Clomiphene Citrate Tablets BP 50mg Taj Pharma

Name of the medicinal product

Clomiphene Citrate Tablets BP 25mg Taj Pharma
Clomiphene Citrate Tablets BP 50mg Taj Pharma
Clomiphene Citrate Tablets BP 100mg Taj Pharma

Qualitative and quantitative composition

a) Each Uncoated tablet contains:
Clomiphene Citrate 25mg
Excipients q.s

b) Each Uncoated tablet contains:
Clomiphene Citrate 50mg
Excipients q.s

c) Each Uncoated tablet contains:
Clomiphene Citrate 100mg
Excipients q.s

Pharmaceutical form

Tablet

Clinical particulars

4.1 Therapeutic indications

Clomiphene Citrate 25mg Tablets 25mg Tablets (Clomiphene Citrate BP) is indicated for the treatment of ovulatory failure in women desiring pregnancy. Clomiphene Citrate 50mg Tablets 25mg Tablets is indicated only for patients in whom ovulatory dysfunction is demonstrated. Other causes of infertility must be excluded or adequately treated before giving Clomiphene Citrate 25mg Tablets 25mg Tablets.

4.2 Posology and method of administration

Route of Administration

Oral

Adults Only:

The recommended dose for the first course of Clomiphene Citrate 50mg Tablets 50mg Tablets (Clomiphene Citrate BP) 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 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. Increase of the dosage or duration of therapy beyond 100mg/day for 5 days should not be undertaken.

The majority of patients who are going to respond will respond to the first course of therapy, and 3 courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the diagnosis should be re-evaluated. Treatment beyond this is not recommended in the patient who does not exhibit evidence of ovulation.

Long-term cyclic therapy.

Not recommended.

The relative safety of long-term cyclic therapy has not been conclusively demonstrated and, since the majority of patients will ovulate following 3 courses, long-term cyclic therapy is not recommended, i.e. beyond a total of about 6 cycles (including 3 ovulatory cycles).

Special Populations

Special care with lower dosage or duration of treatment is particularly recommended if unusual sensitivity to pituitary gonadotrophin is suspected, such as in patients with polycystic ovary syndrome (See Section 5.1).

4.3 Contraindications

Pregnancy: See 4.6

Liver disease: Clomiphene Citrate 25mg Tablets 25mg Tablets (Clomiphene Citrate BP) therapy is contraindicated in patients with liver disease or a history of liver dysfunction.

Abnormal uterine bleeding: Clomiphene Citrate 25mg Tablets 25mg Tablets is contraindicated in patients with hormone-dependent tumours or in patients with abnormal uterine bleeding of undetermined origin.

Ovarian cyst: Clomiphene Citrate 25mg Tablets 25mg Tablets 25mg Tablets 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

Warnings:

General: Good levels of endogenous oestrogen (as estimated 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 Clomiphene Citrate 50mg Tablets. A low level of oestrogen, although clinically less favourable, does not preclude successful outcome of therapy. Clomiphene Citrate 50mg Tablets therapy is ineffective in patients with primary pituitary or primary ovarian failure. Clomiphene Citrate 50mg Tablets therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure, such as thyroid or adrenal disorders. For hyperprolactinaemia there is other preferred specific treatment. Clomiphene Citrate 50mg Tablets is not first line treatment for low weight related amenorrhoea, with infertility, and has no value if a high FSH blood level is observed following an early menopause.

Ovarian Hyperstimulation Syndrome: Ovarian Hyperstimulation Syndrome (OHSS) has been reported in patients receiving Clomiphene Citrate 50mg Tablets therapy for ovulation induction. In some cases, OHSS occurred following the cyclic use of Clomiphene Citrate 50mg Tablets therapy or when Clomiphene Citrate 50mg Tablets was used in combination with gonadotropins. The following symptoms have been reported in association with this syndrome during Clomiphene Citrate 50mg 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 conception results, rapid progression to the severe form of the syndrome may occur.

