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

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Dydrogesterone; Estradiol

Предлага се от:

PCO Manufacturing Ltd.

АТС код:

G03FA; G03FA14

INN (Международно Name):

Dydrogesterone; Estradiol

дозиране:

1 mg/5 milligram(s)

Лекарствена форма:

Film-coated tablet

Терапевтична област:

Progestogens and estrogens, fixed combinations; dydrogesterone and estrogen

Дата Оторизация:

2021-03-05

Листовка

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 1 mg/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.
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 NE

Данни за продукта

Health Products Regulatory Authority
16 June 2023
CRN00DLP8
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(s) with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_ _
_Product imported from the Czech Republic, Poland and 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 blister and outer package of the product on the market
in the country of origin.
Health Products Regulatory Authority
16 June 2023
CRN00DLP8
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 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
PPA0465/464/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: February