PATIENT INFORMATION
PREMARIN® (conjugated estrogens) Vaginal Cream
Read this PATIENT INFORMATION before you start using PREMARIN Vaginal Cream
and read what you get each tim e you refill your PREMARIN Vaginal Cream prescription.
There may be new information. This information does not take the place of talking to your
healthcare provider about your menopausal symptoms and their treatment.
W h a t is th e m o s t im p o rta n t in fo rm a tio n I s h o u ld k n o w a b o u t P R EM A R IN
V a g in a l C re a m (an e s tro g e n m ix tu re )?
• Estrogens may increase the chances of getting cancer of the uterus.
• Report any unusual vaginal bleeding right away while you are using PREMARIN Vaginal
Cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus
(womb). Your healthcare provider should check any unusual vaginal bleeding to find
the cause.
• Do not use estrogens with or without progestins to prevent heart disease, heart attacks,
strokes or dementia.
Using estrogens, with or without progestins, may increase your chance of getting
heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or w ithout
progestins, may increase your chance of getting dementia, based on a study of women
age 65 years or older. You and your healthcare provider should talk regularly about
whether you still need treatment with PREMARIN Vaginal Cream.
W h a t is P R EM A R IN V a g in a l C ream ?
PREMARIN Vaginal Cream is a medicine that contains a mixture of estrogen hormones.
W h a t is P R EM A R IN V a g in a l C re a m used fo r?
P R EM A R IN V a g in a l C ream is used a fte r m e n o p a u s e to :
• T re a t m e n o p a u s a l ch a n g e s in and a ro un d th e v a g in a . You and your
healthcare provider should talk regularly about whether you still need treatment with
PREMARIN Vaginal Cream to control these problems.
• T re a t p a in fu l in te rc o u rs e ca use d by m e n o p a u s a l ch a n g e s o f th e v a g in a .
W h o s h o u ld n ot use P R E M A R IN V a g in a l C ream ?
Do not start using PREMARIN Vaginal Cream if you:
• H ave u n u s u a l v a g in a l b le e d in g .
• C u rre n tly h a ve or h ave had c e rta in ca n c e rs .
Estrogens may increase the chance of getting certain types of cancers, including cancer of
the breast or uterus. If you have or have had cancer, talk with your healthcare provider about
whether you should use PREMARIN Vaginal Cream.
• Had a s tro k e or h e a rt a tta c k .
• C u rre n tly h a ve or h ave had b lo o d c lo ts .
• C u rre n tly h a ve or h ave had liv e r p ro b le m s.
• A re a lle rg ic to P R E M A R IN V a g in a l C re a m or any o f its in g re d ie n ts .
See the list of ingredients in PREMARIN Vaginal Cream at the end of this leaflet.
• T h in k yo u m a y be p re g n a n t.
T e ll y o u r h e a lth c a re p ro v id e r:
• If you have any u nu su al v a g in a l b le e d in g . Vaginal bleeding after menopause may be
a warning sign of cancer of the uterus (womb). Your healthcare provider should check any
unusual vaginal bleeding to find the cause.
• A b o u t a ll o f y o u r m e d ic a l p ro b le m s . Your healthcare provider may need to check
you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy
(seizures), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver,
thyroid, kidneys, or have high calcium levels in your blood.
• A b o u t a ll th e m e d ic in e s you ta k e . This includes prescription and nonprescription
medicines, vitamins, and herbal supplements. Some medicines may affect how PREMARIN
Vaginal Cream works. PREMARIN Vaginal Cream may also affect how your other medicines
work.
• If you are going to have su rg e ry or w ill be on b ed re st. You may need to stop using
PREMARIN Vaginal Cream.
• If you a re b re a st fe e d in g . The hormones in PREMARIN Vaginal Cream can pass into
your milk.
H o w s h o u ld I use P R E M A R IN V a g in a l C ream ?
PREMARIN Vaginal Cream is a cream that you place in your vagina with the applicator
provided with the cream.
• Take the dose recommended by your healthcare provider and talk to him or her about
how well that dose is working for you.
• Estrogens should be used at the lowest dose possible for your treatment only as long
as needed. You and your healthcare provider should talk regularly (for example, every
3 to 6 months) about the dose you are taking and whether you still need treatment with
PREMARIN Vaginal Cream.
1. Remove cap from tube.
2. Screw nozzle end of applicator onto tube.
3.
Gently
squeeze tube from the
bottom
to force sufficient cream into the barrel to provide
the prescribed dose. Use the marked stopping points on the applicator to measure the
correct dose, as prescribed by your healthcare provider.
