Important safety information:
PREMARIN Vaginal Cream should not be used by women with intact uteri unless it is prescribed in association with a progestin. PREMARIN Vaginal Cream should be used only under the supervision of a doctor, with regular follow-up at least once a year to identify side effects associated with its use. Your first follow-up visit should be within 3 to 6 months of starting treatment. Your visit may include a blood pressure check, a breast exam, a Pap smear and pelvic exam. You should have a mammogram before starting treatment and at regular intervals as recommended by your doctor. Your doctor may recommend some blood tests. You should carefully discuss the risks and benefits of hormone replacement therapy (HRT) with your doctor. You should regularly talk with your doctor about whether you still need treatment with HRT.
When PREMARIN Vaginal Cream should not be used:
Before using PREMARIN Vaginal Cream, be sure to tell your doctor if you have any of the following medical problems, as PREMARIN Vaginal Cream should not be used under these conditions:
- Known, suspected, or past history of breast cancer.
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Known or suspected hormone-dependent cancer. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take PREMARIN Vaginal Cream.
- Unexpected or unusual vaginal bleeding.
- Have (or have had) blood clot disorders, including blood clots in the legs or lungs or thrombophlebitis (inflammation of the veins).
- Serious liver disease.
- Active or past history of heart disease, heart attacks or stroke.
- If you are allergic to PREMARIN Vaginal Cream or any of its ingredients, or have had any unusual reactions to its ingredients.
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If you are pregnant or suspect you may be pregnant. Since pregnancy may be possible early in pre-menopause while you are still having spontaneous periods, the use of non-hormonal birth control should be discussed with your physician at this time. If you accidentally take estrogen during pregnancy, there is a small risk of your unborn child having birth defects.
- If you have partially or completely lost vision due to blood vessel disease of the eye.
- If you have overgrowth of the lining of the uterus.
- Have known abnormality of the blood clotting system that increases your risk for having a blood clot (e.g., protein C, protein S, or antithrombin deficiency).
- If you experience migraines with or without aura.
Serious warnings and precautions:
The Women’s Health Initiative (WHI) is a large clinical study that assessed the benefits and risks of oral combined estrogen plus progestin therapy and oral estrogen-alone therapy compared with placebo (a pill with no active ingredients) in postmenopausal women.
The WHI trial indicated an increased risk of myocardial infarction (heart attack), stroke, breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in postmenopausal women taking oral combined estrogen plus progestin.
The WHI trial indicated an increased risk of stroke and deep vein thrombosis in postmenopausal women with prior hysterectomy (surgical removal of the uterus) taking oral estrogen alone.
Therefore, you should highly consider the following:
- There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.
- There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy.
- Estrogens with or without progestins should not be used for the prevention of heart disease or stroke.
- Estrogens with or without progestins should be used at the lowest effective dose and for the shortest period of time possible. Regular medical follow-up is advised.
Other safety information:
- In some studies, the use of estrogen-alone and estrogen plus progestin therapies for 5 or more years has been associated with an increased risk of ovarian cancer.
- The use of estrogens by postmenopausal women has been associated with an increased risk of gallbladder disease requiring surgery.
- The use of estrogen-alone therapy by postmenopausal women who still have a uterus increases the risk of developing endometrial hyperplasia (overgrowth of the lining of the uterus), which increases the risk of endometrial cancer (cancer of the lining of the uterus).
- The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI trial, indicated an increased risk of dementia (loss of memory and intellectual function) in postmenopausal women aged ≥65 taking oral combined estrogen plus progestin compared to women taking placebo, but no difference in risk was seen in post-menopausal women aged ≥65 with prior hysterectomy taking oral estrogen alone compared to women taking placebo.
Side effects with PREMARIN may include:
- Breast pain, leaking of milk from the nipple
- Inflammation of the vagina, vaginal itching and/or discharge
- Breakthrough bleeding, spotting, changes in menstrual flow, painful periods
- Joint pain, leg pain
- Hair loss
- Changes in weight (increase or decrease)
- Nausea, vomiting, bloating, abdominal pain
- Dizziness
- Headache (including migraine)
- Changes in libido
- Mood disturbances, irritability
- Rash, itching, hives, tender red nodules on the shins and legs, acne
The following lists common serious side effects and what you should do if you experience them:
- Blood clots, persistent sad mood – stop taking the drug and seek immediate medical help
- Breast cancer, high blood pressure, unexpected vaginal bleeding – in all cases, talk with your doctor or pharmacist
- Edema – if severe, talk with your doctor or pharmacist
Please consult the patient information leaflet for information on what to do about other less frequent serious side effects.