EEMT 1.25 mg-2.5 mg tablet

Generic name:
Methyltestosterone w/ estrogen - oral

Pronunciation
(METH-ill-tess-TOSS-ter-own/ESS-trow-jen)

Brand name(s)
Covaryx , EEMT , Estratest H.S. , Menogen H.S.

Estrogens may increase the risk of cancer of the uterus (endometrial cancer). If you have a uterus, ask your doctor if taking a progestin can help decrease your risk. Tell your doctor right away if you have any unusual vaginal bleeding.

This medication is used to treat menopause symptoms. It helps reduce episodes of flushing and sweating of the upper body and face, commonly called hot flashes. It also helps treat dryness, itching, and burning around the vagina. These symptoms occur when a woman's body no longer produces the usual amount of hormone (estrogen) at the age when monthly menstrual periods normally stop. This medication is a combination of 2 hormones, estrogen and methyltestosterone.

If you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. You may take it with food or right after a meal to prevent stomach upset. This medication is usually taken on a cycle, once a day for 21 days followed by no medication for 7 days.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Follow your dosing schedule carefully. Do not increase your dose or take this medication more often or for a longer time than directed.

Tell your doctor if your condition does not get better or if it gets worse.

Dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, or breast tenderness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Remember that this medication has been prescribed because your doctor 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 you have any serious side effects, including:

• signs of liver disease (such as nausea/vomiting that doesn't stop, yellowing eyes/skin, stomach/abdominal pain, dark urine)
• mental/mood changes (such as severe depression)
• breast lumps
• swelling of hands/feet
• unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding)
• unusual vaginal discharge/itching/odor
• changes in skin color
• unusual tiredness
• 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

In postmenopausal women, estrogens, taken with or without a progestin, increase the risk of cancer of the breast/ovaries. Discuss the risks and benefits of this medication with your doctor.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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.

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:

• unexplained vaginal bleeding
• abnormal breast exam
• personal or family history of cancer (such as breast cancer, cancer of the uterus/ovaries)
• uterus problems (such as fibroids, endometriosis)
• blood clots (for example, in the legs, eyes, lungs)
• blood clotting disorders (such as protein C or protein S deficiency)
• stroke
• heart problems (such as heart valve disease, irregular heartbeat, previous heart attack)
• high blood pressure
• high cholesterol or triglyceride (blood fat) levels
• diabetes
• obesity
• liver disease (including tumors)
• gallbladder disease
• kidney disease
• underactive thyroid (hypothyroidism)
• a certain hormone problem (hypoparathyroidism)
• mineral imbalance (low or high level of calcium in the blood)
• lupus
• personal or family history of a certain swelling disorder (angioedema)
• asthma
• seizures
• headaches (such as migraines)
• depression
• a certain blood disorder (porphyria)

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 (cannabis) 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 (cannabis).

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 (such as on 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 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. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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 (such as prednisone)
• exemestane
• fezolinetant
• 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 medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding.

Do not share this medication with others.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Lifestyle changes (such as reducing stress, eating a low fat/low salt diet, losing weight if you are overweight) to control or prevent high blood pressure, high cholesterol, and diabetes help to prevent heart disease and strokes. Discuss with your doctor lifestyle changes that might benefit you.

You can also manage hot flashes by keeping a cool body temperature (such as by using a fan, drinking cool beverages, dressing lightly/in layers, avoiding hot/spicy foods). Limiting caffeine and alcohol, exercising regularly, and learning relaxation techniques may help reduce hot flashes. Vaginal lubricants can help lessen discomfort during intercourse.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.