Femoston conti Tablet, film coated 1mg/5mg

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 5 mg; ESTRADIOL 1 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Patient Information leaflet

pharma code
pharma code
PACKAGE LEAFLET: INFORMATION FOR THE USER
Femoston
®
-conti 1mg/ 5mg 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
1mg/ 5mg. 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.
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 s

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
FEMOSTON-CONTI 1MG/ 5MG FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Femoston-conti 1mg/ 5mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
28 tablets, each containing 1 mg 17β-estradiol (as hemihydrate) 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 tablets 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 film-coated tablets are 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.
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SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
FEMOSTON-CONTI 1MG/ 5MG FILM-COATED TABLETS
Femoston-conti 1mg/ 5mg film-coated tablets 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 film-coated
tablets depending on the time since menopause and severity of
symptoms. Women experiencing
a natural menopause should commence treatment with Femoston-conti 1mg/
5mg film-coated
tablets 12 months after their last natural menstrual bleed. For
surgically induced menopause,
treatment may start immediately.
Depending on t