Dulcolax 5mg Suppositories for Children

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Bisacodyl
Available from:
Sanofi-Aventis Ireland Limited T/A SANOFI
ATC code:
A06AB; A06AB02
INN (International Name):
Bisacodyl
Dosage:
5 milligram(s)
Pharmaceutical form:
Suppository
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Contact laxatives; bisacodyl
Authorization status:
Not marketed
Authorization number:
PA0540/184/001
Authorization date:
1986-06-05

Read the complete document

Patient Information Leaflet:

Information for the user

Read all of this leaflet carefully because it contains

important information for you.

This medicine is available without prescription. You need to

use DULCOLAX Suppositories as instructed in this leaflet to

get the best results from it.

Keep this leaflet. You may need to read it again

Ask your pharmacist if you need more information or

advice

You must contact your pharmacist or doctor if your

symptoms worsen or do not improve after 5 days of

treatment

If a side effect occurs and gets troublesome, or seems

serious to you, or if you experience any side effect not

listed in this leaflet, please tell your pharmacist or doctor

In this leaflet:

1. What DULCOLAX Suppositories are and what they are

used for

2. Before you use DULCOLAX Suppositories

3. How to use DULCOLAX Suppositories

4. Possible side effects

5. How to store DULCOLAX Suppositories

6. Further information

1. WHAT DULCOLAX SUPPOSITORIES ARE AND WHAT

THEY ARE USED FOR

DULCOLAX Suppositories contain a medicine called

bisacodyl. This belongs to a group of medicines called

laxatives.

DULCOLAX Suppositories are used for relief of

constipation

This medicine does not help with weight loss

DULCOLAX Suppositories are also used in hospitals to

clear the bowel before surgery, X-rays or other tests

DULCOLAX Suppositories stimulate the muscles of the

bowel (large intestine), helping to return the body to its

natural rhythm. They have a laxative effect usually within

10 to 30 minutes

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 the

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’ of 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 is uncomfortable. It may

make you feel bloated and heavy, or generally “off colour”.

Sometimes it causes headaches.

These healthy tips are recommended to try and 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 bowels when your body tells

2. BEFORE YOU USE DULCOLAX SUPPOSITORIES

Do not use DULCOLAX Suppositories if:

You are allergic (hypersensitive) to bisacodyl or hard fat

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)

You have cracking of the skin around your back passage

(anal fissures)

You have inflammation or ulcers around your back

passage (ulcerative proctitis)

Do not use DULCOLAX Suppositories if any of the above

applies to you. If you are not sure, talk to your pharmacist

or doctor before using this medicine.

Taking other medicines

Please tell your pharmacist or doctor if you are taking or

have recently taken any other medicines, including

medicines obtained without a prescription. This includes

herbal medicines. This is because DULCOLAX Suppositories

can affect the way some other medicines work. Also, some

other medicines can affect the way DULCOLAX

Suppositories work.

In particular, tell your pharmacist or doctor if you are taking

any of the following medicines:

Water tablets (diuretics) such as bendrofluazide or

furosemide (frusemide)

Steroid medicines such as prednisolone

Other laxative medicines

Before using DULCOLAX Suppositories, tell your pharmacist

or doctor if you are not sure if any of the above applies to

you.

Pregnancy and breast-feeding

Talk to you pharmacist or doctor before using DULCOLAX

Suppositories 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.

3. HOW TO USE DULCOLAX SUPPOSITORIES

If this medicine is from your doctor or pharmacist, do exactly

as they have told you. Otherwise, follow the instructions

below. If you do not understand the instructions, or if you

are not sure, ask your pharmacist or doctor.

10 mg SUPPOSITORIES

and

5 mg SUPPOSITORIES

FOR CHILDREN

bisacodyl

439138/IE/3

Technical colors

Diecut-Legendcase

Free area

Glue points

File information

GMID:

660446 / 660447

Plant PM code:

1060026781

Second Plant PM code:

439138/IE/3

Version of artwork:

PM type:

Market:

Format:

160 x 305 mm

Issue date of artwork:

04/Apr/2019

Print colors:

Pan 357

Number of print colors:

Used font:

Bliss 2

Min. font size:

7,5 pt

p2e number:

922293

As with all laxatives, DULCOLAX Suppositories should not

be used every day for more than 5 days. If you need

laxatives every day, or if you have abdominal pain which

does not go away, you should see your doctor.

How to use the suppositories

The suppositories should only be used in your back passage.

1. Take off the foil wrapping

Lie on one side and pull your knees up towards your

chest. Keep one leg drawn up more than the other

3. Use your first finger (index finger) or middle finger to

push in the suppository

4. Gently push the suppository as far as possible into your

back passage, pointed end first

Once it is as far as it will go, push it side-ways to make

sure it touches the wall of the bowel

6. Lower your legs to a comfortable position whilst the

suppository is retained in place

7. Keep the suppository inside you for at least 30 minutes

If you feel the suppository might come out straight

away:

You may not have put it in high enough. Push it in as far as

possible

Try to keep it in for 30 minutes, even if you feel like you

urgently need to go to the toilet. This is how long it takes

to work

How much to use

For constipation

Adults and children over 10 years

Put one 10 mg suppository into the back passage for

immediate effect. Only use one suppository per day

Children under 10 years

DULCOLAX 5 mg Suppositories for Children should only

be used if recommended by a doctor. The usual dose is:

Put one 5 mg suppository into the back passage for

immediate effect. Only use one suppository per day

Children under 4 years

Do not use in children under 4 years of age

For bowel clearance before surgery, X-rays or other tests

In hospitals, when patients are being prepared for surgery,

X-rays or other tests, DULCOLAX Suppositories and

DULCOLAX Tablets are both used. This helps to get

complete bowel clearance.

