Femoston-Conti 0.5mg/2.5mg, film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DYDROGESTERONE; ESTRADIOL

Available from:

Mylan Products Limited

ATC code:

G03FA14

INN (International Name):

DYDROGESTERONE; ESTRADIOL

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DYDROGESTERONE 2.5 mg; ESTRADIOL 0.5 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Patient Information leaflet

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1106236_d1
PROCESS BLACK
FRONT
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Femoston
®
conti 0.5 mg /2.5 mg,
film-coated tablets
Active substances: 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 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.
The
full
name
of
your
medicine
is
Femoston-conti
0.5 mg/2.5 mg. In this leaflet the shorter name Femoston-
conti is used.
What is in this leaflet:
1. What Femoston-conti is and what it is used for
2. What you need to know before you take Femoston-conti
3. How to take Femoston-conti
4. Possible side effects
5. How to store Femoston-conti
6. Contents of the pack and other information
1. What FEMOSTON-CONTI is and what it is used for
Femoston-conti is a Hormone Replacement Therapy (HRT).
It contains two types of female hormones, an oestrogen
called estradiol and a progestogen called dydrogesterone.
Femoston-conti is used in postmenopausal women with at
least 12 months since their last natural period.
Femoston-conti 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-conti alleviates these symptoms after menopause.
You will only be prescribed Femoston-conti if your symptoms
seriously hinder your daily life.
2. What you need to know before you take FEMOSTON-
CONTI
Medical history and regular check-ups
The use of HRT carries risks which need to be considered
when deciding whether to start taking it, or whether to
carry on taking it.
Th

Summary of Product characteristics

Page 1 of 17
1.
NAME OF THE MEDICINAL PRODUCT
Femoston-conti
®
0.5 mg/2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
28 tablets, each containing 0.5 mg 17β-estradiol (as hemihydrate) and
2.5 mg dydrogesterone.
Excipient with known effect: lactose monohydrate 117.4 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, marked 379 on one side (7mm).
Yellow 0.5/2.5 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.
Elderly
The experience in treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Femoston-conti 0.5 mg/2.5 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
0.5 mg/2.5 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.
Page 2 of 17
Continuous combined treatment may be started with Femoston-conti
0.5 mg/2.5 mg depending on
the time since menopause and severity of symptoms. Women experiencing
a natural menopause
should commence treatment with Femoston-conti
0.5 mg/2.5 mg not earlier than at least 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 0.5 mg/2.5 mg.
Patients changing from another continuous combined preparation may
start therapy at any time
If a dose has been forgotten, it should be taken as soon as possible.
If more than 12 hours have
elapsed, treatment