Fematab 1 mg film-coated tablet

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Mevcut itibaren:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC kodu:

G03CA03

INN (International Adı):

ESTRADIOL 1 mg

Farmasötik formu:

FILM-COATED TABLET

Kompozisyon:

ESTRADIOL 1 mg

Reçete türü:

POM

Terapötik alanı:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2024-02-29

Bilgilendirme broşürü

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Package leaflet: Information for the patient
FEMATAB 1MG 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 postmenopau

Ürün özellikleri

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fematab
1 mg 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 6.1.
3.
PHARMACEUTICAL FORM
Round, biconvex, white 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.
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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 use.
Fematab can be taken with or without food.
Paedi