Updated on 04/11/2010 and displayed until Current
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 20-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To section 5.1 "Pharmacodynamic properties" three new paragraphs have been added which provide details of a multicenter, double-blind, controlled clinical study (ENHANCE), were 720 patients with heterozygous familial hypercholesterolemia were randomized to receive ezetimibe 10 mg in combination with simvastatin 80 mg (n = 357) or simvastatin 80 mg (n = 363) for 2 years.
Also in the same section, of the SmPC, details are provided on SEAS (Simvastatin and Ezetimibe for the Treatment of Aortic Stenosis study), a multi-center, double-blind, placebo-controlled study with a median duration of 4.4 years conducted in 1873 patients with asymptomatic aortic stenosis (AS), documented by Doppler-measured aortic peak flow velocity within the range of 2.5 to 4.0 m/s.
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Updated on 08/04/2010 and displayed until 04/11/2010
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 18-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section "4.8 Undesirable effects" and in the postmarketing experience sub-section the following has been added:
"Skin and subcutaneous tissue disorders: erythema multiforme"
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Updated on 05/03/2010 and displayed until 08/04/2010
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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 4.8 - Undesirable Effects
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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: 02-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.2 "Posology and method of administration" and under the sub-section "use in paediatric patients" the following change has been made:
Use in paediatric patients
Initiation of treatment must be performed under review of a specialist.
Adolescents
³10 years (pubertal status: boys: Tanner Stage IIIIChildren and above: girls: at least one year post menarche): noadolescents ³10 years: No dosage adjustment is required (see section 5.2). TheHowever, clinical experience in paediatric and adolescent patients (aged 10 –ages 9 to 17 years old) is, however, limited.
When Ezetrol is administered with simvastatin, the dosage instructions for simvastatin, in adolescents should be consulted.
In section 4.4 "Special warnings and precautions for use" a new sub-section has been created called "Paediatric (10 to 17 years of age) patients".
In section 4.5 "Interaction with other medicinal products and other forms of interaction", a correction has been made to the third paragraph under the sub-heading "Fibrates" as follows:
"Concomitant fenofibrate or gemfibrozil administration modestly increased total ezetimibe concentrations (approximately 1.5- and 1.7-fold respectively). "
In section 4.8 "Undesirable effects", a new sub-section has been created called "Paediatric (10 to 17 years of age) patients".
In section 5.1 " Pharmacodynamic properties", a new sub-section on clinical trials in paediatric patients has been added.
In section 5.2 " Pharmacokinetic properties" the section on "Paediatric patients" has been revised as follows:
"…...Clinical experience in paediatric and adolescent patients includes(ages 9 to 17) has been limited to patients with HoFH, HeFH or sitosterolaemia."
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Updated on 10/08/2009 and displayed until 05/03/2010
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Removal of Black Triangle
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| Date of revision of text on the SPC: 31-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Black triangle special monitoring requirement has been removed by the MHRA.
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Updated on 17/06/2009 and displayed until 10/08/2009
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 2 (Composition)
The quantity of lactose monohydrate contained in each tablet has been added.
Section 4.1 (Indications) and 5.1 (pharmacodynamics)
The statement "Studies to demonstrate the efficacy of ‘Ezetrol’ in the prevention of complications of atherosclerosis have not yet been completed." has been deleted and replaced with "A beneficial effect of Ezetrol on cardiovascular morbidity and mortality has not yet been demonstrated."
Section 4.8: (side effects)
The sub-section "Clinical studies" has been updated. The duration of the trials, number of patients prescribed ezetimibe and simvastatin has been increased. Adverse experiences, reported in these trials, with an incidence greater than placebo have been detailed in a table which shows the frequency.
In the sub-section "Post-marketing experience" the following side effects have been added: "dyspnoea", "
Constipation".
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Updated on 09/02/2009 and displayed until 17/06/2009
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 01-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The only change is to section 6.3 "Shelf life" which is now 3 years.
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Updated on 15/09/2008 and displayed until 09/02/2009
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 30-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 4.8 Undesirable effects and under the sub-heading "post-marketing experience" the following side effects have been added:
Post-marketing Experience
The following additional adverse reactions have been reported in post-marketing experience. Because these adverse experiences have been identified from spontaneous reports, their true frequencies are not known and cannot be estimated.
