PREMARIN

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

conjugated estrogens, Quantity: 0.3 mg

Tilgjengelig fra:

Pfizer Australia Pty Ltd

INN (International Name):

conjugated estrogens

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: sucrose; hyprolose; macrogol 400; Carnauba Wax; hypromellose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; calcium phosphate; powdered cellulose; titanium dioxide; propylene glycol; purified water; isopropyl alcohol; polysorbate 80; quinoline yellow aluminium lake; indigo carmine aluminium lake

Administreringsrute:

Oral

Enheter i pakken:

1 x 28 tablets, 3 x 28 tablets, 4 x 28 tablets, 2 x 28 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Oestrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. 1. PREMARIN is indicated as replacement therapy for oestrogen deficiency states associated with climacteric manifested by: a) Moderate to severe vasomotor symptoms associated with oestrogen deficiency in natural and surgical menopause (sweating, hot flushes). Periodic re-evaluation with a view to short term treatment is recommended. b) Atrophic vaginitis. When prescribing solely for the treatment of symptoms of vaginal atrophy, topical vaginal products should be considered. There is no evidence that oestrogens are effective for anxiety or depression without associated vasomotor symptoms, and they should not be used to treat such conditions. 2. PREMARIN is indicated for the prevention of postmenopausal osteoporosis in select patients. When prescribed solely for the prevention of postmenopausal osteoporosis, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. Life style modifications and the risk benefit profile of PREMARIN should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. (See PRECAUTIONS and DOSAGE AND ADMINISTRATION). 3. Hypoestrogenic states e.g. female hypogonadism, primary ovarian failure or female castration. See BOXED WARNING, particularly when considering PREMARIN for long-term usage.

Produkt oppsummering:

Visual Identification: Green, oval, biconvex, coated tablets, marked "0.3" in white.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2012-05-28

Informasjon til brukeren

PREMARIN
®
_Conjugated estrogens Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
PREMARIN Tablets. It does not
contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist. All medicines have risks
and benefits. Your doctor has
weighed the risks of you taking
PREMARIN against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PREMARIN IS
USED FOR
PREMARIN is a type of treatment
called hormone replacement therapy
(HRT) and contains the hormone
estrogen in the form known as
conjugated estrogens.
PREMARIN helps to relieve the
discomfort many women feel during
and after menopause, including
symptoms such as "hot flushes",
sweating and vaginal dryness. It
helps to prevent thinning of the bones
(osteoporosis), which can cause
fractures.
PREMARIN is also used to treat
women where either the ovary does
not function properly or has been
removed.
If your doctor thinks you will need to
take estrogens for a long time,
including for the prevention of
osteoporosis, he or she will have
considered the benefits and risks of
other treatments before prescribing
PREMARIN for you.
_HOW IT WORKS_
Menopause occurs naturally in
women, typically between the ages of
45 and 55. During menopause, your
body produces less estrogen than it
did beforehand. This can cause
symptoms such as "hot flushes".
Some women also have problems
with dryness of the vagina causing
discomfort during or after sexual
intercourse. Some women develop
osteoporosis during or after
menopause. This is a thinning of the
bones making them weaker and more
likely to break, especially the bones
of the spine, hip and wrist.
Conjugated estrogens are like the
hormones produced by the ovaries
before menopause. When given
during or after menopause, they can
help control the symptoms.
Estrogen is used treat w

Preparatomtale

Version: pfppremt10220
Supersedes: pfppremt10417
Page 1 of 21
AUSTRALIAN
PRODUCT
INFORMATION
–
PREMARIN
® (CONJUGATED ESTROGENS)
WARNING
ENDOMETRIAL CANCER
Adequate diagnostic measures, including endometrial sampling when
indicated, should be
undertaken to rule out malignancy in all cases of undiagnosed
persistent or recurring abnormal
vaginal bleeding (see Section 4.4 Special warnings and precautions for
use, Malignant
neoplasms, Endometrial cancer).
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestogens should not be used for the
prevention of cardiovascular
disease or dementia (see Sections 5.1 Pharmacodynamic properties,
Clinical trials and 4.4
Special warnings and precautions for use,
Cardiovascular risk
and Dementia
).
The estrogen-alone substudy of the Women’s Health Initiative (WHI)
study reported increased
risks of stroke and deep vein thrombosis in postmenopausal women (50
to 79 years of age)
during 7.1 years of treatment with conjugated estrogens (CE 0.625 mg)
relative to placebo (see
Sections 5.1 Pharmacodynamic properties, Clinical trials and 4.4
Special warnings and
precautions for use, Cardiovascular risk).
The estrogen plus progestogen substudy of the WHI reported increased
risks of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli and deep
vein thrombosis in
postmenopausal women (50 to 79 years of age) during 5.6 years of
treatment with conjugated
estrogens combined with medroxyprogesterone acetate (CE 0.625 mg/MPA
2.5 mg) relative to
placebo (see Sections 5.1 Pharmacodynamic properties, Clinical trials
and 4.4 Special warnings
and precautions for use, Cardiovascular risk and Malignant neoplasms,
Breast cancer).
The Women’s Health Initiative Memory Study (WHIMS), a substudy of
WHI, reported
increased risk of developing probable dementia in postmenopausal women
65 years of age or
older during 5.2 years of treatment with CE alone and during 4 years
of treatment with
CE/MPA relative to placebo. It is unknown whether this finding applies
to younger
postmeno