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Angeliq 28 Tablets 1 Mg/2 Mg ingredients estradiol - drospirenone
Each film-coated tablet contains 1 mg of estradiol, 2 mg of drospirenone as well
as titanium dioxide (E171) and iron III oxide as adjuvant (E172).
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Film Coated Tablet
Effects of estradiol:
Angeliqidentical to endogenous human estradiol from chemical and biological aspects
contains 17 β-estradiol synthesized. 17 β-estradiol in women with menopauseestrogen
compensates for the loss ofproduction and relieves menopausal symptoms. Estrogensmenopause
prevent bone loss following removal ofor ovaries.
Effects of Drospirenone:
Drospirenone is a synthetic progestagene. Estrogensdevelopment of endometrium
promote the, while estrogens not combined with progestagen in the cycle
increase the risk of endometrial hyperplasia and cancer. Progestagen supplementationhad a hysterectomy
reduces the risk of estrogen-induced endometrial hyperplasia in women who have not,does
butnot completely eliminate them.
Drospirenone shows aldosterone antagonist activity. Thereforesodium and water
, increase inexcretion, decrease in potassium excretion.
Drospirenoneestrogenic, glucocorticoid or antiglucocorticoidanimal studies
did not showeffect in.
Clinical Trial Information:
• Improvement of estrogen deficiency symptoms and bleeding pattern The
relieving of menopausal symptoms occurred in the first few weeks of treatment.
Amenorrhea treatment 10-12. in 73% of women.women in the
Fracture bleeding and / or spotting infirst three months of treatment 59, 10-12.months
• Prevention of osteoporosis
Estrogen deficiency in menopause is associated with increased bone turnover and reduced bone mass
. The effect of estrogen on bone mineral density is dose dependent. Theosteoporosis
prevention ofcontinues as long as the treatment is continued.hormone replacement therapy
Loss of bone mass after discontinuation of(HRT) occurs at a similar rate as untreated women
The meta-analysis of the WHI study and other studies showed that the use of HRTpredominantly in healthy
alone or in combination with progestagenwomenhip, vertebra and other
reduces the risk ofosteoporotic fractures. HRTlow bone density
can also prevent fractures in women withand / or established osteoporosis, but
there is limited evidence for this.
Oral drospirenone is rapidly and almost completely absorbed. Thedrug
maximum serum levels of the, 21.9 ng / mlapproximately 1single dose of Angeliq
, are reachedhour after a. After repeated administration, the maximum steady state
concentration of 35.9 ng / ml is reached after about 10 days. The absolute
bioavailability is between 76-85%. Open or full belly ingestionbioavailability
does not affect.
After oral administration, serum drospirenone levelsabout 35-39 hours
are reduced in two phases, characterized by an average terminal half-life of. Drospirenone
binds to serum albumin. It does not bind to SHBG (sex hormone binding globulin) or CBG
(corticoid binding globulin).total serum drug concentrations
Only 3-5% ofare available as free steroids. The distribution volumeis
of drospirenoneabout 3.7-4.2 l / kg.
The main metabolites in plasma are in acid form of drospirenone and are pharmacologically
The clearance rate of drospirenone from the serum is approximately 1.2-1.5 ml / min / kg. Drospirenone
is discarded only in very small amounts unchanged. Ithalf-half-
is excreted in the faeces and urine with alifelife of 1.2-1.4.
Oral estradiol is rapidly and almost completely absorbed.
During absorption and the first liver passage, estradiolintense metabolism
undergoes,absolute bioavailability of estrogen todose after oral administration
causingfall to about 5% of the. Maximumapproximately 22 pg / ml are
concentrations of6-8 hours after single-dose oral administration of Angeliq
reached. Open or full stomach ingestion does not affect the bioavailability of estradiol.
After oral administration of Angeliq, serum levels of estradiol24 hours of
only changed relatively withinadministration.
Estradiol is non-specifically bound to serum albumin and specifically to SHBG.
Only about 1 to 2% of circulating estradiol is found as free steroids, 40% to% being
Estradiol is rapidly metabolised, as well as estrone and estrone sulphate, as well as numerous other
metabolites and conjugates.
The metabolic clearance was about 30 ml / min / kg. The metabolites of estradiol are excreted by
urine and bile through a half-life of about 1 day.
After oral administration of Angeliq, steady state estradiol
concentrations are reached in about 5 days.
ofrelated to estrogen deficiency in women with menopause for more than 1 year
Hormone replacement for the treatmentsymptoms.
Prevention of postmenopausal osteoporosis (see Precautions).
Experience in women over the age of 65 is limited.
• Undiagnosed genital bleeding
• Known breast cancer, story or suspected
• malignant tumors known or suspected estrogen-dependent (eg. Endometrial
• Untreated endometrial hyperplasia
• Active venous thrombosis or history (deep vein thrombosis, pulmonary embolism)
• active or recent arterial thromboembolic disease (eg. angina, myocardial infarction)
• acute liver disease or liver function testsnot yetto normal
hadreturnedliver disease history
• severe renal insufficiency or acute renal failure
• known hypersensitivity to any of the active or excipient
Warnings For the
treatment of postmenopausal symptoms, hormone replacementonlylife
should be initiatedfor symptoms that negatively affect the quality of. The risk-to-benefitfor all cases
ratioshould be considered at least on an annual basis, and hormone
replacement should only be continued as long as the benefits prevail over risks.
starting or resuming hormone replacement therapy
A complete anamnesis should be obtained before. Physical examination (including gynecologic and breastmeme
)with the patient's history”Contraindications“ and ezi Warnings / Precautionssections
should be performedtaking into consideration the. Itaccording to the frequencyadapted for each patient
is recommended that periodic examinations should be madeand content. Patientstheir breasts
should betodoctor or nurse about the changes in
advisedinform the. Inspections, including mammography,standard
must comply with theguidelines and be personalized for each patient.
If any of the following conditions are present, if they have been seen before,
and / or are aggravated during pregnancy or prior hormone therapy, patients
should be closely monitored. It should be noted that the following conditions maytreatment with Angeliq
recur or worsen during:
• Leiomyoma (uterine fibroids) or endometriosis
• A history of thromboembolic event or risk factors (see below)
• Risk factors for estrogene-dependent tumors, eg. 1st degreebreast cancer
• Liver diseases (eg liver adenoma)disease
• Diabetes mellitus with or without vascular
• Migraine or (severe) headache
• Systemic lupus erythematosus
• History of endometrial hyperplasia (see below)
situations that require immediate cessation of therapy:
Treatment when a contraindication recognized and should be stopped when:
• worsening of jaundice or liver function
• significant increase in blood pressure,
• the occurrence of migraine headaches
endometrial hyperplasia and cancer whenOestrogens long administered alone
increases the risk (see Side effects / Advers effects).a progestagen by at leastper cycle
Addition of12 daysgreatlythis risk in women who have not had a hysterectomy
Breaking bleeding and spotting may occur in the first months of treatment. If fracture
bleeding or spottinga period of treatment, or if the treatment
occurs afterpersists after discontinuation, the cause should be investigated. This studyendometrial
may also include endometrial biopsy to excludemalignancy.
A randomized placebo-controlled trial, the Women's Health Initiative (WHI)
study and Million Women Study (MWS) epidemiological including the
studies,research,estrogen, estrogen-progestogen combinations or tibolonea years
breast cancerfewof use have reported an increased risk of (bkz.y the
effects / The risk for all HRT is marked by a few years of use and
increases with continued use, butafter discontinuation of treatment
returns to its original state within a few (five) years.
In MWSrelativebreast cancer with conjugated mare estrogens or estradiol (E2)
, therisk ofa sequential or continuous progestagen wasregardless of the progestagen type
was found to be greater whenadded,. There were no differences inroutes of administration
risk between different.
In the WHI studycontinuous combined conjugated mare estrogene and medroxyprogesterone
, breast cancer sizes were slightly larger and local lymph nodeplacebo withacetate
metastases were found more frequent than.
Hormone replacement therapy, especially estrogen-progestagen combination, may
increase the density of mammographic images andradiologicalbreast cancer
adversely affect thefindings of.
HRTdeveloping venous thromboembolism (VTE: deep vein thrombosis or pulmonary embolism)
may present a higher relative risk of. In a randomized controlled
trial and epidemiological studies, theHRT users than those who did not
risk was found to be two to three times higher in.
The incidence of VTE in a 5-year period for those who did not use HRTages of 50-59
was 3 for 1000 women between theand 8 for 1000 women between the ages of 60-69.
The number of additional VTE cases in healthy women with 5 years of HRT use is
between 2 and 6 (closest estimate = 4) for 1000 women aged 50-59, and60-69 years of age
between 5 and 15 (closest estimate = 9) between. Thethis eventHRT use
likelihood ofin the first year ofis higher than after.
Generally defined risk factors for VTE are personal history or family history,
obesity (body mass index> 30kg / m2) and systemic lupus erythematosus.VTE
no common opinion about the possible role of varicose veins in the development of
Patients with a history of VTE or known thrombophilic statusa high risk for VTE
carry. HRT can increase this risk. The history of personal and family thromboembolic events or
recurrent spontaneous abortionswellto rule out a thrombophilic predisposition
should bequestioned.detailed thrombophilic factor research issuch patients
HRT shouldcontraindicated unlessperformed or anticoagulant therapy is initiated in
be considered as. TheHRTin women who have been started on anticoagulant therapy
benefit-risk ratio ofshould be carefully evaluated.
The risk of VTEwith prolonged immobilization, major trauma, or major surgical intervention
may temporarily increase. As with all postoperative patients, theVTEafter surgery should be
prevention ofdevelopmentavoided. Especially inabdominal or lower
prolonged immobilization after orthopedic operations involvingextremities,
cases ofinterrupt HRT 4 to 6 weeks prior to elective surgery
care should be taken to. The treatment should notresumed until the patient is fully mobilize
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