Femoston-conti 1mg/5mg 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:

G03FA14

INN (International Name):

DYDROGESTERONE 5 mg ESTRADIOL 1 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DYDROGESTERONE 5 mg ESTRADIOL 1 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-CONTI 1MG/5MG _FILM-COATED TABLETS
Active substances: estradiol/dydrogesterone
The full name of your medicine is Femoston-conti 1mg/5mg film-coated
tablets. 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 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. This
includes any possible
side effects not listed in this leaflet. See section 4.

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Femoston-conti 1 mg/5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains estradiol hemihydrate equivalent to 1 mg
estradiol and 5 mg dydrogesterone.
Excipient with known effect: lactose monohydrate 114.7 mg
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 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 1 mg/5 mg 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 1 mg/5 mg 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 1
mg/5 mg depending on the time
since menopause and severity of symptoms. Women experiencing a natural
menopause should commence
treatment with Femoston-conti 1 mg/5 mg 12 months after their last
natural menstrual bleed. For
surgically induced menopause, treatment may start immediately.
Depending on the clinical response, the dosage can subsequently be
adjusted.
Patients changing from a continuous sequential or cyclical preparation
should complete the 28 day cycle
and then change to Femoston-conti 1 mg/5 mg.
Patients changing from another continuous combined preparation may
sta