Progynova Tablets (Estradiol Valerate) is used as Hormone replacement therapy (HRT) for the treatment of signs and symptoms of oestrogen deficiency due to the menopause or after surgical removal of the ovaries.

1. Progynova Tablets
Progynova Tablets is used as Hormone
replacement therapy (HRT) for the treatment
of signs and symptoms of oestrogen
deficiency due to the menopause.
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2. Progynova Tablets
Chemical Structure
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3. Progynova Tablets
Active Ingredient
The active pharmaceutical
ingredient contained in Progynova
Tablets is Estradiol Valerate
(Oestradiol Valerate) .
Each 1 mg Progynova tablet for
oral administration contains 1 mg of
Estradiol Valerate.
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4. Progynova Tablets
Indications
Progynova Tablets is used to treat short
term treatment of climacteric complaints
after the cessation of monthly bleeding, or
deficiency symptoms after oophorectomy
or radiological castration for non-carcinomatous
diseases, such as hot
flushes, outbreaks of sweat, sleep
disturbances, depressive moods,
irritability, headaches, dizziness.
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5. Progynova Tablets
Indications
Progynova also has a favourable
influence on bladder irritation, signs of
cutaneous and mucosal involution which
normally occur with advancing age.
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6. Progynova Tablets
Recommended Adult Dosage
Hysterectomised patients may start at any
time.
If the patient is still menstruating and has an
intact uterus, a combination regimen of
Progynova and a progestogen should begin
within the first 5 days of menstruation.
Patients whose periods are very infrequent or
with amenorrhoea or who are postmenopausal
may start at any time, provided pregnancy has
been excluded.
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7. Progynova Tablets
Recommended Adult Dosage
The tablet should be taken at the same time
of day every day.
One tablet is taken daily. The tablets are to
be swallowed whole with some liquid.
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8. Progynova Tablets
Missed Dose
In case of a missed dose, take the tablet
as soon as you remember, within the
following 12 to 24 hours.
If the treatment is discontinued for longer,
irregular bleeding may occur.
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9. Progynova Tablets
Contraindications
Progynova Tablets is contraindicated in
women with the following conditions:
➔Hypersensitivity to Estradiol Valerate
(Oestradiol Valerate) or any inactive
component of this medication.
➔Pregnancy or lactation
➔Undiagnosed vaginal bleeding
➔Acute arterial thromboembolism
(myocardial infarction, stroke) or a recent
history of these conditions
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10. Progynova Tablets
Contraindications
➔Known or suspected cancer of the breast
➔Known or suspected premalignant
conditions or malignancies, if sex steroid
influenced
➔Presence or history of liver tumours
(benign or malignant)
➔Severe hepatic disease
➔Active deep venous thrombosis,
thromboembolic disorders, thrombophlebitis,
or a documented history of these conditions
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11. Progynova Tablets
Contraindications
➔Severe hypertriglyceridamia
➔Hereditary or acquired predisposition to
venous thrombosis
➔A high risk of venous or arterial thrombosis
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12. Progynova Tablets
Side Effects of Progynova Tablets
The common side effects of Progynova
Tablets are Weight increase or Weight
decrease, Headache, Abdominal pain,
Nausea, Rash, Pruritus, Uterine/ Vaginal
bleeding including spotting.
Uncommon side effects of Progynova
Tablets include Hypersensitivity reaction,
Depressed mood, Dizziness, Visual
disturbances, Palpitations, Dyspepsia,
Erythema nodosum, Urticaria, Breast pain,
Breast tenderness and Oedema
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13. Progynova Tablets
Side Effects of Progynova Tablets
Rarely occuring side effects of Progynova
Tablets are Anxiety, Libido decreased or
Libido increased, Migraine, Contact lens
intolerance, Bloating, Vomiting, Hirsutism,
Acne, Muscle cramps, Dysmenorrhoea,
Vaginal discharge, Premenstrual-like
syndrome, Breast enlargement, and Fatigue
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14. Progynova Tablets
Warnings And Precautions
➔Progynova Tablets cannot be used as a
contraceptive.
➔Therapy with Progynova should be discontinued
immediately in case a contraindication is discovered,
as well as in the following situations:
➔Migrainous or frequent and unusually severe
headaches that occur for the first time or other
symptoms that are possible prodroma of
cerebrovascular occlusion.
➔Recurrence of cholestatic jaundice or cholestatic
pruritus which occurred first during pregnancy or
previous use of sex steroids.
➔Symptoms of a thrombotic event or suspicion
thereof.
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15. Progynova Tablets
Warnings And Precautions
➔Some women are predisposed to gallbladder disease
during oestrogen therapy.
➔Hormonal treatment may increase the risk of
probable dementia if initiated in women aged 65 or
older.
➔Suspected prolactinoma should be ruled out before
starting Progynova treatment.
➔Prolonged monotherapy with oestrogens increases
the risk of endometrial hyperplasia and carcinoma in
postmenopausal women.
➔Chloasma may occur occasionally, especially in
women with a history of chloasma gravidarum.
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16. Progynova Tablets
Warnings And Precautions
➔An increased risk of ovarian cancer in
menopausal women taking oestrogen only
replacement therapy was observed in a large
US study Clinical and observational studies
have reported an increased risk of having
breast cancer diagnosed in women who have
used HRT for several years.
➔In rare cases benign, and even more rarely,
malignant liver tumours have been observed
after the use of hormonal substances such as
those contained in HRT products.
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17. Progynova Tablets
Storage Instructions
Keep Progynova Tablets in a cool, dry
place where the temperature stays below
25° C. Do not store Progynova Tablets, or
any other medicine, in a bathroom or near
a sink. Keep away from children and pets.
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18. Progynova Tablets
Overdose Treatment
Even in the case of inadvertent intake of a
multiple of the recommended dose, no
acute toxicity risk is to be expected.
Overdose may cause nausea and vomiting
and irregular bleeding may occur in some
women.
There are no antidotes and treatment
should be symptomatic.
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19. Progynova Tablets
Progynova Tablets manufactured by Schering AG
Berlin. (Manufactured in India in collaboration with
Zydus Healthcare)
For more information click here
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