Crinone 8% progesterone vaginal gel

Product Information *

  • Company:

    Merck
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 27 July 2021

File name

Crinone PIL IE TW2590646 current V1_1627388522.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Minor update to product information. 

Our reference: TW 2590646

Updated on 26 July 2021

File name

Crinone SPC IE TW2590646 current V6.0_1627320068.pdf

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

Update to product information i.e. section 4.8 

Our reference: TW 2590646

Updated on 09 April 2020

File name

Crinone IE TW1735731 current V5.0_1586443529.pdf

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

File name

Crinone 8% IE TW1735731 current V5.0_1561040055.pdf

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

File name

PIL CRINONE 0.08 (15) - IE - Batch release TW1892069_1552903209.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 06 July 2018

File name

Crinone 06-2018 leaflet.pdf

Reasons for updating

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

Updated on 26 June 2018

File name

Crinone8IETW1735731currentV50.docx

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 08 May 2015

File name

PIL_15342_599.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 May 2015

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

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

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

Minor administrative changes throughout the SPC due to QRD version 9 recommendations including ADR reporting.

Updated on 13 August 2013

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 05 June 2013

Reasons for updating

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

Updated on 11 March 2013

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

MA holder now Merck Serono Limited with a new PA number.

Updated on 17 April 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 December 2010

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

Section 4.8 updated as follows:

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 07 June 2010

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

The following statement added to section 4.4:

Sorbic acid may cause local skin reactions, (e.g. contact dermatitis).

Updated on 02 December 2009

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

IMB approved SPC had errors which have now been corrected. See below for corrections:

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.

Updated on 06 November 2009

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

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 06 August 2004

Reasons for updating

  • Improved electronic presentation

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

Updated on 15 July 2004

Reasons for updating

  • New SPC for medicines.ie

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