Femoston 2/10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC code:

G03FB08

INN (International Name):

ESTRADIOL 2 mg DYDROGESTERONE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ESTRADIOL 2 mg DYDROGESTERONE 10 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2008-04-07

Patient Information leaflet

Package Leaflet: Information for the user
FEMOSTON 2/10MG FILM-COATED TABLETS
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, 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
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 estrogen called estradiol
• A progestogen called dydrogesterone.
Femoston is used in postmenopausal women with at least 6 months since
their last natural period.
Femoston is used for:
• RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE.
During the menopause, the amount of the estrogen 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. What you need to know before you take Femoston
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks whic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Femoston 2/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This product contains estradiol hemihydrate equivalent to 2 mg
estradiol per tablet for the first 14 days
of a 28-day cycle (brick-red tablets). For the second 14 days one
tablet contains estradiol hemihydrate
equivalent to 2 mg estradiol and 10 mg dydrogesterone (yellow
tablets).
Excipient(s) with known effect:
Each brick-red tablet contains 118.2 mg of lactose monohydrate.
Each yellow tablet contains 109.4 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet (Tablet)
Estradiol tablets only: Round, biconvex, brick-red, film-coated tablet
with inscription ‘379’ on one
side
Estradiol/ Dydrogesterone combination tablets: Round, biconvex,
yellow, film-coated tablet with
inscription ‘379’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in
postmenopausal women
at least 6 months since the 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)
Elderly population
The experience in treating women older than 65 years is limited
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Femoston 2/10 is a continuous sequential HRTs.
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 estrogen deficiency
are not ameliorated the dosage can be increased by using Femoston
2/10.
Treatment commences with one brick red tablet containing estradiol
taken daily for the first 14 days
during a 28-cycle, during the following 14 days one yellow tablet
containing estradiol and
dydrogesterone is taken daily, as directed on the 28 day calenda