Evista

  • Name:

    Evista

  • Company:
    info
  • Active Ingredients:

    Raloxifene

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/01/18

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Summary of Product Characteristics last updated on medicines.ie: 17/9/2012
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Daiichi Sankyo Ireland Ltd

Daiichi Sankyo Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name BENETOR 10mg, 20 mg and 40 mg film-coated tablets Active Ingredients olmesartan medoxomil
Medicine Name BENETOR PLUS 20mg/12.5mg and 20mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Efient 5mg & 10mg film-coated tablets (Eli Lilly and Company Ltd Daiichi Sankyo UK Ltd) Active Ingredients prasugrel hydrochloride
Medicine Name Evista Active Ingredients Raloxifene
Medicine Name Lixiana Film-Coated Tablets Active Ingredients Edoxaban tosilate
1 - 0 of 5 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 17 January 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 17 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 October 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 17 September 2012 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 September 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Improved electronic presentation
  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 (Posology and method of administration) - Paediatric Population - Evista should not be used in children of any age. There is no relevant use of Evista in the paediatric population.  

Section 4.8 (Undesireable Effects) - Updated in line with QRD template

Updated on 11 September 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 29 October 2008 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 28 August 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 28 August 2008 SmPC

Reasons for updating

  • Change to marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

MA Transfer from Lilly to Daiichi Sankyo

Updated on 14 August 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

NOTE:

 

This SPC has been re-formatted/revised in its entirety due to Evista licence renewal.

 

 

 

2.             QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Added (bolt text):

 

Excipient: each tablet contains lactose (149.40 mg)

 

 

 

4.             CLINICAL PARTICULARS

4.2          Posology and method of administration

 

Added:

 

Use in renal impairment:

EVISTA should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, EVISTA should be used with caution.

 

Use in hepatic impairment:

EVISTA should not be used in patients with hepatic impairment (see section 4.3).

 

4.4          Special warnings and precautions for use

 

Added:

 

Evista contains lactose.

 

4.6          Pregnancy and lactation

 

Amended (bold/strikethrough):

 

It is not known whether raloxifene is excreted in human milk. Its clinical use, therefore, cannot be recommended in breast-feedinglactating women.

 

4.7          Effects on ability to drive and use machines

 

Amended:

 

Raloxifene has no known influence on the ability to drive and use machines.

 

4.8          Undesirable effects

 

Amended throughout section:

 

Undesirable  adverse


 

Deleted:

 

The following convention has been used for the classification of the adverse reactions: very common (¡Ý1/10), common (¡Ý1/100 to <1/10), uncommon (¡Ý1/1,000 to <1/100), rare (¡Ý1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).

 

4.9          Overdose

 

Amended:

 

In some clinical trials, daily doses of 600 mg for 8 weeks and 120 mg, for 3 years doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years. No cases of raloxifene overdose were reported during clinical trials. were well tolerated.

 

 

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Changed:

 

Date of last renewal:                                         08 August 2008

 

10.          DATE OF REVISION OF THE TEXT

 

New date

 

08 August 2008

Updated on 21 May 2007 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

6.             PHARMACEUTICAL PARTICULARS

 

6.3          Shelf-life

                               

Change of shelf-life from 2 to 3 years.

 

 

 

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

               

Changes in bold text

 

Date of first authorisation:                              5 August 1998

Date of last renewal:                                         5 August 2003

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date

 

4 May 2007

Updated on 15 May 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 30 April 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.             CLINICAL PARTICULARS

 

4.8          Undesirable effects

 

Additions in bold text

 

In osteoporosis treatment and prevention studies involving over 13,000 postmenopausal women, all undesirable reactions were recorded.  The duration of treatment in these studies ranged from 6 to 60 months.  The majority of undesirable reactions have not usually required cessation of therapy.

 

The undesirable reactions associated with the use of raloxifene in osteoporosis clinical trials are summarised in the table below.

 

The following statement added above the clinical trial and post-marketing adverse event tables and as such the frequency classifications of adverse events deleted from within the tables.

 

The following convention has been used for the classification of the adverse reactions: very common ( ³1/10), common ( ³1/100 to <1/10), uncommon ( ³1/1,000 to <1/100), rare ( ³1/10,000 to <1/1,000), very rare ( <1/10,000), not known (cannot be estimated from the available data).

 

Added following paragraph

 

In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8% in the raloxifene-treated patients and 4.7% in the placebo-treated patients.

 

Changes to the following paragraph, shown in bold text

 

Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis, occurred at a frequency of approximately 0.8% or 3.22 cases per 1,000 patient years.

 

Added following paragraphs

 

In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0% or 3.88 cases per 1,000 patient-years in the raloxifene group and 1.4% or 2.70 cases per 1,000 patient-years in the placebo group.  The hazard ratio for all VTE events in the RUTH study was HR = 1.44, (1.06 – 1.95).  Superficial vein thrombophlebitis occurred at a frequency of 1% in the raloxifene group and 0.6% in the placebo group.

