Evorel Conti

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/04/19

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Summary of Product Characteristics last updated on medicines.ie: 9/4/2019

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Janssen Sciences Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Caelyx pegylated liposomal 2mg/ml concentrate for solution for infusion Active Ingredients Doxorubicin hydrochloride
Medicine Name CONCERTA XL 18 mg prolonged-release tablets Active Ingredients Methylphenidate Hydrochloride
Medicine Name Concerta XL 27mg Active Ingredients Methylphenidate Hydrochloride
Medicine Name Concerta XL 36 mg prolonged-release tablets Active Ingredients Methylphenidate Hydrochloride
Medicine Name Dacogen 50 mg powder for concentrate for solution for infusion. Active Ingredients Decitabine
Medicine Name Daktacort 2% 1% Cream Active Ingredients Hydrocortisone, Miconazole nitrate
Medicine Name DARZALEX 20 mg/mL concentrate for solution for infusion. Active Ingredients Daratumumab
Medicine Name Durogesic DTrans 100 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 12 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 25 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 50 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 75 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans Transdermal Patch Active Ingredients Fentanyl
Medicine Name Edurant 25mg film-coated tablets Active Ingredients Rilpivirine Hydrochloride
Medicine Name Erleada 60 mg film coated tablets Active Ingredients Apalutamide
Medicine Name Evorel 50 micrograms per 24 hours Transdermal Patch Active Ingredients Estradiol Hemihydrate
Medicine Name Evorel Conti Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name Evra transdermal patch Active Ingredients Ethinylestradiol, Norelgestromin
Medicine Name Gyno-Daktarin 20 mg/g vaginal cream Active Ingredients Miconazole nitrate
Medicine Name Gyno-Pevaryl Once 150mg vaginal pessary Active Ingredients Econazole Nitrate
Medicine Name Haldol Decanoate Active Ingredients Haloperidol decanoate
Medicine Name IMBRUVICA 140 mg, 280 mg, 420 mg and 560 mg film-coated tablets Active Ingredients Ibrutinib
Medicine Name Intelence 200 mg tablets Active Ingredients Etravirine
Medicine Name Invega 3 mg, 6mg, 9mg, 12mg prolonged-release tablets Active Ingredients Paliperidone
Medicine Name Lyrinel XL 5mg & 10mg prolonged release tablets Active Ingredients Oxybutynin Hydrochloride
1 - 0 of 55 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 9 April 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 9 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 June 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 June 2016 SmPC

Reasons for updating

  • Change to section 4 - Clinical particulars
  • 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 4.6 - Pregnancy and lactation
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section:4.3

 

-        Untreated endometrial hyperplasia

-        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 listed in section 6.1

 Section 4.4

 

Endometrial hyperplasia and carcinoma

In women with an intact uterus Tthe risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods. (see section 4.8).  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). After stopping treatment risk may remain elevated for at least 10 years. The addition of a progestogen for at least 12 days per cycle or continuous combined oestrogen-progestogen therapy in non-hysterectomised women prevents the excess risk associated with oestrogen-only HRT .greatly reduces this risk.

Ovarian cancer

Ovarian cancer is much rarer than breast cancer. Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping. Some other studies, including the WHI trial, suggest that the use of combined HRTs may be associated with a similar or slightly smaller risk (see Section 4.8).

 

Venous thromboembolism

HRT is associated with a 1.3-3 fold higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. One randomised controlled trial and epidemiological studies found a two- to threefold higher risk for users compared with non-users. For non-users it is estimated that the number of cases of VTE that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 8 per 1000 women aged 60-69 years. It is estimated that in healthy women who use HRT for 5 years, the number of additional cases of VTE over a 5 year period will be between 2 and 6 (best estimate =4) per 1000 women aged 50-59 years and between 5 and 15 (best estimate =9) per 1000 women aged 60-69 years. The occurrence of such an event is more likely in the first year of HRT than later (See Section 4.8).

Generally recognized risk factors for VTE include a personal history or family history, use of oestrogens, older age, major surgery, prolonged immobilisation,severe obesity (BMI > 30 kg/m2) pregnancy/postpartum period,and systemic lupus erythematosus (SLE) and cancer. There is no consensus about the possible role of varicose veins in VTE.

Patients with a history of VTE or known thrombophilic states have an increased risk of VTE. HRT may add to this risk, HRT is therefore contraindicated in these patients (see section 4.3).

 

In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age Personal or strong family history of thromboembolism or recurrent spontaneous abortion, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening). If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe’ (e.g, antithrombin, protein S, or protein C deficiencies or a combination of defects), HRT is contraindicated. should be investigated in order to exclude a thrombophilic predisposition. Until a thorough evaluation of thrombophilic factors has been made or anticoagulant treatment initiated, use of HRT in such patients should be viewed as contraindicated.

Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.

 

Coronary artery disease (CAD)

There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received combined oestrogen-progestogen or oestrogen-only HRT.

Oestrogen-only: Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy. There is emerging evidence that initiation of oestrogen only therapy in early menopause may reduce CAD risk.

 

Ischaemic Stroke

One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke in healthy women during treatment with continuous combined conjugated oestrogens and medroxyprogesterone acetate  (MPA). For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years. It is estimated that for women who use conjugated oestrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate = 1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years. It is unknown whether the increased risk also extends to other HRT products.

