Dulcolax 5 mg Suppositories for Children *

Section 4.4 (Special Warnings and Precautions for Use)
The fourth paragraph has been amended to include the text "Stimulant" and "including DULCOLAX".

Section 4.5 (Interaction with Other Medicinal Products and Other Forms of Interaction)
A new final paragraph has been added (regarding the concomitant use of other laxatives enhancing the gastrointestinal side effects).

Section 4.8 (Undesirable Effects)
New text of "including ischaemic colitis" has been added to the last sentence of the Gastrointestinal disorders part of this section.

Section 10 (Date of Revision of the Text)
The date has been amended to November 2017.

Section 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/54/2 has been replaced by PA 540/184/1.

Section 10 (Date of Revision of the Text) has been amended from December 2016 to August 2017.

The dosage information for the tablet presentation has been deleted from section 4.2.

 

The suppository dosage information in section 4.2 has been amended to add the word “daily”.

 

The dosage information for adults and children over 10 years has been deleted and replaced with the statement “For adults and children over 10 years of age the SmPC for Dulcolax 10 mg Suppositories should be consulted”.

The statement “Laxatives do not help with weight loss (see section 5.1 Pharmacodynamic properties)” has been added to section 4.4 (Special Warnings and Precautions for Use).

 

The ATC code has been added to section 5.1 (Pharmacodynamic Properties) in line with the Company Core Data Sheet.

 

The text “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” has been added to section 5.1 (Pharmacodynamic Properties) in line with the Company Core Data Sheet.

 

The revision date in section 10 has been updated to December 2016.

Section 4.2 Posology and Method of Administration

The previous first paragraph text of 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 has been deleted from this section.

 

Three new paragraphs have been added to the end of the Short-term treatment for constipation sub-heading text of this section.

 

A new first paragraph starting For preparation of diagnostic procedures … has been added to the For preparation of diagnostic procedures and preoperatively sub-heading text of this section. 

 

The previous first sentence text of Should only be used under medical supervision has been deleted from the For preparation of diagnostic procedures and preoperatively sub-heading text of this section. 

 

The text Instructions for use has been added to this section.

 

The previous text of:

 

When using DULCOLAX to prepare the patient for radiographic examination of the abdomen or employing it preoperatively, tablets should be combined with suppositories in order to achieve complete evacuation of the intestine.

 

In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped.

 

has been deleted from this section.

 

Section 4.4 Special Warnings and Precautions for Use

The words patients with have been added to between in and anal in the penultimate paragraph of this section.

 

The previous final paragraph text of DULCOLAX should not be taken by children under 10 years without medical advice has been deleted from this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

A new sub-heading of Fertility has been added above the last sentence of this section.

 

Section 10 Date of Revision of the Text

The date has been amended from May 2013 to October 2014. 

Section 4.8 Undesirable Effects

Details regarding the reporting of suspected adverse reactions have been added to the end of this section.

 

Section 10 Date of Revision of the Text

The date has been amended from May 2013 to July 2014.

 - In section 4.2 (Posology and method of administration), Information with regard to the time it takes the suppositories to be effective has been updated. A usual range of 10 to 30 minutes has been added.

Section 4.2 Posology and Method of Administration

The penultimate paragraph of this section has been amended with text both added to and deleted from.  The text … , but in some cases it may take up to 45 minutes has been added and the text … (range 10 to 30 minutes) has been deleted.

 

Section 5.2 Pharmacokinetic Properties

This whole section has been amended, with text both added to and deleted from.  The first paragraph has had mainly text deleted from, but has also had some text added to.

 

The text of what are now the second and third paragraphs of this section is mainly new text.

 

The text of what were previously the last four paragraphs of this section has been deleted.

 

Section 10 Date of Revision of the Text

The date has been amended from June 2011 to April 2012.

 

Section 1 Name of the Medicinal Product

The strength text i.e. 5 mg has been moved to now come after the word Dulcolax i.e. from Dulcolax Suppositories for Children 5 mg to Dulcolax 5 mg Suppositories for Children.

