Evra transdermal patch
- Name:
Evra transdermal patch
- Company:
Janssen Sciences Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/06/20

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Janssen Sciences Ireland
Company Products
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 16 February 2021 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 16 February 2021 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 24 June 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
4. Possible side effects
Rare side effects (may affect up to 1 in 1,000 women):
A severe allergic reaction that may include Sswelling of the face, lips, mouth, throat, or tongue or throat which may cause difficulty in swallowing or breathing
Other sources of information
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Updated on 24 June 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
4.8. Undesirable effects
Immune system disorders |
|
uncommon |
Hypersensitivity |
rare |
Anaphylactic reaction* |
* Post‑marketing reports.
Updated on 28 November 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 28 November 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.4 Special warnings and precautions for use
Psychiatric Disorders
Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see section 4.8). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
Updated on 24 October 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Removal/change of distributor
Updated on 10 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 July 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 July 2017 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of the following related to a contraindication for patients receiving drug combinations with Direct-acting antiviral (DAA) agents:
4.3 Contraindications
· Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see sections 4.4 and 4.5).
4.4 Special warnings and precautions for use
ALT elevations
During clinical trials with patients treated for hepatitis C virus infections (HCV) with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) occurred significantly more frequent in women using ethinyl estradiol-containing medications such as combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions
Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin may increase the risk of ALT elevations (see sections 4.3 and 4.4). Therefore, EVRA-users must switch to an alternative method of contraception (e.g., progestagen-only contraception or non-hormonal methods) prior to starting therapy with this combination drug regimen. EVRA can be restarted 2 weeks following completion of treatment with this combination drug regimen.
Updated on 29 June 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 29 June 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 27 May 2016 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Sections 5.1 and 5.2: change of μg symbol to mcg
Updated on 26 May 2016 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 8 May 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Updated on 5 May 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 23 January 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 22 January 2014 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Updated on 21 March 2013 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
information on gallbladder disease.
Section 4.5 -interactions:
Addition of rifabutin (fos)apreptitant, eslicarbazepine, rufinamide, nelfinavir, efavirenz. Addition information on interaction with lamotrigine.
Updated on 21 March 2013 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 20 February 2013 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
The use of any combined oral hormonal contraceptives, including EVRA, carries an increased risk of venous thromboembolism (deep vein thrombosis, pulmonary embolism) compared to no use. Epidemiological studies have shown that the incidence of venous thromboembolism (VTE) in women with no other risk factors for VTE who use low dose oestrogen (<50 micrograms ethinyl estradiol) combined contraceptives ranges from about 20 to 40 cases per 100,000 women-years, but this risk estimate varies according to the type of progestogen. This compares with 5 to 10 cases per 100,000 women-years for non-users and 60 cases per 100,000 pregnancies. VTE is fatal in 1%-2% of cases.
Data from epidemiological studies in women aged 10 to 55 years have suggested that the incidence of VTE in women who used EVRA is up to 2-fold increased in comparison with users of a levonorgestrel-containing oral contraceptive (so-called “second generation” OC).
Updated on 20 July 2012 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Date of latest renewal: 15 June 2012.
Updated on 2 July 2012 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Renewal of licence with included update to Section 4.4 Section 4.5 , Section 5.1 and administrative changes in line with QRD template throughout the SPC.
Section 1: EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch
Change to section 4.4 - Special warnings and precautions for Use
Data from epidemiological studies in women aged 15 10 to 44 55 years have suggested that the incidence of VTE in women who used EVRA is increased in comparison with users of a levonorgestrel-containing oral contraceptive (so-called “second generation” OC).
The incidence was 1.4 fold (95% CI 0.9-2.3) increased in women with or without other risk factors for VTE and 1.5 fold (95% CI 0.8-2.7) increased in women with no other risk factors for VTE.
Section 4.5 Interaction with other medicinal products and other forms of interaction
Hormonal contraceptives may affect the metabolism of certain other active substances. Accordingly, plasma and tissue concentrations may either increase (e.g. ciclosporin) or decrease (e.g. lamotrigine). Dosage adjustment of the concomitant medicinal product may be necessary.
Change to section 5.1 - Pharmacodynamic Properties
Pharmacotherapeutic group: Norelgestromin and estrogen. Sex hormones and modulators of the genital system, progestogens and estrogens, fixed combination
Updated on 22 June 2012 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change to side-effects
- Change to date of revision
Updated on 1 March 2012 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- 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
Section 4.2 Posology
Admiistrative changes to text, no new information:
Section 4.4
Smoki ng warning strengthened, regarding use in women > 35 years who smoke.
Section 4.5
Addition of interaction with etoricoxib
Section 4.6
Administrative changes no new information
Section 4.8
ADRS now in a single table, following MeDRA terms
Updated on 1 March 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to appearance of the medicine
- Change of distributor details
Updated on 20 January 2010 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- 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
Change to section 4.5 – Revisions to section format & content
Change to section 4.8 - Addition of 'abnormal taste' to 4.8.2 Postmarketing Data
Change to section 10 – Changed to 22 December 2009
Updated on 14 January 2010 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 4 February 2009 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
Change to section 2 quantitative and qualitative composition |
Each 20 cm2 transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE). Each transdermal patch releases an average of 203 For a full list of excipients, see section 6.1. |
Change to section 3 pharmaceutical form |
Transdermal patch. EVRA is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and heat-stamped EVRA |
Change to section 10 Date of revision of the text |
Changes to 22 December 2008 |
Updated on 3 February 2009 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 1 July 2008 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 30 June 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 20 September 2007 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Change to joint SPC covering all presentations
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 2 – quantitative and qualitative composition |
|
Change to section 6.6 – Instructions for use, handling and disposal |
|
Change to section 10 – Date of revision of the text |
|
Change to joint SPC covering all presentations |
|
Updated on 20 September 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to date of revision
Updated on 7 March 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Correction of spelling/typing errors
Updated on 28 February 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 26 February 2007 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
- Change to separate SPCs covering individual presentations
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 4.4 – Update to warnings statement concerning VTE risk
Change to section 5.2 – Update to include discussion on PK properties of the patch vs. the oral COC
Change to section 10 – Changed to January 2007
Updated on 9 May 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 28 October 2003 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 29 September 2003 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 July 2003 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Annex 2 - Checklist for PrescribersRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines
Annex 3 Important Information for WomenRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines