Vagifem (Estradiol Vaginal Tablets)

Description

Ovaries produce less estrogen during menopause, resulting in symptoms such as vaginal atrophy. When estradiol vaginal tablets are inserted into the vagina, they release estradiol, which thickens and supplies the vaginal tissues. Two to three weeks after treatment, symptoms usually improve.

Please mention to your healthcare prescriber if your medical regime includes insulin.

After menopause, vaginal changes may be uncomfortable and can be treated. A number of symptoms can occur, including vaginal dryness, irritation, itching, and soreness; painful urination; and pain and bleeding while sexually active (see side effects tab for more information).  Medications (such as Vagifem) that are applied directly inside the vagina should be used first when treating only vaginal symptoms of menopause. Because more estrogen is absorbed when taken by mouth, absorbed through the skin, or injected, oral estrogen may have more side effects.

Vagifem should not be used for conditions for which it was not prescribed. Do not give Vagifem to anyone else, even if they have the same symptoms as you. They may be harmed by it. You should keep Vagifem out of reach of children.

A vaginal insert containing 10 mcg of estradiol, Vagifem is a small, white, round, film-coated device. In a disposable applicator, each vaginal insert measures 6 mm in diameter.

The safety and effectiveness of Vagifem in children are unknown.

Precautions

If you are allergic to estradiol or have any other allergies, tell your doctor or pharmacist before taking it. Inactive ingredients may cause allergic reactions or other problems with this product. For more information, contact your pharmacist.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots), family or personal history of a certain swelling disorder (angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, mental/mood disorders (such as dementia, depression), a certain blood disorder (porphyria).

It is not a good idea to smoke or use tobacco. Women over 35 who smoke and take estrogen are at an increased risk of stroke, blood clots, high blood pressure, and heart attacks.

Consult your doctor if you are having surgery or will be confined to a chair or bed for a long period of time (such as a long flight). The use of estrogen products increases your risk of blood clots. Taking special precautions or stopping this medication may be necessary.

There is a possibility that this medication may cause blotchy, dark patches on your face or skin (melasma). This effect may be exacerbated by sunlight. Don’t spend too much time in the sun. Sunlamps and tanning booths should be avoided. When spending time outdoors, wear sunscreen and protective clothing.

If you wear contact lenses or are nearsighted, you may experience vision problems or trouble wearing them. You should consult your eye doctor if you experience any of these problems.

Usage

Take Vagifem exactly as prescribed by your doctor. Be sure to read all medication guides and instructions on your prescription label.

There is a possibility that estradiol may increase your risk of developing uterine cancer. To lower this risk, your doctor may prescribe a progestin. If you experience any unusual bleeding in your vaginal area, call your doctor immediately.

Before and after inserting Vagifem, wash your hands.

A disposable applicator comes with each Vagifem tablet. After one use, throw away the tablet applicator.

Instructions for use of the applicator:

● Remove one applicator at a time.

● The applicator can be removed from the plastic wrap by separating it from it. When you open the package, if the insert has not fallen out of the package but has come out of the applicator, carefully place it back into it. When handling the insert, please keep your hands clean and dry.

● You should hold the applicator so that your finger can press the plunger with one hand.

● The next step is to choose the position that is most comfortable for you for vaginal insertion of Vagifem vaginal inserts, e.g. reclining or standing.

● Gently and comfortably guide the applicator through the vaginal opening using the other hand. Use a new insert-filled applicator if the insert falls out of the applicator before insertion.

● To insert the applicator, insert it (without forcing) as far as you are comfortable with, or until half of the applicator is inside your vagina.

● To fully depress the plunger, gently press the plunger once the insert-filled applicator has been inserted. As a result, the insert will be ejected into your vagina, where it will dissolve over a period of time.

● You can dispose of the applicator in the same manner as a plastic tampon applicator after depressing the plunger. It is no longer useful and should be disposed of properly. Any time of day is suitable for insertion. Vagifem vaginal inserts should be applied at the same time every day. Your pharmacist or healthcare provider can answer any questions you may have.

To determine whether this treatment should be continued, your doctor should check your progress regularly. When using Vagifem, you should self-examine your breasts monthly for lumps and have a mammogram every year.

Vagifem may need to be stopped for a short period of time if you need major surgery or will be on long-term bed rest. It is important that your doctor or surgeon knows you are using Vagifem.

Dosage