What is Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

Ethinyl estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.
Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.
The combination of ethinyl estradiol and norethindrone is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.
Estradiol and norethindrone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row.
Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, if you have recently had a stroke or heart attack, if you have had your uterus removed (hysterectomy), or if you have ever had an allergic reaction to birth control pills or other hormones.
Before taking ethinyl estradiol and norethindrone, tell your doctor if you have high blood pressure or heart disease, high cholesterol, gallbladder disease, diabetes, asthma, seizures, liver disease, a thyroid disorder, high levels of calcium in your blood, migraine headaches or a history of depression, fibroid tumors in your uterus, or a history of breast cancer or an abnormal mammogram.
Avoid smoking while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by taking hormones.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using ethinyl estradiol and norethindrone.

What should I discuss with my healthcare provider before taking Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row.
Do not use this medication if you have:

• abnormal vaginal bleeding that a doctor has not checked
• a hormone-related cancer such as breast or uterine cancer
• a history of blood clot or circulation problems
• if you have recently had a stroke or heart attack
• if you have had your uterus removed (hysterectomy); or
• if you have ever had an allergic reaction to birth control pills or other hormones

Before using this medication, tell your doctor if you have any of the following conditions.

• high blood pressure or heart disease
• high cholesterol, gallbladder disease, or diabetes
• asthma
• epilepsy or other seizure disorder
• liver disease
• a thyroid disorder
• high levels of calcium in your blood
• migraine headaches or a history of depression
• fibroid tumors in your uterus; or
• a history of breast cancer or an abnormal mammogram

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.
The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

Femhrt 0.5 mg/2.5 mcg Side Effects

What are the possible side effects of Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

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.
Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body
• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
• gallbladder problems (pain in your upper right stomach area with nausea and vomiting)
• jaundice (yellowing of the skin or eyes); or
• a breast lump

Less serious side effects may include:

• mild nausea, vomiting, stomach pain
• breast tenderness or swelling
• freckles or darkening of facial skin
• increased hair growth, loss of scalp hair
• changes in weight or appetite
• problems with contact lenses
• runny nose
• vaginal itching or discharge
• changes in your menstrual periods, decreased sex drive; or
• headache, dizziness, sleep problems

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Femhrt 0.5 mg/2.5 mcg Interactions

What other drugs affect Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

Before taking ethinyl estradiol and norethindrone, tell your doctor if you are taking any of the following medicines:

• acetaminophen (Tylenol)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• prednisolone (Orapred)
• theophylline (Respbid, Theo-Dur)
• St. John’s wort
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), itraconazole (Sporanox), or ketoconazole (Nizoral)
• seizure medication such as carbamazepine (Carbatrol, Tegretol) or phenobarbital (Solfoton)
• rifampin (Rifadin, Rifamate, Rimactane); or
• HIV or AIDS medication such as ritonavir (Norvir, Kaletra)

This list is not complete and there may be other drugs that can interact with ethinyl estradiol and norethindrone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I avoid while taking Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using this medication.
Avoid smoking while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by taking hormones.

Femhrt 0.5 mg/2.5 mcg Dosage

How should I take Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.
Try to take your medicine at the same time each day.
If you need to have any type of 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 using hormones.
It is important to use ethinyl estradiol and norethindrone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using ethinyl estradiol and norethindrone.
Store this medication at room temperature away from moisture and heat.

What happens if I overdose on Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

An overdose of ethinyl estradiol and norethindrone is unlikely to threaten life. Call an emergency room or poison control center for advice.
Symptoms of a ethinyl estradiol and norethindrone overdose might include nausea, vomiting, and vaginal bleeding.

What happens if I miss a dose of Femhrt 0.5 mg/2.5 mcg (Ethinyl Estradiol Norethindrone)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.
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