Not applicable
36 months
No incompatibilities were found with the usual contraceptive devices.
Glycerin, Light Paraffin, Hydrogenated Palm Oil Glyceride, Carbopol 974P, Sorbic acid, Polycarbophil, Sodium hydroxide, Purified water.
The adverse reactions reported below are classified according to frequency of occurrence as follows:
| Very common | (> 1/10) |
| Common | (> 1/100 to < 1/10) |
| Uncommon | (> 1/1,000 to < 1/100) |
| Rare | (> 1/10,000 to < 1/1,000) |
| Very rare | (< 1/10,000) |
Crinone is generally well-tolerated. In clinical studies, the following adverse events have been reported during Crinone therapy. Most adverse events observed in clinical studies cannot be distinguished from the symptoms common in early pregnancy.
Common
Headache, somnolence, abdominal pain, breast tenderness, itching or burning.
Post Marketing Reports
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.
Rare events of urticaria and pruritis were noted.
For adverse reactions identified during post-marketing surveillance, quantification of frequency has not been attempted, but it is most likely uncommon to very rare.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
In rabbits, Crinone was an eye irritant categorised class IV (minimal effects clearing in less than 24 hours), but not a dermal irritant.
A moderate vaginal irritation was found in rabbits after application of 2.0 ml/day of 8% gel for 5 days.
Pharmacotherapeutic group: Sex hormones, ATC code: G03DA04
The pharmacological particulars of the product are those of the naturally occurring progesterone with induction of a full secretory endometrium.
The progesterone vaginal gel is based on a polycarbophil delivery system which attaches to the vaginal mucosa and provides a prolonged release of progesterone for at least three days.
03/2015
Merck Serono Ltd
Bedfont Cross
Stanwell Road
Feltham
Middlesex TW14 8NX
United Kingdom
Store below 25°C
A single use, one piece, white polyethylene applicator with a twist-off top, designed for intravaginal application.
Each applicator contains 1.45g of gel and delivers 1.125g 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 or 15 units of Crinone 8% progesterone vaginal gel.
PL 11648/0261
Pregnancy
In case of corpus luteum deficiency, Crinone can be used during the first month of pregnancy.
Breast-feeding
Do not use during lactation.
Drivers and users of machines are warned that risk of somnolence may occur.
No special requirements
Date of first authorisation: 1st March 2013
Date of latest renewal: 26th June 2004
