PRESCRIBING INFORMATION

DULCOLAX®
Bisacodyl

Tablets 5 mg
Suppositories 10 mg

Manufacturer’s Standard

Stimulant Laxative

Sanofi Consumer Health Inc. Date of Revision:

October 25, 2019
2905 Louis-R.-Renaud Place
Laval, Quebec H7V 0A3

Submission Control No: 232881 s-a version 4.0 dated October 25, 2019

Dulcolax Prescribing Information Page 1 of 12

Table of Contents

PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3

SUMMARY PRODUCT INFORMATION .....................................................................3
INDICATIONS AND CLINICAL USE ..............................................................................3
CONTRAINDICATIONS ...................................................................................................3
WARNINGS AND PRECAUTIONS ...............................................................................4
ADVERSE REACTIONS ....................................................................................................5
DOSAGE AND ADMINISTRATION ................................................................................6
OVERDOSAGE ..................................................................................................................7
STORAGE AND STABILITY ............................................................................................7
DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................8

PART III: CONSUMER INFORMATION................................................................................9

PART III: CONSUMER INFORMATION..............................................................................11

Dulcolax Prescribing Information Page 2 of 12

 DULCOLAX®

Bisacodyl

PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION

Route of Dosage Form / Clinically Relevant Nonmedicinal Ingredients

Administration Strength
Oral tablet 5 mg acacia, white wax, carnauba wax, corn starch
(dried/soluble), methacrylic acid and ethyl acrylate
copolymer dispersion, glycerine, lactose monohydrate,
magnesium stearate, polyethylene glycol, sucrose,
talc, glyceryl monostearate, triethyl citrate,
polysorbate 80, D&C Yellow #10 Aluminum Lake,
D&C red no. 30, povidone, sodium benzoate,
methylparaben, propylparaben and titanium dioxide.

Rectal suppository 10 mg hard fat

INDICATIONS AND CLINICAL USE

DULCOLAX is indicated for:

• Relief of occasional constipation
• Under medical supervision, for the preparation of diagnostic procedures, in pre- and
postoperative treatment, and in conditions which require defecation to be facilitated.

CONTRAINDICATIONS

DULCOLAX is contraindicated in:

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or
component of the container. For a complete listing, see the DOSAGE FORMS,
COMPOSITION AND PACKAGING section of the Prescribing Information.
• Patients with ileus, intestinal obstruction, acute abdominal conditions like acute
appendicitis, acute inflammatory bowel diseases, severe abdominal pain associated with
nausea and vomiting which may be indicative of more severe conditions.
• Severe dehydration.

Dulcolax Prescribing Information Page 3 of 12

• In case of rare hereditary conditions that may be incompatible with an excipient of the
product (lactose or sucrose). See WARNINGS AND PRECAUTIONS.

WARNINGS AND PRECAUTIONS

General
As with all laxatives, DULCOLAX should not be taken on a continuous daily basis or for
extended periods without investigating the cause of constipation. Prolonged excessive use may
lead to fluid and electrolyte imbalance and hypokalaemia.

Do not use DULCOLAX in the presence of abdominal pain, nausea, fever or vomiting, or within
two hours of another medicine since the desired effect of the other medicine may be reduced.

Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In
patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency,
elderly patients) DULCOLAX should be discontinued and only be restarted under medical
supervision.

Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting.

Dizziness and/or syncope have been reported in patients who have taken DULCOLAX. The
details available for these cases suggest that the events would be consistent with defecation
syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal
pain related to the constipation and not necessarily to the administration of DULCOLAX itself.

The use of suppositories may lead to painful sensations and local irritation, especially in patients
with anal fissures and ulcerative proctitis and should be used in these conditions under medical
advice or as directed by a physician.

DULCOLAX coated tablets contain lactose and sucrose. One coated tablet contains 34.9 mg
lactose and 21.4 mg sucrose (saccharose), resulting in 69.8 mg lactose and 42.8 mg sucrose per
maximum recommended daily dose for treatment of constipation. For preparation of diagnostic
procedure this will result in 139.6 mg of lactose and 85.6 mg sucrose per maximum
recommended daily dose in adults. Patients with the rare hereditary conditions of galactose
intolerance, e.g. galactosaemia, or fructose intolerance should not take DULCOLAX tablets.

