Dulcolax 20 tablets coated with 5 mg

Product Description

Indications

Short-term treatment of occasional constipation.

Ingredients

One coated tablet contains: bisacodyl 5 mg. Excipients with known effect: lactose, sucrose, castor oil.

Excipients

COATED TABLETS Lactose monohydrate, maize 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.

Directions for use and dosage

COATED TABLETS - Adults: 1-2 coated tablets per day. Paediatric population - Children over 10 years: 1-2 coated tablets per day. - Children aged 2 to 10 years: 1 coated tablet per day. It is advisable to start with the minimum recommended dose. The dose can then be increased up to the maximum recommended dose to ensure regular stool evacuation. The maximum daily dose should never be exceeded. Instructions for use Take the coated tablets preferably in the evening to induce a bowel movement the following morning (after approximately 10 hours). When administered in the morning, on an empty stomach, the effect is achieved after approximately 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. Swallow with an adequate amount of water (a large glass). A diet rich in liquids promotes the effect of the medicine. SUPPOSITORIES - Adults: 1 adult suppository (10 mg) per day. Paediatric population - Children over 10 years: 1 adult suppository (10 mg) per day. - Children aged 2 to 10 years: 1 children's suppository (5 mg) per day. The maximum daily dose should never be exceeded. Children aged 10 years and under with chronic or persistent constipation should take Dulcolax under the supervision of a doctor. Dulcolax should not be administered to children under two years of age. Instructions for use The effect of the suppositories usually occurs within about 20 minutes (range: 10 - 30 minutes). Do not exceed the recommended doses. Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods requires a doctor's prescription after appropriate evaluation of the individual case.

Storage

Coated tablets: This medicine 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 constipation. In case of diabetes mellitus, hypertension or heart disease, use only after consulting your doctor. Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients. In more severe cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially in case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids. Intestinal loss of fluids can cause dehydration. Symptoms may include thirst and oliguria. In patients for whom dehydration could be dangerous (patients with renal insufficiency, elderly patients), treatment with Dulcolax should be discontinued and resumed only under medical supervision. Hematochezia (blood in the stool) may occur in patients, which is generally mild and resolves on its own. 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 function (intestinal atony). Cases of dizziness and/or syncope have been reported after taking Dulcolax. Data from these cases suggest that these events, rather than being related to the use of Dulcolax, could be interpreted as a manifestation of "defecation syncope" (attributable to the straining of defecation) or as a vasovagal response to abdominal pain related to constipation itself. The use of suppositories may lead to painful sensations and local irritation, in particular, in patients with anal 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 equivalent 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 tablets of this medicine. Dulcolax tablets contain 23.4 mg of sucrose equivalent 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 tablets of this medicine. Dulcolax tablets may cause gastric disturbances and diarrhoea. Precautions for use In children aged between 2 and 10 years, the medicine should only be used after consulting a doctor (see section 4.3). Like all laxatives, it should not be taken daily or for prolonged periods without first evaluating the cause of constipation. The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications, and monitoring during therapy. Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts more than two weeks or when laxative use fails to produce effects. It is also advisable for elderly or otherwise unhealthy individuals to consult their doctor before using the medicine.

Pregnancy and breastfeeding

Pregnancy There are no adequate and well-controlled studies on the use of the medicine during pregnancy. Therefore, although no adverse or toxic effects have ever been reported during pregnancy, like all medicines, Dulcolax should be used only when necessary, under the direct supervision of a doctor, after weighing the expected benefit to the mother against the possible risk to the fetus. Fertility No studies have been conducted to investigate the effects on human fertility. Breastfeeding Clinical data demonstrate 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 medicine should be used only if 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.

Format

Pack of 20 tablets.