DULCOLAX 5 MG GASTRO-RESISTANT TABLETS

Active substance: BISACODYL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
DULCOLAX 5 mg Gastro-resistant Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Bisacodyl 5mg.
For excipients, see 6.1

3

PHARMACEUTICAL FORM
Gastro-resistant tablets for oral administration.
Circular, biconvex, yellow, sugar-coated and enteric-coated tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Short term relief of constipation.

4.2

Posology and method of administration
Children aged 10 years or younger with chronic or persistent constipation should only
be treated under the guidance of a physician. Bisacodyl should not be used in children
aged 4 years or younger.
Short-term treatment for constipation:
Adults and children over 10 years: 1 to 2 coated tablets (5 - 10 mg) daily before
bedtime, or 1 suppository (10 mg) for immediate effect.
Children 4 – 10 years: 1 coated tablet (5 mg) daily before bedtime, or
1 suppository (5 mg) for immediate effect.
For preparation of diagnostic procedures and preoperatively
Should only be used under medical supervision.

Adults and children over 10 years: 2 coated tablets (10 mg) in the morning and
2 coated tablets (10 mg) in the evening and 1 suppository (10 mg) on the following
morning is recommended.
Children aged 4 -10 years of age: 1 coated tablet (5 mg) in the evening and
1 suppository (5 mg) on the following morning is recommended.
When using DULCOLAX to prepare the patient for radiographic examination of the
abdomen or employing it preoperatively, tablets should be combined with
suppositories in order to achieve complete evacuation of the intestine.
In the management of constipation, once regularity has been restarted dosage should
be reduced and can usually be stopped.
It is recommended to take the coated tablets at night to have a bowel movement the
following morning. They should be swallowed whole with an adequate amount of
fluid.
The coated tablets should not be taken together with products which reduce the
acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump
inhibitors, in order not to prematurely dissolve the enteric coating.
Suppositories are usually effective in about 20 minutes, but in some cases it may take
up to 45 minutes. They should be unwrapped and inserted into the rectum pointed
end first.
No specific information on the use of this product in the elderly is available. Clinical
trials have included patients over 65 years and no adverse reactions specific to this
age group have been reported.

4.3

Contraindications
DULCOLAX is contraindicated in patients with ileus, intestinal obstruction,
acute abdominal conditions including appendicitis, acute inflammatory bowel
diseases, and severe abdominal pain associated with nausea and vomiting
which may be indicative of the aforementioned severe conditions.
DULCOLAX is also contraindicated in severe dehydration and in patients
with known hypersensitivity to bisacodyl or any other component of the
product.

4.4

Special warnings and precautions for use
As with all laxatives, DULCOLAX should not be taken on a continuous daily basis
for more than five days without investigating the cause of constipation.

Prolonged excessive use may lead to fluid and electrolyte imbalance and
hypokalaemia.
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 defaecation 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 bisacodyl itself.
There have been isolated reports of abdominal pain and bloody diarrhoea occurring
after taking bisacodyl. Some cases have been shown to be associated with colonic
mucosal ischaemia.
DULCOLAX should not be taken by children under 10 years without medical advice.
DULCOLAX Tablets contain a small amount of lactose (33.2 mg) and sucrose
(23.4 mg) in each tablet. Patients with rare hereditary problems of fructose
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
The concomitant use of antacids and milk products may reduce the resistance
of the coating of the tablets and result in dyspepsia and gastric irritation.
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.

4.6

Pregnancy and lactation
There are no adequate and well-controlled studies in pregnant women. Long
experience has shown no evidence of undesirable or damaging effects during
pregnancy.
Clinical data show that neither the active moiety of bisacodyl (BHPM or bis-(phydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk
of healthy lactating females.

Nevertheless, as with all medicines, DULCOLAX should not be taken in pregnancy,
especially the first trimester, and during breast feeding unless the expected benefit is
thought to outweigh any possible risk and only on medical advice.
No studies on the effect on human fertility have been conducted.

4.7

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.

4.8

Undesirable effects
The most commonly reported adverse reactions during treatment are abdominal pain
and diarrhoea.
Adverse events have been ranked under headings of frequency using the following
convention: Very common ( 1/10); common ( 1/100, < 1/10); uncommon (
1/1000, <1/100); rare ( 1/10000, <1/1000); very rare (<1/10000).









