Crinone 8% progesterone vaginal gel 15 unit dose

Crinone is used for the treatment of infertility due to incorrect levels of the female hormone progesterone during the menstrual cycle. It is also used during in-vitro fertilisation and in women who have normal ovulatory menstrual cycles where there may be problems with the Fallopian tubes or the womb.

Cautious use in severe hepatic insufficiency. 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. Crinone is not indicated in threatened abortion. Treatment should be discontinued in the event of a missed abortion. Although risk of thromboembolism has been associated with estrogens, a link with progestins remains questionable. Therefore, in women with generally recognized risk factors for thrombo-embolic events, such as personal or family history, treatment with Crinone may further increase the risk. In these women, the benefits of Crinone administration need to be weighed against the risks. It should be noted however, that pregnancy itself carries an increased risk of thrombo-embolic events. Avoid concurrent use with other intravaginal preparations. See section 4.5. The excipient sorbic acid may cause local skin reactions (e.g. contact dermatitis) or vaginal irritation. Headaches, Somnolence, Breast Tenderness, Vaginal irritation, Itching or Burning In addition, inter-menstrual bleeding (spotting), 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.

Store below 25°C