CLOMID clomifene citrate 50mg tablet blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
clomifene citrate
Available from:
Sanofi-Aventis Australia Pty Ltd
Authorization status:
Registered
Authorization number:
313131

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,

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 of this

leaflet.

Do not take Clomid if you are

pregnant.

Like most fertility medicines, Clomid

should not be taken during

pregnancy.

To avoid inadvertently taking Clomid

during early pregnancy, you should

perform tests during each treatment

cycle to determine whether ovulation

occurs. You should have a pregnancy

test before the next course of Clomid

therapy.

Do not take Clomid if you have any

of the following conditions:

liver disease or a history of liver

problems

hormone-dependent tumours

abnormal uterine bleeding of

undetermined origin

ovarian cysts, with the exception

of polycystic ovary

Do not take Clomid after the

expiry date (EXP) printed on the

pack.

If you take this medicine after the

expiry date has passed, it may not

work as well.

Do not take Clomid if the

packaging is torn or shows signs of

tampering.

If you are not sure whether you

should start taking Clomid, contact

your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes

Tell your doctor or pharmacist if

you have pre-existing or a family

history of hyperlipidemia (high

cholesterol levels) or

hypertriglyceridemia (high

triglyceride levels in blood).

CLOMID

Tell your doctor or pharmacist if

you are breast-feeding.

Like most fertility medicines, Clomid

is not recommended while you are

breast-feeding.

The chances of multiple

pregnancies are higher when you

use Clomid.

You should be aware of the potential

complications of multiple pregnancy

before taking Clomid. Discuss this

with your doctor.

How to take Clomid

How much to take

The recommended dose for the first

course of Clomid is one tablet per

day for five days at the beginning of

your cycle. If ovulation does not

occur, your doctor may advise you to

increase the dose of Clomid in

subsequent treatment cycles.

Do not take an increased dose

unless instructed to do so by your

doctor.

Taking more than your doctor

prescribes may overstimulate your

ovaries, possibly damaging your

ovaries and endangering your health.

Follow all directions given to you

by your doctor and pharmacist

carefully.

These directions may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

When to take it

Your doctor will advise you on

which day of your cycle to begin to

take Clomid.

If you do not have regular periods

your doctor may prescribe other

tablets e.g. norethisterone for a

number of days, after which a period

may start. Use this bleeding to time

your Clomid course.

Take Clomid at about the same

time each day.

This will help you remember when to

take the tablets.

How long to use it

Clomid tablets are usually taken

daily for five consecutive days at the

beginning of your cycle.

Your doctor will advise you on how

many courses of Clomid, you should

take.

Long term therapy with Clomid is

not recommended. Your doctor

will tell you for how long you

should take Clomid.

If you forget to take it

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or pharmacist or the Poisons

Information Centre (telephone 13

11 26), or go to Accident and

Emergency at your nearest

hospital, if you think that you or

anyone else may have taken too

much Clomid. Do this even if there

are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

Clomid Progress Checks

It will be necessary to monitor your

response to Clomid. Methods used to

do this include:

basal body temperature chart

urine testing

blood tests

mucus testing

The most appropriate method for you

will be discussed by your doctor.

While you are using

Clomid

Things you must not do

Do not give Clomid to anyone else,

even if they have the same

condition as you.

Do not use Clomid to treat any

other complaints unless your

doctor tells you to.

Things to be careful of

Be careful driving or operating

machinery until you know how

Clomid affects you.

Clomid may cause visual

disturbances in some people. Make

sure you know how you react to

Clomid before you drive a car,

operate machinery, or do anything

else that could be dangerous if you

are dizzy or have blurred vision.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Clomid.

Clomid helps many people with

infertility, but it may have unwanted

side effects in a few people. All

medicines can have side effects.

Sometimes they are serious; most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Tell your doctor or pharmacist if

you notice any of the following:

hot flushes

intermenstrual ("between period")

spotting or heavy menstrual

periods

nausea or vomiting

breast discomfort

headache

CLOMID

insomnia, nervousness,

depression, fatigue, dizziness or

light-headedness

rash or skin irritations

increased frequency of urination

hair loss

fever

vaginal discharge

seizures

visual problems

increased heart rate

palpitations

If any of the following happen, stop

taking Clomid and tell your doctor

or pharmacist immediately:

blurred vision, spots or flashes

abdominal discomfort or pelvic

pain, soreness or a "bloated"

feeling

weight gain

The chances of ectopic pregnancies

(foetus growing outside the womb)

are higher if you conceive on

Clomid.

