Dienestrol (dye-en-ES-trol)

Treats vaginal dryness and irritation caused by menopause. Dienestrol is a synthetic estrogen (female hormone).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Cream

• Your doctor will tell you how much medicine to use and how often.
• Wash your hands with soap and water before and after using this medicine.
• The medicine is a cream that is in a tube. You will use an applicator to put the cream into your vagina.
• The applicator is an empty plastic tube called a barrel. There is a plunger on one end and an opening on the other end. There are numbers on the plunger that show how much cream should be squeezed into the applicator for each dose.
• Remove the cap from the end of the tube.
• Make sure the plunger of the applicator is all the way into the barrel.
• Twist the open end of the applicator onto the tube of cream.
• Squeeze the cream into the applicator. This will cause the plunger to move through the barrel. When the plunger reaches the number of the dose you should take, stop squeezing.
• Twist the applicator off of the tube and put the cap back on the tube.
• Put the applicator into your vagina and push the plunger all the way into the barrel.
• After using, pull the plunger all the way out of the applicator and wash both pieces with warm, soapy water. Never use hot or boiling water.

If a dose is missed:

• May be used as soon as possible.
• Skip the missed dose if it is almost time for your next regular dose.
• You should not use two doses at the same time.

How to Store and Dispose of This Medicine:

• Store at room temperature and protect from freezing.
• Keep all medicine out the reach of children.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Check with your doctor before using this medicine if you have epilepsy, migraine headaches, mental depression, or heart, liver, or kidney disease.
• Large amounts of this medicine taken over long periods of time may increase the risk of some kinds of cancer. Talk to your doctor about this risk.
• Unless you have had a hysterectomy (uterus removed), check with your doctor about whether you should also take progesterone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Severe abdominal pain or swelling
• Heavy vaginal bleeding
• Pain or numbness in the chest, groin, or leg (calf)
• Severe headache and vomiting
• Breast lumps
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Mild nausea or vomiting
• Bloated feeling, weight gain
• Dizziness
• Change in sexual desire
• Swollen or tender breasts

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088