Boehringer Ingelheim Limited

Section 4.4 Special Warnings and Special Precautions for Use

A new seventh paragraph has been inserted into this section regarding unconjugated dipyridamole being incorporated into gallstones.

Section 4.8 Undesirable Effects

The text “(See Special Warnings and Precautions for Use”) has been added to the end of the second sentence in the “Dipyridamole” paragraph following the list of disorders/frequencies.

Section 10 Date of Revision of the Text

The word “May”” has been replaced with the text “October”.

Section 4.4 Special Warnings and Special Precautions for Use

New first, second and third paragraphs have been added, i.e. those commencing with Due to the risk of bleeding, Caution should be advised in patients and Headache or migraine-like headache

The text ASASANTIN Retard should be used with caution in patients with coagulation disorders has been deleted from the beginning of what was the third paragraph to now leave just the following text:

In patients with myasthenia gravis readjustment of therapy may be necessary after changes in dipyridamole dosage (see Interactions).

The text Caution should be advised in patients receiving concomitant medication which may increase the risk of bleeding, such as anti-platelet agents (e.g. clopidogrel, ticlopidine) or selective serotonin reuptake inhibitors (SSRIs), please see section 4.5 has been deleted from the beginning of what was the eighth paragraph to now contain text commencing with The product contains 106 mg of lactose and 22.64 mg sucrose per recommended daily dose.

Section 4.5 Interaction with Other Medicaments & Other Forms of Interaction

The words and phenytoin and side effects have been added to the third paragraph of this section.  The word hepatotoxicity has been deleted from this paragraph.  The text now reads Aspirin may enhance the effect of valproic acid and phenytoin with possible increased risk of side effects.

Section 4.8 Undesirable Effects

This section has been completely reworded with new paragraphs and Table 1 inserted.

Section 5.1 Pharmacodynamic Properties

Three new paragraphs have been added to the end of this section (under the Clinical Trials heading).  They commence with the text: The PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes) study, The incidence of the primary endpoint was similar in both and More patients randomised to ASA+ER-DP (4.1%) than to clopidogrel (3.6%).

Section 10 – Date of Revision of the Text:

The words “April 2008” have been deleted from this section and the words “May 2009” added.

Section 4.2 – Posology & Method of Administration:

The text “together with a glass of water” has been added to the second paragraph under the heading “Adults, including the elderly”.

Paragraph regarding alternative regimen in case of intolerable headaches has been added.

Section 4.5 – Interaction with Other Medicaments & Other Forms of Interaction:

The words “Aspirin has been shown to enhance the effect” and “and” have been added to paragraph 2.

The words “Concomitant use” and “aspirin with” have been deleted from paragraph 2.

Section 4.6 – Pregnancy & Lactation:

The words “the” and “regarding dipyridamole and aspirin at low dose” have been added to paragraph 1.

The words “of ASASANTIN Retard” have been deleted from paragraph 1.

The words “only”, “if considered essential by the physician in terms of benefit” and “Asasantin Retard should be completely avoided” have been added to paragraph 3.

The words “, since aspirin is associated with delayed and prolonged labour and an increased” and “of bleeding, its use is contraindicated” have been deleted from paragraph 3.

Section 6.6 – Special Precautions for Disposal:

The title of this section has been changed from “Instructions for use/handling” to “Special Precautions for Disposal”.

Section 9 – Date of First Authorisation/Renewal of the Authorisation:

The words “/Renewal of the Authorisation” have been added to the title of this section.

The words “/22 December 2003” have been added to the text of this section.

Section 10 – Date of Revision of the Text:

The word “(partial)” has been deleted from the title of this section.