Clomid may cause uterine fibroids

to grow in size.

Prolonged Clomid use may be

associated with a small increase in

the risk of ovarian cancer.

Hypertriglyceridemia (high

triglyceride levels in blood) has

been observed in patients who have

pre-existing or a family history of

hypertriglyceridaemia.

Other side effects not listed above

may occur in some patients. Tell

your doctor or pharmacist if you

notice anything that is making you

feel unwell.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After using Clomid

Storage

Keep your tablets in the pack until

it is time to take them.

If you take the tablets out of the pack

they will not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store Clomid or any other

medicine in the bathroom or near a

sink.

Do not leave it in the car on hot

days or on window sills.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells

you to stop taking Clomid or the

tablets have passed their expiry

date, ask your pharmacist what to

do with any that are left over.

Product description

What it looks like

Clomid tablets are beige, round, flat

faced bevel edged with a score line

on one side and M into two

concentric circles engraved on the

other side.

The 50mg strength is available in

boxes of 10 tablets.

Ingredients

Each Clomid tablet contains

clomifene citrate (50mg), sucrose,

lactose monohydrate, maize starch,

pregelatinized maize starch,

magnesium stearate and iron oxide

yellow.

Manufacturer

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

AUST R 313131

Date of preparation: February 2020.

clomid-ccdsv7-cmiv3-feb20

CLOMID

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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

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therapy, the course of Clomid 50mg daily for five days should be started on or about the fifth

day of the cycle.

The majority of patients who are going to respond will respond to the first course of therapy.

If ovulatory menses have not occurred after 3 courses, the diagnosis should be re-evaluated.

Treatment beyond this is not recommended in the patient who does not exhibit evidence of

ovulation.

4.3

CONTRAINDICATIONS

Liver disease

Clomid is contraindicated in patients with known liver disease or a history of liver dysfunction.

Hormone-dependent tumours or abnormal uterine bleeding

Clomid is contraindicated in patients with hormone-dependent tumours or in patients with

abnormal uterine bleeding of undetermined origin.

Pregnancy

Clomid

should

administered

during

pregnancy.

avoid

inadvertent

Clomid

administration during early pregnancy, appropriate tests should be utilised during each

treatment cycle to determine whether ovulation occurs. The patient should have a pregnancy

test before the next course of Clomid therapy.

Ovarian cyst

Clomid should not be given in the presence of an ovarian cyst, except polycystic ovary, since

further enlargement of the cyst may occur. Patients should be evaluated for the presence of

ovarian cyst prior to each course of treatment.

4.4

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Careful evaluation and selection of patients and close attention to dosage instructions,

contraindications and side effects are mandatory. Since Clomid is indicated only in patients

with ovarian dysfunction, other possible causes of infertility should be excluded or treated

before giving Clomid.

A pelvic examination should be made before each course of Clomid is given.

As the relative safety of long-term cyclic therapy with Clomid has not been conclusively

demonstrated, and as the majority of patients will ovulate following 3 courses, long-term

cyclic therapy beyond a total of about 6 cycles (including 3 ovulatory cycles) is not

recommended.

Ovarian hyperstimulation syndrome (OHSS)

Ovarian hyperstimulation syndrome (OHSS) has been reported in patients receiving Clomid

therapy alone or in combination with gonadotrophins. Rare cases of severe forms of OHSS

have been reported where the following symptoms have occurred: pericardial effusion,

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anasarca, hydrothorax, acute abdomen, renal failure, pulmonary oedema, ovarian

haemorrhage, deep venous thrombosis, torsion of the ovary and acute respiratory distress. If

conception results, rapid progression to the severe form of the syndrome may occur.

