Estradiol vaginal tablets

What are estradiol vaginal tablets?
ESTRADIOL (Vagifem™) vaginal tablet is a vaginal insert that contains a natural estrogen female hormone. Estradiol is essential for maintaining normal female functions and is normally produced by the ovaries. After menopause, the ovaries decrease their production of this hormone. Estradiol vaginal tablets can help relieve symptoms of vaginal irritation and dryness and urinary tract irritation that occurs in some women during menopause. Generic estradiol vaginal tablets are not yet available.

What should my health care professional know before I use estradiol vaginal tablets?
They need to know if you have any of these conditions:

asthma
blood vessel disease, blood clotting disorder, or suffered a stroke
breast, cervical, endometrial or uterine cancer
diabetes
fibroids in the womb, or endometriosis
heart, kidney or liver disease
high blood lipids or cholesterol
high blood pressure
high level of calcium in the blood
hysterectomy
mental depression
migraine
porphyria
systemic lupus erythematosus (SLE)
tobacco smoker
vaginal bleeding
an unusual or allergic reaction to estrogens, other hormones, medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?
Estradiol vaginal tablets are only for use in the vagina. Do not take by mouth. Wash your hands before and after use. Read package directions carefully. Unwrap the applicator package; the vaginal tablet will be contained in the applicator. Lie on your back, part and bend your knees. Gently insert the applicator tip high in the vagina and push the plunger to release the tablet into the vagina; gently remove the applicator. For the best results use estradiol vaginal tablets at bedtime, unless your prescriber or health care professional tells you otherwise. Throw away the applicator after use; each tablet of this product has a clean applicator for each dose. Do not use your medicine more often than directed. Finish the full course prescribed by your prescriber or health care professional even if you think your condition is better. Do not stop using except on your prescriber’s advice.

For this medicine:

Before starting this medication, read the paper on your prescription provided by your pharmacist or health care professional. This paper will tell you about the specific product you are taking. Make certain you understand the instructions.

This vaginal medication is not prescribed for children.

What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose and resume your normal schedule. Do not use double or extra doses.

What drug(s) may interact with estradiol vaginal tablets?
The estradiol vaginal tablet releases only a small amount of hormone into the body daily and is unlikely to cause significant drug interactions with most medications. However, if you are on any of the following medications, you may want to ask your health care professional about any needed precautions. Do not use other vaginal medications without the advice of your health care professional.

some antibiotics used to treat infections
some medications used to treat HIV (human immunodeficiency virus) infection or AIDS
ascorbic acid/vitamin C supplements
barbiturates or benzodiazepines used for inducing sleep or treating seizures (convulsions)
bromocriptine
carbamazepine
cimetidine
clofibrate
cyclosporine
dantrolene
medications for diabetes
griseofulvin
hormones
hydrocortisone, cortisone, or prednisolone
imipramine or some other antidepressants
isoniazid (INH)
methotrexate
mineral oil
phenytoin
raloxifene or tamoxifen
rifabutin, rifampin, or rifapentine
some medications for treating migraines
theophylline
thyroid hormones
topiramate
tricyclic antidepressants
warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from using estradiol vaginal tablets?
Side effects that you should report to your prescriber or health care professional as soon as possible:

breakthrough bleeding and spotting
breast enlargement, tenderness, unusual discharge or milk production
chest pain
leg, arm or groin pain
nausea, vomiting
severe headaches
stomach pain (severe)
sudden shortness of breath
swelling of the hands, feet or ankles, or rapid weight gain
vision or speech problems
yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

change in sexual desire
mild stomach upset
mood changes, anxiety, depression, frustration, anger, or emotional outbursts
increased or decreased appetite
skin rash, acne, or brown spots on the face
tiredness
vaginal irritation or itching
vaginal yeast infection (irritation and itching with a white discharge)
weight gain

What should I watch for while taking estradiol vaginal tablets?
Visit your prescriber or health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will also need a regular breast and pelvic exam and “Pap” smear while on estrogens therapy. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests. If you have any unusual bleeding contact your prescriber or health care professional for advice.

Estrogens can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your prescriber or health care professional if you feel you are retaining fluid.

If you have any reason to think you are pregnant; stop using estrogens at once and contact your prescriber or health care professional.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are using estrogens, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye prescriber or health care professional.

If you are going to have elective surgery, you may need to stop taking your estrogens one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.

Where can I keep my medicine?
Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Estradiol vaginal tablets

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