Updated on 27/09/2011 and displayed until Current
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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: 16-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Changes to section 4.5 of the SmPC regarding the combined use of angiotensin receptor blockers (ARBs) with ACEIs. New paragraph added:
Dual blockade (e.g., by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should be limited to individually defined cases with close monitoring of renal function. Some studies have shown that in patients with established atherosclerotic disease, heart failure, or with diabetes with end organ damage, dual blockade of the renin-angiotensin-aldosterone system is associated with a higher frequency of hypotension, syncope, hyperkalaemia, and changes in renal function (including acute renal failure) as compared to use of a single renin-angiotensin-aldosterone system agent.
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Updated on 10/02/2011 and displayed until 27/09/2011
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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 4.6 - Pregnancy and Lactation
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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 5.3 - Preclinical Safety Data
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 13-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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SPC Changes as follows:
Section 4.1: The third bullet point as been amended as follows: Treatment of chronic heart failure (in
adult patients ³ 60 years), when treatment with Angiotensin converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. 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: Within the sub-heading of 'Heart failure' has been amended as follows: The usual initial dose of losartan in patients with heart failure is 12.5 mg once daily. The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily
: Within the sub-heading of 'Heart failure' has been amended as follows:
, 100 mg daily, up to a maximum dose of 150 mg once daily) to the usual maintenance dose of 50 mg once daily, as tolerated by the patient.
Section 4.2: The sub-heading of 'use in paediatric patients' has been revised to 'Paediatric population'.
Section 4.6: The heading 'Pregnancy and lactation' has been replaced with the heading 'Pregnancy and breast-feeding'.
: The heading 'Pregnancy and lactation' has been replaced with the heading 'Pregnancy and breast-feeding'.
Section 4.8: There have been extensive changes made to section 4.8 'undesirable effects' of the SmPC. The key changes made to section 4.8 are the list of adverse reactions which have now all been tabulated. In addition, the adverse reactions of 'Hypersensitivity and angiooedema' have been added to the list of rare side effects. .
: There have been extensive changes made to section 4.8 'undesirable effects' of the SmPC. The key changes made to section 4.8 are the list of adverse reactions which have now all been tabulated. In addition, the adverse reactions of '' have been added to the list of rare side effects. .
Section 5.1: A new paragraph concerning the HEAAL study has been added: HEAAL Study
The Heart Failure Endpoint Evaluation of Angiotensin II Antagonist Losartan (HEAAL) study was a controlled clinical study conducted worldwide in 3834 patients aged 18 to 98 years with heart failure (NYHA Class II-IV) who were intolerant of ACE inhibitor treatment. Patients were randomized to receive losartan 50 mg once a day or losartan 150 mg, on a background of conventional therapy excluding ACE-inhibitors.
Patients were followed for over 4 years (median 4.7 years). The primary endpoint of the study was a composite endpoint of all cause death or hospitalisation for heart failure.
The results showed that treatment with 150 mg losartan (828 events) as compared with 50 mg losartan (889 events) resulted in a 10.1% risk reduction (p=0.027 95% confidence interval 0.82-0.99) in the number of patients reaching the primary composite endpoint. This was mainly attributable to a reduction of the incidence of hospitalisation for heart failure. Treatment with 150 mg losartan reduced the risk if hospitalisation for heart failure by 13.5% relative to 50 mg losartan (p=0.025 95% confidence interval 0.76-0.98). The rate of all cause death was not significantly different between the treatment groups. Renal impairment, hypotension, and hyperkalaemia were more common in the 150 mg group than in the 50 mg group, but these adverse events did not lead to significantly more treatment discontinuations in the 150 mg group.
: A new paragraph concerning the HEAAL study has been added: : The sub-heading of 'use in paediatric patients' has been revised to 'Paediatric population'.: The heading 'Pregnancy and lactation' has been replaced with the heading 'Pregnancy and breast-feeding'.: There have been extensive changes made to section 4.8 'undesirable effects' of the SmPC. The key changes made to section 4.8 are the list of adverse reactions which have now all been tabulated. In addition, the adverse reactions of '' have been added to the list of rare side effects. .: A new paragraph concerning the HEAAL study has been added:
Section 5.3: The term Adverse
: The term Adverse
events has been revised to Adverse reactions in line with standard text.
Section 6.4: Information on the blister packs has been revised as follows: 'Blisters: Store in the original package in order to protect from light and moisture. HDPE Bottle: Do not store above 25oC.
Store in original container in order to protect from light. Keep the bottle tightly closed in order to protect from light and moisture'.
Section 4.6: The sub-heading 'Lactation' has been revised to 'Breastfeeding'.
: The sub-heading 'Lactation' has been revised to 'Breastfeeding'.
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Updated on 22/03/2010 and displayed until 10/02/2011
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 22-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Sections 4.9, 6.1 and 6.5 have minor revisions as follows:
Section 4.9 Overdose:
The wording has been clarified as follows:
Symptoms of intoxication
No case of overdose has been reported Limited data are available with regard to overdose in humans. The most likely symptoms,manifestation of overdose would be depending on the extent of overdose, are hypotension, and tachycardia,.possibly Bbradycardia could occur from parasympathetic (vagal) stimulation.
Treatment of intoxication
If symptomatic hypotension should occur, supportive treatment should be instituted
. Measures are depending on the time of medicinal product intake and kind and severity of symptoms. Stabilisation of the cardiovascular system should be given priority. After oral intake, the administration of a sufficient dose of activated charcoal is indicated. Afterwards, close monitoring of the vital parameters should be performed. Vital parameters should be corrected if necessary.
Neither losartan nor the active metabolite can be removed by haemodialysis."
Section 6.1 List of Excipients
Hydroxypropyl cellulose has been changed to the standard name of Hyprolose.
Hydroxypropyl cellulose has been changed to the standard name of Hyprolose.
Section 6.5 Nature and Contents of Container.
Unit dose packages for use in hospital have been added to the range of pack sizes detailed for the 12.5mg, 50 mg and 100mg tablets. These are not available in the UK.
Unit dose packages for use in hospital have been added to the range of pack sizes detailed for the 12.5mg, 50 mg and 100mg tablets. These are not available in the UK.
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Updated on 14/08/2009 and displayed until 22/03/2010
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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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