Last Updated on eMC 13-08-2015 View medicine  | Boehringer Ingelheim Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:01-08-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 Special Warnings and Precautions for Use

 

Bleeding disorders

Due to the risk of bleeding, as with other antiplatelet agents, ASASANTIN should be used with caution in patients at increased bleeding risk and patients should be followed carefully for any signs of bleeding, including occult bleeding. (see section 4.5).

 

Caution should be advised in patients receiving concomitant medication which may increase the

risk of bleeding, such as anticoagulants, anti-platelet agents (e.g. clopidogrel, ticlopidine) or , selective serotonin reuptake inhibitors (SSRIs), or anagrelide (see section 4.5).

reuptake inhibitors (SSRIs), please see section 4.5.


Cardiovascular disorders

Headache or migraine-like headache which may occur especially at the beginning of ASASANTIN therapy should not be treated with analgesic doses of acetylsalicylic acid.


Among other properties dipyridamole acts as a vasodilator.  ItDipyridamole should be used with caution in patients with severe coronary artery disease, including unstable angina and/or recent myocardial infarction, left ventricular outflow obstruction, or haemodynamic instability (e.g. decompensated heart failure). 

 

The dose of aspirin in ASASANTIN Retard has not been studied in secondary prevention of myocardial infarction. 

 

Myasthenia gravis

Patients being treated with regular oral doses of ASASANTIN Retard should not receive additional intravenous dipyridamole.  Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress testing with intravenous dipyridamole, should discontinue drugs containing oral dipyridamole twenty-four hours prior to stress testing. 


In patients with myasthenia gravis readjustment of therapy may be necessary after changes in dipyridamole dosage (see Interactionssection 4.5).


Biliary disorders

A small number of cases have been reported in which unconjugated dipyridamole was shown to be incorporated into gallstones to a variable extent (up to 70% by dry weight of stone). These patients were all elderly, had evidence of ascending cholangitis and had been treated with oral dipyridamole for a number of years. There is no evidence that dipyridamole was the initiating factor in causing gallstones to form in these patients. It is possible that bacterial deglucuronidation of conjugated dipyridamole in bile may be the mechanism responsible for the presence of dipyridamole in gallstones.

 

Headache or migraine-like headache

Headache or migraine-like headache which may occur especially at the beginning of ASASANTIN therapy should not be treated with analgesic doses of acetylsalicylic acid (see section 4.2).


Hypersensitivity

In addition, caution is advised in patients hypersensitive to non-steroidal anti-inflammatory drugs (NSAIDs).


Aspirin (Acetylsalicylic Acid) related warnings

Due to the aspirin component, ASASANTIN Retard should be used in caution in patients with asthma, allergic rhinitis, nasal polyps, chronic or recurring gastric or duodenal complaints, impaired renal (avoid if severe) or hepatic function (see section 5.2) or glucose-6-phosphate dehydrogenase deficiency.

 

In addition, caution is advised in patients hypersensitive to other non-steroidal anti-inflammatory drugs.


Children and adolescents

ASASANTIN Retard is not indicated for use in children and young people.  There is a possible association between aspirin and Reye’s syndrome when given to children.  Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal.  For this reason aspirin should not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki’s disease).

 

Stress testing with intravenous dipyridamole

Patients being treated with regular oral doses of ASASANTIN Retard should not receive additional intravenous dipyridamole.  Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress testing with intravenous dipyridamole, should discontinue drugs containing oral dipyridamole twenty-four hours prior to being treated with intravenous dipyridamole.


Excipients

The dose of aspirin in ASASANTIN Retard has not been studied in secondary prevention of myocardial infarction. 

 

One capsule contains 53 mg lactose and 11.32 mg sucrose, resulting in 106 mg of lactose and 22.64 mg sucrose per maximum recommended daily dose. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

 

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


NSAIDs/Corticosteroids/Alcohol

Gastrointestinal side effects may increase when aspirin is administered concomitantly with NSAIDs, corticosteroids or chronic alcohol use.


There is some experimental evidence that ibuprofen interferes with aspirin induced inhibition of platelet cyclo-oxygenase.  This interaction could reduce the beneficial cardiovascular effects of aspirin, however the evidence for this is not conclusive.  Further, in view of the known increased risk of gastrointestinal toxicity associated with NSAID and aspirin co-medication, this combination should be avoided wherever possible.  When such a combination is necessary the balance of gastrointestinal and cardiovascular risks should be considered.

 

Drugs affecting coagulation

When dipyridamole is used in combination with other substances impacting coagulation such as anticoagulants and antiplatelet agents,  the safety profile for these medications must be observed.

