United Kingdom - English - eMC (Electronic Medicines Compendium)
PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER
Bisacodyl 5mg Gastro-resistant Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you. Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days of treatment.
What is in this leaflet
What Bisacodyl is and what it is used for
What you need to know before you take Bisacodyl
How to take Bisacodyl
Possible side effects
How to store Bisacodyl
Contents of the pack and other information
1. WHAT BISACODYL IS AND WHAT IT IS USED FOR
Bisacodyl 5mg Gastro-resistant tablets contain a medicine called bisacodyl. This belongs to a group of
medicines called laxatives.
Bisacodyl is used for the short-term relief from occasional constipation.
Bisacodyl can also be used in a hospital to empty a person’s bowel before child birth, surgery or radiological
Bisacodyl gently stimulate the muscles of the bowel (large intestine). This brings predictable, overnight relief
Bisacodyl 5mg Gastro-resistant Tablets have a special coating that helps to ensure the medicine works only
where it is needed.
Bisacodyl 5mg Gastro-resistant Tablets do not help with weight loss.
What is constipation?
Normal and regular bowel movement is important for most people. However, what is ‘normal and regular’ varies
from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you,
it is best that your bowel movement has a regular pattern.
Constipation is an occasional problem for some people. For others, it may happen more often.
It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that
material is not easily eliminated from the body.
The cause of constipation is often not known. It can be associated with:
Sudden change of diet
A diet with not enough fibre
Loss of ‘tone’ in the bowel muscles in older people
Medicines such as morphine or codeine
Having to stay in bed for a long time
Lack of exercise
Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally ‘off
colour’. Sometimes it causes headaches.
These healthy tips are recommended to try to prevent constipation happening:
Eat a balanced diet including fresh fruit and vegetables.
Drink enough water so that you do not become dehydrated.
Keep up your exercise and stay fit.
Make time to empty your bowel when your body tells you.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISACODYL
Do not take Bisacodyl if:
You are allergic to bisacodyl or any of the other ingredients in this medicine. (listed in Section 6).
You are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose and
You have severe dehydration.
You have a bowel condition called ‘ileus’ (blockage in the intestine).
You have a serious abdominal condition such as appendicitis.
You have severe abdominal pain with nausea and vomiting.
You have a blocked bowel (intestinal obstruction).
You have inflammation of the bowel (small or large intestine).
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist
before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bisacodyl
Other medicines and Bisacodyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including
medicines obtained without a prescription. This includes herbal medicines. This is because Bisacodyl can affect
the way some other medicines work. Also, some other medicines can affect the way Bisacodyl works.
In particular, tell your doctor or pharmacist if you are taking:
water tablets (diuretics)such as bendrofluazide or furosemide (frusemide)
steroid medicines such as prednisolone
Other laxative medicines
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Bisacodyl
5mg Gastro-resistant Tablets.
Pregnancy and breast feeding
Talk to your doctor or pharmacist before taking Bisacodyl if you are pregnant, planning to become pregnant or
are breast feeding.
Driving and using machines
Some people may feel dizzy or faint while taking this medicine. If this happens to you, wait until these feelings go
away before driving or using machines.
Bisacodyl contains Lactose, Sucrose and Tartrazine
This medicine contains lactose (a milk sugar) and sucrose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine. The tablets also contain Tartrazine
(E102) which may cause allergic reactions.
3. HOW TO TAKE BISACODYL
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check
with your doctor or pharmacist if you are not sure.
As with all laxatives, Bisacodyl should not be taken every day for more than five days. If you need
laxatives every day, or if you have abdominal pain which does not go away, you should see your doctor.
Taking this medicine:
Swallow the tablets whole with water.
Milk, antacids or proton pump inhibitors (medicines which reduce stomach acid) should not be taken within
one hour before or after taking Bisacodyl. This is because they will stop Bisacodyl from working properly.
How much to take
Adults and children over 10 years old
Take one or two tablets (5 to 10 mg) daily before bedtime.
If you have not taken Bisacodyl 5mg Gastro-resistant Tablets before, start with one tablet and increase to
two if necessary.
When your bowel regularity has returned to normal, the dose can usually be stopped.
Children aged between 4 and 10 years
Bisacodyl 5mg Gastro-resistant Tablets should only be given to children between the ages of 4 and 10 if
recommended by a doctor. The usual dose for children is:
one tablet (5 mg) daily before bedtime.
