Dulcolax

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Bisacodyl 10 mg
Available from:
sanofi-aventis new zealand limited
INN (International Name):
Bisacodyl 10 mg
Dosage:
10 mg
Pharmaceutical form:
Suppository
Composition:
Active: Bisacodyl 10 mg Excipient: Hard fat
Units in package:
Blister pack, 6 suppositories
Class:
Pharmacy only
Prescription type:
Pharmacy only
Manufactured by:
Boehringer Ingelheim Bidachem SpA
Product summary:
Package - Contents - Shelf Life: Blister pack, - 6 suppositories - 60 months from date of manufacture stored at or below 30°C - Blister pack, - 50 suppositories - 60 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-0574/1a
Authorization date:
1969-12-31

New Zealand Consumer Medicine Information

DULCOLAX

Tablets and Suppositories

Bisacodyl

What is in this leaflet

This leaflet answers some common questions about DULCOLAX. It does not contain

all available information, nor does it take the place of talking to your doctor or

pharmacist. Keep this information with your DULCOLAX. You may need to read it

again.

To find out more about DULCOLAX

should

your

doctor

pharmacist

have

questions

about

DULCOLAX or if you have any trouble before, during or after using DULCOLAX.

What DULCOLAX is used for

DULCOLAX is mainly used for the treatment of constipation.

Under medical supervision, DULCOLAX can be used for the evacuation of the bowel

before a radiological examination or as an enema alternative.

DULCOLAX works by acting on the lining of the lower bowel to stimulate movement

and promotes accumulation of water into the bowel to produce soft formed stools.

Dulcolax is ineffective in altering the digestion or absorption of calories or essential

nutrients in the small intestine.

Stimulant laxatives including DULCOLAX do not help with weight loss.

Before you use DULCOLAX

When you must not use DULCOLAX

Do not use DULCOLAX if you are allergic to bisacodyl or any of the other ingredients

DULCOLAX.

ingredients

DULCOLAX

tablets

DULCOLAX

suppositories are listed under Product Description.

Some of the symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin

Do not use DULCOLAX if you have, or have had, any of the following conditions:

an acute abdominal condition including appendicitis

acute inflammatory bowel disease

severe abdominal pain associated with nausea and vomiting

blockage of the bowel (ileus)

a blockage of the intestine

severe dehydration

If you are uncertain as to whether you have, or have had, any of these conditions,

you should raise any concerns with your doctor or pharmacist.

Do not use DULCOLAX after the expiry date (EXP) on the foil, blister pack or carton.

If you use it after the expiry date has passed, it may not work as well.

Do not use DULCOLAX if the packaging is torn or shows signs of tampering.

Before you start to use DULCOLAX

Before using DULCOLAX suppositories, you must tell your doctor or pharmacist if

you have, or have had any medical conditions including:

an anal fissure (painful tear in the lining of the anus)

ulcerative proctitis (inflammation of the rectum [back passage]).

Suppositories may cause pain and local irritation, especially if you have an anal

fissure (painful tear in the lining of the anus) or ulcerative proctitis (inflammation of

the rectum).

If you are uncertain as to whether you have, or have had any of these conditions, you

should raise any concerns with your doctor or pharmacist.

Before using DULCOLAX, you must tell your doctor or pharmacist if you are taking

any other medicines obtained with or without a doctor’s prescription.

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

diuretics (medicines that increase urine volume)

corticosteroids

medicines which stimulate the heart e.g. digoxin.

It is important to discuss this with your doctor or pharmacist because DULCOLAX

may not work as well in the presence of some other medicines or side effects may be

increased.

Use of Dulcolax with other laxatives may enhance gastrointestinal side effects.

After taking DULCOLAX, avoid straining while passing a bowel motion.

Dizziness and fainting while straining have been reported in patients who have taken

DULCOLAX. It is not known if DULCOLAX can cause dizziness or fainting.

You may experience blood in the stool while using DULCOLAX. This is generally mild

and self-limiting. Tell your doctor if you notice this and it worries you.

DULCOLAX is recommended for short-term use only. If symptoms persist, seek

medical advice.

Long-term use of DULCOLAX is not recommended. If you use DULCOLAX every

day, you should consult with your doctor to find out the cause of your constipation.

