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

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Estradiol; Dydrogesterone

Предлага се от:

Mylan IRE Healthcare Limited

АТС код:

G03FA; G03FA14

INN (Международно Name):

Estradiol; Dydrogesterone

дозиране:

0.5/2.5 milligram(s)

Лекарствена форма:

Film-coated tablet

Вид предписание :

Product subject to prescription which may not be renewed (A)

Терапевтична област:

Progestogens and estrogens, fixed combinations; dydrogesterone and estrogen

Статус Оторизация:

Marketed

Дата Оторизация:

2010-10-01

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEMOSTON-CONTI 0.5 MG /2.5 MG, FILM-COATED TABLETS
Active substances: 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.
2
The experience in treating women with a premature menopause (due to
ovar

Данни за продукта

Health Products Regulatory Authority
04 May 2022
CRN00CVH1
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Femoston-conti 0.5mg/2.5mg 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 with known effect: lactose monohydrate 117.4 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, marked 379 on one side (7mm).
Yellow 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.
The experience in treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Femoston-conti 0.5 mg/2.5mg 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 0.5 mg/2.5mg 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 0.5
mg/2.5mg depending on the time since menopause
and severity of symptoms. Women experiencing a natural menopause
should commence treatment with Femoston-conti 0.5
mg/2.5mg not earlier than at least 12 months after their last natural
menstrual bleed. For surgically induced menopause,
treatment may start immediately.
Depending on the clinical response, the dosage can subsequently be
adjusted.
Patients changing from a continuous sequential or cyclical preparation
should complete the 28 day cycle and then change to
Femoston-conti 0.5 mg/2.5mg.
Patients changing from another continuous combined preparation may
start therapy at any time
If a dose has been forgotten, it should be taken as soon as