Adults and children over 10 years

Take two tablets in the morning and two tablets in the

evening and use one 10 mg suppository on the following

morning

Children 4 -10 years

Give one tablet in the evening and one 5 mg suppository

(DULCOLAX 5 mg Suppositories for Children) on the

following morning

Children under 4 years

Do not use in children under 4 years of age

If you use too many DULCOLAX Suppositories

It may be harmful to

Use too many DULCOLAX Suppositories or

Use DULCOLAX Suppositories for too long

This is because using too many 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

‘hypokalaemia’). 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 use more DULCOLAX Suppositories than you should

If you use 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 have any questions on the use of this product, ask

your pharmacist or doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, DULCOLAX Suppositories 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 diarrhoea)

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, pharmacist

or nurse. This includes any possible side effects not listed in

this leaflet. You can also report side effects directly via the

national reporting system (see details below).

By reporting side effects you can help provide more

information on the safety of this medicine.

HPRA Pharmacovigilance

Earlsfort Terrace

IRL – Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

5. HOW TO STORE DULCOLAX SUPPOSITORIES

Keep this medicine out of the sight and reach of children

Do not use DULCOLAX Suppositories after the expiry

date which is stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

Do not store above 25°C

The suppositories should be protected from light. Keep

them in the outer carton

Medicines should not be disposed of via wastewater or

household waste. Ask your pharmacist how to dispose of

medicines no longer required. These measures will help

protect the environment

6. FURTHER INFORMATION

What DULCOLAX Suppositories contain

DULCOLAX 10 mg Suppositories contain 10 mg of the

active ingredient bisacodyl

DULCOLAX 5 mg Suppositories for Children contain 5 mg

of the active ingredient bisacodyl

Both the suppositories are made from hard fat, which is

an ingredient needed to mould the suppository into the

correct shape

What DULCOLAX Suppositories look like and contents

of the pack

The suppositories are white and torpedo shaped

DULCOLAX 10 mg Suppositories are available in packs

of 10, 12 and 20. Not all pack sizes may be marketed

DULCOLAX 5 mg Suppositories for Children are available

in packs of 5

Marketing Authorisations are held by:

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland

Tel: +353 1 4035600

Fax: +353 1 4035687

email: IEmedinfo@sanofi.com.

Malta

Sanofi Malta Ltd., Level 2,

Fort Business Centre, Mriehel Bypass,

Birkirkara BKR3000, Malta.

Tel: +356 21493022

Email: PharmacovigilanceMalta@sanofi.com

DULCOLAX Suppositories are manufactured by:

Istituto De Angeli S.r.I., Località Prulli n. 103/c

50066 Reggello (FI), Italy.

This leaflet was revised in April 2019

® Registered trade mark

439138/IE/3

Read the complete document

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Dulcolax 5mg Suppositories for Children

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each suppository contains 5 mg of bisacodyl.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Suppository

Smooth, white torpedo-shaped suppositories.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For evacuation of the colon in constipation and in preparation for radiological investigations.

4.2 Posology and method of administration

Short-term treatment for constipation:

Children 4 – 10 years: 1 suppository (5 mg) daily for immediate effect.

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.

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.

For preparation of diagnostic procedures and preoperatively.

For preparation of diagnostic procedures, in pre- and postoperative treatment when defaecation needs to be facilitated,

DULCOLAX should be used under medical supervision.

The tablets should be combined with suppositories in order to

achieve complete evacuation of the intestine.

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.

For adults and children over 10 years of age the SmPC for Dulcolax 10 mg Suppositories should be consulted.

Instuctions for use:

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 (usual range 10 to 30 minutes).

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Rarely the laxative effect has been reported 45 minutes after administration. 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.

DULCOLAX Suppositories should not be used when anal fissures or ulcerative proctitis with mucosal damage are

present.

4.4 Special warnings and precautions for use

As with all laxatives, DULCOLAX should not be used 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.

Stimulant laxatives including DULCOLAX do not help with weight loss (see section 5.1 Pharmacodynamic properties).

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.

The use of suppositories may lead to painful sensations and local irritation, especially in patients with anal fissures and

ulcerative proctitis.

4.5 Interaction with other medicinal products and other forms of interaction

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.

The concomitant use of other laxatives may enhance the gastrointestinal side effects of DULCOLAX.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of bisacodyl in pregnant

women.

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Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

As a precautionary measure, it is preferable to avoid the use of bisacodyl during pregnancy, especially in the first

trimester.

Lactation

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 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 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 potientally 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: vomiting, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort.

Common: abdominal pain, abdominal cramps, nausea and diarrhoea.

Rare: colitis including ischaemic colitis.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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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 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

ATC code: A06AB02

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.

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.

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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

Hard fat (adeps solidus).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years.

6.4 Special precautions for storage

Do not store above 25°C. Keep the blister in the outer carton, in order to protect from light.

6.5 Nature and contents of container

Aluminium foil blister strips coated with PVC film or combination lacquer.

Dulcolax Suppositories for Children are available in packs of 5.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Sanofi-Aventis Ireland Ltd

T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0540/184/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 5

June 1986

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Date of last renewal: 5

June 2011

10 DATE OF REVISION OF THE TEXT

November 2017

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6

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