Long-term and excessive use of DULCOLAX may cause an imbalance of salts in the

body (including low potassium), muscle weakness and kidney problems. Loss of

fluids from the body can cause dehydration. Symptoms of dehydration include thirst

and passing less urine than normal. In patients experiencing fluid loss where

dehydration may be harmful (for example, kidney problems, elderly patients)

DULCOLAX should be stopped and only restarted under medical supervision.

Long-term and excessive use may also cause the bowel to become dependent on

DULCOLAX for it to produce a bowel motion.

Pregnancy

As for other medicines, ask for your doctor‘s advice if you are pregnant, or likely to

become pregnant during your course of DULCOLAX.

Special care is recommended during pregnancy. The benefits of DULCOLAX must

be assessed against any risks. Your doctor will discuss the risks and benefits of

using DULCOLAX while you are pregnant.

Breastfeeding

As for other medicines, ask for your doctor‘s advice if you are breastfeeding or likely

to breastfeed during your course of DULCOLAX. DULCOLAX does not pass into

breast milk. Therefore DULCOLAX can be used during breastfeeding.

Children

DULCOLAX should be used in children aged 10 years or younger only on medical

advice.

DULCOLAX tablets may be used in children 4 years of age and over and are not

recommended for use in children under 4 years of age.

DULCOLAX suppositories may be used in children 10 years of age and under.

Using DULCOLAX tablets and suppositories

How to take DULCOLAX tablets

Swallow DULCOLAX tablets whole with a glass of water. Do not crush or chew

DULCOLAX tablets.

Do not take DULCOLAX tablets together with medicines that lower acidity of the

upper gastrointestinal tract (stomach). These medicines include antacids, and a

group of medicines called proton pump inhibitors. If you think you may be taking any

of these medicines, please speak with your doctor or pharmacist.

Do not take milk or antacids within 1 hour of taking DULCOLAX tablets. These may

affect how well DULCOLAX tablets work.

DULCOLAX tablets generally work in 6-12 hours.

How to use DULCOLAX suppositories

Do not coat the suppository in any lubricant such as paraffin oil or paraffin jelly. By

warming the suppository in the hand before it is removed from the foil wrapper,

sufficient lubrication will be produced.

Follow the directions below to use DULCOLAX suppositories:

1. Wash your hands thoroughly with soap and water.

2. Remove all of the foil wrapper from the suppository.

3. Lie on your side and raise your knee to your chest.

4. Push the suppository gently and slowly, pointed end first, into the rectum (back

passage).

5. Throw away used materials and wash your hands thoroughly.

DULCOLAX suppositories generally work in about 20 minutes, but may take up to 45

minutes.

If you are not sure how to use a suppository, ask your doctor or pharmacist for

advice.

Recommended dose of DULCOLAX

DULCOLAX should be taken as needed to relieve constipation. It is recommended to

start

with

lowest

dose.

dose

adjusted

maximum

recommended dose to produce regular stools. The maximum daily dose should not

be exceeded.

DULCOLAX Tablets

Adults and children over 10 years:

one or two DULCOLAX tablets at night

Children 4 to 10 years:

one DULCOLAX tablet at night

DULCOLAX tablets are not recommended in children under 4 years of age.

DULCOLAX Suppositories

Adults and children over 10 years:

one DULCOLAX suppository (10 mg)

Children under 10 years of age:

Use only on medical advice.

If your doctor or pharmacist has changed the recommended dose, you should ask for

further information from your doctor or pharmacist.

Overdose

Seek medical advice if you have used more than the recommended or prescribed

dose of DULCOLAX.

Advice can be provided by a doctor, pharmacist or Poisons Information Centre

(telephone 0800 764766).

If you have taken too much DULCOLAX, you may have diarrhoea, abdominal

cramps, fluid loss, and an imbalance of salts in the body (including low potassium).

As with other laxatives, persistent overdose may cause diarrhoea, abdominal pain,

imbalance of salts in the body (including low potassium), secondary

hyperaldosteronism and kidney stones. If an imbalance of salts (low potassium)

occurs, then kidney disease, metabolic alkalosis and muscle weakness may be

experienced.

While you are using DULCOLAX

Things to consider:

Tell your doctor or pharmacist if you begin taking any other medicine while you are

using DULCOLAX. This applies to all medicines obtained with or without a doctor’s

prescription.

Tell all doctors and pharmacists who are treating you that you are using DULCOLAX.

