To replace Manufacturer “Millmount Healthcare Limited" with "Catalent France Beinheim".

Our reference: TW 4192995

Change to section 4 - how to report a side effect, Change to section 6 - manufacturer & Date of revision

Change to section 4.8 - Undesirable effects; Change to section 10 - Date of revision of the text

Internal Reference number:  TW 3451722

Change to section 4 - possible side effects; Change to section 6 - Contents of the pack and further information & date of revision

Update to product information i.e. section 4.8 

Our reference: TW 2590646

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

4.8        Undesirable effects

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

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.

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.