Clomid 50 mg Tablets (Clomifene Citrate BP) is indicated for the treatment of ovulatory failure in women
desiring pregnancy. Clomid 50 mg Tablets is indicated only for pa􀆟ents in whom ovulatory dysfunc􀆟on is
demonstrated. Other causes of infer􀆟lity must be excluded or adequately treated before giving Clomid 50 mg Tablets.

Posology
Adults
The recommended dose for the first course of Clomid 50 mg Tablets (Clomifene Citrate BP) is 50 mg (1
tablet) daily for 5 days. Therapy may be started at any 􀆟me in the pa􀆟ent who has had no recent uterine
bleeding. If proges􀆟n-induced bleeding is planned, or if spontaneous uterine bleeding occurs before
therapy, the regimen of 50 mg daily for 5 days should be started on or about the fi􀅌h day of the cycle.
When ovula􀆟on occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles
of treatment.
If ovula􀆟on appears not to have occurred a􀅌er the first course of therapy, a second course of 100 mg
daily (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be
started as early as 30 days a􀅌er the previous one. Increase of the dosage or dura􀆟on of therapy beyond
100 mg/day for 5 days should not be undertaken.
The majority of pa􀆟ents who are going to respond will respond to the first course of therapy, and 3
courses should cons􀆟tute an adequate therapeu􀆟c trial. If ovulatory menses have not yet occurred, the
diagnosis should be re-evaluated. Treatment beyond this is not recommended in the pa􀆟ent who does
not exhibit evidence of ovula􀆟on.
Long-term cyclic therapy.
Not recommended.
Efficacy and safety of clomifene for more than 6 treatment cycles have not been demonstrated.
Special Popula􀆟ons
Special care with lower dosage or dura􀆟on of treatment is par􀆟cularly recommended if unusual
sensi􀆟vity to pituitary gonadotrophin is suspected, such as in pa􀆟ents with polycys􀆟c ovary syndrome
(see sec􀆟on 5.1).
Method of Administra􀆟on
Oral.

Pregnancy: See sec􀆟on 4.6. Liver disease: Clomid 50 mg Tablets (Clomifene Citrate BP) therapy is contraindicated in pa􀆟ents with liver disease or a history of liver dysfunc􀆟on. Hormone-Dependent Tumours or Abnormal uterine bleeding: Clomid 50 mg Tablets is contraindicated in pa􀆟ents with hormone-dependent tumours or in pa􀆟ents with abnormal uterine bleeding of undetermined origin. Ovarian cyst: Clomid 50 mg Tablets should not be given in the presence of an ovarian cyst, except polycys􀆟c ovary, since further enlargement of the cyst may occur. Pa􀆟ents should be evaluated for the presence of ovarian cyst prior to each course of treatment.

