Name
DULCOLAX 5 mg coated tablets
DULCOLAX adults 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, accelerating the passage of intestinal 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 your child Dulcolax
- if you and/or your child are allergic to bisacodyl or any of the other ingredients of this medicine (listed in section 6);
- if you and/or your child suffer from an arrest in 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 tummy pain associated with nausea and vomiting which may be signs of serious illness;
- if you and/or your child suffer from obstruction or narrowing of the intestine (intestinal stenosis);
- if you and/or your child suffer from acute inflammation of the stomach and intestines;
- if you and/or your child suffer from rectal bleeding of unknown origin;
- if you and/or your child suffer from severe loss of water from the body (state of dehydration);
- if you and/or your child suffer from a hereditary disease which may be incompatible with the intake of one of the excipients (see paragraph 2. "Dulcolax contains lactose and sucrose");
- if your child is under 2 years old;
- if you and/or your child suffer from anal fissures and ulcers, do not take/give your child the suppositories (pain and perianal bleeding may occur).

If you are pregnant or breast-feeding, see section "Pregnancy and breast-feeding".


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. 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 "fainting (syncope) from defecation" (attributable to the effort of the act of defecation), or as a reflex response to abdominal pain related to constipation itself.
The use of suppositories may lead to painful sensations and local irritation, in particular, in the presence of anal fissures and inflammatory disease of the rectum (ulcerative proctitis) (see paragraph 2 "Do not take/do not give your child Dulcolax").
As with all laxatives, do not take/give your child Dulcolax daily or for prolonged periods without first having your doctor evaluate the cause of the constipation. The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during therapy.
In particular, 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;
• if he is 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 excessive doses) can cause persistent diarrhea resulting in loss of fluids (dehydration) or decreased potassium levels in the blood (hypokalemia).
In more serious cases, the decrease in potassium can cause heart or muscle problems, especially if you are undergoing concomitant treatment with certain heart drugs (cardiac glycosides), with drugs that increase urine production (diuretics) or with those used to treat inflammation (corticosteroids).
Symptoms of intestinal fluid loss (dehydration) may include thirst and reduced urine output (oliguria).
Fluid loss (dehydration) can be dangerous if you/your child have reduced kidney function (renal insufficiency) or if you are elderly; therefore, stop taking Dulcolax and consult your doctor.
Blood in the stool (hematochezia) may also occur, but is usually mild and goes away on its own.
Avoid frequent or prolonged use of the medicine as it can cause habituation and dependence (i.e. the need to gradually increase the dosage and not be able to do without the medicine), as well as chronic constipation and loss of normal intestinal functions (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 people)
• abdominal cramps, abdominal pain, diarrhea, nausea
uncommon (may affect up to 1 in 100 people)
• dizziness (vertigo),
• blood in the stool (hematochezia), vomiting, abdominal discomfort, anorectal discomfort
rare (may affect up to 1 in 1,000 people)
• anaphylactic reactions, swelling of the skin and mucous membranes of the face, lips and throat (angioedema), hypersensitivity,
• loss of fluids (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.