Femoston conti film-coated Tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

dydrogesterone 5 mg, estradiol 1 mg

Inapatikana kutoka:

Abbott Healthcare Products Limited

ATC kanuni:

G03FA14

INN (Jina la Kimataifa):

dydrogesterone, estradiol

Dawa fomu:

film-coated tablet

Idhini hali ya:

Authorised

Idhini ya tarehe:

2008-04-07

Taarifa za kipeperushi

Abbott Olst
Femoston-conti 1mg/ 5mg film-coated tablets
 X
United Kingdom
MKPR-00677-2012
MKP-01830-2012 

Leaflet
158x460mm 
(folded 158x230mm)

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                 30/08/2012            
X
                 29/11/2012
Edwin Branderhorst                           Edwin
Branderhorst
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PACKAGE LEAFLET: INFORMATION FOR THE 
USER
FEMOSTON-CONTI 1MG/5MG FILM-COATED TABLETS
Active substances: estradiol/dydrogesterone
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

Tabia za bidhaa

 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Femoston® 1/10 mg Film-coated Tablets 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 1 mg oestradiol (as hemihydrate) or a
combination of 1 mg 
oestradiol (as hemihydrate) and 10 mg dydrogesterone. 

For a full list of excipients see 6.1 

3. PHARMACEUTICAL FORM 

Film-coated tablets. 

Oestradiol only tablets: Round, biconvex, white film-coated tablets
with inscription 
'379'. 

Oestradiol/dydrogesterone combination tablets: Round, biconvex, grey
film-coated 
tablets with inscription '379'. 

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) 

The experience in treating women older than 65 years is limited. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Femoston 1/10 and Femoston 2/10, are continuous sequential hormone
replacement 
therapies.  

For initiation and continuation of treatment of postmenopausal
symptoms, the lowest 
effective dose for the shortest duration (see also section 4.4)
should be used. 

In general, treatment should start with Femoston 1/10. Depending on
the clinical 
response, the dosage can afterwards be adjusted to individual need.
If the complaints 

linked to oestrogen deficiency are not ameliorated the dosage can be
increased by 
using Femoston 2/10 

Starting Femoston 
In women who are not taking hormone replacement therapy and who are 
amenorrhoeic, or women who switch from a continuous combined
hormone 
replacement therapy, treatment may be started on any convenient day.
In women 
transferring from a cyclic or continuous sequential HRT regimen,
treatment sho