 

In the RUTH study, leg cramps were observed in 12.1% of raloxifene-treated patients and 8.3% of placebo-treated patients.

 

Changes shown in bold text

 

One further change was seen which was not statistically significant (P >0.05), but which did show a significant dose trend.  This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1% for Evista and 1.9% for placebo; and in the treatment population occurred at an incidence of 7.1% for Evista and 6.1% for placebo.  In the RUTH study, peripheral oedema occurred in 14.1% of the raloxifene-treated patients and 11.7% of the placebo-treated patients, which was statistically significant.

 

Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo-controlled clinical trials of raloxifene in osteoporosis.


Added following paragraph

 

In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3% of patients treated with raloxifene and 2.6% of patients treated with placebo.  Cholecystectomy rates for raloxifene (2.3%) were not statistically significantly different from placebo (2.0%).

 

Deletions shown in strikethrough text and changes in bold text

 

The following events have been reported in post-marketing experience are presented in the table below.

 

 

 

5.             PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

 

a)            Skeletal effects

 

Deletions shown in strikethrough text and additions in bold text

 

Evista reduced the new vertebral fracture risk by 39% (RR 0.61; CI 0.43, 0.88).  An effect on non-vertebral fractures has not been demonstrated.  During From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin, and fluorides. An effect on extravertebral fractures has not been demonstrated and all patients in this study received calcium and vitamin D supplementation.

 

In the RUTH study overall clinical fractures were collected as a secondary endpoint.  Evista reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47, 0.89).  These results may have been confounded by baseline differences in BMD and vertebral fractures.  There was no difference between treatment groups in the incidence of new non-vertebral fractures. During the whole length of the study, concomitant use of other bone-active medications was permitted.

 

A similar increase in BMD was seen in the treatment population who received Evista for up to 7 years.

 

b)            Effects on lipid metabolism and cardiovascular risk

 

Additions in bold text

 

Evista therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.  Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalised acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke, see section 4.4).

 

 

d)            Effects on breast tissue

 

Deleted

 

The effect of Evista on breast cancer beyond 4 years is unknown.

 

 

 

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Deletions shown in strikethrough text

 

Date of first authorisation:                              5 August 1998

Date of last renewal of the authorisation:    28 July 2003

 


 

10.          DATE OF REVISION OF THE TEXT

 

New date:

 

27 March 2007

Updated on 19 January 2007 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.             CLINICAL PARTICULARS

 

4.4          Special warnings and precautions for use

 

Added:

 

In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalised acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.  However, there was an increase in death due to stroke in women assigned to raloxifene.  The incidence of stroke mortality was 1.5 per 1,000 women per year for placebo versus 2.2 per 1,000 women per year for raloxifene.  This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischaemic attack or atrial fibrillation.

 

Added:

 

As safety information regarding co-administration of raloxifene with systemic oestrogens is limited, such use is not recommended.

 

Removed:

 

As there is no experience with co-administration of systemic oestrogens, such use is not recommended.

 

4.8                Undesirable effects

 

Added to post-marketing events table:

 

Blood and Lymphatic System Disorders

Very rare (<0.01%): Thrombocytopenia.

General Disorders and Administration Site Conditions

Rare (<0.1%): Peripheral oedema.

Vascular Disorders

Rare (<0.1%): Venous thromboembolic reaction.

Very rare (<0.01%): Arterial thromboembolic reaction.

 

4.9                Overdose

 

Added:

 

In clinical trials, daily doses of 600mg for 8 weeks and 120mg for 3 years were well tolerated.

 

In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120mg as a single ingestion.

 

In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180mg.  In children, symptoms of accidental overdose included ataxia, dizziness, vomiting, rash, diarrhoea, tremor, flushing, and elevation in alkaline phosphatase.

 

The highest overdose has been approximately 1.5 grams.  No fatalities associated with overdose have been reported.


 

Removed:

 

Incidents of overdose in humans have not been reported.  Daily doses of 600mg, administered during an 8 week study, and 120mg, used in clinical trials in more than 2,500 postmenopausal women for 3 years, were well tolerated.

 

10.          DATE OF REVISION OF THE TEXT

 

New date:

 

22 November 2006

Updated on 10 January 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 14 July 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2.             QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Added:

 

Excipient: Lactose (149.40mg).

 

Re-worded:

 

For a full list of excipients, see section 6.1.

 

 

4.             CLINICAL PARTICULARS

 

4.4          Special warnings and precautions for use

 

Addition of warnings regarding the use of Evista in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.

 

6.             PHARMACEUTICAL PARTICULARS

 

6.4          Special precautions for storage

 

Removed:

 

Do not store above 30°C.

 

6.5          Nature and content of container

 

Removal of PVC blisters.

 

10.          DATE OF REVISION OF THE TEXT

 

New date (12 April 2006).

Updated on 9 May 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 June 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 10 October 2003 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 6 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)