Divigel 0.1% Gel
*Company:
Orion Pharma (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 07 February 2024
File name
Divigel 1mg gel PIL 141123.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL updates:
- section 2 - addition of information regarding effect of HRT on other medicinal products. Also some minor formatting updates, e.g. addition of non-breaking spaces.
- section 4 - minor formatting updates, e.g. addition of non-breaking spaces.
- section 6 - date of revision of the text amended.
Updated on 07 February 2024
File name
Divigel 1mg gel SPC 141123.pdf
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
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC updates:
- section 4.5 - addition of information regarding effect of HRT on other medicinal products.
- section 4.8 & 6.1 - minor formatting updates, e.g. addition of non-breaking spaces as per QRD.
- section 10 - date of revision of the text amended.
Updated on 11 November 2022
File name
Divigel 1mg gel SPC 060722.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Summary of changes:
Section 4.2: Patients should be informed that children should not come in contact with the area of the body where estradiol gel was applied
Section 4.4: Information on potential estradiol transfer to children and the actions to be taken if this occurs.
Updated on 11 November 2022
File name
Divigel 1mg gel PIL 060722.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Information added regarding the accidental transferfrom the skin to other people and the actions to be taken, if this occurs.
How to use the Gel: Do not allow other people to touch the area of the skin where the gel was applied until the gel has dried and cover with clothing if needed.
Updated on 06 June 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 June 2016
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
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 03 June 2016
File name
PIL_15146_840.pdf
Reasons for updating
- New PIL for new product
Updated on 03 June 2016
Reasons for updating
- Change to warnings or special precautions for use
Updated on 13 June 2014
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
Updated on 10 June 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 09 August 2013
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
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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
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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 06 August 2013
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
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
Updated on 29 September 2011
Reasons for updating
- New PIL for medicines.ie
Updated on 15 August 2006
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
Updated on 15 August 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)