To minimise the hazard of abnormal ovarian enlargement associated with Clomid therapy,

patients should be given the smallest dose possible of Clomid consistent with an expectation

of good results. It should be borne in mind that maximal ovarian enlargement may not occur

until several days after the treatment cycle is completed. Some patients with polycystic ovary

syndrome who are unusually sensitive to gonadotrophin may have an exaggerated response to

the usual doses of Clomid.

The patient should be instructed to inform the physician of any abdominal or pelvic pain,

weight gain, discomfort or distension after taking Clomid.

Patients who complain of abdominal or pelvic pain, discomfort or distension after receiving

Clomid should be examined for the presence of an ovarian cyst or other cause. Due to the

fragility of enlarged ovaries in severe cases, abdominal and pelvic examination should be

performed very cautiously. If abnormal enlargement of the ovary occurs, additional courses

of Clomid should not be given until the ovaries have returned to pre-treatment size, and then

a shorter course or smaller dose should be administered. Ovarian enlargement and cyst

formation that is associated with Clomid therapy usually regresses spontaneously within a

few days or weeks after discontinuing treatment. Unless surgical indication for laparotomy

exists, such cystic enlargement should be managed conservatively. The dosage and/or

duration of the next course of treatment should be reduced.

Risk of Ovarian Cancer

Available data indicate that the use of clomifene citrate may increase the risk of ovarian

cancer, especially in nulligravid women (see Section

Error! Reference source not found.

dverse effects (undesirable effects)).

Patients should be evaluated for the presence of ovarian neoplasia before the start of

treatment (see Section

Error! Reference source not found.

Contraindications).

Visual symptoms

Patients should be advised that blurring or other visual symptoms such as spots or flashes

(scintillating scotomata) may occasionally occur during or shortly after Clomid therapy.

These visual disturbances are usually reversible; however, cases of prolonged visual

disturbance have been reported including after Clomid discontinuation. The visual

disturbances may be irreversible, especially with increased dosage or duration of therapy. The

significance of these symptoms is not yet understood. If they do occur Clomid should be

discontinued and a complete ophthalmological evaluation should be made. No further courses

of Clomid should be administered.

Patients should be warned that visual symptoms may render such activities as driving a car or

operating machinery hazardous, particularly under conditions of variable lighting. The patient

should be instructed to inform the physician whenever any unusual visual symptoms occur.

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Uterine fibroids

Caution should be exercised when using Clomid in patients with uterine fibroids due to the

potential for further enlargement of the fibroids.

Hypertriglyceridemia

Cases of hypertriglyceridemia have been reported (see Section 4.8 Adverse effects

(Undesirable effects)) in the postmarketing experience with Clomid. Pre-existing or family

history of hyperlipidemia and use of higher than recommended dose and/or longer duration of

treatment with Clomid are associated with risk of hypertriglyceridemia. Periodic monitoring

of plasma triglycerides may be indicated in these patients.

Carcinogenicity/mutagenicity

Epidemiological case control studies reported an increased relative risk for both ovarian

cancer and ovarian tumours of low malignant potential in infertile women who used fertility

drugs compared to women without a history of infertility. However, because infertility is a

primary risk factor for ovarian cancer, and because of other limitations such as small sample

sizes, it cannot be determined from these studies whether the use of fertility drugs increases

the risk of ovarian cancer beyond the effect of infertility. Therefore, prolonged use of Clomid

may increase the risk of developing a borderline or invasive ovarian tumour.

Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic

potential of Clomid.

The mutagenic potential of Clomid has not been evaluated.

Use in the elderly

No data available.

Paediatric use

No data available.

Effects on laboratory tests

No data available.

4.5

INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF

INTERACTIONS

Interactions with other drugs have not been documented.

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4.6

FERTILITY, PREGNANCY AND LACTATION

Effects on fertility

4.6.1.1

Multiple pregnancy

The incidence of multiple pregnancy is increased when conception takes place during a cycle

in which Clomid is given. The potential complications and hazards of multiple pregnancy

should be discussed with the patient.

In a large series of closely monitored patients who became pregnant after receiving Clomid,

there were 6.9% (165) twins, 0.5% (11) triplets, 0.3% (7) quadruplets, and 0.13% (3)

quintuplets. Of the 165 twin pregnancies for which sufficient information was available, the

ratio of monozygotic to dizygotic twins was 1:5.

