Dulcolax® Suppositories

Dependable, immediate relief

Dulcolax<sup>®</sup> Suppositories

Dulcolax® 5 mg and 10 mg Suppositories relieve occasional constipation and irregularity within 15-60 minutes.

  • Relieves constipation and irregularity immediately
  • Comfort-shaped medicated suppository for rectal use only
Drug Facts, FAQs

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Dulcolax® Suppositories

Dependable, immediate relief

Dulcolax® 5 mg and 10 mg Suppositories relieve occasional constipation and irregularity immediately.

  • Relieves constipation and irregularity immediately
  • Comfort-shaped medicated suppository for rectal use only
  • Just one suppository produces a bowel movement within as little as 15-60 minutes. It is designed for rectal use only.
  • The Worlds #1 Pharmacy laxative brand
  • Brand trusted for effective constipation relief for over 60 years
  • Produces a bowel movement within 15 to 60 minutes

Contains the active ingredient Bisacodyl

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Dulcolax® Suppositories

Dulcolax® 5 mg and 10 mg Suppositories can be purchased at competing grocery stores and independent pharmacies nationwide.

Medicine Facts

APPROVED PACKAGE INSERT – DULCOLAX 5 mg & 10 mg SUPPOSITORIES

SCHEDULING STATUS: S0

PROPRIETARY NAME (and dosage form):

  • Dulcolax® 10 mg suppositories
  • Dulcolax® 5 mg suppositories

COMPOSITION:

  • Each adult suppository contains bisacodyl 10 mg.
  • Each paediatric suppository contains bisacodyl 5 mg.

PHARMACOLOGICAL CLASSIFICATION:

A 11.5 Laxatives

PHARMACOLOGICAL ACTION:

DULCOLAX is a laxative that acts by one or more actions on the colonic mucosa to produce effective peristalsis and evacuation of the bowel.

INDICATIONS:

For the relief of occasional constipation.

CONTRA-INDICATIONS:

  • The active ingredient in Dulcolax Suppositories is bisacodyl. Each adult suppository contains 10 mg of bisacodyl and each paediatric suppository contains 5 mg of bisacodyl.
  • Dulcolax Suppositories are used for the relief of occasional constipation. Do not use if you are hypersensitive to bisacodyl or in cases of ileus, intestinal obstruction, undiagnosed symptoms or acute surgical abdominal conditions like acute appendicitis, acture inflammatory bowel disease, or in severe dehydration.
  • Safety in pregnancy and breastfeeding has not been established.

WARNINGS:

  • If you have abdominal pain, nausea or vomiting, do not use this medicine. If you have noticed a sudden change in bowel habits that has lasted for longer than 2 weeks , consult a doctor before using a laxative.
  • If a laxative is needed every day, the cause of the constipation should be investigated. Dulcolax should not be used for longer than 1 week, unless directed by a doctor. Using this medicine often or for a long period may result in dependence on laxatives and loss of normal bowel function.
  • Rectal bleeding or failure to have a bowel movement after use of a laxative, may indicate a serious condition. Stop use and consult a doctor.

SPECIAL PRECAUTIONS:

  • Prolonged use may led to diarrhoea with excessive loss of water and electrolytes, particularly potassium, and possible an atonic non-functioning colon.
  • Dizziness and/or fainting have been reported in patients who have used Dulcolax.
  • Using the suppositories may cause local irritation. Repeated use may cause inflammation of the rectum or sloughing of the epithelium. AK for medical advice in cases of inflammatory bowel disease, rectal fissures or ulcerated haemorrhoids. Children should not use Dulcolax without medical advice.

INTERACTIONS WITH OTHER MEDICINES:

  • Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines). Using diuretics (water tablets) or adreno-corticosteriods at the same time as Dulcolax may increase the risk of electrolyte imbalance if excessive doses of Dulcolax are taken. Electrolyte imbalances may lead increased sensitivity to cardian glycosides (medicines used to treat heart failure and irregular heartbeat).

POSSIBLE SIDE EFFECTS:

  • Dulcolax may cause abdominal discomfort, diarrhoea, abdominal pain and abdominal cramps. Allergic reactions needing urgent medical attention, including isolated cases of sudden life-threatening allergic reactions, have been reported in association with the use of Dulcolax.