Warnings:
General:
Good levels of endogenous oestrogen (as es􀆟mated from vaginal smears, endometrial biopsy, assay of
urinary oestrogen, or endometrial bleeding in response to progesterone) provide a favourable prognosis
for ovulatory response induced by Clomid 50 mg Tablets. A low level of oestrogen, although clinically less
favourable, does not preclude successful outcome of therapy. Clomid 50 mg Tablets therapy is ineffec􀆟ve
in pa􀆟ents with primary pituitary or primary ovarian failure. Clomid 50 mg Tablets therapy cannot be
expected to subs􀆟tute for specific treatment of other causes of ovulatory failure, such as thyroid or
adrenal disorders. For hyperprolac􀆟naemia there is other preferred specific treatment. Clomid 50 mg
Tablets is not first line treatment for low weight related amenorrhoea, with infer􀆟lity, and has no value if
a high FSH blood level is observed following an early menopause.
Ovarian Hypers􀆟mula􀆟on Syndrome:
Ovarian Hypers􀆟mula􀆟on Syndrome (OHSS) has been reported in pa􀆟ents receiving Clomid 50 mg
Tablets therapy for ovula􀆟on induc􀆟on. In some cases, OHSS occurred following the cyclic use of Clomid
50 mg Tablets therapy or when Clomid 50 mg Tablets was used in combina􀆟on with gonadotropins. The
following symptoms have been reported in associa􀆟on with this syndrome during Clomid 50 mg Tablets
therapy: pericardial effusion, anasarca, hydrothorax, acute abdomen, renal failure, pulmonary oedema,
ovarian haemorrhage, deep venous thrombosis, torsion of the ovary and acute respiratory distress. If concep􀆟on results, rapid progression to the severe form of the syndrome may occur.
To minimise the hazard of the abnormal ovarian enlargement associated with Clomid 50 mg Tablets
therapy, the lowest dose consistent with expecta􀆟on of good results should be used. The pa􀆟ent should
be instructed to inform the physician of any abdominal or pelvic pain, weight gain, discomfort or
distension a􀅌er taking Clomid 50 mg Tablets. Maximal enlargement of the ovary may not occur un􀆟l
several days a􀅌er discon􀆟nua􀆟on of the course of Clomid 50 mg Tablets. Some pa􀆟ents with polycys􀆟c
ovary syndrome who are unusually sensi􀆟ve to gonadotropin may have an exaggerated response to
usual doses of Clomid 50 mg Tablets.
The pa􀆟ent who complains of abdominal or pelvic pain, discomfort, or distension a􀅌er taking Clomid 50
mg Tablets should be examined because of the possible presence of an ovarian cyst or other cause. Due
to fragility of enlarged ovaries in severe cases, abdominal and pelvic examina􀆟on should be performed
very cau􀆟ously. If abnormal enlargement occurs Clomid 50 mg Tablets should not be given un􀆟l the
ovaries have returned to pre-treatment size. Ovarian enlargement and cyst forma􀆟on associated with
Clomid 50 mg Tablets therapy usually regress spontaneously within a few days or weeks a􀅌er
discon􀆟nuing treatment. Most of these pa􀆟ents should be managed conserva􀆟vely. The dosage and/or
dura􀆟on of the next course of treatment should be reduced.
Visual Symptoms:
Pa􀆟ents should be advised that blurring or other visual symptoms such as spots or flashes (scin􀆟lla􀆟ng
scotomata) may occasionally occur during or shortly a􀅌er therapy with Clomid 50 mg Tablets. These
visual disturbances are usually reversible; however, cases of prolonged visual disturbance have been
reported including a􀅌er Clomid 50 mg Tablet discon􀆟nua􀆟on. The visual disturbances may be
irreversible especially with increased dosage or dura􀆟on of therapy. The significance of these visual
symptoms is not understood. If the pa􀆟ent has any visual symptoms, treatment should be discon􀆟nued,
and ophthalmologic evalua􀆟on performed.
Pa􀆟ents should be warned that visual symptoms may render such ac􀆟vi􀆟es as driving a car or opera􀆟ng
machinery more hazardous than usual, par􀆟cularly under condi􀆟ons of variable ligh􀆟ng.
Hypersensi􀆟vity reac􀆟ons:
Hypersensi􀆟vity reac􀆟ons, including anaphylaxis and angioedema have been reported with Clomid. If
allergic reac􀆟ons occur, treatment with Clomid should be discon􀆟nued, and appropriate symptoma􀆟c
treatment ini􀆟ated (see sec􀆟on 4.8).
Precau􀆟ons:
Cases of hypertriglyceridemia have been reported (see sec􀆟on 4.8) in the post-marke􀆟ng experience
