The following sections have been updated:
4.2 Posology and method of administration
Method of Administration
Crinone is applied directly from the specially designed sealed applicator into the vagina. The applicator should be removed from the sealed wrapper. The twist-off cap should not be removed at this time.
1. The applicator should be gripped firmly by the thick end. It should be shaken down like a thermometer to ensure that the contents are at the thin end.
2. The tab should be twisted off and discarded.
3. The applicator may be inserted while patient is in a sitting position or when lying on her back with the knees bent. The thin end of applicator should be gently inserted well into the vagina.
4. The thick end of the applicator should be pressed firmly to deposit gel. The applicator should be removed and discarded in a waste container.
4.3 Contra-indications
1. Known hypersensitivity to progesterone or any of the excipients
2. Undiagnosed vaginal bleeding
3. Known or suspected progesterone-sensitive malignant tumours
4. Porphyria
4.4 Special warnings and special precautions for use
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 recognised 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.
4.5 Interaction with medicaments and other forms of interactions
Crinone is not recommended for use concurrently with other vaginal preparations.
Although there is evidence of interaction between oral progestogens and CYP3A4 inducers, resulting in a decrease of serum progestogen levels, no significant consequences on progesterone levels is expected from concurrent administration of CRINONE® vaginal gel with CYP3A inducers
4.8 Undesirable effects
Common (>1/100 – 1/10)
Headache, Somnolence, Breast Tenderness, Vaginal irritation, Itching or Burning
Post Marketing Reports
In addition, intermenstrual bleeding (spotting) and other mild application site reactions have been reported post-marketing.
Rare events of urticaria and pruritis were noted.
6.6 Instructions for use/handling
No special requirements
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