Dulcolax adults 10mg 6 suppositories

Dulcolax Adults 10mg is a bisacodyl -based laxative, indicated for the treatment of occasional constipation . Its suppository formulation guarantees rapid and effective action, gently stimulating intestinal motility and promoting regular evacuation within 20-60 minutes of use . Its localized action reduces the risk of gastric irritation, making it suitable even for those who have difficulty with oral laxatives.

ACTIVE INGREDIENTS

Active ingredients contained in Dulcolax adults 10mg 6 suppositories - What is the active ingredient of Dulcolax adults 10mg 6 suppositories?

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 full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Dulcolax adults 10mg 6 suppositories - What does Dulcolax adults 10mg 6 suppositories contain?

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

Therapeutic indications Dulcolax adults 10mg 6 suppositories - Why is Dulcolax adults 10mg 6 suppositories used? What is it used for?

Short-term treatment of occasional constipation.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Dulcolax adults 10mg 6 suppositories - When should Dulcolax adults 10mg 6 suppositories not be used?

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 pathological conditions, in intestinal obstruction or stenosis, acute inflammation of the gastrointestinal tract, rectal bleeding of unknown origin, severe dehydration. Pregnancy and breast-feeding (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. Suppositories are contraindicated in cases of anal fissures and ulcers (perianal pain and bleeding may occur).

DOSAGE

Quantity and method of taking Dulcolax adults 10mg 6 suppositories - How to take Dulcolax adults 10mg 6 suppositories?

COATED TABLETS - Adults: 1-2 coated tablets per day. Paediatric 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 recommended 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 cause 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 (for example 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 between 2 and 10 years of age: 1 children's suppository (5 mg) per day. The maximum daily dose should never be exceeded. Children aged 10 years or younger 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 suppositories usually occurs in about 20 minutes (range: 10 - 30 minutes). Do not exceed the recommended doses. 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.

CONSERVATION

Storage Dulcolax adults 10mg 6 suppositories - How is Dulcolax adults 10mg 6 suppositories stored?

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

WARNINGS

Warnings Dulcolax adults 10mg 6 suppositories - About Dulcolax adults 10mg 6 suppositories it is important to know that:

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. 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 nutrients. In more serious 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 be thirst and oliguria. In patients for whom dehydration can be dangerous (patients with renal insufficiency, elderly patients), treatment with Dulcolax must be interrupted and resumed only under the supervision of a doctor. Haematochezia (blood in the stool) may occur in patients, which is usually mild and disappears on its own. Abuse of laxatives, especially contact laxatives (stimulant laxatives), may cause dependence (and therefore a possible need to progressively increase the dosage), chronic constipation and loss of normal bowel function (intestinal atony). Cases of dizziness and/or syncope have been reported after taking Dulcolax. Data from 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 straining of the act 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 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 at 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. Dulcolax tablets contain 23.4 mg of sucrose equivalent to 46.8 mg at 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 can only be used after consulting 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 a doctor for diagnosis, prescription of drugs 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 for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable for elderly subjects or those in poor health to consult their doctor before using the medicine.

INTERACTIONS

Interactions Dulcolax adults 10mg 6 suppositories - Which medicines or foods can modify the effect of Dulcolax adults 10mg 6 suppositories?

Concomitant administration of diuretics or adrenocorticosteroids and excessive doses of Dulcolax may lead to an increased 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 simultaneously by mouth. Therefore, avoid taking 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 may modify the effect of the medicine; leave an interval of at least one hour before taking the laxative. Concomitant use of other laxatives may potentiate the gastrointestinal side effects of Dulcolax.

SIDE EFFECTS

Like all medicines, Dulcolax adults 10mg 6 suppositories can cause side effects - What are the side effects of Dulcolax adults 10mg 6 suppositories?

The most commonly reported undesirable effects during treatment with Dulcolax are abdominal pain and diarrhoea. Immune system disorders : anaphylactic reactions, angioneurotic oedema 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 (following, for example, abdominal pain, or the evacuation of stool). Gastrointestinal disorders : abdominal cramps, abdominal pain, diarrhoea, nausea, haematochezia (blood in the stool), vomiting, abdominal discomfort, anorectal discomfort, colitis including ischaemic colitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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

Overdose Dulcolax adults 10mg 6 suppositories - What are the risks of Dulcolax adults 10mg 6 suppositories in case of overdose?

Symptoms Excessive doses may cause abdominal pain and diarrhoea, and significant losses of potassium and other electrolytes. Chronic overdose of Dulcolax, as with other laxatives, may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse. See also the section “Special warnings and precautions for use” regarding laxative abuse. Treatment If treatment is undertaken within a short time of ingestion of the oral form of Dulcolax, absorption may be reduced or prevented by inducing vomiting or gastric lavage. Fluid and electrolyte losses must be replaced. This is particularly important in elderly and young patients. Administration of antispasmodics may be useful.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Dulcolax adults 10mg 6 suppositories.

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, Dulcolax should be used only when necessary, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the foetus. 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 medicinal product should be used only when 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.

DRIVING AND USE OF MACHINERY

Taking Dulcolax adults 10mg 6 suppositories before driving or using machines - Does Dulcolax adults 10mg 6 suppositories affect driving or using machines?

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be informed that due to vasovagal response (e.g. following abdominal spasm), dizziness and/or syncope may occur. If patients experience abdominal spasm, they should avoid potentially hazardous activities such as driving or operating machinery.