Dulcolax 40 coated tablets 5mg

  • Opella Healthcare Italy S.r.l
  • 008997064

Dulcolax is a drug based on the active ingredient bisacodil (DC.IT), belonging to the category of laxatives and specifically contact laxatives. Dulcolax can be prescribed with OTC Recipe - self-medication. Short-term treatment of occasional constipation.

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DULCOLAX * 40CPR RIV 5MG

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage and method of use

COATED TABLETS - Adults: 1-2 coated tablets per day.Pediatric 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 lowest expected dose. The dose can then be increased, up to the maximum recommended dose, for regular stool evacuation. The maximum daily dose must never be exceeded.Instructions for UseTake the coated tablets preferably in the evening to evacuate the next 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. Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine. 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 child suppository (5 mg) per day. The maximum daily dose must never be exceeded. Children aged 10 years and younger with chronic or persistent constipation should take Dulcolax under the supervision of their doctor. Dulcolax should not be given to children younger than two years of age.Instructions for UseThe effect of 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 more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.

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 indicative of serious medical conditions, 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 any of the excipients (see section 4.4 "Special warnings and precautions for use"). Dulcolax is contraindicated in children under 2 years of age. Suppositories are contraindicated in cases of anal fissures and ulcers (pain and perianal bleeding may occur).

Side effects

The most commonly reported side effects during treatment with Dulcolax are abdominal pain and diarrhea.Disorders of the immune system: anaphylactic reactions, angioneurotic edema as well as other hypersensitivity reactions.Metabolism and nutrition disorders: dehydration.Disorders of the nervous system: dizziness, syncope. The phenomena of dizziness and syncope that occur after taking bisacodyl seem to be attributable to a vasovagal response (resulting, for example, from abdominal pain, or to the evacuation of stools).Gastrointestinal disorders: abdominal cramps, abdominal pain, diarrhea, nausea, hematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort, colitis including ischemic colitis.Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.

Special warnings

WarningsLike 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. 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 severe cases, the onset of dehydration or hypokalemia is possible, which can cause cardiac or neuromuscular dysfunctions, 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 be stopped and restarted only under medical supervision. In patients, hematochezia (blood in the stool) may occur, which is usually mild and goes away on its own. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually 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 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 ingredients:Dulcolax tablets contain 33.2 mg oflactoseequivalent 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 ofsucroseequal 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 can cause stomach upset and diarrhea.Precautions for useIn children aged 2 to 10 years, the medicine can only be used after consultation with your 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 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. It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine.

Pregnancy and breastfeeding

PregnancyThere are no adequate and well-controlled studies on the use of the drug in pregnancy. Therefore, although no adverse or toxic effects have ever been reported during pregnancy, like all medicines, Dulcolax should only be used as needed, under the direct supervision of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk to the fetus.FertilityNo studies have been conducted to investigate the effects on human fertility.Feeding timeClinical 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 cases 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.

Expiration and retention

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

Interactions with other drugs

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 an increase in sensitivity to cardiac glycosides. 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 two hours before taking the laxative. Milk or antacids can change 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.

Overdose

SymptomsExcessive doses can cause abdominal pain and diarrhea, and significant losses of potassium and other electrolytes. Chronic overdose of Dulcolax, like other laxatives, can cause chronic diarrhea, abdominal pain, hypokalemia, secondary aldosteronism and kidney stones. In association with chronic laxative abuse, renal tubular injury, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described. See also the information in the section “Special warnings and precautions for use” regarding the abuse of laxatives.TreatmentIf taken shortly after ingestion of the oral form of Dulcolax, absorption can be reduced or avoided by induction of vomiting or gastric lavage. Leaks of fluids and electrolytes must be replaced. This is particularly important in elderly and young patients. The administration of spasmolytics may be useful.

Active principles

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

Excipients

COATED TABLETSLactose 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.

008997064

Data sheet

Packaging
5 mg 40 coated tablets
Product Type
HUMAN DRUG
ATC code
A06AB02
ATC description
Bisacodyl
Therapeutic Group
Laxatives
Active principle
bisacodyl (DC.IT)
Class
C.
Pharmaceutical form
coated tablet
coated tablets
Type of Administration
oral
Container
blister
Quantity
40 coated tablets
Quantity of the Active Ingredient
5MG
Recipe required
OTC - self-medication medicine
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