Estrofem 2 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

estradiol anhydrous

Available from:

Novo Nordisk A/S

ATC code:

G03CA; G03CA03

INN (International Name):

estradiol anhydrous

Dosage:

2 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Natural and semisynthetic estrogens, plain; estradiol

Authorization status:

Marketed

Authorization date:

1996-05-01

Patient Information leaflet

LABELLING
VV-LAB-085801
5
.
0
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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON
1.
NAME OF THE MEDICINAL PRODUCT
Estrofem 2 mg
Film-coated tablets
estradiol
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each film-coated tablet contains: estradiol 2 mg (as estradiol
hemihydrate)
3.
LIST OF EXCIPIENTS
Excipients include lactose monohydrate. See leaflet for further
information
4.
PHARMACEUTICAL FORM AND CONTENTS
1x28 film-coated tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Store below 25
o
C
Do not refrigerate
VV-LAB-085801
5
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0
.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS,
IF APPROPRIATE
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
12.
MARKETING AUTHORISATION NUMBER(S)
PA 218/50/1
13.
BATCH NUMBER
Batch
14.
GENERAL CLASSIFICATION FOR SUPPLY
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER
– 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC
SN
NN
VV-LAB-085801
5
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0
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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
DISPENSER LABEL
1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Estrofem 2 mg
Film-coated tablets
estradiol 2 mg (as estradiol hemihydrate)
Oral use
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
28 film-coated tablets
6.
OTHER
7.
MANUFACTURER / MARKETING AUTORISATION HOLDER
Novo Nordisk A/S
PA 218/50/1
VV-LAB-085801
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0
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PACKAGE LEAFLET
VV-LAB-085801
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ESTROFEM
2 MG FILM-COATED TABLETS
estradiol hemihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE

Summary of Product characteristics

Health Products Regulatory Authority
28 February 2024
CRN00DZ82
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Estrofem 2 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains estradiol 2 mg (as estradiol
hemihydrate).
Excipient with known effect:
Each film-coated tablet contains lactose monohydrate 36.8 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Blue, film-coated, round, biconvex tablets, engraved with NOVO 280.
Diameter 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
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.
Estrofem is particularly for women who have been hysterectomised and
therefore do not require combined
oestrogen/progestagen therapy.
The experience of treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Estrofem is an oestrogen-only product for hormonal replacement.
Estrofem is administered orally, one tablet daily without
interruption.
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.
In women without a uterus, Estrofem may be started on any convenient
day. In women with a uterus who present amenorrhoea
and are being transferred from a sequential HRT, Estrofem may be
initiated on day 5 of bleeding and only in combination with
a progestagen for at least 12-14 days; if transferred from a
continuous-combined HRT, Estrofem along with a progestin, may
be started on any convenient day. The progestagen type and dose should
provide sufficient inhibition of the oestrogen
induced endometrial proliferation (see also section 4.4).
If the patient has forgotten to take a tablet, the table