Summary of Product Characteristics
last updated on the eMC:
02/02/2012
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.
Updated on 02/02/2012 and displayed until Current
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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 5.1 - Pharmacodynamic Properties
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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: 31-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4
New Paragraph inserted after Paragraph 4
Interference with laboratory tests
Increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference the omeprazole treatment should be temporarily stopped five days before CgA measurements.
Section 5.1
Other effects related to acid inhibition
Paragraph 3 amended to:
Chromogranin A (CgA) also increases due to decreased gastric acidity. This CgA modifying effect can not be demonstrated five days after stopping treatment with PPIs.
Section 10
Date of revision changed to 31st January 2012.
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Updated on 29/03/2011 and displayed until 02/02/2012
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change due to harmonisation of SPC
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| Date of revision of text on the SPC: 21-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Due to harmonisation the SPC has been totally revised according to our global template.
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Updated on 21/02/2008 and displayed until 29/03/2011
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Reasons for adding or updating:
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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: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5
Change of text in 2nd & 3rd paragraph to include warnings for use with vitamin K antagonists and voriconazole and New additional text last paragraph:
Concomitant administration of omeprazole and a CYP2C19 and CYP3A4 inhibitor, voriconazole, resulted in more than doubling of the omeprazole exposure. Omeprazole (40 mg once daily) increased voriconazole (a CYP2C19 substrate) Cmax and AUCt by 15% and 41%, respectively. A dose adjustment of omeprazole is not regularly required in either of these situations. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.
Section 4.8
Table includes an additional uncommon skin undesirable effect: dermatitis.
Section 10
New revision date of text: 28 January 2008
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Updated on 21/07/2006 and displayed until 21/02/2008
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3
§ Sentence added:
Omeprazole like other PPIs should not be administered with atazanavir (see section 4.5).
Section 4.5
§ Sentence deleted
Concomitant administration of omeprazole and atazanavir has been reported to reduce the plasma levels of atazanavir.
§ Sentence added:
Co-administration of omeprazole (40mg once daily) with atazanavir 300 mg/ritonavir 100mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 75% decrease in AUC, Cmax, and Cmin). Increasing the atazanavir dose to 400mg did not compensate for the impact of omeprazole on atazanavir exposure. PPIs including omeprazole should not be co-administered with atazanavir (see section 4.3)
Concomitant administration of omeprazole and tacrolimus may increase the serum levels of tacrolimus.
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Updated on 28/06/2006 and displayed until 21/07/2006
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 6. 3 - Shelf Life
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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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Removal of Black Triangle
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Change from BAN to rINN
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1
The black triangle has been removed
Section 2
Omeprazole sodium 42.6mg has been added. Ph. Eur. has been removed
Section 6.3
The following sentences have been added:
After reconstitution in normal saline at 25°C: 12 hours.
After reconstitution in 5% dextrose at 25°C: 3 hours
Section 9
The date of Renewal has been added
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Updated on 04/02/2005 and displayed until 28/06/2006
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 15/11/2004 and displayed until 04/02/2005
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Updated on 02/07/2002 and displayed until 15/11/2004
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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 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 08/04/2002 and displayed until 02/07/2002
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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 21/08/2001 and displayed until 08/04/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 15/02/2000 and displayed until 21/08/2001
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Reasons for adding or updating:
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