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 (see Section 4.8).

Hypothyroidism

Patients who require thyroid hormone replacement therapy should have their thyroid function monitored regularly while on HRT to ensure that thyroid hormone levels remain in an acceptable range.

Angioedema

Oestrogens may induce or exacerbate symptoms of angioedema, in particular in women with hereditary angioedema.

Contact sensitisation is known to occur with all topical applications. Although it is extremely rare, women who develop contact sensitisation to any of the components of the patch should be warned that a severe hypersensitivity reaction may occur with continuing exposure to the causative agent.

 

 

Section 4.5

Ritonavir, telaprevir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.

Herbal preparations containing St. John's Wort (Hypericum perforatum) may induce the metabolism of oestrogens and progestogens.

 

Some laboratory tests may be influenced by oestrogen therapy, such as tests for glucose tolerance or thyroid function.

 

Section 4.6

 

Pregnancy

Evorel Conti is contraindicated during pregnancy. If pregnancy occurs during use of Evorel Conti, treatment should be withdrawn immediately.

Clinically, data on a limited number of exposed pregnancies indicate no adverse effects of norethisterone acetate on the foetus. At doses higher than normally used in oral contraceptives and HRT formulations, masculinisation of female foetuses was observed.

For Evorel Conti, no clinical data on exposed pregnancies are available.

 

 

 

Section 4.8

 

Second adverse event table added

 

Update /additon of warnings

 

Breast Cancer risk

Endometrial Cancer Risk

Ovarian cancer

Risk of venous thromboembolism

Risk of coronary artery disease

Risk of ischaemic stroke

 

Section 4.9 Overdose

Signs and symptoms

Due to the mode of administration overdose of oestradiol or norethisterone is unlikely to occur. Symptoms of overdose of oestrogen and progestogen therapy may include nausea, vomiting, break-through bleeding, breast tenderness, abdominal cramps and/or bloating.  Over dosage of progestogens may lead to a depressive mood, fatigue, acne and hirsutism.

Treatment

These symptoms can be reversed by removing the Evorel Conti patch

Updated on 10 June 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 7 April 2015 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Added to section 4.8

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

 

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

Updated on 2 April 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 20 May 2013 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

 added: endometrial cancer, headache, epilepsy, dizziness, palipitations, vasodilatation, diarrhoea, flatulance, abdominal distension, cholelithiasis, rash eryhthrmatous, steven johnson syndrom, cervocakl polyps, endometrila hyperplasia breast enlargement.

deleted: Premenstrual syndrome, uterine fluid retention, postinflmmatory pigemntation, urticaria, angiodoema, liver function testa elevated, anti-socual feeling, irritability, anaemia aggravated, uterine fibromyoma, endometrial polyps

Updated on 20 May 2013 PIL

Reasons for updating

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

Updated on 16 February 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 3: administrative change

Section 4.2: minor amendment to the text

Section 4.3 Contraindications

Addition of:  pregnancy and lactation, or pre-malignant tumours (e.g. untreated atypical endometrial hyperplasia), cerebrovascular accident, known thrombophilic events.
Deletion of  Severe renal disease

 Section 4.4
Addition of Conditions that require monitoring  

Administrative update in line with Comapny core data sheet

Section 4.6  Fertility, pregnancy and lactation
, not indicated chnages to contraindicated

             

Updated on 15 February 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 1 November 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 May 2009 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



4.5

Interaction with other medicinal products and other forms of interaction

Addition of interaction with lamotrigine

10.

DATE OF REVISION OF THE TEXT

Changed to 30th April 2009

Updated on 15 May 2009 PIL

Reasons for updating

  • Change to date of revision
  • Change to drug interactions

Updated on 28 October 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

7.

MARKETING AUTHORISATION HOLDER

Changed to

Janssen-Cilag Ltd

50 100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

 

10.

DATE OF REVISION OF THE TEXT

Changed from June 2008 to 17th October 2008

 

 

Updated on 27 October 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder address

Updated on 30 June 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 June 2008 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 – Undesirable effects

Addition of 2 adverse events

Change to section 10 – Date of revision of text

Change to June 2008

Updated on 1 May 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 1 – trade name

NAME OF THE MEDICINAL PRODUCT

Updated to include pharmaceutical form and strength

Change to section 2 – quantitative and qualitative composition

Update to add ‘full list of excipients’

Change to section 4.4 – Special Warnings and Precautions for Use

Editorial changes and removal of paragraph relating to breast cancer and HRT use

 

Addition of warning relating to renal insufficiency

Change to section 6.1 – List of Excipients

Addition of tradenames to accompany generic names and in listed format

Change to section 6.3 – Shelf Life

Removed additional text and replaced with ‘2 years’

Change to section 6.4 – Special Precautions for Storage

Remove ‘Keep out of sight of children and other additional text.

Change to section 9 – Date of Renewal of Authorisation

Update Section to include the date of first authorisation and last renewal

Change to section 10 – Date of revision of text

Update revision date to ‘April 2008’

Updated on 1 May 2008 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision

Updated on 13 March 2008 PIL

Reasons for updating

  • Change of contraindications

Updated on 12 March 2008 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Add ‘bosentan’

Change to section 10 – Date of revision of text

Change to ‘March 2008’

 

Updated on 23 August 2007 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 9 May 2006 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 2 September 2004 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 August 2004 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)