Updated on 06/02/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 01-Jan-2012 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 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.
Three asterisks (*) have been added to 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.
|
|
Updated on 13/01/2012 and displayed until 06/02/2012
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.9 - Overdose
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Jan-2012 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 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.
|
|
Updated on 22/12/2010 and displayed until 13/01/2012
|
Reasons for adding or updating:
|
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 5.1 Pharmacodynamic Properties
The text … the active ingredient of DULCOLAX PERLES has been deleted from the first sentence of this section to now read: Sodium picosulfate is a locally acting laxative … as opposed to: Sodium picosulfate, the active ingredient of DULCOLAX PERLES is a locally acting laxative …
Section 10 Date of Revision of the Text
The date has been amended from February 2010 to September 2010.
|
|
Updated on 28/06/2010 and displayed until 22/12/2010
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 10 date of revision of the text
-
Change of product licence name
|
| Date of revision of text on the SPC: 01-Feb-2010 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 1 Name of the Medicinal Product
The product name has been changed to Dulcolax Pico Perles i.e. addition of the word Pico.
Section 5.1 Pharmacodynamic Properties
Reference to the product name in this section has been updated to DULCOLAX PICO PERLES i.e. addition of the word PICO.
Section 10 Date of Revision of the Text
The date has been amended to February 2010.
|
|
Updated on 14/04/2010 and displayed until 28/06/2010
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic indications
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Dec-2009 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.1 Therapeutic Indications
The text:
For bowel clearance before surgery, childbirth or radiological investigations
has been deleted as the third paragraph of this section.
Section 10 Date of Revision of the Text
The date has been amended to December 2009.
|
|
Updated on 26/02/2010 and displayed until 14/04/2010
|
Reasons for adding or updating:
|
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Nov-2009 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 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 from June 2009 to November 2009.
|
|
Updated on 03/07/2009 and displayed until 26/02/2010
|
Reasons for adding or updating:
|
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Jun-2009 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 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.
|
|
Updated on 13/05/2009 and displayed until 03/07/2009
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-May-2009 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 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.
|
|
Updated on 11/05/2009 and displayed until 13/05/2009
|
Reasons for adding or updating:
|
-
Change to section 10 date of revision of the text
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| Date of revision of text on the SPC: 01-Mar-2009 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
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.
|
|
Updated on 02/02/2009 and displayed until 11/05/2009
|
Reasons for adding or updating:
|
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Jan-2009 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Dulcolax Perles SPC changes
Section 4.6 Pregnancy and Lactation
The heading of this section has been amended from Use during pregnancy and lactation to 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 PERLES 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 DULCOLAX PERLES during breast feeding is not recommended.
Section 10 Date of Revision of the Text
The date has been updated to January 2009.
|
|
Updated on 10/12/2008 and displayed until 02/02/2009
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Nov-2008 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.4 – Special Warnings and Precautions for Use
The word “PERLES” has been deleted from the first paragraph after the word “DULCOLAX”.
The word “daily” has been added between the words “continuous” and “basis” of the first paragraph.
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 onset of rebound constipation” have been deleted from what was the third paragraph.
The word “PERLES” has been deleted from what was the fourth paragraph after the word “DULCOLAX”.
Section 10 – Date of revision of the text:
The date has been updated to November 2008.
|
|
Updated on 20/10/2008 and displayed until 10/12/2008
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
|
| Date of revision of text on the SPC: 01-Aug-2008 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.3 - Contraindications
The word "bisacodyl" in the last paragraph of this section has been deleted and the words "sodium picosulfate" added as replacement text
|
|
Updated on 15/09/2008 and displayed until 20/10/2008
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
-
Change to section 10 date of revision of the text
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 01-Aug-2008 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Dulcolax Perles SPC changes
Section 4.5 – Interactions
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.
The words “DULCOLAX PERLES” have been deleted from the end of the now third paragraph and replaced with the words “this product”.
Section 4.8 – Undesirable effects:
The words “Allergic reactions, including skin reactions and angio oedema” have been deleted from the Immune system disorders paragraph and replaced with the words “Hypersensitivity including angioneurotic oedema and skin reactions”.
Section 4.9 – Overdose:
The words “symptoms, emergency procedures, antidotes” have been deleted from the header of this section to leave the word “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”.
|
|
Updated on 29/08/2008 and displayed until 15/09/2008
|
Reasons for adding or updating:
|
-
Change to section 10 date of revision of the text
-
Change to section 4.3 - Contraindications
|
| Date of revision of text on the SPC: 01-Jul-2008 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.3
DULCOLAX PERLES are is contraindicated in patients with ileus, intestinal obstruction, acute surgical abdominal conditions including like 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 and in severe dehydration Not to be used and in patients with a known hypersensitivity to sodium picosulfate or any other component of the product.
Section 10
Date of Revision amended
|
|
Updated on 14/08/2006 and displayed until 29/08/2008
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 03/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 1: Dulco-lax changed to Dulcolax
Section 4.4: addition of following paragraph
As with all laxatives, DULCOLAX PERLES should not be taken on a continuous basis for more than five days.
Section 7: Consumer Healthcare added
|
|
Updated on 26/07/2004 and displayed until 14/08/2006
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 27/08/2003 and displayed until 26/07/2004
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic Indications
-
Change to section 4.2 - Posology and Method of Administration
|
|
Updated on 18/12/2002 and displayed until 27/08/2003
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 3 - pharmaceutical form
|
|
Updated on 16/08/2001 and displayed until 18/12/2002
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 16/08/2001 and displayed until 16/08/2001
|
Reasons for adding or updating:
|
|
|
|