 

Aspirin has been shown to enhance the effect of, when given with anticoagulants (e.g. coumarin derivatives and heparin), antiplatelet drugs (e.g. clopidogrel, ticlopidine) and), selective serotonin reuptake inhibitors (SSRIs) and may), or anagrelide to increase the risk of bleeding. The addition of dipyridamole to aspirin does not increase the incidence of bleeding events. 

 

Aspirin may enhance the effect of valproic acid and phenytoin with possible increased risk of side effects.

 

Gastrointestinal side effects may increase when aspirin is administered concomitantly with NSAIDs, corticosteroids or chronic alcohol use. The addition of dipyridamole to aspirin does not increase the incidence of bleeding events.  When dipyridamole was administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone.

 

Anticonvulsants

Aspirin may enhance the effect of valproic acid and phenytoin with possible increased risk of side effects.

 

Adenosine

Dipyridamole increases the plasma levels and cardiovascular effects of adenosine.  Adjustment of adenosine dosage should therefore be considered if use with dipyridamole is unavoidable.

 

Antihypertensives

Dipyridamole may increase the hypotensive effect of drugs, which reduce blood pressure lowering drugs and.


Cholinesterase inhibitors

Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors thereby potentially aggravating myasthenia gravis. (see section 4.4).


Hypoglycaemics/Methotrexate

The effect of hypoglycaemic agents and the toxicity of methotrexate may be increased by the concomitant administration of aspirin.

Spironolactone/Uricosuric agents

Aspirin may decrease the natriuretic effect of spironolactone and inhibit the effect of uricosuric agents (e.g. probenecid, sulfinpyrazone).

 

There is some experimental evidence that ibuprofen interferes with aspirin induced inhibition of platelet cyclo-oxygenase.  This interaction could reduce the beneficial cardiovascular effects of aspirin, however the evidence for this is not conclusive.  Further, in view of the known increased risk of gastrointestinal toxicity associated with NSAID and aspirin co-medication, this combination should be avoided wherever possible.  When such a combination is necessary the balance of gastrointestinal and cardiovascular risks should be considered.

 

Section 10 Date of Revision of the Text

 

The date has been amended from July 2015 to August 2015.

 

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:01-07-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 Undesirable Effects

Text up to the Reporting of suspected adverse reactions paragraph has been deleted, inserted and moved in this section.

 

The previous Table 1 regarding bleeding events has been deleted.

 

The side effects/frequency of disorders information has been tabulated.

 

Section 10 Date of Revision of the Text

The date has been amended from June 2015 to July 2015.

 

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-06-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.6 Fertility, Pregnancy and Lactation

 

Pregnancy Sub-Heading

The following text has been added:

 

‘(see section 5.3)’ – to the first paragraph

‘see’ – to the second paragraph

‘administered during’ – to the third paragraph

‘of pregnancy when the potential benefits for’ – to the third paragraph

‘mother outweigh the possible risks for the foetus.  ASASANTIN’ – to the third paragraph

‘is contraindicated’ – to the third paragraph

‘of pregnancy’ – to the third paragraph

 

The following text has been deleted:

 

‘please refer to’ – from the second paragraph

‘used with caution in the’ – from the third paragraph

‘if considered essential by’ – from the third paragraph

‘physician in terms of benefit and risk.  Asasantin’ – from the third paragraph

‘should be avoided completely’ – from the third paragraph

 

Lactation Sub-Heading

The following text has been added:

 

‘(see section 5.2) – to the end of the first sentence

‘used in breast-feeding women when the potential benefits for the mother outweigh the possible risks for the newborn’ – to the second sentence

 

The following text has been deleted:

 

‘Therefore’ – from the start of the second sentence

‘administered to nursing mothers if clearly needed’ – from the second sentence

 

Fertility Sub-Heading

The following text has been added:

 

‘Fertility studies were only performed with the individual components.  No impairment of fertility was observed with dipyridamole.  Acetylsalicylic acid can inhibit ovulation in rats (see’ – to become the second, third and fourth sentences

 

The following text has been deleted:

 

‘(please refer to’ – from the first sentence

 

Section 10 Date of Revision of the Text

The date has been updated from September 2014 to June 2015.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:10-09-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following wording relating to the reporting of adverse events has been added to the end of section 4.8 (Undesirable effects):

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

 

 

Section 10 - date of revision of the text has been updated to September 2014.

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-01-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.5 change ‘sulphinpyrazone’ to ‘sulfinpyrazone’

Section 10 - date of revision of the text has been updated to January 2014

Reasons for adding or updating:

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-09-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 6.4 Special Precautions for Storage

The text … in order to protect from moisture has been added to the first sentence of this section.  The text Store below 30°C has also been added.

