Femoston-conti 1 mg/5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Estradiol; Dydrogesterone

Available from:

IMED Healthcare Ltd.

ATC code:

G03FA; G03FA14

INN (International Name):

Estradiol; Dydrogesterone

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Progestogens and estrogens, fixed combinations; dydrogesterone and estrogen

Authorization date:

2022-12-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
FEMOSTON
®
-CONTI 1 MG/5 MG FILM-COATED TABLETS
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
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.
2.
WHAT YOU NEED T

Summary of Product characteristics

Health Products Regulatory Authority
02 December 2022
CRN00CRLJ
Page 1 of 2
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
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Bulgaria_
Round, biconvex marked 379 on one side. Salmon coloured tablets.
4 CLINICAL PARTICULARS
As per PA2010/012/004
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/012/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Lactose monohydrate
Hypromellose
Maize starch
Colloidal anhydrous silica
Magnesium stearate
Film coat:
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Iron oxides, yellow and red (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 container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicine does not require any special storage conditions.
Health Products Regulatory Authority
02 December 2022
CRN00CRLJ
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
The tablets are packaged in blisters of 28 tablets. The blister made
of PVC/PVOC or PVC film and covered with aluminium foil.
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
IMED Healthcare Ltd,
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,
Dublin 15,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/189/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date