - How do you store Regolint 9.7 g 20 sachets powder for oral solution?

Store in the original package in order to protect from moisture.

WARNINGS

Warnings Regolint 9.7 g 20 sachets powder for oral solution - About Regolint 9.7 g 20 sachets powder for oral solution it is important to know that:

Warnings Efficacy data 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 proper nutrition, for example: increased intake of fluids and vegetable fibres appropriate physical activity and restoration of intestinal motility. Organic diseases must be excluded before starting treatment. Laxatives should not be used by subjects with acute abdominal pain or 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 (for example: obstruction or suspected intestinal obstruction, intestinal stenosis or perforation, paralytic ileus, severe inflammatory bowel disease). After a 3-month treatment cycle, complete clinical supervision of constipation must be performed. Abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypokalemia may occur, which may cause cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids. Caution should be exercised in the elderly, in patients with liver failure, renal failure, heart failure. In these cases, it is advisable to periodically check serum electrolyte levels. Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). REGOLINT, not containing any sugar or polyol, can be taken by diabetic patients or by patients undergoing a galactose-free diet. Precautions for use In children, the medicine can only be used after consulting your doctor. The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of drugs and monitoring during therapy. Consult your doctor when the need for the laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable for elderly or unhealthy subjects to consult their doctor before using the medicine. Very rare cases of hypersensitivity reactions (skin rash, urticaria, edema) have been reported with some medicines containing macrogol, including exceptional cases of anaphylactic shock. In these cases, stop taking the medicine and consult a doctor immediately.

INTERACTIONS

Interactions Regolint 9.7 g 20 sachets powder for oral solution - Which medicines or foods can modify the effect of Regolint 9.7 g 20 sachets powder for oral solution?

Laxatives may reduce the residence time in the intestine and therefore the absorption of other drugs administered orally at the same time. Therefore, avoid taking laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least two hours before taking the laxative. Caution should be exercised when Regolint is used with drugs with a narrow therapeutic index (e.g. antiepileptics and immunosuppressive agents). The use of liquorice increases the risk of hypokalaemia.

SIDE EFFECTS

Like all medicines, Regolint 9.7 g 20 sachets powder for oral solution can cause side effects - What are the side effects of Regolint 9.7 g 20 sachets powder for oral solution?

Adverse drug reactions are listed by frequency using the following frequency categories: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000) and not known (frequency cannot be estimated from the available data). Adults : The undesirable effects listed in the following table have been reported in clinical trials involving 600 adult patients and from post-marketing data. The adverse reactions reported are usually mild and transient, and mainly affect the gastrointestinal tract. In case of hypersensitivity reactions, stop taking the medicine and consult a doctor immediately.

Organ system classification	Adverse reactions
Gastrointestinal disorders
Common	Abdominal pain
	Abdominal distension
	Diarrhea
	Nausea
Uncommon	Vomit
	Emergency evacuation
	Fecal incontinence
	Rectal irritation
Metabolism and nutrition disorders
Not known	Electrolyte imbalance (hyponatremia, hypokalemia)
	Dehydration (particularly in the elderly)
Immune system disorders
Very rare	Hypersensitivity reactions (pruritus, rash, urticaria, edema, facial edema, angioedema, dyspnoea, anaphylactic shock)

Paediatric population : The undesirable effects listed in the following table have been reported during clinical trials involving 147 children aged 6 months to 15 years, and from post-marketing data. As in adults, the adverse reactions reported are usually mild and transient, and mainly affect the gastrointestinal system. In case of hypersensitivity reactions, stop taking the medicine and consult a doctor immediately.

Organ system classification	Adverse reactions
Gastrointestinal disorders
Common	Abdominal pain
	Diarrhea*
Uncommon	Vomit
	Abdominal distension
	Nausea
	Rectal irritation
Immune system disorders
Not known	Hypersensitivity

* Diarrhea may cause perianal pain Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance 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.

OVERDOSE

Overdose Regolint 9.7 g 20 sachets powder for oral solution - What are the risks of Regolint 9.7 g 20 sachets powder for oral solution in case of overdose?

Overdose causes diarrhoea which disappears with temporary discontinuation of treatment or dose reduction. Excessive fluid loss due to diarrhoea or vomiting may require correction of electrolyte imbalance. Excessive doses may cause abdominal pain. Aspiration has been reported with nasogastric tube administration of large volumes of polyethylene glycol and electrolytes. Children with neurological impairment who suffer from oromotor dysfunction are particularly at risk of aspiration. See also the section "Special warnings and precautions for use" regarding laxative abuse.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Regolint 9.7 g 20 sachets powder for oral solution.

There are no adequate and well-controlled studies on the use of the medicinal product during pregnancy or breastfeeding. Therefore, the medicinal product should be used only when necessary, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or the infant.

DRIVING AND USE OF MACHINERY

Taking Regolint 9.7 g 20 sachets powder for oral solution before driving or using machines - Does Regolint 9.7 g 20 sachets powder for oral solution affect driving or using machines?

No studies on the ability to drive and use machines have been performed.