Stimulant laxatives including DULCOLAX do not help with weight loss. 1

Dependence/Tolerance
Since extended use of any laxative can cause dependence for bowel function, do not take for
more than one week unless directed by a health professional. If the use of DULCOLAX every
day for a week does not result in a bowel movement, a doctor should be consulted immediately.

Special Populations

Pregnant Women: There are no adequate and well-controlled studies in pregnant women. For

Dulcolax Prescribing Information Page 4 of 12

use during pregnancy, it is recommended that medical advice from a physician first be obtained.
As with all medications, DULCOLAX should only be taken during pregnancy on medical
advice.

Nursing Women: Clinical data show that neither the active moiety of bisacodyl, BHPM (bis-(p-
hydroxyphenyl)-pyridyl-2-methane), nor its glucuronides are excreted into the milk of healthy
lactating human females.Thus, DULCOLAX can be used during breast-feeding.

Fertility: No studies on the effect of human fertility have been conducted.

Effects on ability to drive and use machines

No studies on the effects of DULCOLAX on the ability to drive and use machines have been
performed.

However, patients should be advised that due to a vasovagal response (e.g., to abdominal spasm)
they may experience dizziness and/or syncope. If patients experience abdominal spasm they
should avoid potentially hazardous tasks such as driving or operating machinery.

Pediatrics: Children should not be given DULCOLAX without medical advice.

ADVERSE REACTIONS

The most commonly reported adverse reactions during treatment are abdominal pain and
diarrhea.

Immune system disorders

Hypersensitivity, anaphylactic reactions, angioedema.

Dulcolax Prescribing Information Page 5 of 12

Metabolism and nutrition disorders
Dehydration

Nervous system disorders

Dizziness, syncope.

Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a vasovagal
response (e.g., to abdominal spasm, defecation).

Gastrointestinal disorders
Abdominal cramps, abdominal pain, diarrhea, nausea, haematochezia (blood in stool), vomiting,
abdominal discomfort, anorectal discomfort, colitis (including ischaemic colitis and necrotizing
colitis).2
2

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte
imbalance if excessive doses of DULCOLAX are taken.

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

DULCOLAX tablets have an enteric coating and should not be taken together with products
reducing the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump
inhibitors, in order not to prematurely dissolve the enteric coating.

The concomitant use of other laxatives may enhance the gastrointestinal side effects of
DULCOLAX.2

DOSAGE AND ADMINISTRATION

Dosing Considerations

DULCOLAX should be used under medical supervision for the preparation of diagnostic
procedures, in pre- and postoperative treatment and in medical conditions which require
defecation to be facilitated.

Recommended Dose and Dosage Adjustment

Unless prescribed by the physician otherwise, the following dosages are recommended:

• For constipation
Adults and children over 12 years: Take one to two coated tablets (5 -10 mg) daily, orally or one
adult suppository (10 mg) daily, rectally.

Children 6-12 years: Give one coated tablet (5 mg) daily, orally.

Dulcolax Prescribing Information Page 6 of 12

 • For diagnostic procedures or pre-operatively to achieve complete evacuation of the
intestine:
Adults: Two to four coated tablets (10 - 20 mg), orally the night before the procedure, followed
by one suppository (10 mg), in the morning of the procedure.

Administration
It is recommended to take DULCOLAX coated tablet(s) at night to have a bowel movement the
following morning.

It is recommended to start with the lowest dose (1 tablet). The dose may be adjusted up to a
maximum single dose of 2 tablets to produce regular stools. The maximum daily dose should not
be exceeded.
Tablets have a special coating and therefore should not be taken together with products reducing
the acidity of the upper gastrointestinal tract, such as milk, antacids or certain proton pump
inhibitors in order not to prematurely dissolve the enteric coating.

Tablets should be swallowed whole with an adequate amount of fluid.

Suppositories should take from about 15 minutes to 1 hour to stimulate a bowel movement.
They should be unwrapped and inserted into the rectum pointed end first.

OVERDOSAGE

Symptoms
If high doses are taken, watery stools (diarrhea), abdominal cramps, and a clinically significant
loss of fluid, potassium and other electrolytes can occur.

DULCOLAX, as with other laxatives, when taken in chronic overdose may cause chronic
diarrhea, 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.

Treatment
Within a short time after ingestion of oral forms of DULCOLAX, absorption can be minimized
or prevented by inducing vomiting or gastric lavage. Replacement of fluids and correction of
electrolyte imbalance may be required. This is especially important in the elderly and the young.

