Updated on 12/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: 02-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1 - The printing ink is no longer used, and therefore all reference to this ink and its components are removed from the excipients section of the SmPC.
Section 10 - The date of revision of the text is updated.
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Updated on 13/04/2011 and displayed until 12/03/2012
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 13-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 7 the address of the MAH, Astellas Pharma Ltd., has been updated following a move to new premises. This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.
In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7. This date is updated to 13th December 2010.
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Updated on 23/07/2009 and displayed until 13/04/2011
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 12-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The change to this SPC is in Section 6.1 List of Excipients:
From:
Black printing ink
To:
Black printing ink Opacode black S-1-27794 (containing shellac, IMS, black iron oxide E172, N-butyl alcohol, propylene glycol E1520, isopropyl alcohol)
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Updated on 17/10/2008 and displayed until 23/07/2009
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Reasons for adding or updating:
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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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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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| Date of revision of text on the SPC: 22-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The changes are as follows:
4.3 Contraindications – the following sentence has been added –
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special Warnings and Precaution for Use – the following two paragraphs have been added –
Patients with rare hereditary problems of fructose and galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The colours sunset yellow (E110), tartrazine (E102) and amaranth (E123) may cause allergic reactions.
The following sentence has been deleted –
The sodium benzoate E211 used in the sugar coat can be mildly irritating to the skin, eyes and mucous membranes.
4.8 Undesirable effects – The original paragraph has been deleted and the following table inserted –
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System Organ Class
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Common
>1/100
<1/10
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Uncommon
>1/1000
<1/100
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Rare
>1/10,000
<1/1000
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Immune system disorder
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Hypersensitivity
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Nervous system disorder
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Dizziness
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Sedation, confusion, nervousness, hallucinations, convulsions, insomnia, euphoria
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Memory disturbances
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Eye disorders
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Accommodation disorders
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Cardiac disorders
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Tachycardia
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Gastrointestinal disorders
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Dry mouth, gastrointestinal disturbances
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Renal and urinary disorders
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Urinary retention
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10. Date of Revision of the Text has been updated.
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Updated on 06/01/2006 and displayed until 17/10/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/07/2004 and displayed until 06/01/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments 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 10 (date of (partial) revision of the text
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Updated on 18/06/2003 and displayed until 22/07/2004
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Reasons for adding or updating:
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 11/04/2003 and displayed until 18/06/2003
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Addition of Legal Category
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Updated on 13/05/2002 and displayed until 11/04/2003
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Updated on 07/08/2001 and displayed until 13/05/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/03/2000 and displayed until 07/08/2001
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Updated on 28/01/2000 and displayed until 23/03/2000
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Updated on 06/09/1999 and displayed until 28/01/2000
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