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Evra transdermal patch

  • Name:

    Evra transdermal patch

  • Company:
    info
  • Active Ingredients:

    Ethinylestradiol, Norelgestromin

  • 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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Summary of Product Characteristics last updated on medicines.ie: 24/6/2020

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Janssen Sciences Ireland

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Medicine Name Edurant 25mg film-coated tablets Active Ingredients Rilpivirine Hydrochloride
Medicine Name Erleada 60 mg film coated tablets Active Ingredients Apalutamide
Medicine Name Evra transdermal patch Active Ingredients Ethinylestradiol, Norelgestromin
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1 - 0 of 62 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 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

Section 4.5: Additional information regarding Hepatic metabolism and Management and Substances with variable effects on the clearance of CHCs
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

 addition of ADR reporting statement, plus reformatting of adverse drug reaction table

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

 The SPC has been updated following a review of the risks of thromboembolism. All DVT safety information has been updated

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

Section 4.4

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

Section 4.4

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 203150 micrograms of NGMN and 33.920 micrograms of EE per 24 hours. Medicinal product exposure is more appropriately characterized by the pharmacokinetic profile (see section 5.2).h.

 

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 150/20.

 

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)

Free text change information supplied by the pharmaceutical company

Tick

Change

IPHA – Fragments submitted to IMB

Change to section 4.4 – Special Warnings and Precautions for Use

 

Change to section 10 – Date of revision of text

 

 

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)