Verecolene CM 20 Coated Tablets 5 mg

WARNINGS
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 the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunction, 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, 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 the drug should be interrupted and restarted only under the supervision of the physician. Cases of dizziness or syncope have been reported 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 may 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. Some cases have been related to colonic mucosal ischemia. Patients may experience haematochezia (blood in stool), which is usually mild and self-limiting. In children between 4 and 12 years the medicine can 'be used only 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 that elderly people or those in poor health conditions consult their doctor before using the medicine. The medicine contains sorbitol and sucrose.
PHARMACOTHERAPEUTIC CATEGORY
Contact laxatives.
STORAGE
Store at a temperature not exceeding 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the 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 younger 'less than 4 years. Contraindicated in pregnancy and lactation. The use is contraindicated in case of rare hereditary conditions which may be incompatible with the intake of one of the excipients.
NAME
VERECOLENE CM 5 MG COATED TABLETS
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.
SIDE EFFECTS
The frequency convention used for the classification of undesirable effects is as follows: very common (> = 1/10), common (> = 1/100, <1/10), uncommon (> = 1/1000, < 1/100), rare (> = 1/10000, <1/1000), very rare (<1/10000), not known (frequency cannot be estimated from the available data). Disorders of the immune system. Rare: anaphylactic reactions, angioedema, hypersensitivity '. Metabolism and nutrition disorders. Rare: dehydration. Nervous system disorders. Uncommon: dizziness; rare: syncope. Gastrointestinal disorders. Uncommon: hematochezia (blood in the stool), vomiting, abdominal discomfort, anorectal disorders; 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 drug must be used only 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.
INDICATIONS
Short-term treatment of occasional constipation.
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 change the effect of the medicine by reducing the strength of the tablet coating and causing dyspepsia and gastric irritation, therefore they should not be taken together with the drug tablets. Concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance if bisacodyl is taken in excessive amounts. Electrolyte imbalance can lead to increased sensitivity to cardiac glycosides.
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 an easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but never exceed 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, the drug 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. Ingest together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine.
ACTIVE PRINCIPLES
Bisacodyl 5 mg.