To minimise the hazard of the abnormal ovarian enlargement associated with Clomiphene Citrate 50mg Tablets therapy, the lowest dose consistent with expectation of good results should be used. The patient should be instructed to inform the physician of any abdominal or pelvic pain, weight gain, discomfort or distension after taking Clomiphene Citrate 50mg Tablets. Maximal enlargement of the ovary may not occur until several days after discontinuation of the course of Clomiphene Citrate 50mg Tablets. Some patients with polycystic ovary syndrome who are unusually sensitive to gonadotropin may have an exaggerated response to usual doses of Clomiphene Citrate 50mg Tablets.

The patient who complains of abdominal or pelvic pain, discomfort, or distension after taking Clomiphene Citrate 50mg 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 examination should be performed very cautiously. If abnormal enlargement occurs Clomiphene Citrate 50mg Tablets should not be given until the ovaries have returned to pre-treatment size. Ovarian enlargement and cyst formation associated with Clomiphene Citrate 50mg Tablets therapy usually regress spontaneously within a few days or weeks after discontinuing treatment. Most of these patients should be managed conservatively. The dosage and/or duration of the next course of treatment should be reduced.

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 therapy with Clomiphene Citrate 50mg Tablets. These visual disturbances are usually reversible; however, cases of prolonged visual disturbance have been reported including after Clomiphene Citrate 50mg Tablet discontinuation. The visual disturbances may be irreversible especially with increased dosage or duration of therapy. The significance of these visual symptoms is not understood. If the patient has any visual symptoms, treatment should be discontinued and ophthalmologic evaluation performed.

Patients should be warned that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting.

Precautions:

Cases of hypertriglyceridemia have been reported (see section 4.8 Undesirable effects) in the post-marketing experience with Clomiphene Citrate 50mg Tablets. Pre-existing or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment with Clomiphene Citrate 50mg Tablets are associated with risk of hypertriglyceridemia. Periodic monitoring of plasma triglycerides may be indicated in these patients.

Multiple Pregnancy: There is an increased chance of multiple pregnancy when conception occurs in relationship to Clomiphene Citrate 50mg Tablets therapy. The potential complications and hazards of multiple pregnancy should be discussed with the patient. During the clinical investigation studies, the incidence of multiple pregnancy was 7.9% (186 of 2369 Clomiphene Citrate 50mg 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 information was available, the ratio of monozygotic twins was 1:5.

Ectopic Pregnancy: There is an increased chance of ectopic pregnancy (including tubal and ovarian sites) in women who conceive following Clomiphene Citrate 50mg Tablets therapy. Multiple pregnancies, including simultaneous intrauterine and extrauterine pregnancies, have been reported.

Uterine Fibroids: Caution should be exercised when using Clomiphene Citrate 50mg Tablets in patients with uterine fibroids due to potential for further enlargement of the fibroids.

Pregnancy Wastage and Birth Anomalies: The overall incidence of reported birth anomalies from pregnancies associated with maternal Clomiphene Citrate 50mg Tablets ingestion (before or after conception) during the investigational studies was within the range of that reported in the published references for the general population. Among the birth anomalies spontaneously reported in the published literature as individual cases, the proportion of neural tube defects has been high among pregnancies associated with ovulation induced by Clomiphene Citrate 50mg Tablets, but this has not been supported by data from population based studies.

The physician should explain so that the patient understands the assumed risk of any pregnancy whether the ovulation was induced with the aid of Clomiphene Citrate 50mg Tablets or occurred naturally.

The patient should be informed of the greater pregnancy risks associated with certain characteristics or conditions of any pregnant woman: e.g. age of female and male partner, history of spontaneous abortions, Rh genotype, abnormal menstrual history, infertility history (regardless of cause), organic heart disease, diabetes, exposure to infectious agents such as rubella, familial history of birth anomaly, and other risk factors that may be pertinent to the patient for whom Clomiphene Citrate 50mg Tablets is being considered. Based upon the evaluation of the patient, genetic counselling may be indicated.

