Crinone 8% progesterone vaginal gel
- Name:
Crinone 8% progesterone vaginal gel
- Company:
Merck
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/03/19

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Merck

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 9 April 2020 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 June 2019 SPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 19 March 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 6 July 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 26 June 2018 SPC
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 8 May 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 8 May 2015 PIL
Reasons for updating
- Change to storage instructions
- Change to information about pregnancy or lactation
- Addition of information on reporting a side effect.
Updated on 29 April 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 29 April 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 13 August 2013 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
6.5 Nature and contents of container
A single use, one piece, white polyethylene applicator with a twist-off top, designed for intravaginal application.
Each applicator contains 1.45 g of gel and delivers 1.125 g of gel. Each one is wrapped up and sealed in a paper/aluminium/polyethylene foil overwrap.
The applicators are packed in cardboard boxes containing 6 units of Crinone 8% progesterone vaginal gel, and 15 units of Crinone 8% progesterone vaginal gel.
Not all pack sizes may be marketed
10. DATE OF (PARTIAL) REVISION OF THE TEXT
August 2013
Updated on 5 June 2013 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 11 March 2013 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
Updated on 17 April 2012 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 17 December 2010 SPC
Reasons for updating
- 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
4.8 Undesirable effects
System Organ Class |
Common |
Nervous system disorders |
Headache |
Reproductive system and breast disorders |
Breast tenderness. |
Psychiatric disorders
|
Somnolence |
In addition, intermenstrual bleeding (spotting), vaginal irritation, hypersensitivity reactions usually manifesting as skin rash, and other mild application site reactions have been reported post-marketing
Updated on 7 June 2010 SPC
Reasons for updating
- 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
Sorbic acid may cause local skin reactions, (e.g. contact dermatitis).
Updated on 2 December 2009 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
8% gel
mg/dose
% w/w
Progesterone
90
8.0
Excipients: Contains sorbic acid 0.08% w/w (0.9mg/1.125g dose)
For a full list of excipients see section 6.1
4.3 Contra-indications
Crinone should not be used in individuals with any of the following conditions:e
1. Known hypersensitivity to Crinone (progesterone or to any of the other ingredients). excipients of Crinone ).
2. Undiagnosed vaginal bleeding.
3. Known or suspected malignancy of the breast or genital organs.
4. Acute porphyria.
5. Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or patients with a history of these conditions.
6. Missed abortion.
4.8 Undesirable effects
System Organ Class
Common
Nervous system disorders
Headache
Reproductive system and breast disorders
Breast tenderness.
Psychiatric disorders
Somnolence
In addition, intermenstrual bleeding (spotting), vaginal irritation and other mild application site reactions have been reported post-marketing
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product.
Active Ingredient
8% gel
mg/dose
% w/w
Progesterone
90
8.0
System Organ Class
Common
Nervous system disorders
Headache
Reproductive system and breast disorders
Breast tenderness.
Psychiatric disorders
Somnolence
Updated on 6 November 2009 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 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
See changes as highlighted:
4.3 Contra-indications
Hypersensitivity to any of the components of Crinone Gel.
Crinone should not be used in individuals with any of the following conditions:
1. Known sensitivity to Crinone (progesterone or any of the other ingredients).
2. Undiagnosed uterinevaginal bleeding.
Porphyria
3. Known or suspected malignancy of the breast or genital organs.
4. Acute porphyria.
5. Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or patients with a history of these conditions.
6. Missed abortion.
4.4 Special warnings and special precautions for use
None Stated
In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, non-functional causes should be
considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken.
4.5 Interaction with other medicinal products and other forms of interactions
No interactionsAlthough no interaction with other drugs have been reported. Crinone is not recommended for use concurrently with other vaginal preparations.
4.8 Undesirable effects
Rare cases ofHeadache, somnolence.
Occasional , breast tenderness, intermenstrual bleeding (spotting), vaginal irritation and other mild application site reactions.
Updated on 20 October 2008 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 6 August 2004 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 July 2004 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)