Drink plenty of water while taking laxatives.

An increase in fibre in your diet is recommended, except in cases of medication-

induced constipation.

You should discuss with your doctor or pharmacist if you need to increase the fibre in

your diet when using DULCOLAX to assist in the treatment of constipation.

Effects on Ability to Drive or Operate Machinery

Be careful driving or operating machinery until you know how DULCOLAX affects

you. Do not drive or operate machinery if you experience dizziness or fainting.

Side effects

All medicines carry some risks and all possible risks may not be known at this stage

despite thorough testing. Your doctor or pharmacist has weighed the risks of using

DULCOLAX against the benefits they expect it will have for you.

Ask for the advice of your doctor or pharmacist if you have any concerns about the

effects of using this medicine.

The following side effects of DULCOLAX may occur:

colitis including ischaemic colitis

abdominal discomfort

abdominal cramps

abdominal pain

nausea

vomiting

diarrhoea

anorectal discomfort

blood in the stools

dehydration

dizziness

fainting

Abdominal pain and diarrhoea are the most commonly reported side effects. These

side effects are usually mild and short lived. Tell your doctor immediately or go to

casualty at your nearest hospital if you notice any of the following:

rash, itching or hives on the skin,

swelling of the face, lips, tongue or other parts of the body,

shortness of breath, wheezing or trouble breathing.

These are the symptoms of lifethreatening allergic (anaphylactic) reactions. These

are serious side effects. You may need urgent medical attention or hospitalisation.

Serious side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor

if you notice anything else that is making you feel unwell. Do not be alarmed by this

list of possible side effects. You may not experience any of them.

After using DULCOLAX

Storage

DULCOLAX tablets and DULCOLAX suppositories should be kept in a cool dry place

where the temperature stays below 30°C.

Do not store in direct sunlight or heat. Store DULCOLAX in a safe place where

children cannot reach it.

Disposal

Unused DULCOLAX tablets and DULCOLAX suppositories should be returned to

your pharmacist so they can be disposed of safely.

Product Description

What is DULCOLAX

DULCOLAX is the brand name of your medicine.

DULCOLAX is available as sugar-enteric coated tablets. These tablets are smooth,

round, shiny and brownish-yellow in colour.

Each tablet contains 5 mg of bisacodyl and is available in blister packs of, 30, 100

and 200 tablets.

DULCOLAX is also available as suppositories containing 10 mg of bisacodyl.

Foil-wrapped DULCOLAX suppositories, each containing 10 mg of bisacodyl, are

available in packs of 6 and 50 suppositories. Standard DULCOLAX suppositories are

torpedo-shaped, smooth and white or slightly yellowish in colour.

All foil wrapping of DULCOLAX suppositories carries the name DULCOLAX.

Both DULCOLAX tablets and DULCOLAX suppositories are available from your local

pharmacy without prescriptions.

Ingredients

Each DULCOLAX tablet contains 5 mg of bisacodyl and the following ingredients:

lactose, maize starch, glycerol, magnesium stearate, sucrose, purified talc, acacia,

titanium dioxide, methacrylic acid copolymer, castor oil, macrogol 6000, iron oxide

yellow CI77492, white beeswax, carnauba wax, shellac, and maize starch (soluble).

Each DULCOLAX suppository contains 10 mg of bisacodyl with hard fat as the

suppository base.

Supplier

DULCOLAX tablets are supplied in New Zealand by:

sanofi-aventis new zealand ltd

Level 8, James and Wells Tower

56 Cawley Street

Ellerslie, Auckland

New Zealand

Toll-free: 0800 283 684

This leaflet was prepared on 3

May 2018.

dultabsup-ccds0074-08-cmiv2-03may18

New Zealand Data Sheet

29-Aug-2017

Dulcolax - Bisacodyl

Property of the Sanofi group - strictly confidential

dultabsup-ccds0074-08-ds1-29aug17

Page 1

DATA SHEET

DULCOLAX

DULCOLAX 5 mg enteric coated tablets

DULCOLAX 10 mg suppositories

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet of DULCOLAX contains bisacodyl 5 mg.

Each suppository of DULCOLAX contains biscadyl 10 mg.

For a full list of excipients, see Section 6.1 List of excipients.