Immune system disorders
Rare: anaphylactic reactions, angioedema, hypersensitivity.
Metabolism and nutrition disorders
Rare: dehydration.
Nervous system disorders
Uncommon: dizziness.
Rare: Syncope.
Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a
vasovagal response (e.g. to abdominal spasm, defaecation).
Gastrointestinal disorders
Uncommon: haematochezia (blood in stool), vomiting, abdominal discomfort,
anorectal discomfort.
Common: abdominal cramps, abdominal pain, diarrhoea and nausea.
Rare: colitis.

4.9

Overdose

Symptoms
If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically
significant loss of fluid, potassium and other electrolytes can occur.
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.
Therapy
After ingestion of oral forms of DULCOLAX, absorption can be minimised 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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group
having a dual action. As a contact laxative, for which also antiresorptive hydragogue
effects have been described, bisacodyl stimulates after hydrolysis in the large
intestine, the mucosa of both the large intestine and of the rectum. Stimulation of the
mucosa of the large intestine results in colonic peristalsis with promotion of
accumulation of water, and consequently electrolytes, in the colonic lumen. This
results in a stimulation of defecation, reduction of transit time and softening of the
stool. Stimulation of the rectum causes increased motility and a feeling of rectal
fullness. The rectal effect may help to restore the “call to stool” although its clinical
relevance remains to be established.

5.2

Pharmacokinetic properties
Following either oral or rectal administration, bisacodyl is rapidly hydrolyzed to the
active principle bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), mainly by
esterases of the enteric mucosa.
Administration as an enteric coated tablet was found to result in maximum BHPM
plasma concentrations between 4 – 10 hours post administration whereas the laxative
effect occurred between 6 – 12 hours post administration. In contrast, following the
administration as a suppository, the laxative effect occurred on average
approximately 20 minutes post administration; in some cases it occurred 45 minutes
after administration. The maximum BHPM-plasma concentrations were achieved
0.5 – 3 hours following the administration as a suppository. Hence, the laxative effect
of bisacodyl does not correlate with the plasma level of BHPM. Instead, BHPM acts
locally in the lower part of the intestine and there is no relationship between the
laxative effect and plasma levels of the active moiety. For this reason, bisacodyl

coated tablets are formulated to be resistant to gastric and small intestinal juice. This
results in a main release of the drug in the colon, which is the desired site of action.
After oral and rectal administration, only small amounts of the drug are absorbed and
are almost completely conjugated in the intestinal wall and the liver to form the
inactive BHPM glucuronide. The plasma elimination half-life of BHPM glucuronide
was estimated to be approximately 16.5 hours. Following the administration of
bisacodyl coated tablets, an average of 51.8% of the dose was recovered in the faeces
as free BHPM and an average of 10.5% of the dose was recovered in the urine as
BHPM glucuronide. Following the administration as a suppository, an average of
3.1% of the dose was recovered as BHPM glucuronide in the urine. Stool contained
large amounts of BHPM (90% of the total excretion) in addition to small amounts of
unchanged bisacodyl.

5.3

Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tablet core:
Lactose
Maize starch
Soluble maize starch
Glycerol
Magnesium stearate
Tablet coating:
Magnesium stearate
Sucrose
Talc
Acacia
Titanium dioxide (E171)
Methacrylic acid-methylmethacrylate copolymer (1:1)
Methacrylic acid-methylmethacrylate copolymer (1:2)
Castor oil
Macrogol 6000
Yellow iron oxide (E172)

White beeswax
Carnauba wax
Shellac.

6.2

Incompatibilities
None stated.

6.3

Shelf life
3 years

6.4

Special precautions for storage
Do not store above 25°C.
Keep container in the outer carton.

6.5

Nature and contents of container
Blister packs consisting of opaque white PVC/PVDC blister foil and aluminium foil
(covering foil).
Blister packs consisting of colourless PVC blister foil and aluminium foil (covering
foil).
Packs of 6, 8, 10, 20, 30, 40 and 60.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Limited,
Ellesfield Avenue,

Bracknell,
Berkshire,
RGI2 8YS,
United Kingdom.
Trading as Boehringer Ingelheim Consumer Healthcare

8

MARKETING AUTHORISATION NUMBER(S)
PL 00015/0240

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/06/1992 / 25/02/2005

10

DATE OF REVISION OF THE TEXT
06/02/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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