Administration of antispasmodics may be of value.

For management of a suspected overdose, contact your regional Poison Control Centre.

STORAGE AND STABILITY

Store out of the reach of children.

Tablets: Store at room temperature (15 – 30°C).

Dulcolax Prescribing Information Page 7 of 12

Suppositories: Store at room temperature (15 – 25°C).

DOSAGE FORMS, COMPOSITION AND PACKAGING

Each enteric coated tablet contains bisacodyl 5 mg.

Non-medicinal ingredients: acacia, white wax, carnauba wax, corn starch (dried/soluble),
methacrylic acid and ethyl acrylate copolymer dispersion, glycerine, lactose monohydrate,
magnesium stearate, polyethylene glycol, sucrose, talc, glyceryl monostearate, triethyl citrate,
polysorbate 80, D&C Yellow #10 Aluminum Lake, D&C red no. 30, povidone, sodium
benzoate, methylparaben, propylparaben and titanium dioxide.

Each rectal suppository contains bisacodyl 10 mg (adult).

Non-medicinal ingredient: hard fat.

Coated tablets (5 mg): blister packs of 10, 30, 60, and 100.
Suppositories (10 mg): blister packs of 3, 6, and 100.

Dulcolax Prescribing Information Page 8 of 12

 IMPORTANT: PLEASE READ

• If you are taking any other medications, including those

PART III: CONSUMER INFORMATION available without a prescription, herbal and
complementary medicines.
Dulcolax®
Bisacodyl Suppositories Do not give DULCOLAX to a child unless the doctor tells you to.

This leaflet is part of the "Prescribing Information" published for A laxative should not be taken within two (2) hours of another
DULCOLAX and is designed specifically for Consumers. This medicine because the desired effect of the other medicine may be
leaflet is a summary and will not tell you everything about reduced.
DULCOLAX. Contact your doctor or pharmacist if you have any
questions about the drug. Do not take DULCOLAX for weight loss.

You may experience dizziness and/or fainting (syncope) caused

ABOUT THIS MEDICATION by a malaise triggered by abdominal spasm. If you experience
abdominal spasm, avoid hazardous tasks such as driving or
What the medication is used for: operating machinery.
DULCOLAX is used for relief of occasional constipation.

Under medical supervision DULCOLAX is also used to empty the INTERACTIONS WITH THIS MEDICATION
bowels before and after surgery and before examination.
Drugs that may interact with DULCOLAX include: diuretics (eg.
What it does: hydrochlorothiazide), adreno-corticosteroids (eg. hydrocortisone,
DULCOLAX belongs to a group of medicines known as stimulant prednisone), and cardiac glycosides (eg. digoxin).
laxatives. DULCOLAX stimulates the bowel muscles while also
accumulating water in the intestines. The effect is to soften the This is not an all-inclusive list of examples. Tell your doctor and
stool and to make it pass through more quickly. pharmacist what prescription and nonprescription medications,
vitamins and herbals you are taking.
When it should not be used:
• If you have severe abdominal pain associated with nausea PROPER USE OF THIS MEDICATION
and vomiting.
• If you have intestinal obstruction (ileus), acute
Do not take more than the recommended daily dose. Overuse
inflammatory bowel disease, or appendicitis.
or extended use of any laxative can cause dependence for
• If you are suffering from severe dehydration. bowel function, do not take for more than a week without
• If you are allergic to the drug or any component of it (see consulting a physician.
non-medicinal ingredients)
Usual dose:
What the medicinal ingredient is: For relief of constipation:
Bisacodyl Adults and children over 12 years: One adult suppository (10 mg)
daily.
What the important non-medicinal ingredients are:
Suppositories contain: hard fat. Suppositories should take from about 15 minutes to 1 hour to
stimulate a bowel movement.
What dosage forms it comes in:
Tablets 5 mg One DULCOLAX 10 mg suppository inserted as described
Suppositories 10 mg below:

WARNINGS AND PRECAUTIONS USAGE: Unwrap the suppository from its foil covering. Dip the
tip of the suppository for a few seconds in lukewarm water to
BEFORE you use DULCOLAX talk to your doctor or soften the exterior. Lie down on your side and raise your opposite
pharmacist: knee to your chest. Relax the buttock just before inserting the
• If you are allergic to bisacodyl or any other ingredients in suppository to ease insertion. Gently insert suppository, lubricated
this product. pointed end first, high into rectum so that it will not slip out.
• If you have any pain in the lower abdomen or if you have Push the flat end of the suppository sideways to make sure that
stomach cramps, fever, nausea or vomiting. part of it touches the wall of the rectum. Continue to lie down for
a few minutes and hold the buttocks together to allow the
• If you are pregnant.
suppository to dissolve in the rectum. Try to retain the
• If you have taken DULCOLAX already for a week
suppository in the rectum as long as possible.
without any effect.

