FEMOSTON 110 TABLET

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dydrogesterone, micronized (in grey tablet); ESTRADIOL HEMIHYDRATE 1.03 mg EQV ESTRADIOL (Micronised) (in Grey Tablet); ESTRADIOL HEMIHYDRATE 1.03 mg EQV ESTRADIOL (Micronised) (in White Tablet)

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC code:

G03FA14

Dosage:

10 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Dydrogesterone, micronized (in grey tablet) 10 mg; ESTRADIOL HEMIHYDRATE 1.03 mg EQV ESTRADIOL (Micronised) (in Grey Tablet) 1 mg; ESTRADIOL HEMIHYDRATE 1.03 mg EQV ESTRADIOL (Micronised) (in White Tablet) 1 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

ABBOTT BIOLOGICALS B.V.

Authorization status:

ACTIVE

Authorization date:

2002-04-24

Patient Information leaflet

CCDS Issued 15 Jan 2013 
Updated 21 Oct 2013 
1
_FEMOSTON_
_®_
 _FILM-COATED TABLETS_

1. 
 NAME OF THE MEDICINAL PRODUCT 

Femoston Conti 1/5 film-coated tablets 
Femoston 1/10 film-coated tablets 
Femoston 2/10 film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Femoston Conti 1/5 Tablet 
28 tablets, each containing 1 mg 17ß-estradiol
(as hemihydrate) and 5 mg dydrogesterone. 

Femoston 1/10 Tablet 
14 tablets, each containing 1 mg 17ß-estradiol (as hemihydrate) and 14 tablets, each containing 1 mg 17ß-
estradiol (as hemihydrate) and 10 mg dydrogesterone. 

Femoston 2/10 Tablet 
14 tablets, each containing 2 mg 17ß-estradiol (as hemihydrate) and 14 tablets, each containing 2 mg 17ß-
estradiol (as hemihydrate) and 10 mg dydrogesterone. 

Excipient with known effect: lactose monohydrate 
For the full list of excipients, see section 6.1 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet 
Round, biconvex tablets marked 379 on one side. 

Femoston Conti 1/5 
Salmon-coloured 1/5 mg tablets. 

Femoston 1/10 
White 1 mg tablets and grey 1/10 mg tablets. 

Femoston 2/10 
Brick red 2 mg tablets and yellow 2/10 mg tablets. 

4. 
CLINICAL PARTICULARS 

4.1  
THERAPEUTIC INDICATIONS 

For continuous combined HRT regimen: Femoston Conti 1 /5 
Hormone Replacement Therapy (HRT) for oestrogen
deficiency symptoms in postmenopausal women with 
a uterus, at least 12 months since last menses. 

Prevention of osteoporosis in postmenopausal women with a
uterus, at high risk of future fractures who are 
intolerant of, or contraindicated for,
other medicinal products approved for the
prevention of osteoporosis. 

CCDS Issued 15 Jan 2013 
Updated 21 Oct 2013 
2

For continuous sequential HRT regimen: Femoston 1/10  
Hormone Replacement
Therapy (HRT) for oestrogen defici

Summary of Product characteristics

1
_FEMOSTON_
_® _
_FILM-COATED TABLETS _
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Femoston
_®_
_ _
Conti 1/5 film-coated tablets
Femoston
_®_
_ _
1/10 film-coated tablets
Femoston
_®_
_ _
2/10 film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femoston
_®_
_ _
Conti 1/5 Tablet
28 tablets, each containing 1 mg 17ß-estradiol (as hemihydrate) and 5
mg dydrogesterone.
Femoston
_®_
_ _
1/10 Tablet
14 tablets, each containing 1 mg 17ß-estradiol (as hemihydrate) and
14 tablets, each containing 1 mg 17ß-
estradiol (as hemihydrate) and 10 mg dydrogesterone.
Femoston
_®_
_ _
2/10 Tablet
14 tablets, each containing 2 mg 17ß-estradiol (as hemihydrate) and
14 tablets, each containing 2 mg 17ß-
estradiol (as hemihydrate) and 10 mg dydrogesterone.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex tablets marked 379 on one side.
Femoston
_®_
_ _
Conti 1/5
Salmon-coloured 1/5 mg tablets.
Femoston
_®_
_ _
1/10
White 1 mg tablets and grey 1/10 mg tablets.
Femoston
_®_
_ _
2/10
Brick red 2 mg tablets and yellow 2/10 mg tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For continuous combined HRT regimen: Femoston
_®_
_ _
Conti 1 /5
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women with
a uterus, at least 12 months since last menses.
Prevention of osteoporosis in postmenopausal women with a uterus, at
high risk of future fractures who are
intolerant of, or contraindicated for, other medicinal products
approved for the prevention of osteoporosis.
2
For continuous sequential HRT regimen: Femoston
_®_
_ _
1/10
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women at
least 6 months since last menses.
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.
For continuous sequen