Prometrium

Prometrium is a female hormone important for the regulation of ovulation and menstruation.

Prometrium is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. This medicine is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Prometrium may also be used for purposes not listed in this medication guide.

Prometrium contains peanut oil and should not be used if you are allergic to peanuts.

You should not use Prometrium if you have: a peanut allergy, abnormal vaginal bleeding, a history of breast cancer, liver disease, or have recently had a heart attack, stroke, or blood clot.

Do not use if you are pregnant.

Using Prometrium can increase your risk of blood clots, stroke, heart attack, or cancer.

Prometrium may cause some degree of fluid retention. If you have a condition that might be affected by this, such as heart failure or kidney disease, talk to your healthcare provider.

Prometrium may cause transient dizziness and drowsiness and should be used with caution when driving a motor vehicle or operating machinery. To limit this effect, take Prometrium as a single dose at bedtime.

Do not use Prometrium if you:

• Are allergic to Prometrium, progesterone, or any of the inactive ingredients in the capsules
• Are allergic to peanuts
• Have unusual vaginal bleeding
• Currently have or have had certain cancers
• Had a stroke or heart attack
• Currently have or have had blood clots
• Currently have or have had liver problems.

Estrogen plus progestin treatment may increase the chance of getting certain types of cancers, including cancer ofthe breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Prometrium Capsules.

Before taking Prometrium, tell your healthcare provider about all your medical conditions, including if you have:

• Heart disease, circulation problems;
• Migraines;
• Asthma (wheezing)
• Kidney disease;
• Seizures or epilepsy;
• Diabetes;
• Migraine;
• Endometriosis
• Lupus;
• Problems with your heart, liver, thyroid, or kidneys
• High calcium levels in your blood.

Do not use Prometrium if you are pregnant. It could harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Progesterone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Prometrium may cause serious side effects. Call your doctor at once if you have:

• unusual vaginal bleeding;
• pain or burning when you urinate;
• a breast lump;
• sudden vision problems, severe headache, or pain behind your eyes;
• symptoms of depression (sleep problems, weakness, mood changes);
• severe dizziness or drowsiness, spinning sensation, confusion, shortness of breath;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects of Prometrium may include:

• drowsiness, dizziness;
• breast pain;
• mood changes;
• headache;
• constipation, diarrhea, heartburn;
• bloating, swelling in your hands or feet;
• joint pain;
• hot flashes; or
• vaginal discharge.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects tothe FDA at 1-800-FDA-1088.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take the Prometrium capsule with a full glass of water. It is best to take the medicine at night because this medicine can make you dizzy or drowsy.

Prometrium is sometimes used for only a short time, such as 10 to 12 days during each menstrual cycle. Follow your doctor's dosing instructions very carefully.

Have regular physical exams and self-examine your breasts for lumps every month while using Prometrium.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Prometrium.

Store at room temperature away from moisture, heat, and light.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up for the missed dose.

Call your doctor if you miss more than one dose of this medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Prometrium may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

There may be other drugs that can interact with Prometrium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

The results of some laboratory tests, such as coagulation tests and thyroid function tests, may be altered with the use of estrogen plus progestin therapy.

Store at room temperature, around 25°C (77°F). Excursions are permitted to 15° to 30°C (59° to 86°F).

Protect from excessive moisture.

Prometrium is distributed by Acertis Pharmaceuticals, LLC, Raleigh, NC 27601.

Active ingredient: 100 mg or 200 mg micronized progesterone

Inactive ingredients (100 mg capsule): peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, FD&C Red No. 40, and D&C Yellow No. 10.

Inactive ingredients (200 mg capsule): peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.

Prometrium Capsules 100 mg are round, peach-colored capsules branded with a black imprint "SV."

Prometrium Capsules 200 mg are oval, pale yellow-colored capsules branded with a black imprint "SV2."