IMPORTANT SAFETY INFORMATION

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 menopausal hormone therapy (MHT) with your doctor. You should regularly talk with your doctor about whether you still need treatment with MHT.

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.
• 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 doctor 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
• 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:

In postmenopausal women taking estrogen with progestin, there is an increased risk of:

• Heart attack
• Stroke (bleeding or blood clot in the brain) 
• Breast cancer
• Pulmonary emboli (blood clots in the lungs), and
• Deep vein thrombosis (blood clots in the deep veins of the leg or arm) 

In postmenopausal women taking estrogen-alone who had prior surgery to remove the uterus (called a hysterectomy), there is an increased risk of: 

• Stroke (bleeding or blood clot in the brain)
• Deep vein thrombosis (blood clots in the deep veins of the leg or arm)

Therefore, you should highly consider the following:

• 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: 

• Breast cancer 
• Overgrowth of the lining of the uterus and cancer of the uterus
• Ovarian cancer
• Heart disease and stroke 
• Abnormal blood clotting
• Gallbladder disease 
• Dementia 

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.