IKACLOMIN

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

CLOMIFENE CITRATE

Beszerezhető a:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC-kód:

G03GB02

Gyógyszerészeti forma:

TABLETS

Összetétel:

CLOMIFENE CITRATE 50 MG

Az alkalmazás módja:

PER OS

Recept típusa:

Required

Gyártó:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Terápiás csoport:

CLOMIFENE

Terápiás terület:

CLOMIFENE

Terápiás javallatok:

In women : ovulatory failure in patients desiring pregnancy.

Engedély dátuma:

2011-11-30

Betegtájékoztató

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
IKACLOMIN
® 50 MG
TABLETS
ACTIVE INGREDIENT: CLOMIFENE CITRATE 50 MG
Inactive
and
allergenic
ingredients
in
the preparation - see section 6 “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet contains
concise information about the medicine. If you
have further questions, refer to the doctor or
pharmacist.
The medicine was prescribed for the treatment
of your ailment. Do not pass it on to others. It
may harm them even if it seems to you that their
ailment is similar.
This medicine is not intended for children,
adolescents,
men
or
postmenopausal
women.
THIS PREPARATION SHOULD BE TAKEN
ACCORDING TO THE RECOMMENDATION
OF A SPECIALIST IN THE FIELD OF
GYNECOLOGY OR ENDOCRINOLOGY.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine contains the active ingredient
clomifene citrate. The substance belongs to a
group of medicines called ovulation stimulants.
It works by stimulating the ovaries to release
the egg (ovulation). Ikaclomin is used to treat
different types of infertility in women who do
not ovulate properly.
THERAPEUTIC GROUP
Antiestrogen to treat infertility.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
You are allergic (sensitive) to the active
ingredient or any of the other ingredients
contained in the medicine (listed in section 6).
Signs of the allergic reaction include: a rash,
swelling
or breathing difficulties, swelling of
the lips, face, throat or tongue.
You have or ever had liver diseases.
You have unusual menstrual bleeding where
the cause of bleeding is unknown.
You have a type of cancer that worsens with
use of hormones.
You have an ovarian cyst.
You are pregnant. Before taking the medicine,
you should undergo a test to make sure that
you are not pregnant.
Do not use the medicine if any of the above
conditions apply to you.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE BEFOR

Termékjellemzők

Ikaclomin Tablets SPC KO 01.2018
IKACLOMIN TABLETS
1. NAME OF THE MEDICINAL PRODUCT
Ikaclomin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Clomifene Citrate 50mg as the active
ingredient.
For a full list of excipients, see section 6.1
Each tablet contains:
_Lactose content: 57.7 mg per tablet. _
_Sodium content: 0.24 mg-0.36 mg per tablet_
3. PHARMACEUTICAL FORM
Tablet
White to slightly off white, 8.2 mm diameter, round, flat beveled
edges
tablet, engraved "S" on one side, scored on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In women: ovulatory failure in patients desiring pregnancy. Tablets
are
indicated only for patients on whom ovulatory dysfunction is
demonstrated.
Other causes of infertility must be excluded or adequately treated
before
giving Clomifene citrate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Physicians experienced in managing gynecological or endocrine
disorders
should supervise the workup and treatment of candidate female patients
for
clomifene citrate therapy. Patients should be selected for clomifene
citrate
therapy only after careful diagnostic evaluation (see indications).
The plan of
therapy should be outlined in advance.
Route of Administration
Oral
Adults Only:
The recommended dose for the first course of Clomifene citrate is 50mg
(1
tablet) daily for 5 days. Therapy may be started at any time in the
patient who
has had no recent uterine bleeding. If progestin-induced bleeding is
planned,
or if spontaneous uterine bleeding occurs before therapy, the regimen
of
50mg daily for 5 days should be started on or about the fifth day of
the cycle.
When ovulation occurs at this dosage, there is no advantage to
increasing
the dose in subsequent cycles of treatment.
If ovulation appears not to have occurred after the first course of
therapy, a
_ _
_ _
_ _
Ikaclomin Tablets SPC KO 01.2018
second course of 100mg daily (two 50mg tablets given as a single daily
dose) for 5 days should be given. This course may be started as early
as 30
days after the previous one.