CLOMID clomifene citrate 50mg tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

clomifene citrate, Quantity: 50 mg

Dostupné z:

Sanofi-Aventis Australia Pty Ltd

Forma lieku:

Tablet, uncoated

Zloženie:

Excipient Ingredients: sucrose; lactose monohydrate; maize starch; magnesium stearate; pregelatinised maize starch; iron oxide yellow

Spôsob podávania:

Oral

Počet v balení:

10 tablets, 5 tablets

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

INDICATIONS AS AT 1 JANUARY 1991: CLOMID is indicated for the treatment of ovarian failure in carefully selected infertile women who wish to become pregnant.

Prehľad produktov:

Visual Identification: Beige, round, flat faced bevel edged tablet with a score line on one side and "M" into two concentric circles engraved on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizácia:

Registered

Dátum Autorizácia:

2019-08-08

Príbalový leták

CLOMID
®
(CLO(H)-MID)
_clomifene citrate (clom-i-feen sit-rate)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Clomid.
It does not contain all the available
information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Clomid
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CLOMID IS USED
FOR
About 20% of couples who
experience difficulty in conceiving,
do so because the woman's ovaries
are not producing and releasing an
egg each menstrual cycle
(anovulation). Your doctor has
prescribed Clomid to treat this.
Clomid acts by causing a gland in the
brain (the anterior pituitary) to
release hormones which stimulate
ovulation.
It must be remembered that there are
many causes of anovulation, so
Clomid may not be effective in all
cases.
When taking Clomid there should be
28-32 days from the beginning of one
period to the next. Your ovaries
should release an egg 6-12 days after
a course of Clomid. You should have
intercourse around this time to
maximise your chances of
conception.
If your period does not arrive after
the 35th day there are two likely
possibilities:
•
the dose of Clomid has not been
sufficient to produce ovulation,
or
•
you are pregnant
If your period is overdue, contact
your doctor/fertility unit and they
will advise you what steps to take.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CLOMID
Your doctor will perform a pelvic
examination on you before you begin
to take Clomid. This is to check that
you have no physical conditions
which may stop you falling pregnant
or which might indicate that Clomid
is not a suitable drug for you.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CLOMID IF YOU HAVE AN
ALLERGY TO CLOMID OR ANY OF THE
INGREDIENTS LISTED AT THE END

Súhrn charakteristických

clomid-ccdsv8-piv12-22dec20
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION –
CLOMID (CLOMIFENE CITRATE) TABLETS
1
NAME OF THE MEDICINE
Clomifene citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Clomid tablet contains the active ingredient 50 mg clomifene
citrate.
Excipients with known effect: sugars (sucrose, lactose monohydrate).
For the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, 50 mg (beige, scored on one side and M into two concentric
circles engraved on the
other side).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clomid is indicated for the treatment of ovulatory failure in
carefully selected infertile
women who wish to become pregnant.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose for the first course of Clomid is 50 mg (one
tablet) daily for five
days. When ovulation occurs at this dosage there is no advantage in
increasing the dose in
subsequent cycles of treatment. If ovulation occurs at this dosage but
is not followed by
pregnancy, subsequent courses for a total maximum of six cycles of
Clomid treatment may be
administered.
If ovulation appears not to have occurred after the first course of
therapy, a second course of
100 mg daily (two 50 mg tablets given as a single daily dose) for five
days should be given.
Increase of the dosage or duration of therapy beyond 100 mg daily for
five days should not be
undertaken. If ovulatory menses do not occur, this dose may be
repeated for two additional
cycles but failure to induce ovulation after three consecutive cycles
at this dosage should
constitute an adequate therapeutic trial. If, however, ovulation does
occur at this dosage but is
not followed by pregnancy, subsequent courses for a total maximum of 6
cycles of Clomid
treatment may be administered.
Therapy may be started at any time in a patient who has had no recent
uterine bleeding but if
progestin-induced bleeding is planned, or if spontaneous uterine
bleeding occurs prior to
clomid-ccdsv8-piv12-22dec20
Page 2 of 12
therapy, the co