Summary of Product Characteristics
last updated on the eMC:
27/01/2012
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 27/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 18-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to sections 4.1, 4.5, 5.1, 5.2 to bring product in line with core safety profile and with paediatric and pharmacokinetic information.
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Updated on 15/07/2011 and displayed until 27/01/2012
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 15-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1: Update of indication : urticaria
Section 5.1: Updated to demonstrate efficacy in urticaria
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Updated on 02/06/2008 and displayed until 15/07/2011
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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 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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| Date of revision of text on the SPC: 01-Aug-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 - additional text:
For children aged 2 to 6 years no adjusted dosage is possible with the film-coated tablet formulation. It is recommended to use a paediatric formulation of levocetirine.
Duration of use:
Intermittent allergic rhinitis (symptoms <4days/week or during less than 4 weeks) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms >4days/week and during more than 4 weeks), continuous therapy can be proposed to the patient during the period of exposure to allergens. Clinical experience with 5 mg levocetirizine as a film-coated tablet formulation is currently available for a 6-month treatment period. For chronic urticaria and chronic allergic rhinitis, up to one year's clinical experience is available for the racemate.
4.3 - additiion of allergy to excipients warning.
4.4 - removal of allergy to excipients warning.
4.8 - additional adverse effects from post marketing experience: agitation, convulsions, myalgia
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Updated on 10/07/2007 and displayed until 02/06/2008
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of black triangle.
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Updated on 06/07/2007 and displayed until 10/07/2007
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Reasons for adding or updating:
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