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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 02/04/2012
SPC Evorel Conti

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 02/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4

Addition of:   Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women

Conditions which need supervision:   Mastopathy added

Conditions which require monitoring while on oestrogen therapy:

·         Oestrogens may cause fluid retention. Cardiac or renal dysfunction should be carefully observed

·         Disturbances or mild impairment of liver function

·         History of cholestatic jaundice

·         Pre-existing hypertriglyceridaemia.  Rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition

Endometrial hyperplasia

The reported increase in endometrial cancer risk among oestrogen-only users varies from 2 to 12 fold greater compared with non-users, depending on the duration of treatment and oestrogen dose (see Section 4.8)

All text under the heading ‘Breast cancer’ has been replaced

Venous thrombo-embolism:  Recognised risk factors oestrogens, older age, pregnancy/ postpartum period added

Coronary artery disease (CAD); All text replaced

Stroke,  Addition of:

Combined oestrogen-progestogen and oestrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischaemic stroke. The relative risk does not change with age or time since menopause. However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age.

Ovarian cancer

Ovarian cancer is much rarer than breast cancer. Long-term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies.  Some studies including the WHI trial suggest that the long-term use of combined HRTs may confer a similar, or slightly smaller, risk. It is uncertain whether long-term use of combined HRT confers a different risk than oestrogen-only products

 Dementia  statement updated
Updated on 12/03/2012 and displayed until 02/04/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 Contraindications

 Additions in Bold and underlined.   Deletions scored out


Known, current or past, or suspected breast cancer

Known or suspected oestrogen-dependent malignant tumours (eg endometrial cancer) or pre-malignant tumours (e.g. untreated atypical endometrial hyperplasia)

Undiagnosed genital bleeding

Untreated endometrial hyperplasia

Previous idiopathic or current venous thrombo-embolism (deep venous thrombosis, pulmonary embolism)

Active or recent past arterial thrombo-embolic disease (eg cerebrovascular accident, angina, myocardial infarction)

Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal

Known thrombophilic conditions (e.g. protein C, protein S or antithrombin deficiency, see section 4.4)

Known hypersensitivity to the active substances or to any of the excipients

Porphyria
Updated on 10/01/2012 and displayed until 12/03/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 4.8

frequency estimate of ADRs updated.

Addition of : fatigue, oedema, breast enlargement cervical polyps, endometrial hyperplasia, Stevens- johnson-syndrome, rash erythematous, cholethiasis, abdominal distention, Flatulance, diarrhoea, candidiasis, breast cancer, endometrial cancer dizziness, palpitations, vasodilatation
Updated on 18/05/2011 and displayed until 10/01/2012
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   16-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 removal of peri-menopausal as a indication as thei was an error
Updated on 08/06/2009 and displayed until 18/05/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.5 - Addition of lamotrigine wording.
Change to section 10 - Changed to 2 June 2009.
Updated on 16/01/2009 and displayed until 08/06/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 10 – Date of revision of the text

Changed to 2 December 2008

Change to section 7 – Marketing Authorisation Holder

Change to

Janssen-Cilag Ltd

50 -100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

 

 

Updated on 09/12/2008 and displayed until 16/01/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.8 - Addition of 'urticaria' wording.
Change to section 10 - Changed to 2 December 2008.
Updated on 28/05/2008 and displayed until 09/12/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

Change

eMC - Summary of Change Details Per Section

 

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Addition of Bosentan interaction

 
Updated on 02/03/2006 and displayed until 28/05/2008
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/02/2005 and displayed until 02/03/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change from the BAN of the active substance to the rINN
Updated on 06/10/2004 and displayed until 18/02/2005
Reasons for adding or updating:
  • Change to separate SPCs covering individual presentations
Updated on 30/09/2004 and displayed until 06/10/2004
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  estradiol hemihydrate
  norethisterone acetate