Dulcolax Prescribing Information Page 9 of 12

 IMPORTANT: PLEASE READ

Overdose:
If high doses are taken, watery stool (diarrhea), abdominal cramps,
MORE INFORMATION
and loss of fluid, potassium and other minerals can occur.
DULCOLAX when taken in chronic overdose may cause chronic
diarrhea, abdominal pain, kidney damage, and muscle weakness. This document plus the DULCOLAX Prescribing Information,
prepared for health professionals can be found at: www.sanofi.ca
In case of overdose, contact your physician, pharmacist, or your or by contacting the sponsor, Sanofi Consumer Health Inc. at:1-
regional Poison Control Centre immediately. 800-636-3664.

Please visit our website to see if more up-to-date information has

SIDE EFFECTS AND WHAT TO DO ABOUT THEM been posted.

DULCOLAX may cause side effects. Tell your doctor if any of This leaflet was prepared by Sanofi Consumer Health Inc.
these symptoms are severe or do not go away: abdominal Last revised: October 25, 2019
discomfort (including abdominal cramps, abdominal pain, nausea,
vomiting or diarrhea), dehydration (with symptoms such as dry,
sticky mouth, thirst), dizziness, fainting (syncope), swelling of the
colon (large bowel), anorectal discomfort (discomfort involving
the anus and rectum) and haematochezia (blood in stools).

If you have any of the following symptoms, stop taking

DULCOLAX and call your doctor immediately: allergic reactions
(including swelling of the face, lips, mouth, tongue or throat which
may cause difficulty in swallowing or breathing).

This may not be a complete list of side effects. For any

unexpected effects while taking DULCOLAX, contact your
doctor or pharmacist.

HOW TO STORE IT

Keep out of the reach and sight of children. Store in a cool, dry
place at room temperature (15 - 25°C).

Reporting Side Effects

You can report any suspected side effects associated with the
use of health products to Health Canada by:
• Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/
drugs-health-products/medeffectcanada/adverse-reaction-
reporting.html) for information on how to report online,by
mail or by fax; or
• Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need
information about how to manage your side effects. The
Canada Vigilance Program does not provide medical advice.

Dulcolax Prescribing Information Page 10 of 12

 IMPORTANT: PLEASE READ

BEFORE you use DULCOLAX talk to your doctor or

PART III: CONSUMER INFORMATION pharmacist:
• If you are allergic to bisacodyl or any other ingredients
in this product.
Dulcolax® • If you have any pain in the lower abdomen or if you
Bisacodyl Tablets have stomach cramps, fever, nausea or vomiting.
• If you are pregnant.
This leaflet is part of the "Prescribing Information" published for • If you have taken DULCOLAX already for a week
DULCOLAX and is designed specifically for Consumers. This without any effect.
leaflet is a summary and will not tell you everything about • If you are taking any other medications, including those
DULCOLAX. Contact your doctor or pharmacist if you have any available without a prescription, herbal and
questions about the drug. complementary medicines.

Do not give DULCOLAX to a child unless the doctor tells you to.
ABOUT THIS MEDICATION
A laxative should not be taken within two (2) hours of another
What the medication is used for: medicine because the desired effect of the other medicine may be
DULCOLAX is used for relief of occasional constipation. reduced.

