SIDE EFFECTS: Dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, or breast tenderness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), breast lumps, swelling of hands/feet, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/recurrent bleeding), unusual vaginal discharge/itching/odor, changes in skin color, yellowing eyes/skin, unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, dark urine, worsening of seizures. Women may experience signs of masculinization (male characteristics) from methyltestosterone. To prevent these changes from becoming permanent, stop taking this medication and tell your doctor right away if any of the following occur: hoarseness, deepening of the voice, facial hair growth, new or worsening acne, an enlarged clitoris, menstrual period changes. This medication may rarely cause serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following: chest pain, jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling of legs, trouble breathing, coughing up blood, sudden dizziness/fainting. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to methyltestosterone or estrogen; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (e.g., breast cancer, cancer of the uterus or ovaries), blood clotting disorders (such as protein C or protein S deficiency), current/history of blood clots (such as in the legs, eyes, lungs), liver problems, family medical history (especially breast lumps, cancer, blood clots, angioedema), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, congestive heart failure, heart attack), stroke, kidney disease, underactive thyroid (hypothyroidism), a certain hormone problem (hypoparathyroidism), mineral imbalance (low or high calcium blood level), mental/mood disorders (e.g., dementia, depression), high blood pressure during pregnancy (toxemia), yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, uterus problems (e.g., uterine fibroids, endometriosis), high blood cholesterol/fat (triglyceride) levels, gallbladder disease, obesity, certain blood disorder (porphyria), lupus. If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and of any symptoms such as increased thirst/urination, weakness, or fainting. Your anti-diabetic medication or diet may need to be adjusted. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur. This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Do not smoke cigarettes or use tobacco. Estrogens combined with smoking further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances (such as stopping this medication) because of the increased risk for blood clots. Consult your doctor for details. This medication is not meant for use in children. This medication must not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. This medication is not effective for preventing a miscarriage and should not be used for this purpose. It is unknown if methyltestosterone passes into breast milk. Estrogen passes into breast milk. This medication may harm a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: anastrozole, "blood thinner" (warfarin), corticosteroids (e.g., prednisone), exemestane, ospemifene, raloxifene, tamoxifen, tranexamic acid. Other medications can affect the removal of estrogens from your body, which may affect how this medication works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others. This product can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding.