Verecolene c.m. 5 mg - treatment of occasional constipation 20 coated tablets

Product Description

Coated Tablets

Composition

Each coated tablet contains: Active ingredient: Bisacodyl 5 mg

Excipients

Microcrystalline cellulose, pregelatinized maize starch, talc, glycerol behenate, povidone, sorbitol, shellac, methacrylic acid copolymer, ethyl phthalate, triethyl citrate, titanium dioxide, hypromellose, macrogol stearate 400, macrogol 6000, sucrose.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active substance or to any of the excipients excipients. Patients with paralytic ileus, intestinal obstruction or stenosis, acute abdominal conditions including appendicitis, acute inflammatory bowel disease, and severe abdominal pain associated with nausea and vomiting, which may be indicative of the conditions listed above. Rectal bleeding of unknown origin, severe dehydration, gastroenteritis. Contraindicated in children under 4 years of age. Contraindicated during pregnancy and breastfeeding. The use of VERECOLENE C.M. is contraindicated in case of rare hereditary conditions that may be incompatible with the intake of one of the excipients.

Dosage

Adults and adolescents over 12 years of age: 1 to 2 coated tablets per day. Children 4 to 12 years of age: 1 coated tablet per day, only after consulting a doctor. 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 then be increased, but never exceed the maximum indicated. It is best to take it after the evening meal, so that the laxative's effect, which occurs after 10-12 hours, does not disturb sleep. As with all laxatives, VERECOLENE C.M. should be used as infrequently as possible and in any case for no more than five consecutive days. Use for longer periods 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 medicine's effect.

Warnings and Precautions

Like all laxatives, bisacodyl should not be used for more than five consecutive days without investigating the causes of constipation. In case of diabetes mellitus, hypertension, or heart disease, use only after consulting your doctor. Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium), and other essential nutrients. In more severe cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially in case of concomitant treatment with cardiac glycosides, diuretics, or corticosteroids. Laxative abuse, 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). Intestinal fluid loss can cause dehydration. Symptoms may include thirst and oliguria. In patients for whom dehydration may be a serious health problem, the use of laxatives is contraindicated. be dangerous (patients with renal insufficiency, elderly patients), treatment with VERECOLENE C.M. should be interrupted and restarted only under medical supervision (see “Undesirable effects”). Cases of dizziness or syncope (see “Undesirable effects”) have been reported in patients taking bisacodyl. Available data on these cases suggest that these events may be compatible with defecation-induced syncope (attributable to the straining of defecation itself) or with a vasovagal response to abdominal pain that may be associated with constipation and not necessarily with bisacodyl intake. Isolated cases of abdominal pain and bloody diarrhea have also been reported after taking bisacodyl (see “Undesirable effects”). Some cases have been related to ischemia of the colonic mucosa. Patients may experience haematochezia (blood in the stool), which is generally mild and self-limiting (see "Side effects"). In children between 4 and 12 years of age, the medicine should be used only after consulting a 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 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. Important information about some of the excipients: VERECOLENE C.M. contains sorbitol, therefore patients with rare hereditary problems of fructose intolerance should not take this medicine. VERECOLENE C.M. contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine.

Interactions

Laxatives can 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 2 hours before taking the laxative. Milk and its derivatives, antacids, or proton pump inhibitors may alter the effect of the medicine by reducing the resistance of the tablet coating and causing dyspepsia and gastric irritation, therefore they should not be taken together with VERECOLENE C.M. tablets. Concomitant use of diuretics or corticosteroids may increase the risk of laxatives. Increase the risk of electrolyte imbalance if bisacodyl is taken in excessive amounts. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.