Of these multiple pregnancies, 357 live infants were born of 165 multiple births. After

excluding 60 neonatal deaths, 297 survived, including 27 of 61 live infants from triplet,

quadruplet, and quintuplet pregnancies. In addition, one sextuplet pregnancy has been

reported in a patient treated with Clomid. Patients (and their husbands) should be advised of

the possibility and potential complications and hazards of multiple pregnancy associated with

Clomid therapy.

4.6.1.2

Ectopic pregnancy

There is an increased chance of ectopic pregnancy (including tubal and ovarian sites) in

women who conceive following Clomid therapy.

Use in pregnancy

Category B3.

See Section 4.3 Contraindications, Pregnancy. Clomid was found to damage rat and rabbit

foetuses when given in high doses to the pregnant animal. Clomid should not be used during

pregnancy.

4.6.1.3

Pregnancy wastage

The experience from patients of all diagnoses during clinical investigation of Clomid shows a

pregnancy (single and multiple) wastage or fetal loss rate of 21.4% (abortion rate of 19.0%),

1.18% ectopic pregnancies, 0.17% hydatidiform mole, 0.04% foetus papyraceous and 1.01%

of pregnancies with one or more stillbirths.

Use in lactation

It is not known whether Clomid is excreted in milk. Clomid may reduce lactation.

4.7

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Patients should be warned that visual symptoms, dizziness, seizures or fatigue (see Section

4.8 Adverse Effects (Undesirable Effects)), may render such activities as driving a car or

operating machinery more hazardous than usual, particularly under conditions of variable

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lighting. The patient should be instructed to inform the physician whenever any unusual

visual symptoms occur.

4.8

ADVERSE EFFECTS (UNDESIRABLE EFFECTS)

Side effects are dose-related being more frequent and more severe when higher doses of

Clomid are administered.

During clinical trials, the more common side effects included ovarian enlargement (13.6%),

vasomotor flushes (10.4%), abdominal-pelvic discomfort (distension, bloating, pain or

soreness) (5.5%), nausea and vomiting (2.2%), breast discomfort (2.1%), visual symptoms

(1.5%), headache (1.3%) and intermenstrual spotting or menorrhagia (1.3%).

Vasomotor symptoms resembling menopausal hot flushes are not usually severe and

disappear soon after treatment is discontinued. Abdominal symptoms are most often related

to ovulatory (Mittelschmerz) or pre-menstrual phenomena, or to ovarian enlargement. At

recommended dosage, the normal variation in ovarian size may be exaggerated. Rare

instances of massive ovarian enlargement and rupture of a lutein cyst with haemoperitoneum

have been reported.

Neoplasm, benign, malignant and unspecified (including cysts and polyps): Ovarian

malignancies (frequency not known).

Visual symptoms, described usually as "blurring" or spots or flashes (scintillating scotomata)

increase in incidence with increasing total dose. These symptoms appear to be due to

intensification and prolongation of after-images. After-images as such have also been

reported. Symptoms often first appear or are accentuated with exposure to a more brightly lit

environment.

Ophthalmologically definable scotomata, phosphenes, reduced visual acuity and retinal cell

function (electroretinographic) changes have also been reported. There have been rare reports

of cataracts and optic neuritis.

These visual disturbances are usually reversible; however cases of prolonged visual

disturbances have been reported including after Clomid discontinuation. The visual

disturbances may be irreversible, especially with increased dosage or duration of therapy.

Other less frequently reported symptoms included increased nervous tension, depression,

fatigue, dizziness or light headedness, insomnia, heavier menses, weight gain, urticaria and

allergic dermatitis/rash, increased urinary frequency, alopecia or moderate reversible hair

loss.

Anxiety, nervousness and mood disturbances including altered mood, mood swings and

irritability have been reported.

There have been reports of new cases of endometriosis and exacerbation of pre-existing

endometriosis during Clomid therapy.

Isolated reports have been received of the occurrence of endocrine-related or dependent

tumours/neoplasms or the aggravation of such growths.

