Crinone 8% Gel (Progesterone)

Tell your doctor or pharmacist if:

• you are allergic to any of the ingredients listed above;

• you have abnormal vaginal bleeding;

• you have porphyria (congenital or acquired disorder of the biosynthesis of the red blood stain);

• you have malignant disease of the breast or genital organs, or if such a disease is suspected;

• you have an acute blood clot including inflammation of superficial veins (thrombophlebitis), a vascular occlusion (thormboembolic disorder), or a cerebral apoplexy, or if you have had such disease before;

• you are pregnant with a dead fetus (missed abortion);

• you are breast feeding;

• you have liver disease, epilepsy, heart or kidney problems, or are using any other vaginal product.

One application of CRINONE 8% (90 mg of progesterone) every day, starting the day of the transfer. In some cases, the dose can be increased to two applications of CRINONE 8% daily. If pregnancy occurs, treatment should be continued for up to 10 to 12 weeks.

CRINONE is to be applied directly from the specially designed applicator into the vagina. CRINONE coats the vaginal mucosa to provide long-lasting release of progesterone.

Each applicator contains a slightly larger amount of gel than actually released, as the rest of the product tends to adhere to the inside of the applicator. It is therefore quite normal for a little gel to be left inside the applicator.

Each applicator contains 1.45 g vaginal gel and is designed in such way that with each administration an exactly defined amount of gel (1.125 g) is delivered. Any content of gel remaining in the applicator after use must be discarded.

Each applicator is intended for single use only.

If you forget to use CRINONE on a normal dosage day then use it the following day and then continue as before. Do not administer double doses to make up for a forgotten single dose.

Typically the gel stays attached to the vaginal walls as the medicine absorbs. Do not be concerned if small globules appear as a discharge after several days of usage. It is common, not harmful, to have some gel residue build-up. Gel accumulation may be less likely to occur if the gel is applied in the morning because activities like walking may help spread the gel on the vaginal walls. Therefore, it is not necessary to remain lying down following administration of CRINONE. If gel accumulation becomes bothersome, talk to your doctor.

Remove the applicator from the sealed wrapper. DO NOT remove the twist-off cap at this time.

1. Grip the applicator by the thick end. Shake down like a thermometer to ensure that the contents are at the thin end.

2. Twist-off the tab and discard.

3. The applicator may be inserted into the vagina while you are in a sitting position or when lying on your back with your knees bent. Gently insert the thin end well into the vagina.

4. Press the thick end of the applicator firmly to deposit gel. Remove the applicator and discard into a waste container.