PHARMACEUTICAL FORM

Enteric coated tablet: smooth, round, shiny, brownish-yellow coated tablet.

Suppository: smooth, white or slightly yellowish torpedo-shaped suppository.

CLINICAL PARTICULARS

THERAPEUTIC INDICATIONS

For the use in cases of constipation.

In preparation for diagnostic procedures, in pre- and postoperative treatment and in conditions

which require defecation, the use of DULCOLAX must be under medical supervision.

DOSE AND METHOD OF ADMINISTRATION

Unless otherwise prescribed by a physician, the following dosages are recommended:

Tablets

Adults and children over 10 years: 1 to 2 coated tablets at night (5 to 10mg)

Children 4 to 10 years: One coated tablet at night (5mg).

New Zealand Data Sheet

29-Aug-2017

Dulcolax - Bisacodyl

Property of the Sanofi group - strictly confidential

dultabsup-ccds0074-08-ds1-29aug17

Page 2

Notes: DULCOLAX tablets are coated. The tablets should be taken at night to produce evacuation

the following morning. They should be swallowed whole with adequate fluid.

The coated tablets 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.

Suppositories

Adults and children over 10 years: One suppository (10mg)

Do not coat the suppository in any lubricant such as paraffin oil or paraffin jelly. By warming the

suppository in the hand before it is removed from the foil wrapper, sufficient lubrication will be

produced. Insert into the rectum the pointed end first. Suppositories are usually effective in about

20 minutes (range 10 to 30 minutes).

It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum

recommended dose to produce regular stools. The maximum daily dose should not be exceeded.

Children aged 10 years or younger with chronic or persistent constipation should only be treated

under the guidance of a physician.

CONTRAINDICATIONS

DULCOLAX should not be used by patients with ileus, intestinal obstruction, acute surgical

abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe

abdominal pain associated with nausea and vomiting which may be indicative of more severe

conditions.

DULCOLAX is also contraindicated in severe dehydration and in patients with known

hypersensitivity to bisacodyl or any other component of the product.

In case of rare hereditary conditions that may be incompatible with an excipient of the product

(refer to Section 4.4 Special warnings and precautions for use) the use of the product is

contraindicated.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

As with all laxatives, DULCOLAX should not be taken on a continuous daily basis for extended

periods 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,

New Zealand Data Sheet

29-Aug-2017

Dulcolax - Bisacodyl

Property of the Sanofi group - strictly confidential

dultabsup-ccds0074-08-ds1-29aug17

Page 3

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 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 DULCOLAX itself.

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

with anal fissures and ulcerative proctitis.

One coated tablet contains 33.2 mg lactose, resulting in 66.4 mg lactose per maximum

recommended daily dose for treatment of constipation in adults and children over 10 years of age.

For radiographic examination this will result in 132.8 mg per maximum recommended daily dose

in adults. Patients with rare hereditary conditions of galactose intolerance, e.g. galactosaemia,

should not take this medicine.

One coated tablet contains 23.4 mg sucrose (saccharose), resulting in 46.8 mg sucrose

(saccharose) per maximum recommended daily dose for treatment of constipation in adults and

children over 10 years of age. For radiographic examination this will result in 93.6 mg per

maximum recommended daily dose in adults. Patients with the rare hereditary condition of

fructose intolerance should not take this medicine.

INTERACTION WITH OTHER MEDICINES 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.

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 pregnancy.

Nevertheless, as with all drugs, DULCOLAX should be taken during pregnancy only on medical

advice.

New Zealand Data Sheet

29-Aug-2017

Dulcolax - Bisacodyl

Property of the Sanofi group - strictly confidential

dultabsup-ccds0074-08-ds1-29aug17

Page 4

Clinical data show that neither the active moiety of bisacodyl BHPM (bis-(p-hydroxyphenyl)-

pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating human

females.

Thus, DULCOLAX can be used during breast-feeding.

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 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.

UNDESIRABLE EFFECTS

The most commonly reported adverse reactions during treatment are abdominal pain and

diarrhoea.

Immune system disorders

Anaphylactic reactions, angioedema, hypersensitivity.

Metabolism and nutrition disorders

Dehydration

Nervous system disorders

Dizziness, syncope.

Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a vasovagal

response (e.g., to abdominal spasm, defecation).

