Conjugated estrogens synthetic b (Oral)

Conjugated estrogens synthetic B is used to treat moderate to severe hot flashes and other symptoms of menopause or low levels of estrogen. It is also used to treat changes in and around the vagina (like vaginal dryness, itching, and burning) caused by menopause.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly and does not cause unwanted effects. You may need a pelvic exam, breast exam, and mammogram (breast x-ray) to check for unwanted effects, unless your doctor tells you otherwise. Make sure to keep all appointments.

It is unlikely that a postmenopausal woman may become pregnant. However, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine for a long time may increase your risk of breast cancer, endometrial cancer, or uterine cancer. Discuss this risk with your doctor. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine. Contact your doctor immediately if you have abnormal vaginal bleeding.

Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.

Using this medicine may increase your risk for blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, inability to move arms, legs, or facial muscles, or inability to speak.

Inform the medical doctor or dentist in charge that you are using this medicine before any surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.

Check with your doctor immediately if you experience severe headache or sudden loss of vision or any other change in vision while using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not eat grapefruit or drink grapefruit juice while using this medicine. Grapefruit and grapefruit juice may change how much of this medicine is absorbed in your body.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Enjuvia® is not meant for use in children.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the usefulness of Enjuvia® in this age group. However, older patients are more likely to have breast cancer, dementia, or stroke, which may require caution when taking this medicine.

Breast Feeding

Research suggests that this medication may change milk production or its composition. If you are not given an alternative to this medication, you should watch for side effects in the infant and ensure they are getting enough milk.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is very important for your healthcare professional to know if you are using any of the medicines listed below. The following interactions are based on their potential significance and are not a complete list.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may be necessary to use both medications. If both are prescribed, your doctor may adjust the dose or how often you take one or both of the medicines.

• Levothyroxine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), whether active or in history or
• Breast cancer, known or suspected, or a history of or
• Heart attack, active or in history or
• Liver disease or
• Protein C, protein S, or other known blood clotting disorders or
• Stroke, active or in history or
• Surgery with a long period of inactivity or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Asthma or
• Cancer, history of or
• Diabetes or
• Edema (fluid retention or body swelling) or
• Endometriosis or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hereditary angioedema (swelling of the face, lips, tongue, or throat) or
• Hypercalcemia (high calcium in the blood) or
• Hypertension (high blood pressure) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Hypocalcemia (low calcium in the blood) or
• Hypothyroidism (an underactive thyroid) or
• Jaundice during pregnancy or from past hormonal therapy or
• Liver tumors or
• Migraine headache or
• Porphyria (an enzyme problem) or
• Systemic lupus erythematosus (SLE)—Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if you experience any of the following side effects:

Incidence not known

• Acid or sour stomach
• backache
• belching
• breast pain
• chest pain or discomfort
• clear or bloody discharge from the nipple
• confusion
• difficulty with speaking
• dimpling of the breast skin
• double vision
• full or bloated feeling or pressure in the stomach
• headache
• heartburn
• inability to move the arms, legs, or facial muscles
• inability to speak
• indigestion
• inverted nipple
• loss of appetite
• lump in the breast or under the arm
• nausea and vomiting
• pain or discomfort in the arms, jaw, back, or neck
• persistent crusting or scaling of the nipple
• poor insight and judgment
• problems with memory or speech
• redness or swelling of the breast
• slow speech
• sore on the skin of the breast that does not heal
• stomach discomfort, upset, or pain
• sweating
• swelling of the abdominal or stomach area
• trouble recognizing objects
• trouble thinking and planning
• trouble walking

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how 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:

More common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cough producing mucus
• cramps
• diarrhea
• dizziness
• excess air or gas in the stomach or intestines
• fever
• general feeling of discomfort or illness
• heavy bleeding
• itching of the vagina or genital area
• joint pain
• loss of appetite
• muscle aches and pains
• pain during sexual intercourse
• pain or tenderness around the eyes and cheekbones
• passing gas
• shivering
• sneezing
• sore throat
• stuffy or runny nose
• sweating
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• trouble sleeping
• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Enjuvia

Pharmacologic Class: Estrogen

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For treatment of moderate to severe hot flashes and other symptoms caused by menopause: Adults—At first, 0.3 milligrams (mg) once a day. Your doctor may adjust your dose as needed. Children—Use is not recommended. For treatment of atrophic vaginitis caused by menopause: Adults—0.3 milligrams (mg) once a day. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.