VERECOLENE CM 20CPR RIV 5MG

VERECOLENE C.M. 5 MG STATEMENTS

active ingredients

Each coated tablet contains: • active ingredient: bisacodyle 5 mg. • excipients with known effects: sucrose 11,3 mg and sorbitol (E420) 0.4 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Microcrystalline cellulose, pregelatinized maize starch, talc, glycerol, povidone, sorbitol (E420), lacquer rubber, methacrylic acid copolymer, ethyl phthalate, triethylcytrate, titanium dioxide, hypopromellose, macrogol stearate 400, macrogol 6000, sucrose.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; Patients with paralytic ileum, obstruction or intestinal stenosis, acute abdomen conditions including appendicitis, acute inflammatory diseases of the intestine and intense 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 nursing (see paragraph 4.6).

Population

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

Conservation

Store at temperature not exceeding 30 ° C.

Warnings

Like all laxatives, the bisacodile should not be used for more than seven consecutive days without the cause of constipation being investigated. In case of diabetes mellitus, hypertension or cardiopathy use only after consulting your doctor. Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). The intestinal loss of liquids can cause dehydration. Symptoms can be thirsty and oliguria. In patients, for whom dehydration can be dangerous (patients with kidney failure, elderly patients), treatment with VERECOLENE C.M. must be interrupted and resumed only under the supervision of the doctor (see paragraph 4.8). Cases of dizziness or syncopathetics were reported (see paragraph 4.8) in patients who took bisacodyle. The data available about these cases suggest that such events may be compatible with the defecation syncope (adjustable to the defecation effort itself) or with a vaso-vagal response to abdominal pains that may be associated with stipsi and not necessarily with the assumption of bisacodile. Insulated cases of abdominal pain and hemorrhagic diarrhea were also reported after taking bisacodyle (see paragraph 4.8). Some cases were related to ischemia of the colon mucosa. Patients may manifest hematochetia (blood in feces), generally mild and self-limiting (see paragraph 4.8). In children between 6 and 12 years the medicine can only be used after medical evaluation. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Informing the patient that it is necessary to inform the doctor if the need for laxative comes from a sudden change of previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of laxative fails to produce effects or when the patient is suffering from diabetes mellitus, hypertension or cardiopathy. You should also consult your doctor before using the medicine. Important information about some excipients VERECOLENE C.M. 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-galactosis mal absorption, or sucrasis-isomaltase deficiency, should not take the tablets of this medicine.

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid ingesting laxatives and other drugs at the same time: after taking a medicine let spend a range of at least 2 hours before taking laxative. Milk and its derivatives, antacids or protonic pump inhibitors can change the effect of the drug by reducing the resistance of the coating of the tablets and causing gastric dispepsia and irritation, therefore should not be taken along with tablets of VERECOLENE C.M. Concurrent use of diuretics or corticosteroids can increase the risk of electrolytic imbalance if you take bisacodyle in excessive quantities. Electrolytic imbalance can result in increased sensitivity to cardiac glycosides.

Effects

Below are the adverse reactions identified during post-marketing use. The frequency convention used for the classification of unwanted effects is as follows: very common (≥1/10), common (≥1/100, immune system disorders Rare: anaphylactic reaction, hypersensitivity. Pathologies of skin and subcutaneous tissue Rare: angioedema. Disorders of metabolism and nutrition Rare: dehydration. Diseases of the nervous system Raro: syncope (see paragraph 4.4). Ear and labyrinth pathologies Not common: vertigo (see paragraph 4.4). Gastrointestinal diseases Not common: hematochetia (blood in the feces) vomiting, abdominal disorder, anorenal discomfort (see paragraph 4.4); Town: abdominal pain, abdominal cramps, nausea, diarrhea; Rare: colitis. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Signs and symptoms Excessive doses can cause abdominal cramps, aqueous feces (diarrhea) clinically significant losses of liquids, potassium and other electrolytes. Laxatives, assumed in chronic overdose, can cause chronic diarrhea, abdominal pain, hypokaliemia, secondary hyperaldosteronism and kidney stones. In association with chronic laxative abuse they have been described: renal tubular damage, metabolic alkalosis and secondary muscle weakness to hypokalemia. See also paragraph 4.4 about the abuse of laxatives. Treatment After ingestion of VERECOLENE C.M., it can be minimized or prevented by causing vomiting. Liquid reintegration and the correction of electrolytic imbalance (especially hypokaliemia). This is particularly important in older patients and young people. Spasmolytic administration may be useful.

Studies have not been conducted to investigate the effects on human fertility. There are no adequate and well-controlled studies on the use of the medicinal product in pregnancy. Therefore, although no toxic effects were reported during pregnancy, the medicinal product should only be used if necessary, under the direct control 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 bisacodile (BHPM or bis-(p-hydroxyfenil)-piridil-2-methane), nor its glucuronic derivatives are excreted in breast milk of healthy women, however the medicinal product must be used only in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk.

Source: Farmadati