 

The previous text of This medicinal product does not require any special temperature storage precautions has been deleted from this section.

 

Section 10 Date of Revision of the Text

The date has been amended from July 2012 to September 2012.

 

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.6 Pregnancy and Lactation

This section’s title header has been amended to Fertility, pregnancy and lactation i.e. addition of the word Fertility.

 

A new sub-heading title (Pregnancy) has been added in front of the first paragraph.

 

The second sentence of the second paragraph of what is now the Pregnancy sub-heading has been amended with the words Fertility studies and being deleted and the text (please refer to section 5.3) being added.

 

A new sub-heading title (Lactation) has been added in front of the fourth paragraph.

 

A new sub-heading title (Fertility) and corresponding text has been added as a final paragraph.

 

Section 5.3 Preclinical Safety Data

A new third, final paragraph regarding fertility has been added to this section.

 

Section 10 Date of Revision of the Text

The date has been amended from June 2012 to July 2012.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-06-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 Special Warnings and Precautions for Use

The first sentence of the final paragraph of this section has been amended from The product contains 106 mg of lactose …… to One capsule contains 53 mg lactose and 11.32 mg sucrose, resulting in 106 mg of lactose ……

 

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

The first paragraph of this section has been amended from When dipyridamole is used in combination with aspirin or with warfarin, the statements regarding precautions, warnings and tolerance for these preparations must be observed to When dipyridamole is used in combination with other substances impacting coagulation such as anticoagulants and antiplatelet agents, the safety profile for these medications must be observed.

 

Section 4.7 Effects on Ability to Drive and Use Machines

The previous text of None stated has been deleted and replaced with completely new text.

 

Section 4.8 Undesirable Effects

A minor typographical error in the left hand column of Table 1 in this section has been corrected i.e. the text Any Bleeding has been amended to Any bleeding.

 

Section 4.9 Overdose

A minor typographical error in the second paragraph of the Therapy sub-heading of this section has been corrected i.e. from … of more than 250 mg/kg.  the plasma … to … of more than 250 mg/kg.  The plasma …

 

Section 5.1 Pharmacodynamic Properties

Some of the Clinical Trials: sub-heading text of this section has had the following changes made:

 

From:

 

In ESPS-2 ASASANTIN Retard reduced the risk of stroke by 22.1% compared to ASA 50 mg /day alone (p=0.008) and reduced the risk of stroke by 24.4% compared to extended-release dipyridamole 400 mg/day alone (p=0.002).  ASASANTIN Retard reduced the risk of stroke by 36.8% compared to placebo (p<0.001).

 

To:

 

In ESPS-2 ASASANTIN Retard reduced the risk of stroke by 23.1% compared to ASA 50 mg /day alone (p=0.006) and reduced the risk of stroke by 24.7% compared to extended-release dipyridamole 400 mg/day alone (p=0.002).  ASASANTIN Retard reduced the risk of stroke by 37% compared to placebo (p<0.001).

 

Section 5.2 Pharmacokinetic Properties

A minor typographical error in the final sentence of the Metabolism sub-heading of this section has been corrected i.e. the word that has been added.

 

Section 7 Marketing Authorisation Holder

A minor typographical error in the company name has been corrected in this section.  The word Limited now starts with an upper case letter and now lower case as previously.

 

Section 10 Date of Revision of the Text

The date has been amended from August 2010 to June 2012.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-08-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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.

Reasons for adding or updating:

  • 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:01-07-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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.

 

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-06-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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.

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:01-05-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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.

Reasons for adding or updating:

  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-04-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation

Date of revision of text on the SPC:01-10-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:01-10-2009

Legal Category:POM

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 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”.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • 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:01-05-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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.

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:01-04-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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.

 

The words “December 2007” have been deleted from this section and the words “April 2008” added.

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:01-12-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.1 and 5.2 - extensively rewritten/reworded

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-08-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3 - 4th paragraph new.
Section 4.4 - last 2 paragraphs new.
Section 4.5 - reworded/rewritten.
Section 4.8 - migraine-like added to paragraph 1, angina and arrhythmia added to paragraph 2, skin haemorrhages added to last paragraph,
Section 4.9 - rewritten/reworded.

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients

Date of revision of text on the SPC:01-04-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.1: 'methacrylic acid-methyl methacrylate copolymer' has replaced 'eudragit S 100'

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use

Reasons for adding or updating:

  • Change to section 3 - pharmaceutical form
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 3 - pharmaceutical form
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied