Verecolene CM Omega Chefaro 20 Coated Tablets

Verecolene CM Omega Chefaro - Laxative

Verecolene CM is a bisacodyl-based contact laxative to be taken preferably after the evening meal, so that the laxative effect, which occurs after 10-12 hours, does not disturb sleep.

Composition

Each coated tablet contains: Active Ingredient: Bisacodyl 5 mg For a full list of excipients see 6.1

Excipients

Microcrystalline cellulose, pregelatinised 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. Patients with paralytic ileus, intestinal obstruction or stricture, 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 in pregnancy and lactation (see "Fertility, pregnancy and lactation"). The use of VERECOLENE CM is contraindicated in case of rare hereditary conditions which may be incompatible with the intake of one of the excipients (see section 4.4 "Special warnings and precautions for use").

Dosage

Adults and adolescents over 12 years of age: 1 to 2 coated tablets per day. Children from 4 to 12 years: 1 coated tablet per day, only after consulting your doctor. 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. Take preferably after the evening meal, so that the effect of the laxative, which occurs after 10-12 hours, does not disturb sleep. As with all laxatives, VERECOLENE CM should be used as infrequently as possible and in any case for no more than five continuous 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 favors the effect of the medicine.

Warnings and Precautions

Like all laxatives, bisacodyl should not be used for more than five consecutive days without the cause of the constipation being investigated. In case of diabetes mellitus, hypertension or heart disease use only after consulting your doctor. The 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 nutritional factors. In the most severe cases, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Intestinal fluid loss can cause dehydration. Symptoms can be thirst and oliguria. In patients, for whom dehydration can be dangerous (patients with renal insufficiency, elderly patients), treatment with VERECOLENE CM should be stopped and restarted only under medical supervision (see “Undesirable effects”). There have been reports of dizziness or syncope (see “Undesirable Effects”) in patients who have taken bisacodyl. The available data on these cases suggest that these events may be compatible with defecation syncope (attributable to the effort of defecation itself) or with a vaso-vagal response to abdominal pain that can be associated with constipation and not necessarily with the intake of bisacodyl. . There have also been isolated reports of abdominal pain and haemorrhagic diarrhea after taking bisacodyl (see “Undesirable effects”). Some cases have been related to colonic mucosal ischemia. Patients may experience hematochezia (blood in the stool), which is usually mild and self-limiting (see “Undesirable effects”). In children between 4 and 12 years the medicine can only be used after consulting your doctor. The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the surveillance during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects or when the patient is suffering from diabetes mellitus, hypertension or heart disease. It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine. Important information about some of the ingredients: VERECOLENE CM contains sorbitol therefore patients with rare hereditary problems of fructose intolerance should not take this medicine. VERECOLENE CM contains sucrose therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take tablets of this medicine.

Interactions

Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting 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 can modify the effect of the medicinal product by reducing the resistance of the tablet coating and causing dyspepsia and gastric irritation, therefore they should not be taken together with VERECOLENE CM tablets. diuretics or corticosteroids may increase the risk of electrolyte imbalance if you take too much bisacodyl. Electrolyte imbalance can lead to increased sensitivity to cardiac glycosides.

Side effects

Adverse reactions identified during post-marketing use are listed below. The frequency convention used for the classification of undesirable effects is as follows: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1000 to <1/100) , rare (≥1 / 10,000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). Immune system disorders Rare: anaphylactic reactions, angioedema, hypersensitivity. Metabolism and nutrition disorders Rare: dehydration. Nervous system disorders Uncommon: dizziness (see “Special warnings and special precautions for use”). Rare: syncope (see “Special warnings and special precautions for use”). Gastrointestinal disorders: Uncommon: haematochezia (blood in faeces) vomiting, abdominal discomfort, anorectal discomfort (see “Special warnings and special precautions for use”). Common: abdominal pain, abdominal cramps, nausea, diarrhea. Rare: colitis.

Pregnancy and breastfeeding

No studies have been conducted to investigate the effects on human fertility. There are no adequate and well-controlled studies on the use of the drug in pregnancy. Therefore, although no toxic effects have ever been reported during pregnancy, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus. A clinical study shows that neither the active form of bisacodyl (BHPM or bis- (p-hydroxyphenyl) -pyridyl-2-methane) nor its glucuronic derivatives are excreted in the breast milk of healthy women, however the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the infant.

Format

Pack of 20 coated tablets.