Femoston-conti 0.5 mg/2.5 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Estradiol; Dydrogesterone

Tilgjengelig fra:

PCO Manufacturing Ltd.

ATC-kode:

G03FA; G03FA14

INN (International Name):

Estradiol; Dydrogesterone

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Progestogens and estrogens, fixed combinations; dydrogesterone and estrogen

Autorisasjon dato:

2022-02-18

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
FEMOSTON
®
-CONTI 0.5 MG/2.5 MG_ _FILM-COATED TABLETS
estradiol (as hemihydrate)/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
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMOSTON
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.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is
l

Preparatomtale

Health Products Regulatory Authority
21 February 2022
CRN00CS5Q
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Femoston-conti 0.5 mg/2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains estradiol hemihydrate equivalent to 0.5 mg
estradiol and 2.5 mg dydrogesterone.
Excipient(s) with known effect: lactose monohydrate
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product sourced from Czech Republic:_
Round, biconvex, yellow tablets marked 379 on one side.
4 CLINICAL PARTICULARS
As per PA2010/012/003
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/012/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core:
Lactose monohydrate
Hypromellose
Maize starch
Colloidal anhydrous silica
Magnesium stearate
Film-coating:
Macrogol 3350
Polyvinyl alcohol
Talc
Titanium dioxide (E171)
Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the market
in the country of origin.
Health Products Regulatory Authority
21 February 2022
CRN00CS5Q
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicine does not require any special storage conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Calendar packs of 84 (3 x 28) tablets in PVC-Aluminium blister strips
in a printed carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
This medicinal product may pose a risk to the aquatic environment.
Medicines no longer required should not be disposed of
via wastewater or household waste. Any unused product or waste
material should be disposed of in accordance with local
requirements or returned to the pharmacy.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.,
Unit 10,
Ashbourne Business Park,
Rath,
Ashbourne,
Co. Meath,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/464/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
February 2022