Boehringer Ingelheim Limited

Section 4.2 Posology and Method of Administration

A new sub heading entitled Paediatric population has been added to this section. 

New information for children aged 13 to 18 years has been added to this section.

Section 4.4 Special Warnings and Precautions for Use

A new final paragraph regarding the excipient Amaranth (E123) has been added to this section.

Section 4.8 Undesirable Effects

Replacement text regarding SOC categories and side effect details following the first paragraph of this section has been inserted.  This information is now listed in a tabular format after the sentence A full list of currently known adverse reactions is presented below:

Section 10 Date of Revision of the Text

The date has been updated from August 2009 to June 2010.

Section 6.3 Shelf Life

The text 120 days has been replaced with the text 4 months in the second paragraph of this section.

Section 6.4 Special Precautions for Storage

The text … to protect from light have been added to the end of the second sentence of this section.

Section 6.5 Nature and Contents of Container

The text Not all pack sizes may be marketed has been added as a second paragraph to this section.

Section 10 Date of Revision of Text

The date has been updated from May 2009 to August 2009.

Section 2 Qualitative and Quantitative Composition

The second and third sentences of this section have been added as new text.

Section 10 Date of Revision of the Text

The date November 2008 has been replaced with the date May 2009.

Oramorph Concentrated Oral Solution SPC changes

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

The word medicaments has been replaced with the words medicinal products in the header of this section.

New fourth and fifth paragraphs have been added.  Paragraph 4 begins with the words Interactions have been reported … and paragraph 5 begins with the words In a study involving healthy volunteers …

Section 4.7 Effects on Ability to Drive and Use Machines

The word Effect has been replaced with the word Effects in the header of this section.

Section 6.6 Special Precautions for Disposal

The words Instructions for Use/Handling have been replaced with the words Special Precautions for Disposal in the header of this section.

Section 9 Date of First Authorisation/Renewal of the Authorisation

The words have been put in upper case to align with the rest of the document’s main section headings.

This section’s text now reads:

Date of first authorisation: 16^th August 1988

Date of last renewal: 16^th August 1993

as opposed to:

Date of first authorisation/renewal of the authorisation

16.08.88 / 16.08.93

Section 10 Date of Revision of the Text

The section header wording has been changed from Date of (partial) revision of the text to Date of revision of the text and put into upper case letters.

The date of revision has been updated from August 2008 to November 2008.

Oramorph Concentrated Oral Solution SPC changes

Section 4.3 – Contraindications

The words “Oramorph is contraindicated in patients known to be hypersensitive to morphine sulphate or to any other component of the product” have been added as a new paragraph 2.

Section 4.4 – Warnings and Precautions

The words “Hypersensitivity and anaphylactic reaction have both occurred with the use of Oramorph.  Care should be taken to elicit any history of allergic reactions to opiates” have been added as a final paragraph.

Section 4.8 – Undesirable Effects

The words “Immune system disorders: hypersensitivity reactions including anaphylaxis.  Urticaria, pruritis” have been added as a final paragraph i.e. after the “General” adverse reactions section.

Section 10 – Date of Revision of the Text

The words “July 2006” have been replaced with the words “August 2008”.