DOSAGE AND DIRECTIONS FOR USE:

  • Unless otherwise prescribed by your doctor, the following dosages are recommended:
  • Adults and children 12 years and over: One 10 mg suppository as a single daily dose.
  • Children 1 - 12 years: One 5 mg suppository as a single daily dose.
  • The suppositories should be unwrapped and inserted into the rectum pointed end first.
  • Bowel movements is generally produced within 15 minutes to one hour.

OVERDOSAGE:

  • Consult your doctor or pharmacist. If neither is available , contact the nearest hospital or poison control centre.
  • Keep out of reached of children.

Side-effects:

DULCOLAX may cause abdominal discomfort, diarrhoea, abdominal pain and abdominal cramps.
Allergic reactions, including isolated cases of angio-oedema and anaphylactoid reactions have been reported in association with the administration of DULCOLAX.

Special precautions:

  • Prolonged use may lead to diarrhoea with excessive loss of water and electrolytes, particularly potassium, and possible atonic non-functioning colon.
  • Dizziness and/or syncope have been reported in patients who have taken DULCOLAX.
  • Administration of suppositories may cause local irritation. Repeated use may cause proctitis or sloughing of the epithelium.
  • The suppositories should be used with caution in patients with rectal fissures or ulcerated haemorrhoids.
  • Care should be taken in patients with inflammatory bowel disease.
  • Children should not take DULCOLAX without medical advice.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Symptoms:
If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of potassium and other electrolytes can occur.
Chronic overdose with DULCOLAX may cause chronic diarrhoea, 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 .

Therapy:
Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young.

IDENTIFICATION:

DULCOLAX 5 mg suppositories and DULCOLAX 10 mg suppositories - smooth, white or slightly yellow, torpedo-shaped suppositories in aluminium foil with the name printed on the foil.

PRESENTATION:

  • DULCOLAX 10 mg suppositories - Boxes of 10 suppositories.
  • DULCOLAX 5 mg suppositories - Boxes of 10 suppositories.

STORAGE INSTRUCTIONS:

Store below 25 °C. Keep out of reach of children.

REGISTRATION NUMBERS:

DULCOLAX 10 mg suppositories: E/11.5/532

DULCOLAX 5 mg suppositories: E/11.5/534

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:

Ingelheim Pharmaceuticals (Pty) Ltd
Pine Avenue
Randburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

20 September 2013

BOTSWANA Reg. No.:

DULCOLAX 5 mg Suppositories B9305045

DULCOLAX 10 mg Suppositories B9305040

NAMIBIA Reg. No.:

DULCOLAX 5 mg Suppositories 04/11.5/0976

DULCOLAX 10 mg Suppositories 04/11.5/0974

FAQ

Dulcolax® Suppositories

What time of day should I use take Dulcolax® Suppositories?

You may use a Dulcolax® Suppository anytime. It generally produces a bowel movement in 15 to 60 minutes.

How often can I use Dulcolax® Suppositories? Is it safe for daily use?

You may use 1 Dulcolax® Suppository a day for up to 7 days. If you need to use a laxative for more than 7 days, consult a doctor.

How many Dulcolax® Suppositories can I take?

Adults and children over 12 years can use 1x 10 mg Dulcolax® Suppository a day. Children 1 to under 12 years of age can use a 1 x 5mg suppository a day.

How do I use Dulcolax® Suppositories?

Remove the suppository from the wrapping and insert the suppository, pointed end first, into the rectum.

Do you need to remove the suppository after it has been inserted?

The Dulcolax® Suppository does not need to be removed after it has been inserted; it works in the rectum within 15-60 minutes.

How do Dulcolax® Suppositories work?

Dulcolax® Suppositories containing bisacodyl, which stimulates the muscles in the intestine to promote bowel activity.

How should Dulcolax® Suppositories be used?

Dulcolax® Suppositories are to be inserted rectally. They are not intended for oral use.

Should Dulcolax® Suppositories be used on an empty or full stomach?

Dulcolax® Suppositories may be used before or after a meal, however please note, these products are to be used in the rectum and not eaten.

For additional questions regarding usage, side effects, or storage instructions, please refer to the Dulcolax® Suppository Drug Medicine Panel or contact your healthcare professional.

Video

Dulcolax® Suppositories