DULCOLAX 20CPR RIV 5MG

DULCOLAX

active principles

COATED TABLETS One coated tablet contains: bisacodyl 5 mg. Excipients with known effect: lactose, sucrose, castor oil. ADULTS SUPPOSITORIES One suppository contains: bisacodyl 10 mg. CHILDREN SUPPOSITORIES One suppository contains: bisacodyl 5 mg. For the complete list of excipients, see section 6.1.

Exceptions

COATED TABLETS Lactose monohydrate, corn starch, modified starch, glycerol, magnesium stearate, sucrose, talc, gum arabic, titanium dioxide (E171), methacrylic acid/methyl methacrylate copolymer (1:1), methacrylic acid/methyl methacrylate copolymer (1:2), castor oil, macrogol 6000, iron oxide (E172), white wax, carnauba wax, shellac. SUPPOSITORIES Triglycerides of saturated fatty acids.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Dulcolax is also contraindicated in patients with paralytic ileus, acute abdominal conditions, such as appendicitis, and severe abdominal pain associated with nausea and vomiting which may be signs indicative of serious pathological conditions, in intestinal obstruction or stricture, acute inflammation of the gastrointestinal tract, bleeding rectal of unknown origin, severe dehydration. Pregnancy and lactation (see section 4.6). The use of Dulcolax 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"). Dulcolax is contraindicated in children under 2 years of age. The suppositories are contraindicated in cases of anal fissures and ulcers (perianal pain and bleeding may occur).

Posology

COATED TABLETS - Adults: 1-2 coated tablets per day. Pediatric population - Children over 10 years: 1-2 coated tablets per day. - Children aged between 2 and 10 years: 1 coated tablet per day. It is advisable to start with the minimum expected dose. The dose can then be increased, up to the maximum recommended dose, for regular stool evacuation. The maximum daily dose should never be exceeded. Instructions for Use Take the coated tablets preferably in the evening to determine an evacuation the following morning (after about 10 hours). With administration in the morning, on an empty stomach, the effect is obtained after about five hours. The coated tablets should not be administered together with products that reduce the acidity of the upper gastrointestinal tract, such as milk, antacids (e.g. bicarbonate) or proton pump inhibitors. The coated tablets should be swallowed whole. Ingest together with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicinal product. SUPPOSITORIES - Adults: 1 adult suppository (10 mg) per day. Pediatric population - Children over 10 years: 1 adult suppository (10 mg) per day. - Children aged between 2 and 10 years: 1 suppository children (5 mg) per day. The maximum daily dose should never be exceeded. Children 10 years of age and younger with chronic or persistent constipation should take Dulcolax under doctor's supervision. Dulcolax should not be given to children younger than two years of age. Instructions for Use The effect of the suppositories usually occurs in about 20 minutes (range: 10 - 30 minutes). Do not exceed the recommended dose. Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.

Storage

Coated tablets: This medicinal product does not require any special storage conditions. Suppositories: Do not store above 30°C.

Warnings

Warnings Like all laxatives, Dulcolax should not be taken continuously every day or for long periods of time without investigating the cause of the constipation. 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 serious cases, the onset of dehydration or hypokalaemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. 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 Dulcolax should only be interrupted and restarted under medical supervision. Patients may experience hematochezia (blood in stool), which is usually mild and goes away on its own. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, the possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Cases of dizziness and/or syncope have been reported after taking Dulcolax. The data relating to these cases suggest that the events, rather than a phenomenon related to the intake of Dulcolax, could be interpreted as a manifestation of "defecation syncope" (attributable to the effort of the act of defecation), or as a vasovagal response to the abdominal pain related to constipation itself. The use of suppositories can lead to painful sensations and local irritation, in particular, in patients with fissures and ulcerative proctitis (see section 4.3 "Contraindications"). Stimulant laxatives including Dulcolax do not contribute to weight loss (see section 5.1 "Pharmacodynamic properties"). Important information about some of the excipients: Dulcolax tablets contain 33.2 mg of lactose equal to 66.42 mg when taking the maximum daily dose, for the treatment of constipation in adults and adolescents over 10 years of age. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine tablets. Dulcolax tablets contain 23.4 mg of sucrose equal to 46.8 mg when taking the maximum daily dose for the treatment of constipation in adults and adolescents over 10 years of age. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine tablets. Dulcolax tablets can cause stomach upset and diarrhoea. Usage precautions In children aged between 2 and 10 years the medicinal product can only be used after consulting the doctor (see section 4.3). Like all laxatives it should not be taken daily or for prolonged periods without first assessing the cause of the constipation. The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for a laxative derives from a sudden change in previous bowel habits (frequency and characteristics of evacuations) that has lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that the elderly or in poor health conditions consult their doctor before using the medicine.

Interactions

Concomitant administration of diuretics or adrenocorticosteroids and excessive doses of Dulcolax may lead to an increased risk of electrolyte imbalance. This imbalance, in turn, can lead to increased sensitivity to cardiac glycosides. Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other medicines at the same time: after taking a medicine, leave an interval of at least two hours before taking the laxative. Milk or antacids can modify the effect of the medicine; leave an interval of at least an hour before taking the laxative. Concomitant use of other laxatives may potentiate the gastrointestinal side effects of Dulcolax.

Effects

The most commonly reported side effects during treatment with Dulcolax are abdominal pain and diarrhoea. Immune system disorders: anaphylactic reactions, angioneurotic edema as well as other hypersensitivity reactions. Metabolism and nutrition disorders: dehydration. Nervous system disorders: dizziness, syncope. The phenomena of dizziness and syncope that occur after taking bisacodyl seem to be attributable to a vasovagal response (consequent, for example, to abdominal pain, or to the evacuation of faeces). Gastrointestinal pathologies: Abdominal cramps, abdominal pain, diarrhoea, nausea, hematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort, colitis including ischemic colitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous 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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdose

Symptoms Excessive doses can cause abdominal pain and diarrhea, and significant losses of potassium and other electrolytes. Chronic overdose of Dulcolax, as with other laxatives, can cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and kidney stones. Renal tubular injury, metabolic alkalosis, and muscle weakness secondary to hypokalemia have also been described in association with chronic laxative abuse. See also what is reported in the paragraph "Special warnings and precautions for use" about the abuse of laxatives. Treatment If action is taken soon after ingestion of the oral form of Dulcolax, absorption can be reduced or avoided by induction of vomiting or gastric lavage. Leaked fluids and electrolytes must be replaced. This is especially important in elderly patients and young people. The administration of spasmolytics may be useful.

Pregnancy

There are no adequate and well-controlled studies on the use of the medicine in pregnancy. Therefore, although undesirable or toxic effects have never been reported during pregnancy, like all medicines, Dulcolax should only be used if necessary, under direct medical supervision, after evaluating the expected benefit for the mother in relation to the possible risk to the fetus.

Fertility

No studies have been conducted to investigate the effects on human fertility.

Feeding time

Clinical data show that neither the active form of bisacodyl BHPM, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), nor its glucuronic derivatives are excreted in breast milk, however the medicinal product should only be used in case of necessary, under the direct supervision of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the infant.

Source: Farmadati