Updated on 18/05/2011 and displayed until Current
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 01-May-2011 |
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| Section 4.5 …..
Drug interactions: effects of anagrelide on other substances
· Anagrelide demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other co-administered medicinal products sharing that clearance mechanism e.g. theophylline.
· Anagrelide is an inhibitor of PDE III. The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide.
· In vivo interaction studies in humans have demonstrated that anagrelide does not affect the pharmacokinetic properties of digoxin or warfarin.
· At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may theoretically potentiate the effects of other medicinal products that inhibit or modify platelet function e.g. acetylsalicylic acid.
· A clinical interaction study performed in healthy subjects showed that co-administration of repeat-dose anagrelide 1 mg once daily and acetylsalicylic acid 75 mg once daily may enhance the anti-platelet aggregation effects of each drug compared with administration of acetylsalicylic acid alone. In some ET patients concomitantly treated by acetylsalicylic acid and anagrelide, major haemorrhages occurred. Therefore, due to the lack of data in ET patients, the potential risks of the concomitant use of anagrelide with acetylsalicylic acid should be assessed, particularly in patients with a high risk profile for haemorrhage before treatment is initiated.
· Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Food interactions
· Food delays the absorption of anagrelide, but does not significantly alter systemic exposure.
·The effects of food on bioavailability are not considered clinically relevant to the use of anagrelide. ...........
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Updated on 08/12/2010 and displayed until 18/05/2011
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 26-Nov-2010 |
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| Section 4.8 Undesirable Effects: was amended to add ' Tubulointerstitial nephritis' to the subsection, 'Renal and urinary disorders'. The incidence rate is not known.
Section 10 Date of Revision of the Text: was amended to reflect the approval date of 11/10.
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Updated on 28/05/2010 and displayed until 08/12/2010
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-May-2010 |
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4.4 Special warnings and special precautions for use
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GeneralMonitoring
Therapy requires close clinical supervision of the patient which will include a full blood count (haemoglobin and white blood cell and platelet counts), and assessment of liver function (ALT and AST) and renal function (serum creatinine and urea) tests.
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4.8 Undesirable effects
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Hepatobiliary disorders
Uncommon: Hepatic enzymes increased
Not known: Hepatitis
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10. DATE OF REVISION OF THE TEXT
04/201005/2010
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Updated on 30/04/2010 and displayed until 28/05/2010
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 20-Apr-2010 |
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| In section 6.3, the shelf-life has been changed from 3 to 4 years.
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Updated on 13/11/2009 and displayed until 30/04/2010
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5 - Pharmacological Properties
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 30-Oct-2009 |
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| Renewal. EC Decision 30-Oct-2009. Administrative updates to Annex I (SmPC) and Annex III (Labelling and Package Leaflet) in line with comments from QRD during renewal assessment.
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Updated on 27/03/2009 and displayed until 13/11/2009
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to MA holder contact details
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| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: POM |
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| Due to recent clinical study - the interactions with aspirin have been updated
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Updated on 11/03/2009 and displayed until 27/03/2009
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: POM |
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| As a result of a clinical study there are changes with respect to interactions with aspirin.
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Updated on 11/12/2008 and displayed until 11/03/2009
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Change to section 4.2 - Posology and method of administration
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 01-Nov-2008 |
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Section 4.2
Elderly - No specific pharmacokinetic studies have been conducted in this patient population
New text: The observed pharmacokinetic differences between elderly and young patients with ET (see section 5.2) do not warrant using a different starting regimen or different dose titration step to achieve an individual patient-optimised anagrelide regimen.
Section 5.2 Pharmacokinetic properties
New PK paragraph following review of Study 203.
New text:
Elderly: Pharmacokinetic data from fasting elderly patients with ET (age range 65-75 years) compared to fasting adult patients (age range 22-50 years) indicate that the Cmax and AUC of anagrelide were 36% and 61% higher respectively in elderly patients, but that the Cmax and AUC of the active metabolite, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline, were 42% and 37% lower respectively in the elderly patients. These differences were likely to be caused by lower presystemic metabolism of anagrelide to 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in the elderly patients.
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Updated on 04/02/2008 and displayed until 11/12/2008
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 03/2008 |
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Section 2 - Update in line with standard QRD statement
Section 4.2 - Update in line with standard QRD statement
Section 5.1 - Update ATC Code
Section 5.2 - Update in line with standard QRD Template
Section 5.3 - Revision to preclincial statement
Section 6.6 - Update in line with standard QRD Heading
Section 10 - New date of revision of text
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Updated on 02/04/2007 and displayed until 04/02/2008
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Correction of spelling/typing errors
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 03/2007 |
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Section 4.4: Addition of lactose statement
Section 4.8: Addition of 'allergic alveolitis'
Various minor typographical/spelling changes throughout text
Section 10: Date of revision updated to 28 March 2007
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Updated on 16/08/2006 and displayed until 02/04/2007
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 08/2006 |
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Section 4.2: Posology and method of administration: deletion of last two sentences under the Renal Impairment subheading concerning dose titration and administration to patients with mild to severe renal impairment
Section 4.8: Undesirable effects: Addition of 'pulmonary hypertension' and 'hepatic enzymes increased'. Correction to placing of 'migraine' so that it is under 'Nervous system disorders'
Section 4.9: Update to overdose statement
Section 5.1: Deletion of 'Proposed' in relation to ATC code
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Updated on 09/03/2006 and displayed until 16/08/2006
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Change to section 4.8 - Undesirable Effects
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Updated on 23/11/2005 and displayed until 09/03/2006
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Change to section 4.3 - Contra-indications
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Change to section 5.2 - Pharmacokinetic Properties
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Updated on 28/09/2005 and displayed until 23/11/2005
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5 - Pharmacological Properties
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Updated on 27/09/2005 and displayed until 28/09/2005
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5 - Pharmacological Properties
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Pending awaiting re-submission
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Updated on 28/01/2005 and displayed until 27/09/2005
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