ESTRING VAGINAL RING 2 mgring

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

ESTRADIOL

Fáanlegur frá:

PFIZER PRIVATE LIMITED

ATC númer:

G03CA03

Skammtar:

2 mg/ring

Lyfjaform:

INTRAUTERINE DEVICE

Samsetning:

ESTRADIOL 2 mg/ring

Stjórnsýsluleið:

INTRAUTERINE

Gerð lyfseðils:

Prescription Only

Framleitt af:

Q-PHARMA AB

Leyfisstaða:

ACTIVE

Leyfisdagur:

1999-09-11

Upplýsingar fylgiseðill

1
PATIENT INFORMATION
ESTRING
(ESTRADIOL VAGINAL RING)
Read this Patient Information before you start using ESTRING and each
time you get a refill.
There may be new information. This information does not take the place
of talking to your
healthcare provider about your menopausal symptoms or your treatment.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ESTRING (AN
ESTROGEN
HORMONE)?

Using estrogen-alone may increase your chance of getting cancer of the
uterus (womb).
Report any unusual vaginal bleeding right away while you are using
ESTRING.
Vaginal bleeding after menopause may be a warning sign of cancer of
the uterine
(womb). Your healthcare provider should check any unusual vaginal
bleeding to find
out the cause.

Do not use estrogen-alone to prevent heart disease, heart attacks,
strokes, or dementia
(decline in brain function).

Using estrogen-alone may increase your chances of getting strokes or
blood clots.

Using estrogen-alone may increase your chance of getting dementia,
based on a study
of women 65 years of age or older.

Do not use estrogens with progestins to prevent heart disease, heart
attacks, strokes, or
dementia.

Using estrogens with progestins may increase your chance of getting
heart attacks,
strokes, breast cancer, or blood clots.

Using estrogens with progestins may increase your chance of getting
dementia, based
on a study of women 65 years of age or older.

You and your healthcare provider should talk regularly about whether
you still need
treatment with ESTRING.
WHAT IS ESTRING?
ESTRING (estradiol vaginal ring) is an off-white, soft, flexible ring
with a center that contains 2
mg of estradiol (an estrogen hormone). ESTRING releases estradiol into
the vagina in a
consistent, stable manner for 90 days. The soft, flexible ring is
placed in the upper third of the
vagina (by the physician or the patient). ESTRING should be removed
after 90 days of
continuous use. If continuation of therapy is indicated, the flexible
ring should be replaced.
WHAT IS ESTRING

Vara einkenni

ESTRING
®
(ESTRADIOL VAGINAL RING)
PHYSICIAN’S LEAFLET
WARNINGS: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER AND PROBABLE DEMENTIA
ESTROGEN-ALONE THERAPY
ENDOMETRIAL CANCER
There is an increased risk of endometrial cancer in a woman with a
uterus who uses unopposed
estrogens. Adding a progestin to estrogen therapy has been shown to
reduce the risk of endometrial
hyperplasia, which may be a precursor to endometrial cancer. Adequate
diagnostic measures, including
directed and random endometrial sampling when indicated, should be
undertaken to rule out malignancy
in all cases of undiagnosed persistent or recurring abnormal genital
bleeding. (See WARNINGS,
MALIGNANT NEOPLASMS, ENDOMETRIAL CANCER.)
CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA
Estrogen-alone therapy should not be used for the prevention of
cardiovascular disease or dementia. (See
CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS, and PROBABLE
DEMENTIA.)
The Women’s Health Initiative (WHI) estrogen-alone substudy reported
increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of
age) during 7.1 years of
treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone,
relative to placebo. (See
CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS.)
The WHI Memory Study (WHIMS)estrogen-alone ancillary study of the WHI
reported an increased risk
of developing probable dementia in postmenopausal women 65 years of
age or older during 5.2 years of
treatment with daily CE (0.625 mg)-alone, relative to placebo. It is
unknown whether this finding applies
to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS,
PROBABLE
DEMENTIA and PRECAUTIONS, GERIATRIC USE.)
In the absence of comparable data, these risks should be assumed to be
similar for other doses of CE and
other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the
lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the
individual wo