Progesterone Vaginal Insert 100 mg

Instructions

This medicine is for use in the vagina. DO NOT take this medicine by mouth.

This medicine needs to be placed into the vagina. Please ask your doctor or pharmacist to show you how to use this medicine correctly.

Use the applicator to insert the medicine high into the vagina.

Use the medicine at about the same time each day.

Keep the medicine at room temperature. Avoid heat and direct light.

Wash your hands before and after using this medicine.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Do not use tampons or douche on the days that you are using the medicine.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Do not take the medicine more than three times during 24 hours.

Cautions

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

This medicine is associated with an increased risk for serious blood clots. Speak with your doctor about the benefits and risks from using this medicine.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

If possible, avoid using with marijuana or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Please check with your doctor before drinking alcohol while on this medicine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

If you become pregnant, continue using this medicine for a total of 10 weeks, or as directed by your doctor.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• pain in the abdomen
• bloating
• breast pain or swelling
• drowsiness or sedation
• headaches
• irritability

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• chest or jaw pain
• swelling of the legs, feet, and hands
• bulging eyes
• fainting
• severe or persistent headache
• sudden leg pain, swelling, warmth or redness
• shortness of breath
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• unsteadiness while walking
• vaginal pain
• sudden change or loss of vision
• yellowing of eyes or skin

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.