Dulcolax 5 mg - cure for occasional constipation 40 tablets

Product Description

Tablets for occasional constipation.

Indications

Dulcolax 5 mg coated tablets is a contact laxative recommended for occasional constipation.
It stimulates intestinal movements, accelerates stool transit and promotes evacuation.
The tablets, coated with gastro-resistant layers, dissolve and release the active ingredient only where needed: in the colon.
Taken in the evening, it takes effect in about 12 hours.
Taken in the morning on an empty stomach, it takes effect in about 6 hours and is indicated for adults and children aged 2 years and up (up to 8 years, under medical supervision).
During pregnancy and breastfeeding, the medicine should be used only when necessary and under the direct supervision of a doctor.

Composition

Active ingredients
One 5 mg coated tablet contains: bisacodyl 5 mg. One adult suppository contains: bisacodyl 10 mg. One suppository for children contains: bisacodyl 5 mg.

Excipients
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.

Directions for use and Dosage

Adults: 1-2 coated tablets per day.
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 recommended dose.
The dose can be increased. The recommended daily dose may then be increased to the maximum recommended dose for regular stool evacuation.
The maximum daily dose should never be exceeded.
Take the coated tablets preferably in the evening to induce evacuation the following morning (after approximately 10 hours).
With administration in the morning, on an empty stomach, the effect is obtained 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 or proton pump inhibitors.
The coated tablets should be swallowed whole.
Swallow together with an adequate amount of water (a large glass).
A diet rich in liquids promotes the effect of the medicine.

Warnings

The medicine 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.
Abuse of laxatives can cause persistent diarrhea with consequent loss of water, mineral salts, and other essential nutrients.
In more severe 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.
Intestinal fluid loss can cause dehydration.
Symptoms may include thirst and oliguria.
In patients for whom dehydration could be dangerous, treatment should be discontinued.
In patients with severe dehydration, treatment should be discontinued. Hematochezia (blood in the stool) may occur, which is usually mild and disappears on its own.
Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence, chronic constipation, and loss of normal bowel function (intestinal atony).
Cases of dizziness and/or syncope have been reported.
Data from these cases suggest that the events 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, particularly in patients with fissures and ulcerative proctitis.
Stimulant laxatives do not contribute to weight loss.
The tablets contain lactose and sucrose. The tablet may contain lactose. cause gastric disturbances and diarrhea.
In children between 2 and 10 years of age, the medicine should be used only after consulting a doctor.
Like all laxatives, it should not be taken daily or for prolonged periods without first evaluating the cause of constipation. 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 that lasts for more than a few days. two weeks or when the use of the laxative fails to produce effects.
It is also advisable for elderly or unhealthy subjects to consult their doctor before using the medicine.
For further information, read the package leaflet carefully.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
Patients with paralytic ileus, acute abdominal conditions, such as appendicitis, and severe abdominal pain associated with nausea and vomiting that may be indicative of serious pathological conditions, in intestinal obstruction or stenosis, acute inflammation of the gastrointestinal tract, rectal bleeding of unknown origin, severe dehydration.
Pregnancy and breastfeeding.
Use is contraindicated in case of rare hereditary conditions that may be incompatible with the intake of one of the excipients.

Interactions

Concomitant administration of diuretics or adrenocorticosteroids or excessive doses of the drug may increase the risk of electrolyte imbalance.
This imbalance, in turn, may lead to increased sensitivity to cardiac glycosides.
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, wait at least two hours before taking the laxative.
Milk or antacids may alter the effect of the medicine; wait at least one hour before taking the laxative.
Concomitant use of other laxatives may increase the risk of electrolyte imbalance. potentiate gastrointestinal side effects.

Undesirable effects

The most commonly reported adverse effects during treatment are abdominal pain and diarrhea.
Immune system disorders: anaphylactic reactions, angioneurotic edema as well as 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 appear to be attributable to a vasovagal response.
Gastrointestinal disorders: abdominal cramps, abdominal pain, diarrhea, nausea, hematochezia, vomiting, abdominal discomfort, anorectal discomfort, colitis including ischemic colitis.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. 

Pregnancy and Breastfeeding

Pregnancy
There are no adequate and well-controlled studies on the use of the medicinal product during pregnancy.
Therefore, although no undesirable or toxic effects have ever been reported during pregnancy, like all medicines, the drug should only be used in if necessary, after evaluating the expected benefit for the mother in relation to the possible risk to the fetus.
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, after evaluating the expected benefit for the mother in relation to the possible risk to the infant.

Format

40 5 mg coated tablets.