FEMATAB 2 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
ESTRADIOL
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
ESTRADIOL
Dosage:
2 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
PATIENT INFORMATION LEAFLET
_FEMATAB_
_® _
_1 MG & 2MG_
FILM-COATED TABLETS
ESTRADIOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• 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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Fematab is and what it is used for
2. Before you take Fematab
3. How to take Fematab
4. Possible side effects
5. How to store Fematab
6. Further 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
v
This information is confidential
Estradiol
SOLID 1000560079
1.0
Fematab is suitable for postmenopa
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fematab 2mg Film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Estradiol hemihydrate equivalent to 2 mg estradiol per tablet.
Excipients - Contains Lactose Monohydrate 118.2mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Round, biconvex, brick-red 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
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.
Fematab can be taken with or without food.
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
Read the complete document
