Boehringer Ingelheim Limited Consumer Healthcare

Section 4.4 Special warnings and special precautions for use

A new third paragraph regarding dizziness and/or syncope has been added to this section.

Section 4.7 Effects on ability to drive and use machines

This section has been completely reworded, with the addition of two new paragraphs replacing the previous text of “None stated”.

Section 4.8 Undesirable effects

Text regarding “not known” has been added to the headings of frequency convention paragraph of this section.

The text “Not known” has replaced the previous text of “Rare” in the immune system disorders sub-heading of this section.

A new sub-heading and subsequent text entitled Nervous system disorders has been added to this section.

The text “Very common: Diarrhoea” has been added to the Gastrointestinal disorders sub-heading of this section, resulting in the deletion of the text “and diarrhoea” from the end of the “Common:” sentence.

A new final asterisked (*) marked paragraph has been added to this section.

Section 4.3 Contraindications

A new third, final paragraph regarding rare hereditary conditions has been added to this section.

Section 4.9 Overdose

The word fluid has been inserted into the first sentence of the Symptoms sub-heading i.e. … loss of fluid, potassium and other electrolytes can occur.

Section 10 Date of Revision of the Text

The date has been amended to January 2012.

Section 5.1 Pharmacodynamic Properties

The words the, of and causing peristalsis have been deleted from this section.  The first sentence now reads: Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the colon has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum.  The word with has been added to this sentence which previously read: Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the colon has a the dual-action of stimulation of the mucosa of both the large intestine causing peristalsis and of the rectum. 

The typographical error “defecation” in the third sentence of this section has been corrected to “defaecation”.

Section 5.2 Pharmacokinetic Properties

The sentence Urinary excretion reflects low systemic burden after oral administration has been deleted from the end of the second paragraph of this section, which now reads: After oral administration, only small amounts of the drug are systemically available.

Section 10 Date of Revision of the Text

The date has been amended from February 2010 to September 2010.

Section 1 Name of the Medicinal Product

The product name has been changed to Dulcolax Pico Liquid i.e. addition of the word Pico.

Section 2 Quantitative and Qualitative Composition

Reference to the product name in this section has been updated to Dulcolax Pico Liquid i.e. addition of the word Pico.

Section 4.4 Special Warnings and Special Precautions for Use

References to the product name in this section have been updated to Dulcolax Pico Liquid i.e. addition of the word Pico.

Section 10 Date of Revision of the Text

The date has been amended to February 2010.

Section 4.1 Therapeutic Indications

The text:

For bowel clearance before surgery, childbirth or radiological investigations

has been deleted as the second sentence of the Pharmacy only paragraph.

Section 5.1 Pharmacodynamic Properties

The word with has been added to the first sentence of this paragraph.

The words of and causing peristalsis have been deleted from the first sentence of this paragraph.

The first sentence of this section now reads:

Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the colon, has a dual action with stimulation of the mucosa of both the large intestine and of the rectum.

Section 5.2 Pharmacokinetic Properties

The text:

Urinary excretion reflects low systemic burden after oral administration

has been deleted as the second sentence from the second paragraph of this section.

Section 10 Date of Revision of the Text

The date has been amended to December 2009. 

Section 5.1 Pharmacodynamic Properties

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

Section 5.2 Pharmacokinetic Properties

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

Section 10 Date of Revision of the Text

The date has been amended to November 2009.

Section 4.6 Pregnancy and Lactation

The following text has been deleted as a second paragraph:

There is no evidence as to whether sodium picosulphate is excreted into breast milk.

and replaced with the following text:

Clinical data show that neither the active moiety of sodium picosulfate (BHPM or bis-(p-hydroxyphenyl)-pryidyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.

Section 10 Date of Revision of the Text

The date has been amended to June 2009.

Section 4.8 Undesirable Effects

The words Uncommon: Nausea, vomiting have been added as a second sentence to the Gastrointestinal disorders paragraph.

Section 10 Date of Revision of the Text

The date has been amended to May 2009.

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

The words … broad spectrum … have been deleted from the third sentence of this section i.e. the text now reads Concurrent administration of antibiotics may reduce the laxative action of this product.

Section 10 Date of Revision of the Text

The date has been amended from January 2009 to March 2009.

Dulcolax Liquid 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 this product have been deleted from the first paragraph of this section.

The words There is no evidence as to whether sodium picosulphate 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:

used

to the foetus

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

as with all

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 is not known to be excreted in breast milk, use of this product during breast feeding is not recommended.

Section 10 Date of Revision of the Text

The date has been updated to January 2009. 

Dulcolax Liquid SPC changes

Section 4.4 – Special Warnings and Precautions for Use

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

The words “… long periods.  Patients who need to take laxatives frequently should do so under medical supervision only and should have the cause of their constipation investigated” have been deleted from the first paragraph.

The words “… and may precipitate onset of rebound constipation” have been deleted from the second paragraph.

The words “Not to be taken by children under 10 years without medical advice” have been deleted from the third paragraph and replaced with the words “DULCOLAX should not be taken by children under 10 years without medical advice”.

Section 10 – Date of revision of the text:

The word “medicaments” has been deleted from the header of this section and the words “medicinal products” added.

The words “if excessive doses of DULCOLAX are taken” have been added to the first 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 second paragraph.

Section 4.8 – Undesirable effects:

All text from the previous two paragraphs have been deleted and replaced with the following new 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).

Immune system disorders

Rare:  Hypersensitivity including angioneurotic oedema and skin reactions.

Gastrointestinal disorders

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

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 “when taken” and “may” have been added to the first sentence of paragraph 3.  The words “are known to” have been deleted from the first sentence of paragraph 3.

Section 10 – Date of revision of the text:

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

DULCOLAX is contraindicated Not to be used in patients with ileus, intestinal obstruction, acute surgical abdominal conditions like acute  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 Not to be used in patients with a known hypersensitivity to sodium picosulfate or any other component of the product.

Section 10
Date of Revision amended

Section 1 – Trade name of the medicinal product:

The word “DULCOLAX” has replaced the word “LAXOBERAL”.

Section 2 – Qualitative and quantitative composition:

The following paragraphs have been added:

“Dulcolax^® Liquid also contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol and the colouring agent sunset yellow FCF (E110).

For full list of excipients , see section 6.1.”

Section 4.4 – Special warnings and special precautions for use:

In paragraph 1, the word “DULCOLAX” has replaced the word “LAXOBERAL”.

The following paragraphs have been added:

“Dulcolax^® Liquid contains 5.9 vol % ethanol (alcohol) i.e. up to 480 mg per dose, equivalent to 12 ml beer, 5 ml wine per dose.  Harmful for those suffering from alcoholism.  To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

Dulcolax^® Liquid contains the preservatives methyl parahydroxybenzoate, propyl parahydroxybenzoate and the colouring agent  sunset yellow FCF (E110) which may cause allergic reactions (possibly delayed).”

Section 4.9 – Overdose:

In paragraph 2, the word “DULCOLAX” has replaced the word “LAXOBERAL”.

Section 6.1 – List of excipients:

The text “(E218)” has been added following “Methyl Parahydroxybenzoate”.

The text “(E216)” has been added following “Propyl Parahydroxybenzoate”.

Section 10 – Date of revision of the text:

The words “February 2006” have been replaced with the words “November 2007”.