Fematab 1mg film-coated tablet

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Estradiol hemihydrate

Tilgjengelig fra:

Mylan IRE Healthcare Limited

ATC-kode:

G03CA; G03CA03

INN (International Name):

Estradiol hemihydrate

Dosering :

1 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

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

Terapeutisk område:

Natural and semisynthetic estrogens, plain; estradiol

Autorisasjon status:

Marketed

Autorisasjon dato:

1999-04-16

Informasjon til brukeren

Package leaflet: Information for the patient
FEMATAB 1MG & 2MG FILM-COATED TABLETS
estradiol
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, pharmacist or
nurse.
• 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Fematab is and what it is used for
2. What you need to know before you take Fematab
3. How to take Fematab
4. Possible side effects
5. How to store Fematab
6. Contents of the pack and other information
1. What Fematab is and what it is used for
WHAT FEMATAB IS
The name of your medicine is Fematab. It belongs to a group of
medicines called Hormone Replacement Therapy (HRT).
Fematab contains a form of the female oestrogen hormone called
estradiol.
WHAT FEMATAB IS USED FOR
Fematab is used in postmenopausal women with at least 6 months since
their last natural period.
• FOR THE RELIEF OF THE 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”). Fematab alleviates these
symptoms after menopause. You will only be prescribed
Fematab if your symptoms seriously hinder your daily life.
• TO PREVENT THINNING OF THE BONES (OSTEOPOROSIS) IN POST MENOPAUSAL
WOMEN
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 Fematab to prevent osteoporosis after menopause. Fematab is
suitable for postmenopausal wo

Preparatomtale

Health Products Regulatory Authority
10 November 2023
CRN00DV6R
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fematab 1mg film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Estradiol Hemihydrate equivalent to 1
mg estradiol per tablet.
Excipients - Contains Lactose Monohydrate 119.1mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White, round, biconvex, film-coated tablet with inscription '379' on
one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women at least 6 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)
Older people
The experience of treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet daily to be taken orally.
The initial daily dosage is 1 mg. The dosage may be increased to 2 mg
if required. 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.
Treatment of hysterectomised women and postmenopausal women may be
started on any convenient day.
If the patient is menstruating, treatment is started on day one of
bleeding.
In women with a uterus, a progestagen should be added to Fematab for
12-14 days each month/28 day cycle.
Unless there is a previous diagnosis of endometriosis, it is not
recommended to add a progestagen in hysterectomised women.
If a dose has been forgotten, it should be taken as soon as possible.
If more than 12 hours have elapsed, treatment should be
continued with the next tablet without taking the forgotten tablet.
Forgetting a dose may increase the likelihood of
breakthrough bleeding and spotting.
Method of administration
For oral us