Short-term treatment of occasional constipation.
Indications
Stixenil 5 mg is based on bisacodyl. It is indicated for the treatment of occasional constipation.
Composition
Active ingredients
One coated tablet contains: Active ingredient: bisacodyl 5 mg. Excipients with known effects: lactose, sucrose.
Excipients
Lactose monohydrate, corn starch, sucrose, talc, glyceryl behenate, magnesium carbonate, methacrylic copolymers, PEG 4000, titanium dioxide.
Directions for use and Dosage
Children aged 10 years and under with chronic constipation must be treated under strict medical supervision.
Bisacodyl should not be used in children aged 2 years and under.
Dosage. Short-term treatment of constipation.
Adults and children over 10 years of age: 1-2 coated tablets (5-10 mg) daily at bedtime.
Paediatric population.
Children from 2 to 10 years of age: 1 coated tablet (5 mg) daily at bedtime.
Method of administration: Do not take together with milk or antacids; separate the medicine from taking it by at least one hour.
Do not take together with other oral medicines: separate the laxative from taking it by at least two hours.
The correct dose is the minimum sufficient to produce easy evacuation of soft stools.
It is advisable to initially use the minimum recommended doses.
When necessary, the dose can be increased. The dose may then be increased, but without ever exceeding the maximum indicated. Preferably take in the evening.
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.
The tablets should be swallowed whole. Swallow with an adequate amount of water (a large glass).
A diet rich in liquids promotes the effect of the medicine.
Warnings
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 can lead to serious complications. cause cardiac or neuromuscular dysfunction, especially in case of concomitant treatment with cardiac glycosides, diuretics, or corticosteroids.
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 function (intestinal atony).
Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications, and monitoring during therapy.
Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts more than two weeks, or when the use of the laxative fails to produce effects, or when the patient suffers from diabetes mellitus, hypertension, or heart disease.
It is also advisable for elderly or otherwise unhealthy subjects to consult their doctor before using the medicine.
In children under 12 years of age, the medicine should be used only after consulting a doctor. The use of laxatives in patients with inflammatory bowel disease or in the presence of abdominal pain, nausea, or vomiting can be dangerous and therefore requires careful evaluation by a doctor.
Cases of dizziness or syncope during defecation have been reported with the use of bisacodyl, compatible with defecation-induced syncope (attributable to the straining of defecation itself) or a vasovagal response to abdominal pain that may be associated with constipation. Important information about some excipients: Stixenil contains 20 mg of sucrose per tablet; this should be taken into account when the product is taken by diabetics or those following low-calorie diets.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
Stixenil contains 60 mg of lactose per tablet.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Laxatives are contraindicated in subjects with acute or unknown abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.
Generally contraindicated during pregnancy and breastfeeding.
Generally contraindicated in pediatric age.
The medicine contains sucrose: therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
The medicine contains lactose; therefore, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Interactions
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 medicines at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.
Concomitant use of diuretics or corticosteroids may increase the risk of laxatives becoming absorbed. Increase the risk of electrolyte imbalance if you take excessive amounts of bisacodyl.
Electrolyte imbalance may lead to increased sensitivity to glycosides.
Milk and antacids may alter the effect of the medicine; leave an interval of at least one hour before taking the laxative.
Undesirable effects
The frequency of adverse events is ranked according to the following criteria:
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),
not known (frequency cannot be estimated from the available data).
Common: The most commonly reported undesirable effects during treatment with STIXENIL are abdominal pain and diarrhoea.
Immune system disorders: anaphylactic reactions, angioedema, and other hypersensitivity reactions. Nervous system disorders: dizziness, syncope (the phenomena of dizziness and syncope that occur after taking bisacodyl appear to be attributable to a vasovagal response following, for example, abdominal pain or stool evacuation).
Metabolism and nutrition disorders: dehydration.
Gastrointestinal disorders: colitis, abdominal cramps, abdominal pain, diarrhea, vomiting, nausea, hematochezia (blood in the stool), abdominal discomfort, anorectal discomfort. Reporting of suspected adverse reactions.
Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.
Overdose
Excessive doses can cause abdominal pain and diarrhea; the resulting loss of fluids and electrolytes must be replaced.
Pregnancy and breastfeeding
There are no adequate and well-controlled studies on the use of Stixenil during pregnancy or breastfeeding. Therefore, the medicine should be used only if necessary, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk to the fetus or infant.
Storage
Do not store above 25°C.
Format
20 coated tablets.
Product Code:FRCM160056
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