Gastrointestinal disorders

Abdominal cramps, abdominal pain, diarrhoea, vomiting, nausea, haematochezia (blood in stool),

abdominal discomfort, anorectal discomfort, colitis including ischaemic colitis.

New Zealand Data Sheet

29-Aug-2017

Dulcolax - Bisacodyl

Property of the Sanofi group - strictly confidential

dultabsup-ccds0074-08-ds1-29aug17

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Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are

asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/

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.

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.

Treatment

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.

For advice on the management of overdose please contact the National Poisons Centre on 0800

POISON (0800 764766).

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMIC PROPERTIES

Actions

Bisacodyl, the active ingredient of DULCOLAX, is a locally acting laxative from the

diphenylmethane derivatives group. It is a contact laxative, for which antiresorptive hydragogue

laxative effects have been described. After metabolism by hydrolysis in the large intestine,the

active form of bisacodyl stimulates peristalsis of the colon and promotes 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.

New Zealand Data Sheet

29-Aug-2017

Dulcolax - Bisacodyl

Property of the Sanofi group - strictly confidential

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Page 6

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.

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.

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 data sheet.

PHARMACEUTICAL PARTICULARS

LIST OF EXCIPIENTS

Coated tablets: Lactose monohydrate, maize starch dried, glycerol, magnesium stearate, sucrose,

talc, acacia, titanium dioxide, methacrylic acid-methyl methacrylate copolymer (1:1) and

methacrylic acid-methyl methacrylate copolymer (1:2), Castor oil, macrogol 6000, iron oxide

yellow (E172), beeswax white, carnauba wax, shellac, maize starch (soluble).

New Zealand Data Sheet

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Dulcolax - Bisacodyl

Property of the Sanofi group - strictly confidential

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Page 7

Suppositories: Hard fat (Witepsol W45)

INCOMPATIBILITIES

None.

SHELF LIFE

Suppositories: 5 years.

Tablets: 3 years.

SPECIAL PRECAUTIONS FOR STORAGE

Store in a safe place out of reach of children.

Store below 30 C.

NATURE AND CONTENTS OF CONTAINER

Suppository: 10mg, foil wrapped and carry the name DULCOLAX in packs of 6 and 50.

Tablets: 5mg, blister packs of 30 and 100.

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

None.

MEDICINE SCHEDULE

Pharmacy only medicine

SPONSOR

sanofi-aventis new zealand ltd

Level 8, James and Wells Tower

56 Cawley Street

Ellerslie, Auckland

New Zealand

Toll-free: 0800 283 684

New Zealand Data Sheet

29-Aug-2017

Dulcolax - Bisacodyl

Property of the Sanofi group - strictly confidential

dultabsup-ccds0074-08-ds1-29aug17

Page 8

DATE OF FIRST APPROVAL

5 mg Tablet: 31/12/1969

10 mg suppository: 31/12/1969

DATE OF REVISION OF THE TEXT

29 August 2017

Source Document BPI No.: 0074-08 dated 20jul17

Table 1 ­ 1.1

SUMMARY TABLE OF CHANGES

New Zealand Data Sheet prepared in accordance with the updated data sheet SPC­style format.

Source documents used:

New Zealand Data Sheet – dated 4 October 2013

SECTION

ADDITIONAL TEXT ADDED

Update to headings and reference to align with SPC-style format

1 PRODUCT NAME

Addition of strength and dosage form

2. QUALITATIVE AND QUANTITATIVE

COMPOSITION

New Section

3 PHARMACEUTICAL FORM

Reworded visual description to align with CMI

4.4 Special warnings and precautions for use

Addition of precaution regarding weight loss.

4.5 Interaction with other medicines and other

forms of interaction

Additional warning regarding concomitant use of other laxatives.

4.8 Undesirable effects

Additional adverse reactions.

Addition of reporting of suspected adverse reactions sub-section.

4.9 Overdose

Addition of Poison Centre contact details.

5.3 Preclinical safety data

New Section

6.2 Incompatibilities

New Section

6.3 Shelf Life

New Section

6.5 Nature and contents of container

Reworded pack type and size information

6.6 Special precautions for disposal and other

handling

New Section

8 SPONSOR

Change to sponsor name & address to reflect Sanofi assuming sponsorship

of the product from Boehringer Ingelheim.

9 DATE OF FIRST APPROVAL

New Section

DULCOLAX

is a registered trademark

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