FEMOSTON 1/10 1 mg, 10 m Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-04-2024
Summary of Product characteristics
(SPC)
23-04-2024
Active ingredient:
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
Dosage:
1 mg, 10 m 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
Package Leaflet: Information for the user
FILM-COATED TABLETS
estradiol (as hemihydrate), dydrogesterone
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.
The full name of your medicine is Femoston 2/10mg
Film-coated Tablets. In this leaflet the shorter name
Femoston is used.
IN THIS LEAFLET:
1. What Femoston is and what it is used for
2. Before you take Femoston
3. How to take Femoston
4. Possible side effects
5. How to store Femoston
6. Further information
1. WHAT FEMOSTON IS AND WHAT IT IS USED FOR
WHAT FEMOSTON IS
The name of your medicine is Femoston. It belongs to a
group of medicines called Hormone Replacement
Therapy (HRT). Femoston is suitable for postmenopausal
women with at least 6 months since their last natural
period.
Femoston contains two types of female hormones:
• An estrogen called estradiol
• A progestogen called dydrogesterone.
Estradiol in Femoston is made from plant materials.
Dydrogesterone is a manufactured progestogen which is
very similar to the progestogen naturally produced by
women.
WHAT FEMOSTON IS USED FOR
Femoston is used if you are having your menopause (are
menopausal):
• FOR THE RELIEF OF SYMPTOMS OCCURRING AFTER
MENOPAUSE.
During the menopause, the amount of the estrogen
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 li
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Femoston 1/10mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
This product contains estradiol hemihydrate equivalent to 1mg estradiol per tablet for the first 14 days of a 28 day cycle
(white tablets). For the second 14 days , one tablet contains estradiol hemihydrate equivalent to 1mg estradiol and
10mg dydrogesterone (grey tablet).
Excipients:
Each white tablet contains 119.1 mg of lactose monohydrate.
Each grey tablet contains 110.2 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Estradiol only tablets: Round, biconvex, white film-coated tablet with inscription '379' on one side.
Estradiol/dydrogesterone combination tablets: Round, biconvex, grey, film-coated tablet with inscription '379' on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women at least 6 months
since the 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)
Elderly population
The experience in treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Femoston 1/10 is a continuous sequential HRT.
In general, treatment should start with Femoston 1/10. Depending on the clinical response, the dosage can afterwards
be adjusted to individual need. If the complaints linked to estrogen deficiency are not ameliorated the dosage can be
increased by using Femoston 2/10.
Treatment commences with one white tablet containing estradiol taken daily for the first 14 days during a 28-cycle, ;
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