4. Unscrew applicator from tube.
5. Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply
into vagina and press plunger downward to its original position.
TO CLEANSE: Pull plunger to remove it from barrel. Wash with mild soap and warm water.
DO NOT BOIL OR USE HOT WATER.
W h a t a re th e p o s s ib le s id e e ffe c ts o f P R E M A R IN V a g in a l C ream ?
PREMARIN Vaginal Cream is only used in and around the vagina; however, the risks
associated with oral estrogens should be taken into account.
S id e e ffe c ts are g ro up e d by h o w s e rio u s th e y a re and h o w o fte n th e y h appen
w h e n you are tre a te d .
S e rio u s , b u t le ss c o m m o n s id e e ffe c ts in c lu d e :
• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer
• High blood pressure
• Liver problems
• High blood sugar
• Enlargement of benign tum ors of the uterus (“fibroids”)
S o m e o f th e w a rn in g s ig n s o f th e s e s e rio u s s id e e ffe c ts in c lu d e :
• Breast lumps
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vom iting
• Yellowing of the skin, eyes, or nail beds
Call your healthcare provider right away if you get any of these warning signs, or any
other unusual symptoms that concern you.
Less s e rio u s , b ut c o m m o n , s id e e ffe c ts in c lu d e :
• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vom iting
• Hair loss
• Fluid retention
• Vaginal yeast infection
• Reactions from inserting PREMARIN Vaginal Cream, such as vaginal burning, irritation,
and itching
These are not all the possible side effects of PREMARIN Vaginal Cream. For more
information, ask your healthcare provider or pharmacist.
W ha t can I do to lo w e r m y chances o f getting a se rio u s sid e effect w ith
PREM ARIN V a g in a l C ream ?
• Talk with your healthcare provider regularly about whether you should continue using
PREMARIN Vaginal Cream.
• If you have a uterus, talk with your healthcare provider about whether the addition of a progestin
is right for you. The addition of a progestin is generally recommended for a woman with a
uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right
away if you get vaginal bleeding while using PREMARIN Vaginal Cream.
• Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless
your healthcare provider tells you something else. If members of your fam ily have had
breast cancer or if you have ever had breast lumps or an abnormal mammogram, you
may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are
overweight, or if you use tobacco, you may have higher chances for getting heart disease.
Ask your healthcare provider for ways to lower your chances for getting heart disease.
G eneral inform a tio n about the safe and effective use of PREMARIN V aginal Cream
Medicines are sometimes prescribed for conditions that are not mentioned in patient
information leaflets. Do not use PREMARIN Vaginal Cream for conditions for which it was
not prescribed. Do not give PREMARIN Vaginal Cream to other people, even if they have the
same symptoms you have. It may harm them. Keep PR EM AR IN V a g in a l C ream o ut o f
th e re a ch o f c h ild re n .
Latex or rubber condoms, diaphragms and cervical caps may be weakened and fail when
they come into contact with PREMARIN Vaginal Cream.
This leaflet provides a summary of the most important information about PREMARIN Vaginal
Cream. If you would like more information, talk with your healthcare provider or pharmacist.
You can ask for information about PREMARIN Vaginal Cream that is written for health
professionals. You can get more information by calling the toll free number 1-800-934-5556.
W h a t a re th e in g re d ie n ts in P R E M A R IN V a g in a l C ream ?
PREMARIN Vaginal Cream contains a mixture of conjugated estrogens, which are a mixture
of sodium estrone sulfate and sodium equilin sulfate and other components, including
sodium sulfate conjugates: 17 a-dihydroequilin, 17 a-estradiol, and
17 p-dihydroequilin. PREMARIN Vaginal Cream also contains cetyl esters wax, cetyl
alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate,
benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil.
PREMARIN (conjugated estrogens) Vaginal Cream— Each gram contains 0.625 mg
conjugated estrogens, USP.
Combination package:
Each contains a net wt. 1.5 oz (42.5 g) tube with one plastic applicator
calibrated in 0.5 g increments to a maximum of 2 g (NDC 0046-0872-93).
S to re at 2 0 ° to 25°C (6 8 ° to 7 7°F ); e x cu rs io n s p e rm itte d to 1 5 ° to 30°C (5 9 ° to
8 6°F ) [se e USP C o n tro lle d R oom T e m p e ra tu re ].
This product’s label may have been updated. For current package insert and further
product information, please visit www.wyeth.com or call our medical comm unications
department toll-free at 1-800-934-5556.
W yeth'
© 2009, Wyeth Pharmaceuticals Inc.,
Philadelphia, PA 19101
W 10413C015
ET01
Rev 11/08
252407-01