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Hypertriglyceridemia, in some cases with pancreatitis, has been observed in patients with pre-

existing or a family history of hypertriglyceridemia and/or with dose and duration of

treatment exceeding the label recommendations.

Seizures have been rarely reported. Transient paraesthesia has been reported.

Tachycardia, palpitations and pancreatitis have been reported.

Multiple pregnancies, including simultaneous intrauterine and extrauterine pregnancies, have

been reported.

There is an increased chance of ectopic pregnancy (including tubal and ovarian sites) in

women who conceive following Clomid therapy.

Reduced endometrial thickness has been reported.

Defects at birth have been reported in 58 infants from 2,369 delivered pregnancies in mothers

treated with Clomid. Four of the infants were in the abortion/stillbirth category, 14 were from

multiple pregnancies, and the remaining were single births. The defects have included

Down's syndrome (5 infants), congenital heart lesions (8 infants), microcephaly (2 infants),

harelip and cleft palate (2 infants), hypospadias (3 infants), undescended testes (2 infants),

club foot (4 infants), gastrointestinal malformations (4 infants), congenital hip (2 infants) and

polydactyly (both of twins).

Eight of the total of 58 infants were born to 7 of 158 mothers who received (inadvertently) a

course of Clomid during the first 6 weeks after conception.

Clomid when given continuously for prolonged periods, may interfere with cholesterol

synthesis. Serum from patients treated in this way appears to have elevated desmosterol

levels. In patients taking recommended doses of Clomid, serum sterol patterns are not

significantly altered.

Bromosulphophthalein (BSP) retention of greater than 5% has been reported in 32 of 141

patients in whom it was measured. Increased transaminases have been reported. Other liver

function tests were usually normal. Retention was usually minimal unless associated with

prolonged continuous Clomid administration or with apparently unrelated liver disease.

In some patients, pre-existing BSP retention decreased even though Clomid therapy was

continued. One patient developed jaundice on the 14th day of Clomid therapy; liver biopsy

revealed bile stasis without evidence of hepatitis. Clomid has not been reported to cause

significant abnormality in the haematopoietic or renal system, the protein bound iodine or in

serum cholesterol.

Reporting suspected adverse effects

Reporting suspected adverse reactions after registration of the medicinal product is important.

It allows continued monitoring of the benefit-risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions at

www.tga.gov.au/reporting-problems.

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4.9

OVERDOSE

Toxic effects of acute overdosage of Clomid have not been reported, but the number of

overdose cases recorded is small. In the event of an overdose, appropriate supportive

measures should be employed.

For information on the management of overdose, contact the Poison Information Centre on

131126 (Australia).

5

PHARMACOLOGICAL PROPERTIES

5.1

PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: Ovulation stimulants, ATC code: G03BG02

Commonly associated diagnoses include polycystic ovary syndrome, lactation amenorrhoea

syndrome, psychogenic amenorrhoea, certain cases of secondary amenorrhoea of

undetermined aetiology, and post-oral contraceptive amenorrhoea. In such patients,

approximately 70% will ovulate and (provided that there is no other cause of infertility in

them or in their partners) about 30% will become pregnant. It is worthwhile to note that the

data from which these percentages were derived included patients who were single and some

who either did not desire pregnancy at the time of treatment or had impediments to

achievement of pregnancy other than ovulatory dysfunction.

Good levels of endogenous oestrogen (estimated from vaginal smears, endometrial biopsy,

assay or urinary oestrogen, or from bleeding in response to progesterone) are a favourable

prognosis for treatment with Clomid, but reduced oestrogen levels do not always rule out the

possibility of successful therapy.

Some anovulatory patients that appear to respond to Clomid but either do not actually ovulate

or whose luteal phases are so short that the opportunity to conceive is limited may benefit by

having, following Clomid courses, injections of human chorionic gonadotrophin (HCG) at

about the expected time of ovulation.

Clomid therapy is ineffective in patients in whom primary pituitary or ovarian failure

precludes the possibility of stimulating normal function.

