DULCOLAX 5 MG COATED TABLETS 40 COATED TABLETS IN PVC/PVDC/AL BLISTER

Name
DULCOLAX 5 mg coated tablets
DULCOLAX adults 10 mg suppositories
Bisacodyl


What is it and what is it used for?
Dulcolax contains bisacodyl. It belongs to a group of medicines called contact laxatives.
Dulcolax works by stimulating intestinal 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 stomach 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 water loss from the body (dehydration);
- if you and/or your child suffer from a hereditary disease that may be incompatible with taking one of the excipients (see section 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 (perianal pain and bleeding may occur).

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


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 from these cases suggest that these events, rather than being related to Dulcolax, could be interpreted as a manifestation of "fainting (syncope) on defecation" (attributable to straining during bowel movements) 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 consulting your doctor to determine the cause of the constipation. Treatment of chronic or recurrent constipation always requires medical attention for diagnosis, medication prescription, and ongoing monitoring.
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 (cardiac disease).

Laxative abuse
Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in fluid loss (dehydration) or decreased potassium levels in the blood (hypokalemia).
In more severe cases, low potassium levels can cause heart or muscle problems, especially if you are taking certain heart medications (cardiac glycosides), drugs that increase urine production (diuretics), or medications 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 failure) 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 patients)
• 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 experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.