Estrogens (Esterified) and Methyltestosterone

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have your blood pressure checked often. Talk with your doctor.
• Have your blood work checked. Talk with your doctor.
• There may be a higher chance of endometrial cancer in women or breast cancer.
• Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take estrogens and methyltestosterone.
• Avoid cigarette smoking. Smoking raises the chance of heart disease. Talk with your doctor.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• This medicine is not approved for use in children. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.

Use estrogens and methyltestosterone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine at the same time of day.
• There may be days when you will not take estrogens and methyltestosterone.
• Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very bad dizziness or passing out.
• Very bad belly pain.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• Change in eyesight.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Mood changes.
• Memory problems or loss.
• Fever.
• Not able to pass urine or change in how much urine is passed.
• Pain when passing urine.
• Swelling in hands or feet.
• A deep voice or more facial hair.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Dizziness.
• Upset stomach or throwing up.
• Cramps.
• Bloating.
• Swelling.
• Hair loss.
• Enlarged breasts.
• Breast soreness.
• Vaginal bleeding or spotting.
• Lowered interest in sex.
• Pimples (acne).
• This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Covaryx H.S.: Esterified estrogens 0.625 mg and methyltestosterone 1.25 [contains tartrazine]

Covaryx: Esterified estrogens 1.25 mg and methyltestosterone 2.5 mg [contains tartrazine]

EEMT HS: Esterified estrogen 0.625 mg and methyltestosterone 1.25 mg

EEMT: Esterified estrogen 1.25 mg and methyltestosterone 2.5 mg

Generic: Esterified estrogen 0.625 mg and methyltestosterone 1.25 mg; esterified estrogens 1.25 mg and methyltestosterone 2.5 mg

• Covaryx
• Covaryx H.S.
• EEMT
• EEMT HS

• Estrogen and Androgen Combination

Vasomotor symptoms associated with menopause: Treatment of moderate to severe vasomotor symptoms associated with menopause not improved by estrogens alone