 

Section 2 Qualitative and Quantitative Composition

The words … a full list of and … section have been added to the second sentence of this section to now read: For a full list of excipients, see section 6.1.

 

Section 6.4 Special Precautions for Storage

The text In order to protect from light has been moved to the end of the second sentence of this section.

 

The sentence now reads: Keep the blister in the outer carton, in order to protect from light.

 

Section 10 Date of Revision of the Text

The date has been updated from March 2011 to June 2011.

Section 4.6 Fertility, Pregnancy and Lactation

A new final sentence/paragraph has been added to the Lactation paragraph of this section i.e. No studies on the effect on human fertility have been conducted.

 

Section 4.7 Effects on Ability to Drive and Use Machines

A new second/final paragraph regarding vasovagal response and dizziness/syncope has been added to this section.

 

Section 4.8 Undesirable Effects

A new first sentence/paragraph regarding abdominal pain and diarrhoea has been added to this section.

 

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

 

This complete section has been reworded, with text being both added to and deleted from.

 

A new sub-heading, Nervous system disorders, has been added.

 

Section 10 Date of Revision of the Text

The date has been updated from January 2011 to March 2011.

Section 4.2 Posology and Method of Administration

This section has been reworded.  Two of the original paragraphs remain the same, the rest of the section’s text is new.

Section 4.2 Posology and Method of Administration

This section has been reworded.  Two of the original paragraphs remain the same, the rest of the section’s text is new.

 

Section 5.1 Pharmacodynamic Properties

This section has been reworded, with text being both added and deleted.

 

Section 5.2 Pharmacokinetic Properties

This section has been reworded, with text being both added and deleted.

 

Section 10 Date of Revision of the Text

The date has been updated from June 2010 to January 2011.

Section 4.4 Special Warnings and Precautions for Use

New third and fourth paragraphs have been added to this section regarding intestinal loss of fluids and haematochezia (blood in stool).

 

The paragraph commencing with the text Dizziness and / syncope has been amended with both text being deleted from and added to. 

 

Section 4.6 Pregnancy and Lactation

This section has been completely re-written, with the exception of the final paragraph, with new separate sub-headings regarding Pregnancy and Lactation.

 

The word DULCOLAX in the final paragraph of this section has been replaced with the word bisacodyl and the following text has been deleted from this paragraph:

 

… in pregnancy, especially the first trimester

 

Section 4.8 Undesirable Effects

The following text has been added to the Immune system disorders sub-heading of this section:

 

Rare: hypersensitivity

 

The second sentence of the Immune system disorders sub-heading has been amended to now read:

 

Not known: anaphylactic reactions, angioedema

 

i.e. deletion of the words neurotic and other hypersensitivity

 

A new sub-heading regarding Metabolism and nutrition disorders has been added to this section.

 

The following text has been added to the Uncommon sentence of the Gastrointestinal disorders sub-heading of this section:

 

…, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort

 

The words Abdominal discomfort have been deleted from the Common sentence of the Gastrointestinal disorders sub-heading of this section.

 

What was the final paragraph of this section (regarding local irritation when the suppository formulation has been administered) has been deleted.

 

Section 4.9 Overdose

The first paragraph of this section has been amended to include the text watery stools, brackets round the word diarrhoea and the text fluid.

 

The first paragraph of the Therapy sub-heading has had the text or gastric lavage added to the end of the first sentence.

 

The text Within a short time, Otherwise gastric lavage should be performed and (particularly hypokalaemia) has been deleted from the first paragraph of the Therapy sub-heading.

 

The word some has been deleted from between the words of and value in the second paragraph of the Therapy sub-heading of this section.

 

Section 10 Date of Revision of the Text

The date has been updated to June 2010.

Section 4.7 Effects on Ability to Drive and Use Machines

The following text:

 

None stated.

 

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 10 Date of Revision of the Text

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

None provided