Blood and lymphatic system disorders: thrombocytopenia
: thrombocytopenia
Immune system disorders: hypersensitivity, including rash, urticaria, anaphylaxis and angioedema
: hypersensitivity, including rash, urticaria, anaphylaxis and angioedema
Psychiatric disorders: depression
: depression
Nervous system disorders: dizziness; paraesthesia
: dizziness
Gastro-intestinal disorders: nausea; pancreatitis
nausea; pancreatitis
Hepatobiliary disorders: hepatitis, cholelithiasis, cholecystitis Musculoskeletal and connective tissue disorders: arthralgia; myalgia; myopathy/rhabdomyolysis (see section 4.4).
: hepatitis, cholelithiasis, cholecystitis arthralgia; myalgia; myopathy/rhabdomyolysis (see section 4.4).
Laboratory values: increased transaminases; increased CPK
increased transaminases; increased CPK
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Updated on 26/06/2008 and displayed until 15/09/2008
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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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| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.7 "Effects on ability to drive and use machines" has been amended as follows:
"No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles or operating machines it should be taken into account that dizziness has been reported. Ezetrol' is not expected to affect the ability to drive and use machines.
Section 4.8 "Undesirable Effects" and under the sub-section "Post-marketing experience", the frequency rating has been removed and the following statement added:
"Because these adverse experiences have been identified from spontaneous reports, their true frequencies are not known and cannot be estimated."
In addition the side effect "dizziness" has also been added.
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Updated on 15/11/2007 and displayed until 26/06/2008
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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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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Some changes have been made to the section 4.5 Interaction with other medicinal products and other forms of interaction, and under the sub-heading "fibrates". The first paragraph under this section has been moved to the third paragraph under this section and the wording "However, these increases are not considered clinically significant" has been removed. The last paragraph under this sub-heading has been revised as follows:
"Fibrates may increase excretion into the bile, leading to cholelithiasis. In animal studies, ezetimibe increased cholesterol in the gallbladder bile, but not all species (see section 5.3). A lithogenic risk associated with the therapeutic use of 'Ezetrol' cannot be ruled out.
* Section 5.1 The pharmacotherapeutic group has been updated to "other lipid modifying agents. ATC code: C10A X09.
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Updated on 08/01/2007 and displayed until 15/11/2007
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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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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4, 4.5 and 4.8 have been revised to include more detailed safety information on use of Ezetrol with fenofibrate( ie increased risk of gall-bladder disease and cholelithiasis), and additional AE information on the use of the Ezetrol with fenofibrate.
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Updated on 15/09/2006 and displayed until 08/01/2007
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Correction of spelling/typing errors
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Updated on 07/09/2006 and displayed until 15/09/2006
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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 - Interactions with other Medicaments and other forms of Interaction
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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 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
· Revised wording of text on use in children below age 10 based on new QRD template.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
· Added reference to fluindione and changed subheading from Warfarin to Anticoagulants.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
· Added a sentence stating that interaction studies have only been performed in adults based on new QRD template.
· Added references to fluindione and changed subheading from Warfarin to Anticoagulants.
4.6 PREGNANCY AND LACTATION
· Changed section heading from Use during pregnancy and lactation to Pregnancy and lactation based on new QRD template.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
· Deleted the word “of” in the phrase “use of machines” based on new QRD template.
4.8 UNDESIRABLE effects
· Added anaphylaxis (very rare) to Post-marketing Experience subsection as an additional event associated with hypersensitivity reactions.
5.1 PHARMACODYNAMIC PROPERTIES
· Added a sentence describing the molecular target of ezetimibe and deleted the sentence stating that the molecular mechanism of action is not fully understood.
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Updated on 02/12/2005 and displayed until 07/09/2006
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Updated on 05/07/2005 and displayed until 02/12/2005
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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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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Updated on 28/10/2004 and displayed until 05/07/2005
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Change to section 4.8 - Undesirable Effects
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Updated on 17/05/2004 and displayed until 28/10/2004
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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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Updated on 25/09/2003 and displayed until 17/05/2004
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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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Updated on 24/04/2003 and displayed until 25/09/2003
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