FEMOSTON 2 mg, 10 m Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESTRADIOL HEMIHYDRATE, DYDROGESTERONE

Available from:

BGP Products Ltd

ATC code:

G03FB08

INN (International Name):

ESTRADIOL HEMIHYDRATE, DYDROGESTERONE

Dosage:

2 mg, 10 m Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral use

Units in package:

28 film-coated tablets

Prescription type:

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

Manufactured by:

Abbott Biologicals BV

Therapeutic group:

Sequential hormone replacement therapy

Therapeutic area:

Progestogens and estrogens, sequential preparations

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.

Authorization status:

Authorised

Authorization date:

2015-03-27

Patient Information leaflet

Package Leaflet: Information for the user 
FEMOSTON 2/10MG FILM-COATED TABLETS 
estradiol (as hemihydrate) / 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.  

The full name of your medicine
is Femoston 2/10mg Film-coated Tablets. In this leaflet the
shorter name Femoston is used. 
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 ava

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Femoston 2/10mg 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).
Excipients:
Each brick-red tablet contains 118.2mg of lactose monohydrate.
Each yellow tablet contains 109.4 mg of lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
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