OVA-MIT TABLET 50MG

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

CLOMIPHENE CITRATE

متاح من:

EUCOGEN SDN BHD

INN (الاسم الدولي):

CLOMIPHENE CITRATE

الوحدات في الحزمة:

10Tablet Tablets; 1000Tablet Tablets

المصنعة من قبل:

Remedica Ltd.

نشرة المعلومات

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
OVA-MIT TABLET
_ _
Clomifene citrate (50 mg)
my-pl-ova-mit-tabs-a2-trans Page 1 of 4
WHAT IS IN THIS LEAFLET
1. What Ova-mit is used for
2. How Ova-mit works
3. Before you use Ova-mit
4. How to use Ova-mit
5. While you are using Ova-mit
6. Side effects
7. Storage and disposal of Ova-mit
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT OVA-MIT IS USED FOR
Ova-mit is used for some types of
infertility,
in
women
who
are
not
ovulating properly.
HOW OVA-MIT WORKS
Ova-mit contains a medicine called
clomifene citrate. This belongs to a
group of medicines called ovulation
stimulants. It works by stimulating the
release
of
eggs
from
the
ovary
(ovulation).
BEFORE YOU USE OVA-MIT
_- When you must not use it _
Do not take this medicine if any of the
following apply to you:
▪
you are allergic (hypersensitive)
to clomifene or any of the other
ingredients
of
this
medicine
(listed in section 8).
Signs of an allergic reaction include: a
rash,
swallowing
or
breathing
problems, swelling of your lips, face,
throat or tongue.
▪
if
you
are
having
an
early
menopause or have been told you
are infertile.
▪
if
you
have
or
ever
had
liver
disease.
▪
if
you
have
unusual
menstrual
bleeding where the cause is not
known.
▪
if you have a type of cancer that is
made worse by hormones.
▪
if you have a cyst on your ovary.
▪
if you are pregnant. You should
have a test to make sure you are
not pregnant before you take Ova-
mit.
_- Before you start to use it _
Talk to your doctor about the risks of:
▪
becoming
pregnant
with
more
than one child at the same time
(multiple pregnancies).
▪
pregnancies
where
the
baby
grows
outside
of
the
womb
(ectopic).
▪
Ovarian Hyperstimulation
Syndrome.
▪
problems with your vision.
Any
pregnancy
could
lead to
birth
defects
or
miscarriage.
This
can
happen even if you are not taking Ova-
mit. You should talk to your doctor
about the possible risks before you
take Ova-mit.
_- Taking other medicines _

خصائص المنتج

my-pi-ova-mit-tabs-a0 page 1 of 10
Package Insert
1. Product name
Ova-mit 50 mg tablets
2. Name and Strength of Active Ingredient
Each tablet contains clomifene citrate 50 mg.
3. Product description
Tablet.
Light orange, round, flat scored tablets with Remedica’s logo on one
side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
4. Pharmacological Properties
Pharmacodynamics
Pharmacotherapeutic
group:
Sex
hormones
and
modulators
of
the
genital
system;
Gonadotropins and other ovulation stimulants, ATC code: G03GB02
Mechanism of action
The ovulatory response to cyclic clomifene citrate tablets therapy is
mediated through
increased output of pituitary gonadotrophins, which in turn stimulates
the maturation and
endocrine activity of the ovarian follicle.
Pharmacodynamic effects
Clomifene citrate tablets is a triarylethylene compound (related to
chlorotrianisene and
triparanol). It is a non-steroidal agent which stimulates ovulation in
a high percentage of
appropriately selected an ovulatory women.
Pharmacokinetics
Orally administered
14
C labelled clomifene citrate was readily absorbed when administered
to humans. Cumulative excretion of the
14
C label by way of urine and faeces averaged
about 50% of the oral dose after 5 days in 6 subjects, with mean
urinary excretion of 7,8%
and mean faecal excretion of 42,4%. A mean rate of excretion of 0,73%
per day of the
14
C
dose after 31 days to 35 days and 0,45% per day of the
14
C dose after 42 days to 45 days
my-pi-ova-mit-tabs-a0 page 2 of 10
was seen in faecal and urine samples collected from 6 subjects for 14
to 53 days after
clomifene citrate
14
C administration. The remaining drug/metabolites may be slowly
excreted from a sequestered enterohepatic recirculation pool.
When Ova-mit is administered over prolonged periods it may interfere
with cholesterol
synthesis. Patients on prolonged therapy may show elevated blood
levels of desmosterol.
5. Clinical Particulars
Indications
Ova-mit is indicated for the treatment