DULCOLAX*40COATED TABLETS 5MG

Dulcolax 5 mg coated tablets
Dulcolax adult 10 mg suppositories
Bisacodyl

What it is and what it is used for
Dulcolax contains bisacodyl. It belongs to a group of medicines called contact laxatives.
Dulcolax works by stimulating bowel movements, speeding up the passage of bowel contents.
Dulcolax is used in adults, children and adolescents aged 2 to 18 years for the short-term treatment of occasional constipation.
Contact your doctor if you do not feel better or if you feel worse after 7 days.

What you need to know before taking the medicine
Do not take/give Dulcolax to your child
- if you and/or your child are allergic to bisacodyl or any of the other ingredients of this medicine (listed in paragraph 6);
- if you and/or your child suffer from an arrest of the progression of intestinal contents due to a blockage of the intestinal muscles (paralytic ileus);
- if you and/or your child suffer from acute abdominal conditions, such as inflammation of the appendix, a part of the intestine (appendicitis), and severe abdominal pain associated with nausea and vomiting which may be indicative signs of serious illnesses;
- if you and/or your child suffer from intestinal obstruction or narrowing (intestinal stenosis);
- if you and/or your child suffer from acute inflammation of the stomach and intestine; if you and/or your child suffer from bleeding from the rectum of unknown origin;
- if you and/or your child suffer from severe loss of water from the body (dehydration);
- if you and/or your child suffer from a hereditary disease that may be incompatible with the assumption of one of the excipients (see paragraph 2 Dulcolax contains lactose);
- if your child is under 2 years of age;
- if you and/or your child suffer from anal fissures and ulcers, do not take/do not give your child suppositories (perianal pain and bleeding may occur).

If you are pregnant or breastfeeding, see the Pregnancy and breastfeeding section.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Dulcolax to your child.
Cases of dizziness and/or fainting (syncope) have been reported after taking Dulcolax. Data relating to these cases suggest that the events, rather than a phenomenon related to taking Dulcolax, could be interpreted as a manifestation of fainting (syncope) from defecation (attributable to the effort of defecation), or as a reflexive response to abdominal pain related to constipation itself.
The use of suppositories can lead to painful sensations and local irritation, especially in the presence of fissures and inflammatory disease of the rectum (ulcerative proctitis) (see paragraph 2 Do not take/do not give Dulcolax to your child).
Like all laxatives, do not take/do not give Dulcolax to your child daily or for prolonged periods without your doctor having first evaluated the cause of constipation. The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medicines and monitoring during therapy.
In particular, consult your doctor:
• when the need for the laxative results 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;
• if you are elderly or in poor health;
• if you/your child suffer from diabetes mellitus, high blood pressure (hypertension) or heart disease (cardiopathy).

Laxative abuse
Laxative abuse (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent fluid loss (dehydration) or decreased blood potassium levels (hypokalemia).
In the most severe cases, the decrease in potassium can cause heart or muscle disorders, especially if you are undergoing simultaneous treatment with certain heart medications (cardiac glycosides), with medications that increase urine production (diuretics) or with those used to treat inflammation (corticosteroids).
Symptoms of intestinal fluid loss (dehydration) can be thirst and reduced urine output (oliguria).
Fluid loss (dehydration) can be dangerous if you/your child suffer from reduced kidney function (renal insufficiency) or if you are elderly; therefore, stop treatment with Dulcolax and consult your doctor. The presence of blood in the stools (hematochezia) may also occur, which is generally mild and resolves on its own.
Avoid frequent or prolonged use of the medicine as it can lead to addiction and dependence (i.e., the need to progressively increase the dosage and not be able to do without the medicine) as well as chronic constipation and loss of normal bowel function (intestinal atony).
Stimulant laxatives including Dulcolax do not contribute to weight loss.

Children
In children aged between 2 and 10 years, the medicine can only be used after consulting a doctor.
Dulcolax should not be used in children under two years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are listed by frequency:

common (may affect up to 1 in 10 patients)
• abdominal cramps, abdominal pain, diarrhea, nausea.
uncommon (may affect up to 1 in 100 patients)
• dizziness;
• blood in the stools (hematochezia), vomiting, abdominal discomfort, anorectal discomfort.
rare (may affect up to 1 in 1,000 patients)
• anaphylactic reactions, swelling of the skin and mucous membranes of the face, lips and throat (angioedema);
• hypersensitivity, fluid loss (dehydration);
• fainting (syncope);
• inflammation of the intestine (colitis, including ischemic colitis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.