Mechanism of action

The ovulatory response to cyclic Clomid therapy appears to be mediated through increased

output of pituitary gonadotrophins, which in turn stimulates the maturation and endocrine

activity of the ovarian follicle and the subsequent development and function of the corpus

luteum. The role of the pituitary is indicated by increased urinary excretion of gonadotrophins

and the response of the ovary, as manifested by increased urinary oestrogen excretion.

Ovulation most often occurs from 6-12 days after a course of Clomid. With this in mind,

coitus should be timed to coincide with the expected time of ovulation.

Although there is no evidence of a "carry over effect" of Clomid, spontaneous ovulatory

menses have been noted after Clomid therapy in some patients.

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Infertile patients with the polycystic ovary syndrome who have not responded to wedge

resection of the ovary may respond to Clomid.

Clinical trials

No data available.

5.2

PHARMACOKINETIC PROPERTIES

Absorption

Orally administered 14C labelled clomifene citrate was readily absorbed when administered

to humans.

Excretion

Cumulative excretion of the 14C label in 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%. Less than 1% per day was excreted in faecal and urine samples collected

from 31 to 53 days after clomifene citrate 14C administration. Some clomifene and/or its

metabolites (here measured as 14C) may therefore remain in the body during early pregnancy

in women who conceive in the menstrual cycle of Clomid treatment.

5.3

PRECLINICAL SAFETY DATA

Genotoxicity

Clomifene citrate did not induce gene mutations in bacteria (Ames test) or chromosome

aberrations in cultured human peripheral blood lymphocytes. Clomifene citrate at oral doses

up to 2000 mg/kg/day did not induce genotoxic effects in rats.

The mutagenic potential of Clomid has not been evaluated. See Section 4.4 Special warnings

and precautions for use.

Carcinogenicity

Epidemiological case control studies reported an increased relative risk for both ovarian

cancer and ovarian tumours of low malignant potential in infertile women who used fertility

drugs compared to women without a history of infertility. However, because infertility is a

primary risk factor for ovarian cancer, and because of other limitations such as small sample

sizes, it cannot be determined from these studies whether the use of fertility drugs increases

the risk of ovarian cancer beyond the effect of infertility.

Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic

potential of Clomid.

See Section 4.4 Special warnings and precautions for use.

clomid-ccdsv7-piv11-04feb20

Page 10 of 12

6

PHARMACEUTICAL PARTICULARS

6.1

LIST OF EXCIPIENTS

Sucrose, lactose monohydrate, pregelatinised maize starch, maize starch and magnesium

stearate, iron oxide yellow.

6.2

INCOMPATIBILITIES

Incompatibilities were either not assessed or not identified as part of the registration of this

medicine.

6.3

SHELF LIFE

In Australia, information on the shelf life can be found on the public summary of the

Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the

packaging.

6.4

SPECIAL PRECAUTIONS FOR STORAGE

Store below 25 degrees Celsius.

6.5

NATURE AND CONTENTS OF CONTAINER

Clomid is available in PVC/Al blister packs of 5 or 10♦ tablets.

Marketed pack

6.6

SPECIAL PRECAUTIONS FOR DISPOSAL

In Australia, any unused medicine or waste material should be disposed of by taking to your

local pharmacy.

6.7

PHYSICOCHEMICAL PROPERTIES

Clomifene citrate is a white to pale yellow powder.

Chemical structure

Clomid contains clomifene citrate, a triarylethylene compound (related to chlorotrianisene and

triparanol).

2-[4–(2–chloro–1,2–diphenylethenyl)phenoxyl]–N,N–diethylethanamine

2–hydroxy–1,2,3-

propanetricarboxylate (1:1) or 2–[p–(2–chloro–1,2–diphenylvinyl) phenoxy] triethylamine

citrate (1:1).

The empirical formula is C

CINO,C

(MW = 598.09).

Public Summary

Summary for ARTG Entry:

313131

CLOMID clomifene citrate 50mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

8/08/2019

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. CLOMID clomifene citrate 50mg tablet blister pack

Product Type

Single Medicine Product

Effective date

8/08/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

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.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

5 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Tablet, uncoated

Route of Administration

Oral

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

Active Ingredients

clomifene citrate

50 mg

Public Summary

Page 1 of

Produced at 30.08.2019 at 04:03:49 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 30.08.2019 at 04:03:49 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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