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Details for: DULCOLAX

Company: SANOFI CONSUMER HEALTH INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00254142DULCOLAXBISACODYL5 MGTABLET (ENTERIC-COATED)ORAL
00003875DULCOLAXBISACODYL10 MGSUPPOSITORYRECTAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Suppositories

DULCOLAX is used for relief of occasional constipation.

Under medical supervision DULCOLAX is also used to empty the bowels before and after surgery and before examination.

Tablets

DULCOLAX is used for relief of occasional constipation.

Under medical supervision DULCOLAX is also used to empty the bowels, before and after surgery and before examination.

What it does

Suppositories

DULCOLAX belongs to a group of medicines known as stimulant laxatives. DULCOLAX stimulates the bowel muscles while also accumulating water in the intestines. The effect is to soften the stool and to make it pass through more quickly.

Tablets

DULCOLAX belongs to a group of medicines known as stimulant laxatives. DULCOLAX stimulates the bowel muscles while also accumulating water in the intestines. The effect is to soften the stool and to make it pass through more quickly.

When it should not be used

Suppositories

  • If you have severe abdominal pain associated with nausea and vomiting.
  • If you have intestinal obstruction (ileus), acute inflammatory bowel disease, or appendicitis.
  • If you are suffering from severe dehydration.
  • If you are allergic to the drug or any component of it (see non-medicinal ingredients)

Tablets

  • If you have severe abdominal pain associated with nausea and vomiting.
  • If you have intestinal obstruction (ileus), acute inflammatory bowel disease, or appendicitis.
  • If you are suffering from severe dehydration.
  • If you are allergic to the drug or any component of it (see non-medicinal ingredients).
  • If you have a rare hereditary condition of galactose or fructose intolerance you should not use DULCOLAX tablets.
  • If you are allergic to the tartrazine colouring agent, you should not use DULCOLAX tablets.
What the medicinal ingredient is

Suppositories

Bisacodyl

Tablets

Bisacodyl

What the non-medicinal ingredients are

Suppositories

Suppositories contain: hard fat.

Tablets

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.

What dosage form it comes in

Suppositories

Tablets 5 mg
Suppositories 10 mg

Tablets

Tablets 5 mg
Suppositories 10 mg

Warnings and precautions

Suppositories

BEFORE you use DULCOLAX talk to your doctor or pharmacist:

  • If you have ever had an allergic reaction to this or any other medicines.
  • If you have any pain in the lower abdomen or if you have stomach cramps, fever, nausea or vomiting.
  • If you are pregnant.
  • If you have taken DULCOLAX already for a week without any effect.
  • If you are taking any other medications, including those available without a prescription, herbal and complementary medicines.

Do not give DULCOLAX to a child unless the doctor tells you to.

A laxative should not be taken within two (2) hours of another medicine because the desired effect of the other medicine may be reduced.

You may experience dizziness and/or fainting (syncope) caused by a malaise triggered by abdominal spasm. If you experience abdominal spasm, avoid hazardous tasks such as driving or operating machinery.

Tablets

BEFORE you use DULCOLAX talk to your doctor or pharmacist:

  • If you have ever had an allergic reaction to this or any other medicines.
  • If you have any pain in the lower abdomen or if you have stomach cramps, fever, nausea or vomiting.
  • If you are pregnant.
  • If you have taken DULCOLAX already for a week without any effect.
  • If you are taking any other medications, including those available without a prescription, herbal and complementary medicines.

Do not give DULCOLAX to a child unless the doctor tells you to.

A laxative should not be taken within two (2) hours of another medicine because the desired effect of the other medicine may be reduced.

You may experience dizziness and/or fainting (syncope) caused by a malaise triggered by abdominal spasm. If you experience abdominal spasm, avoid hazardous tasks such as driving or operating machinery.

Interactions with this medication

Suppositories

Drugs that may interact with DULCOLAX include: diuretics (eg. hydrochlorothiazide), adreno-corticosteroids (eg. hydrocortisone, prednisone), and cardiac glycosides (eg. digoxin).

This is not an all-inclusive list of examples. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins and herbals you are taking.

Tablets

Drugs that may interact with DULCOLAX include: diuretics (eg. hydrochlorothiazide), adreno-corticosteroids (eg. hydrocortisone, prednisone), cardiac glycosides (eg. digoxin), antacids or certain proton pump inhibitors (eg. lansoprazole, omeprazole, pantoprazole).

Do not take indigestion remedies at the same time of day as DULCOLAX tablets. Do not take with milk or antacids.

This is not an all-inclusive list of examples. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins and herbals you are taking.

Proper use of this medication

Suppositories

Do not take more than the recommended daily dose. Overuse or extended use of any laxative can cause dependence for bowel function, do not take for more than a week without consulting a physician.

Usual dose

For relief of constipation:
Adults and children over 12 years: One adult suppository (10 mg) daily.

Suppositories should take from about 15 minutes to 1 hour to stimulate a bowel movement.

One DULCOLAX 10 mg suppository inserted as described below:

USAGE: Unwrap the suppository from its foil covering. Dip the tip of the suppository for a few seconds in lukewarm water to soften the exterior. Lie down on your side and raise your opposite knee to your chest. Relax the buttock just before inserting the suppository to ease insertion. Gently insert suppository, lubricated pointed end first, high into rectum so that it will not slip out. Push the flat end of the suppository sideways to make sure that 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 suppository to dissolve in the rectum. Try to retain the suppository in the rectum as long as possible.

Overdose

If high doses are taken, watery stool (diarrhoea), abdominal cramps, and loss of fluid, potassium and other minerals can occur. DULCOLAX when taken in chronic overdose may cause chronic diarrhoea, abdominal pain, kidney damage, and muscle weakness.

In case of overdose, contact your physician, pharmacist, or your regional Poison Control Centre immediately.

Tablets

Do not take more than the recommended daily dose. Overuse or extended use of any laxative can cause dependence for bowel function, do not take for more than a week without consulting a physician.

Do not crush or chew tablets; swallow them whole. Do not take with milk or antacids.

Usual dose

For relief of constipation:
Adults and children over 12 years: One to two tablets daily.
Children 6-12 years: One tablet daily.

Take DULCOLAX tablets at night to have a bowel movement the next 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 should be swallowed whole with an adequate amount of liquid (NOT MILK).

Overdose

If high doses are taken, watery stool (diarrhoea), abdominal cramps, and loss of potassium and other minerals can occur.
DULCOLAX when taken in chronic overdose may cause chronic diarrhoea, abdominal pain, kidney damage, and muscle weakness.

In case of overdose, contact your physician, pharmacist, or your regional Poison Control Centre immediately.

Side effects and what to do about them

Suppositories

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 diarrhoea), 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.

Tablets

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 diarrhoea), 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

Suppositories

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

Tablets

Keep out of the reach 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:

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.

More information

This document plus the DULCOLAX Prescribing Information, prepared for health professionals can be found at: www.sanofi.ca or by contacting the sponsor, sanofi-aventis Canada Inc., at: 1-800-265-7927.

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

This leaflet was prepared by sanofi-aventis Canada Inc.
Last revised: November 7, 2017

Date modified: