Evalon (Estriol Tablets)

Evalon Pills (Estriol Tablets) are used to relieve moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause and treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. It is also used treat certain forms of infertility, improve wound healing in postmenopausal women undergoing vaginal surgery or help assess cervical smears taken from postmenopausal women and for prevention of osteoporosis.

1. Evalon Tablets
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Evalon Pills (Estriol Tablets) are used to relieve moderate
to severe vasomotor symptoms and moderate to severe
symptoms of vulvar and vaginal atrophy associated with
the menopause and treatment of hypoestrogenism due to
hypogonadism, castration or primary ovarian failure. It is
also used treat certain forms of infertility, improve wound
healing in postmenopausal women undergoing vaginal
surgery or help assess cervical smears taken from
postmenopausal women and for prevention of osteoporosis.

2. Evalon Tablets
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The active pharmaceutical ingredients
contained in Evalon tablets is
Estriol. Each Evalon tablet contains 1
mg of Estriol.
Active Ingredient

3. Evalon Tablets
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Chemical Structure
Estriol Structure

4. Evalon Tablets
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Menopausal Hormone Replacement Therapy:
For starting and continuation of treatment of
postmenopausal symptoms, the lowest effective
dose for the shortest possible duration should be
used. The initial dosage is 1 mg to 2 mg daily for
1 month followed by 0.5 mg to 1 mg daily. A
progestogen is required if administered to women
with a uterus.
Infertility due to cervical hostility: The normal
dose is 0.25 mg to 1 mg/day on days 6 to 15 of
the menstrual cycle. Increase the dose each
month until an optimal therapeutic effect is
obtained.
Recommended Dosage

5. Evalon Tablets
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For Treatment Of Female Hypoestrogenism
Due To Hypogonadism, Castration, Or Primary
Ovarian Failure: Treatment is usually started
with a dose of 1 mg to 2 mg daily of Estriol,
adjusted as necessary to control presenting
symptoms.
Prevention Of Osteoporosis: When prescribing
solely for the prevention of postmenopausal
osteoporosis, treatment with Estriol tablets must
be considered only for women at significant risk of
osteoporosis and for whom non-Estrogen
medicines are not considered to be appropriate.
Recommended Dosage

6. Evalon Tablets
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Contraindications
Evalon Tablets (Estriol Pills) is
contraindicated in patients with the
following conditions:
➔Hypersensitivity to Estriol or any inactive
component of this medication.
➔Undiagnosed abnormal genital bleeding.
➔Known or suspected pregnancy.
➔Known, suspected, or history of cancer of the
breast.
➔Known or suspected estrogen-dependent
neoplasia.

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Contraindications
➔Active or recent (within the past year) arterial
thromboembolic disease (for example, stroke,
myocardial infarction).
➔Liver dysfunction or disease.
➔Porphyria

8. Evalon Tablets
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Side Effects of Estriol Tablets
The most frequent possible side effects of
Evalon tablets (Estriol pills) include include
Breast discomfort and pain, Postmenopausal
spotting,Cervical discharge, Flu-like symptoms,
Nausea and Fluid retention.
Therapy should be discontinued if any of the
following situations arise: Jaundice or
deterioration in liver function, Significant
increase in blood pressure, New onset of
migraine-type headache, Pregnancy or
Endometrial hyperplasia.

9. Evalon Tablets
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Warnings And Precautions
➔HRT:Hormone Replacement Therapy (HRT) must only be started
for symptoms that adversely affect quality of life. An appraisal of the
risks and benefits must be undertaken at least each year. During
treatment with Evalon tablets, periodic check-ups are advised of a
frequency and nature adapted to the individual woman.
➔Medical History: Existing vaginal infections must be treated
before therapy with Evalon tablets is started. Patients with certain
medical conditions including, leiomyoma or endometriosis, a history of
or risk factors for thromboembolic disorders, hypertension, liver
disorders, diabetes mellitus with or without vascular involvement,
cholelithiasis, migraine or (severe) headache, systemic lupus
erythematosus, a history of endometrial hyperplasia, epilepsy, asthma
and otosclerosis, will need close supervision particularly when the
condition is active, or has occurred previously and/or was aggravated
during pregnancy or previous hormone treatment.

10. Evalon Tablets
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Warnings And Precautions
➔Cardiovascular Events: Discontinue treatment if
contraindicated, jaundice or a deterioration in liver function
occurs, there is a significant increase in blood pressure, a
new onset of migraine or pregnancy occurs.
➔Myocardial Infarctions: An increase in the number of
myocardial infarctions and strokes and Venous
thromboembolism (VTE) has been observed in women
receiving Estrogens compared to placebo.
➔Endometrial Cancer: The use of unopposed estrogens
in women with intact uteri has been associated with an
increased risk of endometrial cancer.

11. Evalon Tablets
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Warnings And Precautions
➔Cardiovascular Events: Breast Cancer: The use of
estrogens and progestins by postmenopausal women has
been reported to increase the risk of breast cancer.
➔Dementia:The use of estrogens and progestins by
postmenopausal women has been reported to increase
the absolute risk of probable dementia.
➔Gallbladder disease: A 2- to 4-fold increase in the risk of
gallbladder disease requiring surgery in postmenopausal
women receiving estrogens has been reported.
➔Hypercalcemia: Estrogen administration can lead to
severe hypercalcemia in patients with breast cancer and
bone metastases.

12. Evalon Tablets
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Overdose Symptoms
The acute toxicity of oestriol in
animals is extremely low.
Symptoms of acute Evalon tablets
overdose are nausea, vomiting and
withdrawal bleeding in females may
develop.
No specific antidote is known at
present. In case required a
symptomatic treatment should be
given.

13. Evalon Tablets
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Estriol Tablets During Pregnancy
Estriol tablets have been classified by the
US FDA as Pregnancy Category X.
Animal studies conducted have proved
that high doses of estrogens have
produced urogenital malformations in the
offspring. There are no adequate and well-
controlled studies conducted in pregnant
women.
There is no indication for Estriol tablets in
pregnancy.

14. Evalon Tablets
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Estriol Tablets (Evalon Pills)
Manufactured by Organon
Pharmaceuticals