Femoston-conti 1mg/5mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Dydrogesterone; Estradiol

थमां उपलब्ध:

Viatris UK Healthcare Ltd

ए.टी.सी कोड:

G03FA14

INN (इंटरनेशनल नाम):

Dydrogesterone; Estradiol

डोज़:

5mg ; 1mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 06040101; GTIN: 5012781033158

सूचना पत्रक

pharma code
pharma code
PACKAGE LEAFLET: INFORMATION FOR THE USER
Femoston
®
-conti 1mg/ 5mg film-coated tablets
Active substances: estradiol/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
1mg/ 5mg. In this leaflet the shorter name Femoston-
conti is used.
What is in this leaflet:
1.
What Femoston-conti is and what it is used for
2.
What you need to know before you take Femoston-
conti
3.
How to take Femoston-conti
4.
Possible side effects
5.
How to store Femoston-conti
6.
Contents of the pack and other information
1.
What Femoston-conti is and what it is used for.
Femoston-conti is a Hormone Replacement Therapy
(HRT). It contains two types of female hormones,
an oestrogen called estradiol and a progestogen
called dydrogesterone. Femoston-conti is used in
postmenopausal women with at least 12 months since
their last natural period.
Femoston-conti 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-conti alleviates these symptoms
after menopause. You will only be prescribed Femoston-
conti if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
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 s

उत्पाद विशेषताएं

OBJECT 1
FEMOSTON-CONTI 1MG/ 5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 24-Nov-2016 | Mylan
Products Limited
1. Name of the medicinal product
Femoston-conti 1mg/ 5mg film-coated tablets
2. Qualitative and quantitative composition
28 tablets, each containing 1 mg 17β-estradiol (as hemihydrate) and 5
mg dydrogesterone.
Excipient with known effect: lactose monohydrate 114.7 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Round, biconvex tablets marked 379 on one side (7mm)
Salmon coloured 1/5 mg 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.
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)
The experience in treating women older than 65 years is limited.
4.2 Posology and method of administration
Femoston-conti 1mg/ 5mg film-coated tablets are 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 1mg/ 5mg film-coated tablets 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 1mg/
5mg film-coated tablets
depending on the time since menopause and severity of symptoms. Women
experiencing a natural
menopause should commence treatment with Femoston-conti 1mg/ 5mg
film-coated tablets 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.
Pa