Verecolene CM 5 mg 20 coated tablets

Verecolene CM 5 mg 20 coated tablets is a bisacodyl-based laxative , specifically formulated for the short-term treatment of occasional constipation in adults, adolescents and children over 6 years of age. Each coated tablet contains 5 mg of bisacodyl, an active ingredient known for its rapid and targeted action in promoting intestinal regularity and facilitating stool evacuation. The coated tablet formulation ensures simple administration and targeted release of the active ingredient in the intestine, reducing the risk of gastric irritation.

Verecolene CM is indicated for those who suffer from temporary intestinal problems and need an effective laxative drug to restore normal intestinal function. Thanks to its stimulating action on intestinal motility , the product is ideal for adults and adolescents, but can also be used in children over 6 years of age only after medical evaluation. The tablets are convenient to take orally and are particularly suitable for those looking for a reliable and fast solution against occasional constipation.

The presence of excipients such as sucrose and sorbitol makes the product suitable even for those who prefer delicate formulations, while the coating of the tablets contributes to better tolerability. Verecolene CM 5 mg 20 coated tablets is the ideal choice for those who want to regain intestinal regularity in a safe and controlled way, with a product of proven efficacy and quality.

ACTIVE INGREDIENTS

Active ingredients contained in Verecolene CM 5 mg 20 coated tablets - What is the active ingredient of Verecolene CM 5 mg 20 coated tablets?

Each coated tablet contains: • active substance : bisacodyl 5 mg. • excipients with known effect : sucrose 11.3 mg and sorbitol (E420) 0.4 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Verecolene CM 5 mg 20 coated tablets - What does Verecolene CM 5 mg 20 coated tablets contain?

Microcrystalline cellulose, pregelatinized maize starch, talc, glycerol behenate, povidone, sorbitol (E420), shellac, methacrylic acid copolymer, ethyl phthalate, triethyl citrate, titanium dioxide, hypromellose, macrogol stearate 400, macrogol 6000, sucrose.

DIRECTIONS

Therapeutic indications Verecolene CM 5 mg 20 coated tablets - Why is Verecolene CM 5 mg 20 coated tablets used? What is it used for?

Short-term treatment of occasional constipation.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Verecolene CM 5 mg 20 coated tablets - When should Verecolene CM 5 mg 20 coated tablets not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; 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 6 years of age; Contraindicated in pregnancy and breastfeeding (see section 4.6).

DOSAGE

Quantity and method of taking Verecolene CM 5 mg 20 coated tablets - How to take Verecolene CM 5 mg 20 coated tablets?

Dosage The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is recommended to initially use the minimum doses provided. Do not exceed the maximum recommended daily dose. Adults and adolescents over 12 years of age The recommended dose is 1 - 2 tablets per day. Children from 6 to 12 years of age 1 coated tablet per day, only after medical evaluation. Duration of treatment Laxatives should be used as infrequently as possible and for no more than seven days. The prescription for prolonged use should be established after adequate clinical evaluation. Method of administration For oral use. Take preferably after the evening meal. The tablets should be swallowed whole. Swallow with an adequate quantity of water (a large glass).

CONSERVATION

Storage Verecolene CM 5 mg 20 coated tablets - How should Verecolene CM 5 mg 20 coated tablets be stored?

Store at a temperature not exceeding 30° C.

WARNINGS

Warnings Verecolene CM 5 mg 20 coated tablets - About Verecolene CM 5 mg 20 coated tablets it is important to know that:

Like all laxatives, bisacodyl should not be used for more than seven consecutive days without investigating the causes of constipation. In case of diabetes mellitus, hypertension or heart disease, use only after consulting your doctor. 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 more serious cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially in the 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 functions (intestinal atony). Intestinal loss of fluids can cause dehydration. Symptoms may include thirst and oliguria. In patients for whom dehydration may be dangerous (patients with renal insufficiency, elderly patients), treatment with VERECOLENE CM should be interrupted and restarted only under medical supervision (see section 4.8). Cases of dizziness or syncope (see section 4.8) 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 strain 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 haemorrhagic diarrhoea have also been reported after bisacodyl intake (see section 4.8). Some cases have been related to ischaemia of the colonic mucosa. Patients may experience haematochezia (blood in the stool), which is generally mild and self-limiting (see section 4.8). In children between 6 and 12 years of age, the medicine can only be used after medical evaluation. The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of drugs and monitoring during therapy. Inform the patient that it is necessary to inform the doctor if the need for the laxative arises from a sudden change in previous intestinal habits (frequency and characteristics of evacuations) that lasts for 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 subjects or those in poor health to consult their doctor before using the medicine. Important information about some of the excipients VERECOLENE CM contains: • sorbitol . This medicine contains 0.4 mg of sorbitol per tablet. Patients with rare hereditary problems of fructose intolerance should not take this medicine; • sucrose . Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

INTERACTIONS

Interactions Verecolene CM 5 mg 20 coated tablets - Which medicines or foods can modify the effect of Verecolene CM 5 mg 20 coated tablets?

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 2 hours before taking the laxative. Milk and its derivatives, antacids or proton pump inhibitors may modify the effect of the medicine by reducing the resistance of the coating of the tablets and causing dyspepsia and gastric irritation, therefore they should not be taken together with VERECOLENE CM tablets. The concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance if bisacodyl is taken in excessive quantities. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

SIDE EFFECTS

Like all medicines, Verecolene CM 5 mg 20 coated tablets can cause side effects - What are the side effects of Verecolene CM 5 mg 20 coated tablets?

Adverse reactions identified during post-marketing use are listed below. The frequency convention used in the classification of undesirable effects is: 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 (cannot be estimated from the available data). Immune system disorders Rare : anaphylactic reaction, hypersensitivity. Skin and subcutaneous tissue disorders Rare : angioedema. Metabolism and nutrition disorders Rare : dehydration. Nervous system disorders Rare: syncope (see section 4.4). Ear and labyrinth disorders Uncommon : vertigo (see section 4.4). Gastrointestinal disorders Uncommon : haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort (see section 4.4); Common : abdominal pain, abdominal cramps, nausea, diarrhoea; Rare : colitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Verecolene CM 5 mg 20 coated tablets - What are the risks of Verecolene CM 5 mg 20 coated tablets in case of overdose?

Signs and symptoms Excessive doses may cause abdominal cramps, watery stools (diarrhoea), clinically significant losses of fluids, potassium and other electrolytes. Laxatives, taken in chronic overdose, may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal stones. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have been described in association with chronic laxative abuse. See also section 4.4 regarding laxative abuse. Treatment After ingestion of VERECOLENE CM, absorption can be minimised or prevented by inducing vomiting. Fluid replacement and correction of electrolyte imbalance (especially hypokalaemia) may be necessary. This is particularly important in elderly and young patients. The administration of antispasmodics may be useful.

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 Verecolene CM 5 mg 20 coated tablets.

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 medicinal product during pregnancy. Therefore, although no toxic effects have ever been reported during pregnancy, 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. 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 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 infant.

DRIVING AND USE OF MACHINERY

Taking Verecolene CM 5 mg 20 coated tablets before driving or using machines - Does Verecolene CM 5 mg 20 coated tablets affect driving or using machines?

No studies on the effects of bisacodyl on the ability to drive and use machines have been performed. However, patients should be informed that due to vasovagal response (e.g. following abdominal spasm) (see sections 4.4 and 4.8), dizziness and/or syncope may occur. If patients experience abdominal spasm, they should avoid potentially hazardous activities such as driving or operating machinery.