Summary of Product Characteristics
last updated on the eMC:
14/08/2009
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 14/08/2009 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 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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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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| Date of revision of text on the SPC: 05-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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4.1 and 4.2: Age range in children and adolescents clarified as 6 - 18 years and not 6-16 years.
4.3: Lactation removed as a contraindication in line with the class labelling wording of the CHMP Pharmacovigilance working party, for AIIAs in pregnancy and lactation.
4.6: Lactation wording amended as for 4.3.
4.8: Details of the patient populations and numbers in clinical trials added. AEs under the heading of "investigations" added to hypertension and heartfailure safety profiles replacing information previously under "investigations" at the end of 4.8.
Under postmarketing AEs, the following have been added:
tinnitus. pancreatitis, malaise, photosensitivity, rhabdomyolysis, erectile dysfunction/impotence, depression
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Updated on 27/05/2009 and displayed until 14/08/2009
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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 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 06-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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. The changes to the SPC are as follows:
Section 4.1: The essential hypertension indication is updated to include children and adolescents 6-16 years of age.
The essential hypertension indication is updated to include children and adolescents 6-16 years of age.
In addition the heart failure indication has been better worded to state "The patients should have a left ventricular ejection fraction <40% and should be clinically stable and on an established treatment regimen for chronic heart failure."
Section 4.2
The dosage recommendations for paediatric patients has been moved to the end of the section but the information remains the same.
Section 5.1
A paediatric study (protocol P 326) in hypertensive and normotensive children with proteinuria was conducted and the results of this study have now been approved to be added to the Cozaar SPC.
The results of protocol 326 are now described in 2 paragraphs at the end of this section.
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Updated on 11/03/2009 and displayed until 27/05/2009
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 06-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| With agreement from the MHRA, the black triangle recently added to Cozaar is now noted to advise that
* Intensive monitoring is requested only when used for the recently-licensed indication in chronic heart failure.
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Updated on 18/02/2009 and displayed until 11/03/2009
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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Change to joint SPC covering all presentations
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Addition of Black Triangle
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Introduction of new strength
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Change due to harmonisation of SPC
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| Date of revision of text on the SPC: 06-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| The losartan range of products has been through an Article 30 referral procedure, which is a process of harmonisation of the SPCs and PILs during which European regulators assessed the available data and came to a concensus on what should be licenced through the EU in terms of indications and warnings, precautions and side-effects.
Cozaar now has an additional indication for the treatment of chronic heart failure. This carries a starting dose of 12.5 mg for which a new tablet strength has been licensed and will be available shortly. The MHRA have advised that addition of the new indication requires that the product carries a black triangle.
A number of changes have been made to the nature, format and wording of the Contraindications, Special warnings and precautions for use and Undesirable effects sections and to most parts of the SPC. The main changes are:
Section 4.3 now includes an additional contraindication to use in patients with severe hepatic impairment.
Section 4.4 now includes new statements with regards to use in further special populations.
Section 4.8 now includes additional information on post-marketing experience. In addition, it has been reformatted and is now presented in a format as required by current guidelines.
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Updated on 25/01/2007 and displayed until 18/02/2009
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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: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 of the SPC has been updated with new wording on interaction with NSAIDs and with Lithium.
The new wording relates to the possible interaction between AIIAs and NSAIDS leading to impaired renal function.
In addition a new warning on a possibility of a Lithium interaction with AIIAs has been added with a recommendation that coadministration should be undertaken with caution and that serum lithium levels should be monitored if concomitant use is deemed essential. This wording is class-labelling for all the AIIAs imposed by the European Medicines Agency Pharmacovigilance working party.
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Updated on 08/12/2005 and displayed until 25/01/2007
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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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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 5.2 - Pharmacokinetic Properties
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Updated on 13/06/2005 and displayed until 08/12/2005
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 02/09/2003 and displayed until 13/06/2005
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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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Updated on 25/10/2002 and displayed until 02/09/2003
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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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 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Updated on 27/09/2002 and displayed until 25/10/2002
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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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 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Updated on 11/02/2002 and displayed until 27/09/2002
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Reasons for adding or updating:
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