Under medical supervision DULCOLAX is also used to empty the Do not take DULCOLAX for weight loss.
bowels, before and after surgery and before examination.
You may experience dizziness and/or fainting (syncope) caused
What it does: by a malaise triggered by abdominal spasm. If you experience
DULCOLAX belongs to a group of medicines known as stimulant abdominal spasm, avoid hazardous tasks such as driving or
laxatives. DULCOLAX stimulates the bowel muscles while also operating machinery.
accumulating water in the intestines. The effect is to soften the
stool and to make it pass through more quickly.
INTERACTIONS WITH THIS MEDICATION
When it should not be used:
• If you have severe abdominal pain associated with nausea Drugs that may interact with DULCOLAX include: diuretics (eg.
and vomiting. hydrochlorothiazide), adreno-corticosteroids (eg. hydrocortisone,
• If you have intestinal obstruction (ileus), acute prednisone), cardiac glycosides (eg. digoxin), antacids or certain
inflammatory bowel disease, or appendicitis. proton pump inhibitors (eg. lansoprazole, omeprazole,
• If you are suffering from severe dehydration. pantoprazole).
• If you are allergic to the drug or any component of it (see
non-medicinal ingredients). Do not take indigestion remedies at the same time of day as
• If you have a rare hereditary condition of galactose or DULCOLAX tablets. Do not take with milk or antacids.
fructose intolerance you should not use DULCOLAX
tablets. This is not an all-inclusive list of examples. Tell your doctor and
pharmacist what prescription and non-prescription medications,
What the medicinal ingredient is: vitamins and herbals you are taking.
Bisacodyl
PROPER USE OF THIS MEDICATION
What the important non-medicinal ingredients are: Do not take more than the recommended daily dose. Overuse
acacia, white wax, carnauba wax, corn starch (dried/soluble), or extended use of any laxative can cause dependence for
methacrylic acid and ethyl acrylate copolymer dispersion, bowel function, do not take for more than a week without
glycerine, lactose monohydrate, magnesium stearate, polyethylene consulting a physician.
glycol, sucrose, talc, glyceryl monostearate, triethyl citrate,
polysorbate 80, D&C Yellow #10 Aluminum Lake, D&C red no. Do not crush or chew tablets; swallow them whole. Do not take
30, povidone, sodium benzoate, methylparaben, propylparaben and with milk or antacids.
titanium dioxide.
Usual dose: For relief of constipation
What dosage forms it comes in: Adults and children over 12 years: One to two tablets daily.
Tablets 5 mg Children 6-12 years: One tablet daily.
Suppositories 10 mg
Take DULCOLAX tablets at night to have a bowel movement the
WARNINGS AND PRECAUTIONS next morning.

Dulcolax Prescribing Information Page 11 of 12

 IMPORTANT: PLEASE READ

It is recommended to start with the lowest dose (1 tablet). The dose

MORE INFORMATION
may be adjusted up to a maximum single dose of 2 tablets to
produce regular stools. The maximum daily dose should not be
exceeded. This document plus the DULCOLAX Prescribing Information,
prepared for health professionals can be found at: www.sanofi.ca
Tablets should be swallowed whole with an adequate amount of or by contacting the sponsor, Sanofi Consumer Health Inc. at:1-
liquid (NOT MILK). 800-636-3664.

Overdose: Please visit our website to see if more up-to-date information has
If high doses are taken, watery stool (diarrhea), abdominal cramps, been posted.
and loss of potassium and other minerals can occur.
DULCOLAX when taken in chronic overdose may cause chronic This leaflet was prepared by Sanofi Consumer Health Inc.
diarrhea, abdominal pain, kidney damage, and muscle weakness. Last revised: October 25, 2019

In case of overdose, contact your physician, pharmacist, or your

regional Poison Control Centre immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

DULCOLAX may cause side effects. Tell your doctor if any of

these symptoms are severe or do not go away: abdominal
discomfort (including abdominal cramps, abdominal pain, nausea,
vomiting or diarrhea), dehydration (with symptoms such as dry,
sticky mouth, thirst), dizziness, fainting (syncope), swelling of the
colon (large bowel), anorectal discomfort (discomfort involving
the anus and rectum), and haematochezia (blood in stools).

If you have any of the following symptoms, stop taking

DULCOLAX and call your doctor immediately: allergic reactions
(including swelling of the face, lips, mouth, tongue or throat which
may cause difficulty in swallowing or breathing).

This may not be a complete list of side effects. For any

unexpected effects while taking DULCOLAX, contact your
doctor or pharmacist.

HOW TO STORE IT

Keep out of the reach and sight of children. Store in a cool, dry
place at room temperature (15 – 30°C).

Reporting Side Effects

You can report any suspected side effects associated with the
use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

(https://www.canada.ca/en/health-canada/services/
drugs-health-products/medeffectcanada/adverse-reaction-
reporting.html) for information on how to report online,by
mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need

information about how to manage your side effects. The
Canada Vigilance Program does not provide medical advice.

Dulcolax Prescribing Information Page 12 of 12