FEMOSTON-CONTI 1mg/5mg Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-04-2024
Summary of Product characteristics
(SPC)
27-04-2024
Active ingredient:
ESTRADIOL DYDROGESTERONE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
ESTRADIOL DYDROGESTERONE
Dosage:
1mg/5mg Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
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.
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 wom
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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
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