Progesterone

What it is used for

Progesterone vaginal insert is a vaginal insert that contains the hormone progesterone. Progesterone vaginal insert is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program.

Progesterone is one of the hormones essential for helping you to become and to stay pregnant. If you are undergoing ART treatment, your doctor may prescribe progesterone vaginal insert to provide the progesterone your body needs.

How to take it

• Use progesterone vaginal insert exactly as prescribed. The usual dose of progesterone vaginal insert is one insert placed in your vagina 2 to 3 times a day for up to a total of 10 weeks, unless your healthcare provider advises otherwise.
• Place an progesterone vaginal insert in your vagina with the disposable applicator provided.

Follow the steps below:

• 1. Unwrap the applicator.
• 2. Put one insert in the space provided at the end of the applicator. The insert should fit snugly and not fall out.
• 3. Place applicator with the insert into the vagina while you are standing, sitting, or when lying on your back with your knees bent. Gently place the thin end of the applicator well into the vagina.
• 4. Push the plunger to release the insert.
• 5. Remove the applicator and throw it away in the trash.

Other information for using Progesterone Vaginal Insert

• If you forget a dose of progesterone vaginal insert, take the dose as soon as you remember, but do not use more than your daily dose.
• Call your doctor if you use too much progesterone vaginal insert.
• Do not use any other vaginal products when you are using progesterone vaginal insert.

Side effects, and when to stop

Common side effects seen with ART and progesterone vaginal insert included pelvic pain after surgery, abdominal pain, nausea, and swollen ovaries (ovarian hyperstimulation syndrome).

Other reported side effects included abdominal bloating, headache, urinary infections, uterine cramping, constipation, vomiting, tiredness, and vaginal bleeding.

Vaginal products with progesterone may also cause vaginal irritation, burning, and discharge.

Serious Risks of Progesterone

Progesterone can increase your chance of getting blood clots. Blood clots can be serious and lead to death.

Serious blood clots include those in the:

• legs (thrombophlebitis)
• lungs (pulmonary embolus)
• eyes (blindness)
• heart (heart attack)
• brain (stroke)

Call your doctor or get medical help right away if you have:

• persistent pain in the lower leg (calf)
• sudden shortness of breath
• coughing up blood
• sudden blindness, partial or complete
• severe chest pain
• sudden, severe headache, vomiting, dizziness, or fainting
• weakness in an arm or leg, or trouble speaking
• yellowing of the skin and/or white of the eyes indicating possible liver problem

Other risks of progesterone use include:

• headache
• breast tenderness
• bloating or fluid retention
• mood swings and depression
• irritability
• drowsiness

Call your doctor immediately if you have abnormal vaginal bleeding.

These are not all the side effects with progesterone vaginal insert. Ask your doctor or pharmacist for more information.

Who should not take it

Do not use progesterone vaginal insert if you:

• Are allergic to anything in progesterone vaginal insert. See the end of this leaflet for a complete list of ingredients.
• Have unusual vaginal bleeding that has not been evaluated by a doctor.
• Currently have or have had liver problems.
• Have or have had blood clots in the legs, lungs, eyes, or elsewhere in your body.

Progesterone Vaginal Insert may not be right for you. Before starting Progesterone Vaginal Insert, tell your doctor about all your health problems.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vaginal products, vitamins, herbal supplements. Some medicines may affect progesterone vaginal insert.

Know what medicines you take. Keep a list of your medicines to show to the doctor and pharmacist.

Storing it

• Store progesterone vaginal insert at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
• Do not use progesterone vaginal insert after the expiration date that is printed on the carton.
• Keep progesterone vaginal insert and all medicines out of the reach of children.

General information about Progesterone Vaginal Insert

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use progesterone vaginal insert for a condition for which it was not prescribed. Do not give progesterone vaginal insert to other women, even if they have the same condition as you do. It may harm them.

This leaflet summarizes the most important information about progesterone vaginal insert. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about progesterone vaginal insert that was written for healthcare professionals. For more information call Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115.