Summary of Product Characteristics
last updated on the eMC:
24/11/2011
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 24/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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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 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: 22-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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UK/H/0151/005/IB/076
To update section 3 of the SPC in order to fulfil a commitment made during a UK national consent marketing application. In addition, sections 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 6.6 and 10 of the SPC are updated in line with the QRD template and European SPC guidelines.
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Updated on 14/01/2011 and displayed until 24/11/2011
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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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| Date of revision of text on the SPC: 16-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8- wording changed to ‘In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occour is not known (can not be estimated from available data)’:
Incidence of ≥ 1/ 10 000, <1/1 000 has been deleted.
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Updated on 16/09/2008 and displayed until 14/01/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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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| Date of revision of text on the SPC: 09-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 3 (Pharmaceutical form): Following description of tablet added:
'marked with “03” on one side and “e” on the other side.'
Section 4.4 (Special warnings and precautions for use): The following wording added:
Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class, have been associated with the adverse events, tachycardia and palpitations (see section 4.8).
Section 4.8 (Undesirable effects): Cardiac disorders (palpitations and tachycardia) has been added.
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Updated on 24/09/2007 and displayed until 16/09/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 (Marketing Authorisation Holder): change to sanofi-aventis.
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Updated on 15/06/2007 and displayed until 24/09/2007
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Reasons for adding or updating:
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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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Company name change or merger
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2
Removal of the words "and safety" after "efficacy" from the following statement
Children under 6 years of age
The efficacy of Fexofenadine hydrochloride has not been established in children under 6 years of age.
Section 4.8
Addition of the following text
In controlled clinical trials in 845 children aged 6 months to 5 years with allergic rhinitis, 415 children were administered 15 mg or 30 mg of fexofenadine hydrochloride (capsule content sprinkled onto dosing vehicle) and 430 children were administered placebo. There were no unexpected adverse events in the children treated with fexofenadine and the adverse event profile was similar to that of older children and adults (see section 4.2).
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Updated on 17/09/2004 and displayed until 15/06/2007
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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Updated on 08/06/2004 and displayed until 17/09/2004
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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