Boehringer Ingelheim Limited

Section 4.4 Special warnings and precautions for use

This section’s header has been amended from Special warnings and special precautions for use to Special warnings and precautions for use.

Section 4.5 Interaction with other medicinal products and other forms of interaction

This section’s header has been amended from Interaction with other medicaments and other forms of interaction to Interaction with other medicinal products and other forms of interaction.

Section 4.8 Undesirable effects

The text … treated with has been replaced with the text … were allocated to in the first paragraph of this section.

The text *PRoFESS: intracranial haemorrhage (1.0%) and intraocular haemorrhage (0.2%) has been replaced with the text *definition in PRoFESS also includes intraocular haemorrhage (0.2%) in Table 1 of this section.

The paragraph In addition to those side effects listed for ASASANTIN, for the relevant monocompounds also the below listed side effects are established; however, have not been reported for ASASANTIN yet has been replaced with the paragraph Additional established side effects for the relevant monocompounds are the following and are also considered listed for Asasantin Retard above the Dipyridamole sub-heading of this section.

Section 6.6 Special precautions for disposal

The p of precautions and d of disposal have been changed from upper case to lower case in this section’s header.

Section 8 Marketing authorisation number(s)

This section’s header has been amended to Marketing authorisation number(s) from Marketing authorisation number.

Section 9 Date of first authorisation/renewal of the authorisation

This section has changed from 12 May 1998 / 22 December 2003 to Date of First Authorisation: 12 May 1998 Date of Last Renewal: 22 December 2003.

Section 10 Date of revision of the text

The date has been updated from July 2010 to August 2010.

Section 5.2 Pharmacokinetic Properties

The typographical error aetylsalicylic has been amended to acetylsalicylic in the first sentence of the first paragraph of this section.

New first, second and last paragraphs have been added to the Distribution sub-heading of the Dipyridamole heading of this section. 

Section 10 Date of Revision of the Text

The date has been amended from June 2010 to July 2010.

Section 6.3 Shelf Life

This section has been amended from:

30 months

to:

Unopened: 36 months

In-use: Discard any capsules remaining 6 weeks after first opening.

Section 6.4 Special Precautions for Storage

This section has been amended from:

Store below 25ºC.

Discard any capsules remaining 6 weeks after first opening.

to:

Store in the original container.  Keep the bottle tightly closed.

This medicinal product does not require any special temperature storage precautions.

Section 6.5 Nature and Contents of Container

This section has been amended from:

White polypropylene tubes with low-density polyethylene Air-sec stoppers filled with desiccating agent (90% white silicon gel/10% molecular sieves).  Packs contain 60 capsules.

to:

White polypropylene bottles with child resistant multipart polypropylene/polyethylene screw cap containing a desiccant made from silica gel/molecular sieves.  Pack size of 60 capsules.

Section 10 Date of Revision of the Text

The date has been amended from May 2010 to June 2010.

Section 5.1 Pharmacodynamic Properties

A new first sentence has been added to the third paragraph of this section regarding platelet aggregation.

The third paragraph now commences with the following text:

Thus, platelet aggregation in response to various stimuli such as platelet activating factor (PAF), collagen and adenosine diphosphate (ADP) is inhibited. 

The word already has been replaced with the word previously in the first sentence of the fourth paragraph under the Clinical Trials heading in this section.

The following text has been deleted as a second sentence of the fourth paragraph under the Clinical Trials heading in this section:

Individuals who were ≥ 55 years of age and who had had an ischemic stroke within 90 days of entry to the study were included.

Section 10 Date of Revision of the Text

The date has been amended from April 2010 to May 2010.

Section 4.9 has been revised to include that “tachycardia might be observed” and to add the sentence “Dizziness and tinnitus can, particularly in elderly patients, be symptoms of overdose” to this section.

Section 10 – date has been revised to April 2010

Section 4.6 Pregnancy and Lactation

The word avoided in the last sentence of the third paragraph of this section has moved location from after the word completely to before the word completely.

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.