Bisacodyl 5mg gastro-resistant tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Bisacodyl
Available from:
Teva UK Ltd
ATC code:
A06AB02
INN (International Name):
Bisacodyl
Dosage:
5mg
Pharmaceutical form:
Gastro-resistant tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01060200

PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER

Bisacodyl 5mg Gastro-resistant Tablets

(Bisacodyl)

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

investigations.

Bisacodyl gently stimulate the muscles of the bowel (large intestine). This brings predictable, overnight relief

from constipation.

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

Pregnancy

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

sucrose).

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

enough urine.

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

dose.

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

dizziness.

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)

Dehydration

Allergic reactions which may cause a skin rash

Fainting

Uncommon side effects (affect less than 1 in 100 people)

Blood in the stools

Vomiting

Abdominal discomfort

Discomfort inside and around the back passage

Dizziness

Common side effects (affect less than 1 in 10 people):

Abdominal cramps or pain

Diarrhoea

Nausea

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

Website: www.mhra.gov.uk/yellowcard

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.

Manufacturer

Chanelle Medical, Loughrea, Co. Galway, Ireland.

This leaflet was last revised in: April 2018.

LF7762

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Bisacodyl 5 mg, gastro-resistant tablets

2.

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.

3.

Pharmaceutical Form

Gastro-resistant tablets for oral administration.

Yellow shiny biconvex sugar coated and enteric coated tablet.

4.

Clinical Particulars

4.1

Therapeutic Indications

For short-term relief of occasional constipation.

Constipation, either chronic or of recent onset,

whenever a stimulant laxative

is required.

4.2

Posology and Method of Administration

Posology

Route of administration:

Oral.

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

4.3

Contraindications

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.

4.4

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

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), 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

and self-limiting.

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

years.

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 medicine.

This product contains Tartrazine lake (E102) which may cause allergic

reactions.

4.5

Interactions 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 bisacodyl are taken.

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

4.6

Fertility, Pregnancy and Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Long

experience has shown no evidence of undesirable or damaging effects during

pregnancy.

Breastfeeding:

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

advice.

Fertility:

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 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.

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

including ischaemic colitis.

This product contains Tartrazine lake (E102) which may cause allergic

reactions.

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:

www.mhra.gov.uk/yellowcard.

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 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.

5.

Pharmacological Properties

5.1

Pharmacodynamic Properties

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.

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 preclinical safety 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

Core tablet;

Lactose monohydrate

Liquid paraffin

Maize starch

Magnesium stearate (E572)

Enteric Coat;

Methacrylic acid -ethyl acrylate co-polymer (1:1) dispersion 30%.

Macrogol 3350

Talc

Simethicone Emulsion

Sugar Coat;

Povidone K30

Talc

Kaolin light

Sucrose

Colour Coat;

Titanium dioxide (E171)

Tartrazine lake (E102)

Polishing;

Carnauba wax

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

3 years.

6.4

Special Precautions for Storage

Do not store above 25

Store in the original container.

Keep the container tightly closed (for polypropylene container only).

6.5

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

PVDC

Not all pack sizes may be marketed

6.6

Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in

accordance with local requirements

7.

Marketing Authorisation Holder

Chanelle Medical, Loughrea, Co. Galway, Ireland.

8.

Marketing Authorisation Number

PL 13931/0005

9.

Date of First Authorisation/Renewal of Authorisation

18/07/01 / 22/02/09

10

DATE OF REVISION OF THE TEXT

01/05/2020

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