Children under 4 years
Bisacodyl 5mg Gastro-resistant Tablets are not recommended for children under 4 years.
If you take more Bisacodyl than you should
It may be harmful to:
take too much bisacodyl
take bisacodyl for too long
This is because taking too much for too long may lead to:
Imbalance of fluid and salts in the body. This can affect the tightness of muscles such as those in the bowel.
It can also affect the salts in the blood.
Low levels of potassium in the blood (called ‘hypo-kalaemia’). This can make you tired, dizzy, make your
muscles weak and cause an uneven heart-beat.
Dehydration, making you thirsty, feel faint and giving you headaches. It can also mean you cannot pass
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the
medicine pack with you; this is so the doctor knows what you have taken.
If you forget to take Bisacodyl
If you have forgotten to take your tablet at night, wait for the next dose and continue as before. Do not take any
more tablets in one day than your doctor has prescribed. Do not take a double dose to make up for a missed
If you feel that the effect of your medicine is too strong or too weak, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bisacodyl can cause side effects, although not everybody gets them. The following side effects
may happen with this medicine:
Rare side effects (affect less than 1 in 1000 people)
Severe allergic reactions which may cause swelling of the face or throat and difficulty in breathing or
If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away.
Colitis (inflammation of the large intestine which causes abdominal pain and diarrhea)
Allergic reactions which may cause a skin rash
Uncommon side effects (affect less than 1 in 100 people)
Blood in the stools
Discomfort inside and around the back passage
Common side effects (affect less than 1 in 10 people):
Abdominal cramps or pain
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via Yellow Card Scheme
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BISACODYL
Keep this medicine out of the sight and reach of children.
Do not use Bisacodyl after the expiry date which is stated on the label after EXP. The expiry date refers to the last
day of that month.
Do not store above 25
C. Store in the original container.
Keep the container tightly closed (for polypropylene containers only).
Do not use Bisacodyl if you notice any deterioration or damage to the outer packaging
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Bisacodyl contains
The active substance is Bisacodyl. Each tablet contains 5 mg of bisacodyl.
The other ingredients are: Core Tablet: Lactose monohydrate, Liquid paraffin, Maize starch and Magnesium
stearate. Enteric Coating: Methacrylic acid Co-Polymer Ethyl Acrylate Co Polymer (1:1) dispersion 30%
material, Macrogol 3350, Talc and Simethicone PD30. Sugar Coat; Povidone K30, Talc, Kaolin light and
Sucrose. Colour Coat; Titanium dioxide (E171) and Tartrazine lake (E102). Polishing; Carnauba wax.
What Bisacodyl looks like and contents of the pack
Bisacodyl are yellow shiny biconvex sugar coated gastro resistant tablets.
Bisacodyl 5mg, gastro-resistant tablets are available in blister packs (cartons) of 20, 60 and 100 tablets and in
polypropylene containers of 500 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Chanelle Medical, Loughrea, Co. Galway, Ireland.
Chanelle Medical, Loughrea, Co. Galway, Ireland.
This leaflet was last revised in: April 2018.
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Bisacodyl 5 mg, gastro-resistant tablets
Qualitative and Quantitative Composition
Each tablet contains Bisacodyl 5 mg.
Excipients: This product contains 64.42 mg lactose monohydrate, 53.00 mg sucrose
0.04 mg tartrazine lake (E102) per tablet.
For the full list of excipients, see section 6.1.
Gastro-resistant tablets for oral administration.
Yellow shiny biconvex sugar coated and enteric coated tablet.
For short-term relief of occasional constipation.
Constipation, either chronic or of recent onset,
whenever a stimulant laxative
Posology and Method of Administration
Route of administration:
Short-term treatment for constipation:
Adults and children over 12 years: 1 – 2 tablets (5 – 10 mg) daily.
It is recommended to start with the lowest dose. The dose might be adjusted
up to the maximum recommended dose to produce regular stools. The
maximum daily dose should not be exceeded.
In the management of constipation, once regularity has been restarted dosage
should be reduced and can usually be stopped.
Bisacodyl 5 mg gastro-resistant tablets should not be used in children and
adolescents under the age of 12 years .
Method of administration
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.
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
Bisacodyl 5 mg, gastro-resistant tablets are contrainidicated 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.
Bisacodyl 5 mg gastro-resistant tablets are also contra-indicated in severe
dehydration and in patients with known hypersensitivity to bisacodyl or any
other component of the product.
