Brand Name

Provera {Pfizer; Distributed by Pharmacia & Upjohn Company}

Generic Name

medroxyprogesterone acetate USP, pronounced me DROX ee proe JES ter one

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is PROVERA?

Provera used to treat certain conditions like absent or irregular menstrual periods or
abnormal uterine bleeding. As a form of progesterone, the progestin in Provera is a female
hormone that helps regulate both ovulation and menstrual periods. Provera may be prescribed to
decrease the risk of endometrial hyperplasia, which is a condition that can lead to uterine
cancer. You may receive Provera to prevent overgrowth in the lining of your uterus, especially if
you are postmenopausal and undergoing hormone replacement therapy with estrogen.

Provera may be used for purposes not described in this medication guide.

Key Facts About PROVERA

PREGNANCY/BREASTFEEDING: Provera can harm your unborn baby and cause birth defects. You should
not use Provera if you are pregnant, and you must tell your doctor immediately if you become
pregnant during treatment with this medication. We know that Provera can pass into breast milk
and may harm a nursing baby, and it may also slow your breast milk production. You should not
breast-feed while you are taking Provera.

Provera should not be used to prevent heart disease, stroke, or dementia, because it may
actually increase your risk of developing these conditions. Talk to your doctor if you are
concerned about your risk for developing any of these conditions.

Do not start Provera if you have had a Heart Attack within the last year, if you have had
blood clots or a liver problem.

Taking Provera, or any hormones, may increase your risk of blood clots, stroke, or a heart
attack, particularly if you have diabetes, high blood pressure, high cholesterol or
triglycerides, if you are overweight or if you smoke. Your doctor may evaluate your condition
every 3-6 months to determine if Provera is still the best treatment for you.

Do not use Provera if you have undiagnosed vaginal bleeding

Before You Take PROVERA

If you are allergic to Provera you should not use Provera.

If you have a bleeding or blood-clotting disorder, a history of stroke or circulation
problems, abnormal vaginal bleeding that a doctor has not checked or any type of breast, uterine,
or hormone-dependent cancer you should not take Provera.

If you have a historyuncontrolled high blood pressure, heart disease, angina, high cholesterol
or triglycerides, asthma or diabetes you should talk to your doctor before taking Provera.

Do not use Provera if you have epilepsy, low levels of calcium in your blood, severe pelvic
pain, a recent miscarriage or abortion, migraines or lupus without talking to your doctor
first.

Tell your doctor if you kidney disease, congestive heart failure or a thyroid disorder before
using Provera.

PROVERA Drug Interactions

There are no particular drug interactions for Provera. However, other drugs you take that are
not listed may interact with Provera. You should tell your doctor about all of the medications
you use. This includes prescription drugs, vitamins, supplements and herbal products, and over
the counter medications. You should not begin taking a new medication without telling your doctor
first.

Directions for Using PROVERA

Use Provera exactly as your doctor has prescribed you to. Do not use it in larger or smaller
amounts or for shorter or longer than recommended. Provera comes with patient instructions for so
you can use this medication safely and effectively. Be sure to follow these instructions
carefully.

Provera is usually given for 12 to14 days in a row every month. Provera is not necessary in
women who do not have a uterus. Your doctor may have prescribed for you to start taking this
medication on a specific day during your menstrual cycle. You should follow your doctor’s
instructions exactly.

You should have regular physical exams and mammograms, and self-examine your breasts for lumps
each month while using Provera. Your doctor should check your progress every 3 to 6 months to
evaluate whether you should continue taking Provera.

If you need medical tests or surgery, or if you will need to be on bed rest, you may need to
stop using Provera for a short period of time. Be sure to tell any doctor or surgeon who treats
you should know that you are being treated with Provera.

You should not smoke while you take Provera, as it will increase your risk of developing blood
clots, a stroke, or a heart attack.

If you miss a dose of Provera you should take it as soon as you remember. If it is almost time
for your next dose you should skip the dose you missed.

Provera needs to be stored in a cool, dry place, away from heat and moisture.

PROVERA Side Effects

Seek emergency medical assistance at once if you have a serious side effect such
as:

• allergic reaction including breathing difficulties, hives and swelling of your face, lips,
  throat or tongue
• chest pain or a heavy feeling with pain spreading to your arm or shoulder, nausea, sweating
  and a general ill feeling
• headache that is severe or sudden with confusion, problems with vision, speech or balance,
  difficulty answering simple questions.
• numbness and weakness that is sudden, or on one side of your body
• Seek medical assistance at once for the following serious side effects of hormonal
  replacement therapy:
• breast lump
• coughing and wheezing with rapid breathing and a fast heart rate
• depression symptoms
• faint feeling or feeling like you might pass out
• fever
• jaundice or a yellowing of your skin or eyes
• pain and swelling in one or both legs
• swelling in your hands, ankles, feet or legs, along with warmth and redness
• vaginal bleeding that is unusual, especially if you are past menopause

Less serious side Provera effects may include

• headache
• appetite loss
• bloating
• breast tenderness or pain
• darkening of facial skin with or without acne
• menstrual cycle changes, break-through bleeding
• nausea
• rash and mild itching
• scalp hair loss
• stomach pain
• vaginal itching or discharge
• weight changes

It should be noted that this is not a complete list of possible side effects of Provera. You
should contact your physician for a complete list and medical advice regarding these effects.

PROVERA Description

PROVERA is available in tablet form in the following dosages from Pfizer Pharmaceuticals:

PROVERA 2.5 mg circular, orange tablets scored on one side and imprinted Provera:2.5 on the
other.

PROVERA 5 mg hexagonal, white tablets scored on one side and imprinted with Provera; 5 on the
other.

PROVERA 10 mg circular, white tablets scored on one side and imprinted with Provera; 10 on the
other side.

You should take Provera exactly as your doctor has directed you to. Do not change your dose of
Provera or stop taking this medication without talking to your doctor first.

If you believe that you have overdosed with Provera you should seek medical help
immediately.

Ingredients in Provera

Provera 2.5mg contains 2.5mg medroxyprogesterone acetate. Each tablet also contains the
inactive ingredients calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose,
talc and FD&C Yellow no.6.

Provera 5mg contains 5mg medroxyprogesterone acetate. Each tablet also contains calcium
stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, and talc.

Provera 10mg contains 10mg medroxyprogesterone acetate. Each tablet also contains calcium
stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, and talc.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.