Boehringer Ingelheim Limited Consumer Healthcare

Section 4.6 Pregnancy and Lactation

A new final (now fourth) paragraph has been added regarding the conduction of studies on the effect on human fertility.

Section 4.7 Effects on Ability to Drive and Use Machines

A new final (now second) paragraph has been added regarding vasovagal response and dizziness and/or syncope.

Section 4.8 Undesirable Effects

A new first paragraph has been added entitled “The most commonly reported adverse events …”.

The text “Not known – incidence cannot be estimated from the available data” has been deleted from after the “Adverse events have been ranked under headings of frequency …” paragraph.

All Immune System Disorders now come under the “Rare” heading.  The “Not known” heading has been deleted from the Immune System Disorders paragraph.

The text “Not known” has been replaced with the text “Rare” in the Metabolism and Nutrition Disorders paragraph.

A new paragraph regarding Nervous System Disorders has been added to this section.

The colitis listing in the Gastrointestinal Disorders paragraph has been changed from “Not known” to “Rare”.  The “Not known” text has been deleted.

Section 10 Date of Revision of the Text

The date has been updated from August 2010 to October 2010.

Section 5.1 Pharmacodynamic Properties

Text has been both added to and deleted from this section to align with Company Core Data Sheet.

Section 5.2 Pharmacokinetic Properties

Text has been both added to and deleted from this section to align with Company Core Data Sheet.

Section 10 Date of Revision of the Text

The date has been updated to August 2010.

Section 4.7 Effects on Ability to Drive and Use Machines

The previous text of:

DULCOLAX has no effect on ability to drive and use machinery.

has been replaced with the following text:

No studies on the effects of DULCOLAX on the ability to drive and use machines have been performed.

Section 6.6 Special Precautions for Disposal

The previous text of:

See patient information leaflet

has been replaced with the following text:

None stated.

Section 10 Date of Revision of the Text

The date has been updated to May 2010.

Section 4.2 Posology and Method of Administration

Text for the entire section has been reworded and replaced, with the exception of the two paragraphs commencing with the following:

When using DULCOLAX to prepare the patient for radiographic examination …

and

No specific information on the use of this product is the elderly is available …

which remain as before.

Section 10 Date of Revision of the Text

The date has been updated to March 2010.

Section 4.4 Special Warnings and Special Precautions for Use

New third and fourth paragraphs have been inserted as follows:

Third paragraph now starts with Intestinal loss of fluids can promote dehydration.

Fourth paragraph now starts with Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting.

What is now the fifth paragraph (that starting with Dizziness and/or syncope…) has had text both deleted from and added to.

Section 4.6 Pregnancy and Lactation

What used to be the second paragraph has been deleted i.e. text There is no evidence as to whether bisacodyl is excreted into breast milk.

A new second paragraph has been inserted which now starts with the text Clinical data show that neither the active moiety of bisacodyl …

Section 4.8 Undesirable Effects

The text Rare: hypersensitivity has been added to the Immune system disorders.

The text … neurotic o… and … and other hypersensitivity has been deleted from the Not known paragraph in Immune system disorders.

A whole new paragraph regarding Metabolism and nutrition disorders has been added.

The text …, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort has been added to the Uncommon paragraph in Gastrointestinal disorders.

The text … abdominal discomfort has been deleted from the Common paragraph in Gastrointestinal disorders.

The text Local irritation has been reported when the suppository formulation has been administered has been deleted as the last paragraph of this section.

Section 4.9 Overdose

The words watery stools, brackets either side of the word diarrhoea and word fluid have all been added to the first paragraph of the Symptoms section.

Text (including reference to gastric lavage) has both been deleted from and added to the Therapy section.

Section 10 Date of Revision of the Text

The date has been updated from January 2009 to March 2010.

Dulcolax Suppositories 5 mg SPC changes

Section 4.6 Pregnancy and Lactation

The words … adequate and well-controlled studies in pregnant women.  Long experience has shown no evidence of undesirable or damaging effects during pregnancy have been added to the first paragraph of this section.

The words … reports of undesirable or damaging effects during pregnancy or to the foetus attributable to the use of DULCOLAX have been deleted from the first paragraph of this section.

The words There is no evidence as to whether bisacodyl is excreted into breast milk have been added as a new second paragraph.

In what was previously the second paragraph of this section, the following text has been deleted:

medicines

used

to the foetus

In what was previously the second paragraph of this section, the following text has been added:

as with all medicines, DULCOLAX

taken

and during breast feeding

and only on medical advice

The following text has been deleted (from what was previously the third paragraph):

Although the active ingredient of DULCOLAX is not known to be excreted in breast milk, its use during breast feeding is not recommended.

Section 10 Date of Revision of the Text

The date has been updated to January 2009.

Dulcolax Suppositories for Children, 5 mg SPC changes

Section 4.4 – Special Warnings and Precautions for Use

The text “There have been isolated reports of abdominal pain and bloody diarrhoea occurring after taking bisacodyl.  Some cases have been shown to be associated with colonic mucosal ischaemia.” has been added as a new fourth paragraph.

Section 4.8 – Undesirable Effects

The whole of this section has been removed and replaced with the following text:

“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).

Not known – incidence cannot be estimated from the available data.

Immune system disorders

Not known: anaphylactic reactions, angioneurotic oedema and other hypersensitivity.

Gastrointestinal disorders

Uncommon: vomiting.

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

Not known: colitis.

Local irritation has been reported when the suppository formulation has been administered.”

Section 10 – Date of revision of the text:

The date has been updated to December 2008.

Section 4.4 – Special Warnings and Precautions for Use

The words “without investigating the cause of constipation” have been added at the end of the first paragraph i.e. after the words “… more than five days”.

The words “If laxatives are needed every day, the cause of constipation should be investigated” have been deleted as the second paragraph.

The words “and may precipitate the onset of rebound constipation” have been deleted from what was the third paragraph.

The words “Children under 10 years should not take DULCOLAX without medical advice” have been deleted from what was the sixth paragraph and the words “DULCOLAX should not be used by children under 10 years without medical advice” added.

Section 10 – Date of revision of the text:

The date has been updated to November 2008.

Section 4.5 – Interactions

The words “if excessive doses of DULCOLAX are taken” have been added to the second paragraph and the words “However, this situation only arises if excessive doses of DULCOLAX are taken (See Overdose Section)” deleted.

The words “Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides” have been added as a third paragraph.

Section 4.9 – Overdose:

The words “This may also lead to increased sensitivity to cardiac glycosides” have been deleted from the Symptoms paragraph.

The words “Laxatives, when taken in” have been added to the first sentence of paragraph 2.  The words “with laxatives” have been deleted from the first sentence of paragraph 2.

Section 10 – Date of revision of the text:

The words “July 2008” have been replaced with the words “August 2008”.

Section 4.3

DULCOLAX is contraindicated must not be used in patients with ileus, intestinal obstruction, acute surgical abdominal conditions including such as acute 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 DULCOLAX is also contraindicated in patients with a known hypersensitivity to bisacodyl or any other ingredient in component of the product.

Section 10
Date of revision amended