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About Dulcolax
What Dulcolax is used for
DULCOLAX is used for relief of occasional constipation.
Under medical supervision DULCOLAX is used in preparation for diagnostic procedures, before and after surgery and in conditions which require defecation to be facilitated.
What Dulcolax does
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 Dulcolax should not be used
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If you have severe abdominal pain associated with nausea and vomiting.
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If you have intestinal obstruction (ileus), acute inflammatory bowel disease, or appendicitis.
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If you are suffering from severe dehydration.
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If you are allergic to the drug or any component of it (see What the important nonmedicinal ingredients are:)
What the medicinal ingredient is
Bisacodyl
What the important nonmedicinal ingredients for Dulcolax are
Suppositories contain: hard fat.
What dosage forms Dulcolax comes in
Tablets 5 mg.
Suppositories 5 mg (children) and 10 mg (adults).
Warnings and Precautions
BEFORE you use DULCOLAX talk to your doctor or pharmacist
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If you have ever had an allergic reaction to this or any other medicines.
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If you have any pain in the lower abdomen or if you have stomach cramps, fever, nausea or vomiting.
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If you are pregnant or breast-feeding.
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If you are planning to give DULCOLAX to a child.
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If you have taken DULCOLAX already for a week without any effect.
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If you are taking any other medications, including those available without a prescription, herbal and complementary medicines.
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A laxative should not be taken within two (2) hours of another medicine because the desired effect of the other medicine may be reduced.
Interactions with Dulcolax
Drugs that may interact with DULCOLAX include: diuretics, adreno-corticosteroids, and cardiac glycosides.
Proper Use of Dulcolax
Do not take more than the recommended daily dose. 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).
Children 6-12 years: one children suppository (5 mg).
Children under 6 years: Use only as directed by your doctor.
Suppositories should take from about 15 minutes to 1 hour to stimulate a bowel movement.
One DULCOLAX 5 mg or 10 mg suppository inserted as described below:
Usage
Unwrap the suppository from its foil covering. Insert suppository, 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. Retain the suppository in the rectum as long as possible. If you have difficulty inserting the suppository because you have had anal fissures or hemorrhoids, coat the end of the suppository with a lubricant (like petroleum jelly) to make the insertion easier.
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 for Dulcolax and What to Do About Them
While using DULCOLAX some patients have experienced abdominal discomfort (including abdominal cramps, abdominal pain, nausea or diarrhoea).
Allergic reactions have been reported.
The prolonged use of suppositories may lead to painful sensations and local irritation of the rectum.
This may not be a complete list of side effects. For any unexpected effects while taking DULCOLAX, contact your doctor or pharmacist.
About Dulcolax
Technical InformationDrug Interactions
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 certain proton pump inhibitors.
Information for the Patient
Dulcolax
Dosage and Administration
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.
Unless prescribed by the physician otherwise, the following dosages are recommended:
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For constipation:
Adults and children over 12 years: Take one to two coated tablets (5-10 mg) orally or one adult suppository (10 mg) rectally.
Children 6-12 years: Give one coated tablet (5 mg) orally or one paediatric suppository (5 mg) rectally.
Children under 6 years: Use only as directed by your doctor.
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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.
Children 6 years and over: One coated tablet (5 mg) orally at bedtime, and one paediatric suppository (5 mg) inserted rectally the following morning.
It is recommended to take DULCOLAX coated tablet(s) at night to have a bowel movement the following morning.
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.
Adverse Reactions
anaphylactic reactions, angioneurotic oedema and other hypersensitivity.
colitis, abdominal cramps, abdominal pain, diarrhoea, vomiting, nausea, abdominal discomfort.
Indications and Clinical Use
DULCOLAX is indicated for:
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relief of occasional constipation
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Under medical supervision, for the preparation of diagnostic procedures, in pre- and postoperative treatment, and in conditions which require defecation to be facilitated.
Overdosage
If high doses are taken, watery stools (diarrhoea), abdominal cramps, and a clinically significant loss of potassium and other electrolytes can occur.
DULCOLAX, as with other laxatives, when taken in chronic overdose 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.
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.
Dosage Forms, Composition and Packaging
Each yellow, enteric-coated tablet contains: bisacodyl 5 mg. Nonmedicinal ingredients: acacia, beeswax, carnauba wax, corn starch, dibutyl phthalate, eudragit, glycerine, lactose, magnesium stearate, polyethylene glycol, sucrose, talc, tartrazine (yellow) and titanium dioxide. Packages of 10, 30, 60 and 100.
Each rectal suppository contains: bisacodyl 5 mg (children formula) or 10 mg (adult formula). Nonmedicinal ingredient: hard fat. Boxes of 3 (5 mg); boxes of 3, 6 and 100 (10 mg).
Warnings and Precautions
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.
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.
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 which may be related to the constipation that prompted the patients in question to resort to the use of laxatives and not necessarily to the administration of DULCOLAX itself.
The use of suppositories may lead to painful sensations and local irritation, especially in 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 33.2 mg lactose and 23.4 mg sucrose (saccharose), resulting in 66.4 mg lactose and 46.8 mg sucrose per maximum recommended daily dose for treatment of constipation. For preparation of diagnostic procedure this will result in 132.8 mg of lactose and 93.6 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.
The tablet formulation contains tartrazine as a colouring agent; this agent may cause allergic reactions. Patients with tartrazine allergy should not take Dulcolax tablets.
Children should not be given DULCOLAX without medical advice.
There are no adequate and well-controlled studies in pregnant women. For 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.
Whether DULCOLAX passes into breast milk has not been characterized in detail, but detection of trace amounts of milk has been reported. As with all medications, DULCOLAX should only be taken by nursing women on medical advice.
Storage and Stability
Store out of the reach of children.
Tablets: Store at room temperature (15-30°C).
Suppositories: Store at room temperature (15-25°C).
Contraindications
DULCOLAX is contraindicated in:
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Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see Dosage Forms, Composition and Packaging.
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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.
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Severe dehydration.
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In case of rare hereditary conditions that may be incompatible with an excipient of the product (lactose or sucrose) see Warnings and Precautions.