Updated on 28/09/2011 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 |
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Additional information added to section 4.5 of the SmPC regarding the combined use of angiotensin receptor blockers (ARBs) with ACEIs- new paragraph:
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 28/09/2011
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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 4.9 - Overdose
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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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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. For full details of all changes made the SmPC, see annotated SmPC attached below.
: 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. For full details of all changes made the SmPC, see annotated SmPC attached below.
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. For full details of all changes made the SmPC, see annotated SmPC attached below.: 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 4.9: The sub-section of 'Symptoms of intoxication' has been revised as follows: Limited data are available with regard to overdose in humans.No case of overdose has been reported. The most likely manifestationsymptoms, depending on the extent of overdose, would be are hypotension, and tachycardia., possibly bBradycardia could occur from parasympathetic (vagal) stimulation).
Section 4.9: The sub-section of 'Treatment of intoxication' has been revised as follows: 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.
Section 6.4: New sentence regarding storage conditions of the kit has been added as follows:
Kit: Do not store above 25°C.
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Store in the original package.
Store the prepared suspension in a refrigerator at 2-8°C.
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Updated on 08/12/2009 and displayed until 10/02/2011
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 02-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 30/11/2009 and displayed until 08/12/2009
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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 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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| Date of revision of text on the SPC: 17-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The changes made to the SmPC are as follows:
Section 4.1
Treatment of essential hypertension in adults and in children and adolescents is age range 6-18 now instead of 6-16
years of age. This has been changed where it appears throughout the SmPC.
The heart failure indication wording has been clarified to make more sense ie
Angiotensinconverting 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 stabilised under the treatment regimen for of the chronic heart failure.
Section 4.2
The information on paediatric patients has moved towards the end of the section and the age range revised to 6-18 as in 4.1.
Section 4.4
The lactose warning has been revised as follows in line with standard text:
Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorptionExcipients
This medicinal product contains lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Section 4.8
Adverse
events has been revised to Adverse reactions throughout in line with standard text.
Under Postmarketing experince, the following additional Adverse reactions have been added:
Tinnitus, pancreatitis, malaise, photosensitivity, rhabdomyolysis, erectile dysfunction/impotence, depression, hyponatraemia.
Section 5.1
Two paragraphs are added towards the end describing the results from protocol 326, a paediatric study done in normotensive and hypertensive patients with proteinuria.
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Updated on 07/07/2009 and displayed until 30/11/2009
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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