with Clomid 50 mg Tablets. Pre-exis􀆟ng or family history of hyperlipidemia and use of higher than
recommended dose and/or longer dura􀆟on of treatment with Clomid 50 mg Tablets are associated with
risk of hypertriglyceridemia. Periodic monitoring of plasma triglycerides may be indicated in these
pa􀆟ents.
Mul􀆟ple Pregnancy:
There is an increased chance of mul􀆟ple pregnancy when concep􀆟on occurs in rela􀆟onship to Clomid 50
mg Tablets therapy. The poten􀆟al complica􀆟ons and hazards of mul􀆟ple pregnancy should be discussed
with the pa􀆟ent. During the clinical inves􀆟ga􀆟on studies, the incidence of mul􀆟ple pregnancy was 7.9%
(186 of 2369 Clomid 50 mg Tablets associated pregnancies on which outcome was reported). Among
these 2369 pregnancies, 165 (6.9%) twin, 11 (0.5%) triplet, 7 (0.3%) quadruplet and 3 (0.13%)
quintuplet. Of the 165 twin pregnancies for which sufficient informa􀆟on was available, the ra􀆟o of
monozygo􀆟c twins was 1:5.
Ectopic Pregnancy:
There is an increased chance of ectopic pregnancy (including tubal and ovarian sites) in women who
conceive following Clomid 50 mg Tablets therapy. Mul􀆟ple pregnancies, including simultaneous
intrauterine and extrauterine pregnancies, have been reported.
Uterine Fibroids:
Cau􀆟on should be exercised when using Clomid 50 mg Tablets in pa􀆟ents with uterine fibroids due to
poten􀆟al for further enlargement of the fibroids.
Pregnancy Wastage and Birth Anomalies:
The overall incidence of reported birth anomalies from pregnancies associated with maternal Clomid 50
mg Tablets inges􀆟on (before or a􀅌er concep􀆟on) during the inves􀆟ga􀆟onal studies was within the range
of that reported in the published references for the general popula􀆟on. Among the birth anomalies
spontaneously reported in the published literature as individual cases, the propor􀆟on of neural tube
defects has been high among pregnancies associated with ovula􀆟on induced by Clomid 50 mg Tablets,
but this has not been supported by data from popula􀆟on-based studies.
The physician should explain so that the pa􀆟ent understands the assumed risk of any pregnancy whether
the ovula􀆟on was induced with the aid of Clomid 50 mg Tablets or occurred naturally.
The pa􀆟ent should be informed of the greater pregnancy risks associated with certain characteris􀆟cs or
condi􀆟ons of any pregnant woman: e.g. age of female and male partner, history of spontaneous
abor􀆟ons, Rh genotype, abnormal menstrual history, infer􀆟lity history (regardless of cause), organic
heart disease, diabetes, exposure to infec􀆟ous agents such as rubella, familial history of birth anomaly,
and other risk factors that may be per􀆟nent to the pa􀆟ent for whom Clomid 50 mg Tablets is being
considered. Based upon the evalua􀆟on of the pa􀆟ent, gene􀆟c counselling may be indicated.
Popula􀆟on based reports have been published on possible eleva􀆟on of risk of Down’s Syndrome in
ovula􀆟on induc􀆟on cases and of increase in trisomy defects among spontaneously aborted fetuses from
sub-fer􀆟le women receiving ovula􀆟on inducing drugs (no women with Clomid 50 mg Tablets alone and
without addi􀆟onal inducing drug). However, as yet, the reported observa􀆟ons are too few to confirm or
not confirm the presence of an increased risk that would jus􀆟fy amniocentesis other than for the usual
indica􀆟ons because of age and family history.
The experience from pa􀆟ents of all diagnosis during clinical inves􀆟ga􀆟on of Clomid 50 mg Tablets shows
a pregnancy (single and mul􀆟ple) wastage or fetal loss rate of 21.4% (abor􀆟on rate of 19.0%), ectopic
pregnancies, 1.18%, hyda􀆟diform mole, 0.17%, fetus papyraceous, 0.04% and of pregnancies with one or
more s􀆟llbirths, 1.01%.
pregnancies in the clinical inves􀆟ga􀆟ons. Of these 158 pregnancies 8 infants (born of 7 pregnancies)
were reported to have birth defects.
There was no difference in reported incidence of birth defects whether Clomid 50 mg Tablets was given
before the 19th day a􀅌er concep􀆟on or between the 20th and 35th day a􀅌er concep􀆟on. This incidence
is within the an􀆟cipated range of general popula􀆟on.
Ovarian Cancer:
There have been rare reports of ovarian cancer with fer􀆟lity drugs; infer􀆟lity itself is a primary risk factor.

