This gel contains a hormone called progesterone. When the gel is inserted into your vagina, the progesterone is slowly released into your bloodstream throughout the day. Progesterone is used to give you extra progesterone in the treatment of infertility due to incorrect levels of progesterone during the menstrual cycle or when you are having an assisted fertility procedure. This is to help you get pregnant. You may also be asked to continue using Progesterone to support your new pregnancy.

Insert the contents of one applicator of Progesterone into your vagina each day, starting after your doctor tells you that you have ovulated, or on the 18 th -21 st day of your menstrual cycle. (The first day of your menstrual cycle is the day your period starts.)

When used during in-vitro fertilisation, from the day of the embryo transfer, insert the contents of one applicator of Progesterone into your vagina each day, preferably in the morning. Once tests confirm that you are pregnant, you may be asked to keep using Progesterone to support your new pregnancy- for a total of 30 days.

The applicator is designed in such a way that an exact amount of gel (1.125 g, containing 90 mg progesterone) is delivered. It is expected that a small amount of gel will be left in the applicator. This can be thrown away as you will have received all of the medicine that you need.

Administration

Getting your applicator ready: Grip the applicator by the thick end between your thumb and index finger. Face the thin end of the applicator down to the ground and shake the applicator down to move all the gel inside to the thin end. Grip the applicator by the flat part of the thick end. Twist off and remove the cap from the opposite thin end. To stop the gel from flowing out before use, do not press the air tank at the thick end at this stage.

Inserting your applicator: Lean back or lie down with your knees bent and spread apart. Carefully insert the applicator well into your vagina, until your hand touches your body. Press the air tank at the thick end of the applicator firmly to deliver the gel from the applicator into your vagina.

After using your applicator: Throw away the applicator, including the small amount of gel that is left inside. Use each applicator only once. Progesterone gel can stay in your vagina for several days. You may get a beige to brownish clumpy or cloudy white discharge during this time. This is nothing to worry about.

• if you are allergic to the active substance or any of the other ingredients of this medicine.
• if you have unexplained vaginal bleeding.
• if you have porphyria (an inability to break down certain substances (porphyrins) in your blood that is passed down in families).
• if you have or think you might have cancer in your breasts or genital organs.
• if you have ever had a blood clot due to swollen veins (thrombophlebitis), a blocked blood vessel (thromboembolic disorder) or a stroke.
• if you are pregnant but your baby has died inside of you (missed abortion).

Common (may affect up to 1 in 10 people):

• headache
• feeling very tired
• stomach or gut (gastro-intestinal) cramps
• breast tenderness

Caution should be taken

• if you have liver or kidney problems
• if you have heart problems or diabetes
• if you have asthma
• if you have epilepsy or often get migraines
• if you have ever had depression.

Use in Special Populations

Progesterone is not for use in children or adolescents.

Pregnancy & Lactation

Progesterone is not normally used during pregnancy. However, if you used Progesterone to help you get pregnant, you may be asked to continue using it to support your new pregnancy. The use of Progesterone during breast-feeding is not recommended.