Femoston 1/10 film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DYDROGESTERONE; ESTRADIOL

Available from:

Mylan Products Limited

ATC code:

G03FB08

INN (International Name):

DYDROGESTERONE; ESTRADIOL

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DYDROGESTERONE 10 mg; ESTRADIOL 1 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Active
substances:
oestradiol
hemihydrate
and
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 or nurse.
- 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 or nurse. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1.
What Femoston is and what it is used for
2.
What you need to know before you take Femoston
3.
How to take Femoston
4.
Possible side effects
5.
How to store Femoston
6.
Contents of the pack and other information
1. WHAT FEMOSTON IS AND WHAT IT IS USED
FOR
Femoston
is
a
Hormone
Replacement
Therapy
(HRT). It contains two types of female hormones,
an oestrogen and a progestogen. HRT is used in
woman who require oestrogen replacement and who
have not had their womb removed (hysterectomy).
Femoston is used in postmenopausal women at least
6 months since last menses.
Femoston is used for:
Relief of symptoms occurring after menopause
During
the
menopause,
the
amount
of
oestrogen
produced by a woman’s body drops. This can cause
symptoms such as hot face, neck and chest (“hot
flushes”). Femoston alleviates these symptoms after
menopause. You will only be prescribed Femoston if
your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile
bones (osteoporosis). You should discuss all available
options with your doctor. If you are at an increased risk
of fractures due to osteoporosis and other medicines
are not suitable for you, you can use Femoston to
prevent osteoporosis after menopause.
2. BEFORE YOU TAKE FEMOSTON
Medical history and regular check-ups
The use of HRT carries risks which ne

Summary of Product characteristics

Page 1 of 18
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.
Excipient with known effect: lactose monohydrate
For the 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
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. (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.
Page 2 of 18
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 should
begin the day following completion of the prior re