None stated.

Clomid 50 mg Tablets is not indicated during pregnancy. Although there is no evidence that Clomid 50
mg Tablets has a harmful effect on the human fetus, there is evidence that Clomid 50 mg Tablets has a
deleterious effect on rat and rabbit fetuses when given in high doses to the pregnant animal. To avoid
inadvertent Clomid 50 mg Tablets administra􀆟on during early pregnancy, appropriate tests should be
u􀆟lised during each treatment cycle to determine whether ovula􀆟on occurs. The pa􀆟ent should have a
pregnancy test before the next course of Clomid 50 mg Tablets therapy.
It is not known whether Clomifene citrate is excreted in human milk. Clomifene may reduce lacta􀆟on.

Pa􀆟ents should be warned that visual symptoms may render such ac􀆟vi􀆟es as driving a car or opera􀆟ng
machinery more hazardous than usual, par􀆟cularly under condi􀆟ons of variable ligh􀆟ng (see sec􀆟on
4.4).
 

Symptoms/Signs/Condi􀆟ons:
Adverse effects appeared to be dose-related, occurring more frequently at the higher dose and with the
longer courses of treatment used in inves􀆟ga􀆟onal studies. At recommended dosage, adverse effects are
not prominent and infrequently interfere with treatment.
During the inves􀆟ga􀆟onal studies, the more commonly reported adverse effects included ovarian
enlargement (13.6%), vasomotor flushes (10.4%), abdominal-pelvic discomfort (disten􀆟on, bloa􀆟ng)
(5.5%), nausea and vomi􀆟ng (2.2%), breast discomfort (2.1%), visual symptoms (1.5%), headache (1.3%)
and intermenstrual spo􀆫ng or menorrhagia (1.3%).
Ovarian enlargement:
At recommended dosage, abnormal ovarian enlargement is infrequent although the usual cyclic
varia􀆟on in ovarian size may be exaggerated. Similarly, cyclic ovarian pain (mitelschmerz) may be accentuated. With higher or prolonged dosage, more frequent ovarian enlargement and cyst forma􀆟on
may occur, and the luteal phase of the cycle may be prolonged.
Rare instances of massive ovarian enlargement are recorded. Such an instance has been described in a
pa􀆟ent with polycys􀆟c ovary syndrome whose Clomid 50 mg Tablets therapy consisted of 100 mg daily
for 14 days. Abnormal ovarian enlargement usually regresses spontaneously; most of the pa􀆟ents with
this condi􀆟on should be treated conserva􀆟vely.
Eye/Visual Symptoms:
Symptoms described usually as “blurring” or spots or flashes (scin􀆟lla􀆟ng scotomata) increase in
incidence with increasing total dose.
These symptoms appear to be due to intensifica􀆟on and prolonga􀆟on of a􀅌er-images. A􀅌er-images as
such have also been reported. Symptoms o􀅌en first appear or are accentuated with exposure to brightlight
environment. Ophthalmologically definable scotomata, phosphenes and reduced visual acuity have
been reported.
There are rare reports of cataracts and op􀆟c neuri􀆟s.
These visual disturbances are usually reversible. However, cases of prolonged visual disturbance have
been reported, including a􀅌er Clomid 50 mg Tablets have been discon􀆟nued. The visual disturbances
may be irreversible, especially with increased dosage or dura􀆟on of therapy.
Genitourinary:
There are reports of new cases of endometriosis and exacerba􀆟on of pre-exis􀆟ng endometriosis during
Clomid 50 mg Tablets therapy.
Mul􀆟ple pregnancies, including simultaneous intrauterine and extrauterine pregnancies, have been
reported. There is an increased chance of ectopic pregnancy in women who conceive following Clomid
50 mg Tablets therapy.
Reduced endometrial thickness (frequency not known)
Tumours/neoplasms:
Isolated reports have been received on the occurrence of endocrine-related or dependent neoplasms or
their aggrava􀆟on (see sec􀆟on 4.4).
Central nervous system:
Convulsions have been reported; pa􀆟ents with a history of seizures may be predisposed, transient
paraesthesia (frequency not known), dizziness (frequency not known). In inves􀆟ga􀆟onal pa􀆟ents, CNS
symptoms/signs, condi􀆟ons of dizziness, light-headedness/ver􀆟go (0.9%), nervous tension/insomnia
(0.8%) and fa􀆟gue/depression (0.7%) were reported. A􀅌er prescrip􀆟on availability, there were isolated
addi􀆟onal reports of these condi􀆟ons and also reports of other condi􀆟ons such as syncope/fain􀆟ng,
cerebrovascular accident, cerebral thrombosis, psycho􀆟c reac􀆟ons including paranoid psychosis,
neurologic impairment, disorienta􀆟on and speech disturbance.
Psychiatric disorders: 
Anxiety (frequency not known), depression (frequency not known), mood disturbances (including mood
altered, mood swings and irritability) (frequency not known), nervousness (frequency not known),
insomnia (frequency not known).
Dermatoses:
Derma􀆟􀆟s and rash were reported by inves􀆟ga􀆟onal pa􀆟ents. Condi􀆟ons such as rash and ur􀆟caria were
the most common ones reported a􀅌er prescrip􀆟on availability but also reported were condi􀆟ons such as
allergic reac􀆟on, erythema mul􀆟forme, ecchymosis and angioneuro􀆟c oedema. Hair thinning (alopecia)
has been reported very rarely.
Liver func􀆟on:
Bromsulphalein (BSP) reten􀆟on of greater than 5% was reported in 32 of 141 pa􀆟ents in whom it was
measured, including 5 of 43 pa􀆟ents who took approximately the dose of Clomid 50 mg Tablets now
recommended. Reten􀆟on was usually minimal unless associated with prolonged con􀆟nuous Clomid 50
mg Tablets administra􀆟on or with apparently unrelated liver disease. Other liver func􀆟on tests were
usually normal. In a later study in which pa􀆟ents were given 6
consecu􀆟ve monthly courses of Clomid 50 mg Tablets (50 mg or 100 mg daily for 3 days) or matching
placebo, BSP tests were done on 94 pa􀆟ents. Values in excess of 5% reten􀆟on were recorded in 11
pa􀆟ents, 6 of whom had taken drug and 5 placebos.
In a separate report, one pa􀆟ent taking 50 mg of Clomid 50 mg Tablets daily developed jaundice on the
19th day of treatment; liver biopsy revealed bile stasis without evidence of hepa􀆟􀆟s.
Metabolism disorders:
Hypertriglyceridemia (frequency not known), in some cases with pancrea􀆟􀆟s, has been observed in
pa􀆟ents with pre-exis􀆟ng or a family history of hypertriglyceridemia and/or with dose and dura􀆟on of
treatment exceeding the label recommenda􀆟ons.
Immune system disorders:
Hypersensi􀆟vity reac􀆟ons, including anaphylaxis and angioedema (frequency not known).
Cardiac disorders:
Tachycardia, (frequency not known) palpita􀆟ons (frequency not known)
Hepatobiliary disorders:
Increased Transaminases
Gastrointes􀆟nal disorders:
Pancrea􀆟􀆟s (frequency not known)
To report any side effect(s):
• Saudi Arabia:
- The Na􀆟onal Pharmacovigilance and Drug Safety Centre (NPC)
• SFDA call center : 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: htps://ade.sfda.gov.sa/
• Sanofi- Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com

