Femoston Conti 0.5mg2.5mg Film Coated Tablet

देश: मलेशिया

भाषा: अंग्रेज़ी

स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

सक्रिय संघटक:

ESTRADIOL HEMIHYDRATE; DYDROGESTERONE

थमां उपलब्ध:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (इंटरनेशनल नाम):

ESTRADIOL HEMIHYDRATE; DYDROGESTERONE

पैकेज में यूनिट:

28tablet Tablets

द्वारा बनाया गया:

Abbott Biologicals B.V., Veerweg

सूचना पत्रक

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
FEMOSTON® CONTI 0.5MG/2.5MG
FILM-COATED TABLET
Estradiol hemihydrate (0.5mg), dydrogesterone (2.5mg)
Page no. 1
WHAT IS IN THIS LEAFLET
1. What Femoston® Conti is used for
2. How Femoston® Conti works
3. Before you use Femoston® Conti
4. How to use Femoston® Conti
5. While you are using it
6. Side effects
7. Storage and disposal of
Femoston® Conti
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT FEMOSTON® CONTI
IS USED FOR
Femoston® Conti is used
in
postmenopausal women with at least
12 months since their last natural
period to relief symptoms such as hot
flushes.
HOW FEMOSTON® CONTI WORKS
Femoston® Conti acts as a hormone
replacement therapy by providing
two
types of female hormones, an
oestrogen called estradiol and a
progestogen called dydrogesterone.
BEFORE YOU USE FEMOSTON® CONTI
_- When you must not use it_
Do not take Femoston® Conti if:
•
If you have or have ever had
breast cancer, or if you are
suspected of having it if you
have cancer which is
sensitive to oestrogens, such
as cancer of the womb lining
(endometrium), or if you are
suspected of having it.
•
if you have or your doctor
thinks you might have a
tumor that is dependent on
progestogens. An example is
a tumor in the brain
(meningioma).
•
if you have any unexplained
vaginal bleeding
•
if you have excessive
thickening of the womb
lining (endometrial
hyperplasia) that is not being
treated
•
if you have or have ever had
a blood clot in a vein
(thrombosis) such as in the
legs (deep venous
thrombosis) or the lungs
(pulmonary embolism)
•
if you have a blood clotting
disorder (such as protein C,
protein S, or antithrombin
deficiency)
•
if you have or recently have
had a disease caused by
blood clots in the arteries,
such as a heart attack, stroke
or angina
•
you have or have ever had a
liver disease and your liver
function tests have not
returned to normal
•
if you are allergic
(hypersensitive) to estradiol,
dydrogesterone

उत्पाद विशेषताएं

1.
NAME OF THE MEDICINAL PRODUCT
Femoston Conti 0.5mg/2.5mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
28 tablets, each containing 0.5 mg 17β-estradiol (as hemihydrate) and
2.5 mg dydrogesterone.
Excipient(s): Lactose monohydrate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
A round, biconvex, marked 379 on one side.
Yellow 0.5/2.5 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.
Elderly population
The experience in treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Femoston Conti 0.5mg/2.5mg is 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 0.5mg/2.5mg 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 0.5
mg/2.5mg depending on
the time since menopause and severity of symptoms.
Women experiencing a natural menopause should commence treatment with
Femoston Conti 0.5
mg/2.5mg not earlier than at least 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.
Patients changing from a continuous sequential or cyclical preparation
should complete the 28 day
cycle and then change to Femoston Conti 0.5mg/2.5mg.
Patients changing from another continuous combined preparation may
start therapy at any time.
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