Divigel 0.1% Gel

  • Name:

    Divigel 0.1% Gel

  • Company:
    info
  • Active Ingredients:

    Estradiol Hemihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/06/16

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Summary of Product Characteristics last updated on medicines.ie: 6/6/2016
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Orion Pharma (Ireland) Ltd

Orion Pharma (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Bufomix Easyhaler 160 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Bufomix Easyhaler 320 micrograms/9 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Bufomix Easyhaler 80 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Comtess Active Ingredients Entacapone
Medicine Name Dexdor 100 micrograms/ml concentrate for solution for infusion Active Ingredients Dexmedetomidine hydrochloride
Medicine Name Divigel 0.1% Gel Active Ingredients Estradiol Hemihydrate
Medicine Name Fareston Active Ingredients Toremifene Citrate
Medicine Name Indivina Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/2.5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 2 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Methotrexate 10mg tablets Active Ingredients Methotrexate
Medicine Name Methotrexate 2.5mg tablet Active Ingredients Methotrexate
Medicine Name Stalevo 100 mg/25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 200 mg/50 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Toilax micro enema suspension Active Ingredients Bisacodyl
Medicine Name Veramil 120 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
Medicine Name Veramil 40 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
Medicine Name Veramil 80 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
1 - 0 of 24 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 6 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 6 June 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

In section 4.4, the wording has been updated for the information about 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-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.

Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see Section 4.8).

In section 4.8, the wording for the information about ovarian cancer has been updated: 
Use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see section 4.4).

A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.

 

Updated on 3 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 June 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 13 June 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Update of of the SmPC according to the change of Core Safety Profile for estradiol all formulations which was changed during work-sharing UK/H/PSUR/0072/001. As a consequence the safety sections of the text have been updated.

Updated on 10 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 9 August 2013 SmPC

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

  • In section 4.2 the following wording, in orange, has been added:

In patients with an intact uterus, it is necessary to combine Divigel with an adequate dosage of progestogen for adequate duration, at least 12-14 consecutive days per month/28 day cycle or to oppose oestrogen-stimulated hyperplasia of the endometrium.

In women who are not using hormone replacement therapy (HRT), or women transferring from continuous combined HRT-product, treatment with Divigel may be started on any convenient day. In women transferring from a continuous sequential or cyclic HRT regimen, treatment should begin the day following completion of the prior 28 days regimen.

  • In section 4.3 the following text has been updated to include the section where the excipients can be found: Hypersensitivity to the active substances or any of the excipients listed in section 6.1
  • In section 4.4 hereditary angioedema has been added to the list of conditions which need supervision.

    The following statement has also been added:  Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should minimise exposure to the sun or ultraviolet radiation whilst taking HRT. 

  • In section 4.8 this first part of this section has been completely updated including the table to undesirable effects.
  • In section 5.1 the following paragraph has been added: 

    As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestagen greatly reduces the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women.

Updated on 6 August 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 17 August 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

The text has been updated in line with the European core safety text for HRT products.

Updated on 29 September 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 August 2006 SmPC

Reasons for updating

  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

MA number has been amended

Updated on 15 August 2005 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 20 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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