Consumer Information

femHRT

Generic name: Norethindrone acetate/ethinyl estradiol
Brand names: femHRT

Why is femHRT prescribed?

femHRT is prescribed for hormone replacement therapy. It contains estrogen and progestin hormones. femHRT is used to relieve menopausal symptoms such as hot flashes and vaginal itching. It is also used to help prevent thinning bones (osteoporosis).

Most important fact about femHRT

Using estrogen, with or without progestin, may increase your risk for heart attack, stroke, dementia, breast cancer, and blood clots. If you or a family member has a history of these conditions, talk to your doctor about whether femHRT is right for you.

How should you take femHRT?

Take one tablet at the same time each day, with or without food. Estrogen should be used at the lowest dose possible and only when treatment is clearly needed. You should talk regularly with your doctor (usually every 3 to 6 months) about the dose you are taking and whether you still need treatment with femHRT.

If you miss a dose...
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take two doses at the same time.

Storage instructions...
Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this product.

Side effects may include:
Abdominal pain, breast tenderness or enlargement, enlargement of uterine fibroids (benign growths in the uterus), headache, nausea and vomiting, retention of extra fluid (edema), spotty darkening of the skin

Less common but serious side effects of estrogen therapy may include breast cancer, uterine cancer, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer. See your doctor immediately if you developing any of the warning signs listed below.

Warning signs of serious side effects may include:
Breast lumps, changes in speech or vision, chest pain, dizziness, fainting, pain or swelling in your legs, severe headaches, shortness of breath, unusual vaginal bleeding, vomiting, yellowing of the eyes or skin

Why should femHRT not be prescribed?

Do not take femHRT if you have:

A history of any cancer stimulated by estrogen, such as breast or uterine cancer
Endometrial hyperplasia (overgrowth of the uterus lining)
A history of heart attack, heart disease, or stroke
Unexplained or unusual vaginal bleeding
A loss of vision due to blood vessel disease in the eye
Migraine headaches
A history of blood circulation problems, including blood clots
A history of liver problems
Sensitivity to estrogen, progestin, or any other ingredient in femHRT
Any reason to believe that you are pregnant

If you've had your uterus removed, you don't need the progestin in this product, and should take a different type of hormone replacement therapy.

Special warnings about femHRT

Tell your doctor about your complete medical history, especially if you have any of the following: problems with your heart, liver, thyroid, or kidneys; asthma; epilepsy or a history of seizures; migraine headaches; endometriosis; high cholesterol; high blood pressure; diabetes; a history of using tobacco; or high levels of calcium in your blood. Also tell your doctor if you are going to have surgery or be on bed rest; you may need to stop taking estrogen.

In addition to increasing the chances of uterine cancer, estrogen replacement therapy may also raise the odds of breast cancer if taken at high doses or for long periods of time. Be sure to get regular breast exams and mammograms, and see your gynecologist for yearly checkups.

Estrogen replacement therapy typically doubles the chances of gallbladder disease. Notify your doctor if you experience pain, tenderness, or swelling in your abdomen.

Estrogen replacement increases the risk of blood clots in the veins, especially during the first year of therapy. Call your doctor immediately if you experience any of the following warning signs: bulging eyes, changes in vision or speech, coughing up blood, dizziness, double vision, faintness, migraine headaches, pains in the calves or chest, severe headache or vomiting, sudden shortness of breath, sudden vision loss, weakness or numbness of an arm or leg.

Estrogen therapy sometimes causes high blood pressure, so be sure to get periodic checkups. In women prone to high blood lipid levels, estrogen can also cause a sharp spike in triglycerides, possibly leading to pancreatitis. Fluid retention is another possibility. If it develops, it can aggravate conditions such as asthma, epilepsy, heart disease, kidney disease, and migraine headaches.

Make sure your doctor knows if you have ever been diagnosed with depression. Treatment with estrogen therapy should be discontinued if depression recurs.

If you have diabetes, watch your blood sugar levels especially carefully. There's a chance that estrogen/progestin products may make diabetes worse.

Possible food and drug interactions when taking femHRT

Tell the doctor about all prescription, over-the-counter, and herbal medications you are taking. If estrogen is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining femHRT with the following:

Acetaminophen
Antibiotics such as clarithromycin and erythromycin
Antifungal drugs such as itraconazole and ketoconazole
Anti-HIV drugs such as ritonavir
Aspirin
Clofibrate
Cyclosporine
Grapefruit juice
Morphine
Seizure medications such as carbamazepine, and phenobarbital
Steroid medications such as prednisolone
Rifampin
St. John's wort
Temazepam
Theophylline

Special information if you are pregnant or breastfeeding

Although femHRT is intended only for women who are no longer in their childbearing years, it's important to note that femHRT should never be taken during pregnancy, since it can harm the developing baby. Additionally, do not use femHRT if you are breastfeeding; the hormones in femHRT can pass into breast milk.

Recommended dosage for femHRT

ADULTS

The recommended dose is one tablet daily.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

Symptoms of overdose may include:
Acne, bloating, breast pain, depression, excessive or abnormal hair growth, fluid retention, nausea, tiredness, vaginal bleeding