Progynova 2mg

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ESTRADIOL VALERATE

Disponible depuis:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

Code ATC:

G03CA03

DCI (Dénomination commune internationale):

ESTRADIOL VALERATE 2 mg

forme pharmaceutique:

TABLET

Composition:

ESTRADIOL VALERATE 2 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2007-05-09

Notice patient

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Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROGYNOVA 2 MG TABLETS
Estradiol valerate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT PROGYNOVA IS AND WHAT IT IS USED
FOR…………………………………………1
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROGYNOVA……………………………2
MEDICAL HISTORY AND REGULAR CHECK-UPS
.....................................................................................................
2
DO NOT TAKE PROGYNOVA
................................................................................................................................
2
WARNINGS AND
PRECAUTIONS………………………………………………………………………………….3
HRT AND
CANCER…………………………………………………………………………………………….3
EFFECTS OF HRT ON HEART OR CIRCULATION……..
……………………………………………………………4 BLOOD CLOTS IN A VEIN
(THROMBOSIS)………………………………………………………………..4 HEART DISEASE (HEART
ATTACK)...…………………………………………………………………….5 STROKE………………………………………………………………………………………………5
OTHER CONDITIONS
...........................................................................................................................................
6
OTHER MEDICINES AND PROGYNOVA
........

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Progynova

2 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each memo pack contains 28 tablets each containing estradiol valerate
2.0 mg.
Excipients with known effect
Lactose monohydrate and sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White sugar coated tablet for oral administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
peri- and
postmenopausal women.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures
who are intolerant of, or contraindicated for, other medicinal
products approved for
the prevention of osteoporosis.
See also Section 4.4.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
•
POSOLOGY
Progynova is an oestrogen-only product.
One tablet of Progynova 2 mg to be taken daily. It does not matter at
what time of day
the woman takes her tablet, but once she has selected a particular
time she should
keep to it every day. Treatment is continuous, which means that the
next pack follows
immediately without a break.
For initiation and continuation of treatment of menopausal symptoms,
the lowest
effective dose for the shortest duration (see also section 4.4) should
be used.
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Treatment to control menopausal symptoms should be initiated with
Progynova 1 mg.
If
considered
necessary,
Progynova
2
mg
should
be
used.
Once
treatment
is
established the lowest effective dose necessary for relief of symptoms
should be used.
For prevention of postmenopausal osteoporosis one tablet of Progynova
2 mg is to be
taken daily.
In women with an intact uterus, a progestogen should be added to
Progynova for at
least 12 - 14 days each month/28 day cycle. Unless there is a previous
diagnosis of
endometriosis,
it
is
not
recommended
to
add
a
progestogen
in
hysterectomised
women.
•
How to start Progynova 2 mg
If the woman has an intact uterus and is still menstruating, a
com