Dulcolax® Laxative Tablets

Overnight relief (6-12 hours)

  • For dependable, effective relief of occasional constipation
  • Trusted for more than 60 years
  • Suitable for children 6 years and over
  • Suitable for breastfeeding women

How do Dulcolax® Laxative Tablets work?

Dulcolax® Tablets belong to a group of medicines known as stimulant laxatives. Each small tablet contains a precisely measured amount of the active ingredient bisacodyl, which stimulates bowel muscles while also accumulating water in the intestines. The effect is to soften the stool and make it pass through more quickly.

Dulcolax® Tablets have a special coating that ensures that the active ingredient is released right where it's needed. The coating resists the acidic digestive juices of the stomach and small intestine.

How should Dulcolax® Laxative Tablets be taken?*

  • For the relief of occasional constipation:
    • Adults 12 years and over: take 1 to 2 tablets (5-10mg) daily
    • Children 6-12 years: take one tablet (5mg) daily
  • Take the tablets at night to have a bowel movement in the morning
  • Do not crush or chew tablets; swallow them whole. Do not take with milk or antacids
  • Do not give Dulcolax® Laxative Tablets to a child less than 6 years of age unless the doctor tells you to

*Consumer information : Product Label

Product Label

This leaflet is part of the “Prescribing Information” published for Dulcolax® and is designed specially for Consumers. This leaflet et is a summary and will not tell you everything about Dulcolax®. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

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:

Dulcolax® belongs to a group of medicines know n
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:

  • 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:

Bisacodyl

What the important non-medicinal ingredients are:


Enteric coated tablets contain: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 forms it comes in:


Tablets 5 mg 



WARNINGS AND PRECAUTIONS 


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.


Do not takeDulcolax® for weight loss.

If you experience abdominal spasm, avoid hazardous tasks such as driving or operating machinery.

INTERACTIONS WITH THIS MEDICATION 


Drugs that may interact with Dulcolax® include: diuretics (e.g. hydrochlorothiazide), adreno- corticosteroids (e.g. hydrocortisone, prednisone), cardiac glycosides (e.g. digoxin), antacids or certain proton pump inhibitors (e.g. 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


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

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 dif culty 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 SUSPECTED 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 16, 2017