Toxic effects of acute overdosage of Clomid 50 mg Tablets have not been reported but the number of
overdose cases recorded is small. In the event of overdose, appropriate suppor􀆟ve measures should be
employed.

Pharmacotherapeu􀆟c group: ovula􀆟on s􀆟mulants, synthe􀆟c
ATC code: G03BG02
Mechanism of ac􀆟on:
The ovulatory response to cyclic Clomid 50 mg Tablets therapy is mediated through increased output of
pituitary gonadotrophins, which in turn s􀆟mulates the matura􀆟on and endocrine ac􀆟vity of the ovarian
follicle.
Pharmacodynamic effects:
Clomid 50 mg Tablets is a triarylethylene compound (related to chlorotrianisene and triparanol). It is a
non-steroidal agent which s􀆟mulates ovula􀆟on in a high percentage of appropriately selected
anovulatory women.

Orally administered 14C labelled Clomifene citrate was readily absorbed when administered to humans.
Cumula􀆟ve excre􀆟on of the 14C label by way of urine and feces averaged about 50% of the oral dose
a􀅌er 5 days in 6 subjects, with mean urinary excre􀆟on of 7.8% and mean fecal excre􀆟on of 42.4%.
A mean rate of excre􀆟on of 0.73% per day of the 14C dose a􀅌er 31 – 35 days and 0.45% per day of the
14C dose a􀅌er 42 – 45 days was seen in fecal and urine samples collected from 6 subjects for 14 – 53
days a􀅌er Clomifene citrate 14C administra􀆟on.
The remaining drug/metabolites may be slowly excreted from a sequestered enterohepa􀆟c recircula􀆟on
pool.

Long-term carcinogenicity studies have not been performed to evaluate the carcinogenic poten􀆟al of
Clomid.
Clomifene citrate did not induce gene muta􀆟ons in bacteria (Ames test) or chromosome aberra􀆟ons in
cultured human peripheral blood lymphocytes. Clomifene citrate at oral doses up to 2000 mg/kg/day did
not induce genotoxic effects in rats. At the highest dose tested of 2000 mg/kg/day in rats, the ra􀆟os of
exposure ranged from 2 – 232 for Z-clomifene and E-clomifene respec􀆟vely, taking into account limited
PK data available in humans.

Sucrose
Lactose
Soluble starch
Maize starch
Magnesium stearate
Iron oxide yellow E172
Purified Water

Not applicable.

3 years.

Store in original container, do not store above 25C.

Blister pack:
Base: 250-micron PVC
Foil: 20 micron hard-tempered aluminium
(in cardboard cartons)
Pack sizes: 30 and 100 tablets.

None.