In case of hereditary conditions that may be incompatible with an excipient of
the product (see section 4.4) the use of the product is contraindicated.
Special warnings and precautions for use
As with all laxatives, Bisacodyl 5 mg gastro-resistant tablets should not be
taken on a continuous daily basis for more than five days without
investigating the cause of constipation.
Long –term everyday use of stimulant laxatives may harm the intestinal
function and should be avoided. If laxatives are needed every day the cause
of the constipation should be investigated. This product should only be used
if a therapeutic effect cannot be achieved by a change of diet or the
administration of bulk forming agents.
Prolonged excessive use may lead to fluid and electrolyte imbalance and
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), bisacodyl should
be discontinued and only be restarted under medical supervision.
Stimulant laxatives (including bisacodyl) do not help with weight loss (see
section 5.1) .
Patients may experience haematochezia (blood in stool) that is generally mild
Dizziness and / or syncope have been reported in patients who have taken
bisacodyl. 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 related to the
constipation, and not necessarily to the administration of biscodyl itself.
There have been isolated reports of abdominal pain and bloody diarrhea
occurring after taking bisacodyl. Some cases have been shown to be
associated with colonic mucosal ischaemia.
If the symptoms worsen during the use of medicinal product, a doctor or
pharmacist should be consulted
Bisacodyl should not be used by children and adolescents under the age of 12
This product contains a small amount of lactose (64.42 mg) and sucrose
(53.00 mg) in each tablet. Patients with rare hereditary problems of galactose
intolerance, fructose intolerance, the Lapp lactase deficiency, sucrase-
isomaltase insufficiency or glucose-galactose malabsorption should not take
This product contains Tartrazine lake (E102) which may cause allergic
Interactions with other medicinal products and other forms of
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 bisacodyl are taken.
Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.
Fertility, 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
Clinical data show that neither the active moiety of bisacodyl (BHPM or bis-
(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into
the milk of healthy lactating females.
Nevertheless, as with all medicines, bisacodyl should not be taken during
pregnancy, especially the first trimester, and during breast feeding unless the
expected benefit is thought to outweigh any possible risk and only on medical
No studies on the effect on human fertility have been conducted.
Effects on ability to Drive and use machines
No studies on the effects of bisacodyl 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.
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);
1/1000, <1/100); rare (
1/10000, <1/1000); very rare
Immune system disorders
Rare: anaphylactic reactions, angioedema, hypersensitivity.
Metabolism and nutrition disorders
Nervous system disorders
Dizziness and syncope occurring after taking bisacodyl appear to be
consistent with a vasovagal response (e.g. to abdominal spasm, defaecation).
Uncommon: haematochezia (blood in stool), vomiting, abdominal
Common: abdominal cramps, abdominal pain, diarrhoea and nausea.
including ischaemic colitis.
This product contains Tartrazine lake (E102) which may cause allergic
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit / risk
balance of the medicinal product. Healthcare professionals are asked to report
any suspected adverse reactions via the Yellow Card Scheme at:
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.
After ingestion of oral forms of Bisacodyl 5 mg gastro-resistant tablets,
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.
ATC code: A06AB02
Mechanism of action
Bisacodyl is a locally acting laxative from diphenylmethane derivatives
group having a dual action. As a contact laxative, for which also anti-
resorptive 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.
As a laxative that acts on the colon, bisacodyl specifically stimulates the
natural evacuation process in the lower region of the gastrointestinal tract.
Therefore, bisacodyl is ineffective in altering the digestion or absorption of
calories or essential nutrients in the small intestine.
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.
Preclinical Safety Data
There are no preclinical safety data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.
List of Excipients
Magnesium stearate (E572)
Methacrylic acid -ethyl acrylate co-polymer (1:1) dispersion 30%.
Titanium dioxide (E171)
Tartrazine lake (E102)
Special Precautions for Storage
Do not store above 25
Store in the original container.
Keep the container tightly closed (for polypropylene container only).
Nature and Contents of Container
Blister packs (cartons) of 20 tablets and 60 tablets.
Blister strips are composed of Aluminium PVC 250 um White PVC / 60gsm
Not all pack sizes may be marketed
Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements
Marketing Authorisation Holder
Chanelle Medical, Loughrea, Co. Galway, Ireland.
Marketing Authorisation Number
Date of First Authorisation/Renewal of Authorisation
18/07/01 / 22/02/09
DATE OF REVISION OF THE TEXT