FEMOSTON-CONTI 1mg/5mg Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESTRADIOL, DYDROGESTERONE

Available from:

BGP Products Ltd

ATC code:

G03FA14

INN (International Name):

ESTRADIOL, DYDROGESTERONE

Dosage:

1mg/5mg Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral use

Units in package:

packs of 28, 84 (3 x 28) or 280 (10 x 28) tablets

Prescription type:

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

Therapeutic group:

: Genito urinary system and sex hormones, progestogens and oestrogens, fixed combinations

Therapeutic area:

Progestogens and estrogens, fixed combinations

Therapeutic indications:

Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 12 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

Authorization status:

Authorised

Authorization date:

2015-03-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
_ _
_FEMOSTON-CONTI 1MG/5MG _FILM-COATED TABLETS 
Active substances: estradiol/dydrogesterone 

The full name of your medicine is Femoston-conti 1mg/5mg. In
this leaflet the shorter name Femoston is 
used. 

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 called estradiol and a progestogen called
dydrogesterone. Femoston is used in postmenopausal 
women with at least 12
months since their last natural period.  

FEMOSTON IS USED FOR 
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE  
During the menopause, the amount of the 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.  

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 medi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Femoston-conti 1 mg/5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
28 tablets, each containing 1 mg 17 -estradiol (as hemihydrate) and 5 mg dydrogesterone.
Excipient(s) with known effect: lactose monohydrate 114.7mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex marked 379 on one side (7mm)
Salmon coloured 1/5 mg tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 12 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 conti
®
1mg /5mg is a continuous combined HRT for oral use.
The oestrogen and the progestogen are given every day without interruption.
The dosage is one tablet per day for a 28 day cycle.
Femoston conti
®
1mg /5mg should be taken continuously without a break between packs.
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.
Continuous combined treatment may be started with Femoston conti
®
1mg /5mg depending on the time since
menopause and severity of symptoms. Women experiencing a natural menopause should commence treatment with
Femoston conti
®
1mg /5mg 12 months after their last natural menstrual bleed. For surgically induced menopause,
treatment may start immediately.
Depending on the clinic