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|Prochieve Gel

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Prochieve Gel

Generic Name: Progesterone Vaginal 8% Gel (pro-JESS-ter-ohn)
Brand Name: Crinone and Prochieve

Prochieve Gel is used for:

Supplementing or replacing progesterone in infertile women with progesterone deficiency. It is also used in certain women who do not menstruate and have not responded to lower strengths of Prochieve Gel. It may also be used to treat other conditions as determined by your doctor.

Prochieve Gel is a hormone. It works by preparing the uterus (womb) for implantation of a fertilized egg and protecting the lining of the uterus. It is also needed for the maintenance of a healthy pregnancy.

Do NOT use Prochieve Gel if:

you are allergic to any ingredient in Prochieve Gel
you have cancer of the breast, ovary, lining of the uterus, cervix, or vagina; a history of blood clots or clotting problems; vaginal bleeding of unknown cause; or liver disease; or you have had a stroke, a recent miscarriage, or bleeding in the brain

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prochieve Gel:

Some medical conditions may interact with Prochieve Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines or other substances
if you have heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, asthma, migraine headaches, or lupus
if you have a history of seizures, depression or other mental/mood problems, cancer, or tobacco use
if you have a family history of blood clots
if you are very overweight

Some MEDICINES MAY INTERACT with Prochieve Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

Rifampin because the effectiveness of Prochieve Gel may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prochieve Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prochieve Gel:

Use Prochieve Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Review the patient insert for proper preparation and use of the vaginal applicator.
This medication comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about Prochieve Gel.
If you miss a dose of Prochieve Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Prochieve Gel.

Important safety information:

Prochieve Gel may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Prochieve Gel. Using this medicine alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
Prochieve Gel may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
Do not use Prochieve Gel at the same time as other vaginal therapy without checking with your doctor. If other vaginal therapy is to be used, administer it 6 or more hours before or after Prochieve Gel, unless advised otherwise by your health care provider.
Prochieve Gel may be harmful if swallowed.
Diabetes patients - Prochieve Gel may worsen blood sugar control. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.
LAB TESTS and/or medical tests, such as monthly breast self-exams, yearly breast exams, Pap smears, and pelvic exams, should be performed to monitor your progress or to check for serious side effects. Be sure to keep all doctor and lab appointments.
Prochieve Gel is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Prochieve Gel during pregnancy. Prochieve Gel is excreted in breast milk. If you are or will be breast-feeding while you are using Prochieve Gel, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Prochieve Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast enlargement; breast pain; changes in sex drive; constipation; cramps; depression; diarrhea; difficult or painful sexual intercourse; drowsiness; fatigue; fluid retention/bloating; headache; increased appetite; joint pain; nausea; nervousness; pain around vaginal area; sleep disorder; urination at night; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; calf/leg pain or tenderness; change in emotions, mood, or behavior; chest pain; coughing blood; dizziness; fainting; inflammation of the eye; numbness of arm or leg; one-sided weakness; pain in the groin; partial or complete loss of vision; seizure; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; tremor; unusual vaginal discharge or odor; vaginal itching; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Prochieve Gel:

Store at room temperature, below 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Keep Prochieve Gel out of the reach of children and away from pets.

General information:

If you have any questions about Prochieve Gel, please talk with your doctor, pharmacist, or other health care provider.
Prochieve Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Prochieve Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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