Eemt ds

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication is usually taken in a cycle of 3 weeks on and 1 week off. Follow your doctor's instructions.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using esterified estrogens and methyltestosterone.

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

Store at room temperature away from moisture and heat.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• swelling, rapid weight gain;

• confusion, unusual thoughts or behavior;

• pain, swelling, or tenderness in your stomach;

• nausea, stomach pain, loss of appetite jaundice (yellowing of the skin or eyes);

• breast lump, nipple discharge;

• acne, skin color changes, increased facial hair, male pattern baldness, voice changes; or

• changes in your menstrual periods, break-through bleeding.

Less serious side effects may include:

• mild nausea, stomach upset;

• swollen or painful breasts;

• headache;

• hair loss;

• depression, anxiety; or

• decreased sex drive, impotence, or difficulty having an orgasm.

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 to FDA at 1-800-FDA-1088.

Applies to esterified estrogens / methyltestosterone: oral tablet

Along with its needed effects, esterified estrogens / methyltestosterone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking esterified estrogens / methyltestosterone:

• Absent, missed, or irregular menstrual periods
• acne or oily skin
• decreased breast size
• enlarging clitoris
• hoarseness or deepening of the voice
• menstrual changes
• stopping of menstrual bleeding
• unnatural hair growth or loss

• Continuing nausea
• cough
• dark-colored urine
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• hives
• itching
• light-colored stools
• loss of appetite
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• purple or red-colored spots on the body or inside the mouth or nose
• shortness of breath
• skin rash
• sore throat
• tightness in the chest
• unusual tiredness or weakness
• vomiting
• wheezing

• Abdominal or stomach bloating, cramps, or pain
• anxiety
• bleeding from gums or nose
• blistering, peeling, or loosening of the skin
• bloating
• bloody or cloudy urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in vaginal discharge
• changes in skin color, pain, or tenderness
• chest pain or discomfort
• chills
• clay-colored stools
• clear or bloody discharge from nipple
• confusion
• constipation
• convulsions
• darkening of urine
• decrease in amount of urine
• diarrhea
• difficult, burning, or painful urination
• difficulty with breathing
• difficulty with moving
• difficulty with speaking
• dimpling of the breast skin
• dizziness or lightheadedness
• double vision
• eye pain
• fainting
• fever
• fluid-filled skin blisters
• frequent urge to urinate
• headache
• heavy bleeding
• inability to move the arms, legs, or facial muscles
• inability to speak
• indigestion
• inverted nipple
• irregular heartbeats
• itching of the vagina or genital area
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• lump in the breast or under the arm
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain or stiffness
• nausea
• noisy, rattling breathing
• numbness and tingling around the mouth, fingertips, or feet
• pain
• pain during sexual intercourse
• pain in the ankles or knees
• pain or discomfort in the arms, jaw, back, or neck
• pain or feeling of pressure in pelvis
• painful, red lumps under the skin, mostly on the legs
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pelvic pain
• persistent crusting or scaling of the nipple
• pinpoint red or purple spots on the skin
• poor insight and judgment problems with memory or speech
• red, irritated eyes
• redness or swelling of the breast
• ringing in the ears
• sensitivity to the sun
• shortness of breath
• skin thinness
• slow speech
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• sudden shortness of breath or troubled breathing
• sweating
• swelling
• swelling of the fingers, hands, feet, or lower legs
• tenderness of the breast
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• tremor
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• troubled breathing at rest
• unexpected or excess milk flow from breasts
• unpleasant breath odor
• vaginal bleeding
• vision changes
• vomiting of blood
• weakness
• weight gain
• yellow eyes or skin

Some side effects of esterified estrogens / methyltestosterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blemishes on the skin
• brown, blotchy spots on the exposed skin
• decreased interest in sexual intercourse
• depression
• headache, severe and throbbing
• inability to have or keep an erection
• increase or decrease in weight
• increased hair growth, especially on the face
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• irritability
• leg cramps
• loss in sexual ability, desire, drive, or performance
• loss of hair
• mental depression
• pimples
• redness of the skin
• swelling or inflammation of the mouth
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

Applies to esterified estrogens / methyltestosterone: oral tablet

Cardiovascular

Cardiovascular side effects have included increased risks of myocardial infarction, pulmonary embolism, deep and superficial venous thrombosis, stroke, and increased blood pressure.[Ref]

Oncologic

Oncologic side effects have included increase risk of breast cancer[Ref]

Genitourinary

Genitourinary side effects have included changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, endometrial cancer, and cystitis-like syndrome. Side effects involving the breasts have included tenderness, enlargement, pain, nipple discharge, galactorrhea, and fibrocystic breast changes. Side effects of androgen therapy are amenorrhea and other menstrual irregularities, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, and enlargement of hepatic hemangiomas. Additional side effects have included alterations in liver function test, rarely hepatocellular neoplasms, and peliosis hepatis.[Ref]

Dermatologic

Dermatologic side effects have included chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, acne, and rash.[Ref]

Ocular

Ocular side effects have included retinal vascular thrombosis, steepening of corneal curvature, and intolerance to contact lenses.[Ref]

Nervous system

Nervous system side effects have included headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, and dementia. Additional side effects have included increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.[Ref]

Hematologic

Hematologic side effects have included suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, polycythemia, and aggravation of porphyria.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioedema, and anaphylactoid/anaphylactic reactions.[Ref]

Respiratory

Respiratory side effects have included exacerbation of asthma.[Ref]

General

General side effects have included increase or decrease in weight, edema, arthralgias, and leg cramps.[Ref]

Metabolic

Metabolic side effects have included reduced carbohydrate tolerance, increased serum cholesterol, retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.[Ref]

Some side effects of EEMT DS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.