Population based reports have been published on possible elevation of risk of Down’s Syndrome in ovulation induction cases and of increase in trisomy defects among spontaneously aborted foetuses from subfertile women receiving ovulation inducing drugs (no women with Clomiphene Citrate 50mg Tablets alone and without additional inducing drug). However, as yet, the reported observations are too few to confirm or not confirm the presence of an increased risk that would justify amniocentesis other than for the usual indications because of age and family history.

The experience from patients of all diagnosis during clinical investigation of Clomiphene Citrate 50mg Tablets shows a pregnancy (single and multiple) wastage or foetal loss rate of 21.4% (abortion rate of 19.0%), ectopic pregnancies, 1.18%, hydatidiform mole, 0.17%, foetuspapyraceous, 0.04% and of pregnancies with one or more stillbirths, 1.01%.

Clomiphene Citrate 50mg Tablets therapy after conception was reported for 158 of the 2369 delivered and reported pregnancies in the clinical investigations. 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 Clomiphene Citrate 50mg Tablets was given before the 19th day after conception or between the 20th and 35th day after conception. This incidence is within the anticipated range of general population.

Ovarian Cancer: There have been rare reports of ovarian cancer with fertility drugs; infertility itself is a primary risk factor. Epidemiological data suggest that prolonged use of Clomiphene Citrate 50mg Tablets may increase this risk. Therefore the recommended duration of treatment should not be exceeded (see section 4.2).

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

Clomiphene Citrate 25mg Tablets is not indicated during pregnancy. Although there is no evidence that Clomiphene Citrate 25mg Tablets has a harmful effect on the human foetus, there is evidence that Clomiphene Citrate 50mg Tablets has a deleterious effect on rat and rabbit foetuses when given in high doses to the pregnant animal. To avoid inadvertent Clomiphene Citrate 50mg Tablets administration during early pregnancy, appropriate tests should be utilised during each treatment cycle to detennine whether ovulation occurs. The patient should have a pregnancy test before the next course of Clomiphene Citrate 50mg Tablets therapy.

It is not known whether Clomiphene citrate is excreted in human milk. Clomiphene may reduce lactation.

4.7 Effects on ability to drive and use machines

Patients should be warned that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting. (See ‘Warnings’)

4.8 Undesirable effects

Symptoms/Signs/Conditions: Adverse effects appeared to be dose—related, occurring more frequently at the higher dose and with the longer courses of treatment used in investigational studies. At recommended dosage, adverse effects are not prominent and infrequently interfere with treatment.

During the investigational studies, the more commonly reported adverse effects included ovarian enlargement (13.6%), vasomotor flushes (10.4%), abdominal-pelvic discomfort (distention, bloating) (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%).

Ovarian enlargement: At recommended dosage, abnormal ovarian enlargement is infrequent although the usual cyclic variation in ovarian size may be exaggerated. Similarly, cyclic ovarian pain (mittelschmerz) may be accentuated. With higher or prolonged dosage, more frequent ovarian enlargement and cyst formation 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 patient with polycystic ovary syndrome whose Clomiphene Citrate 50mg Tablets therapy consisted of 100mg daily for 14 days. Abnormal ovarian enlargement usually regresses spontaneously; most of the patients with this condition should be treated conservatively.

Eye/Visual Symptoms: 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 bright-light environment. Ophthalmologically definable scotomata, phosphenes and reduced visual acuity have been reported.

There are rare reports of cataracts and optic neuritis.

These visual disturbances are usually reversible. However, cases of prolonged visual disturbance have been reported, including after Clomiphene Citrate 50mg Tablets have been discontinued. The visual disturbances may be irreversible, especially with increased dosage or duration of therapy.

Genitourinary: There are reports of new cases of endometriosis and exacerbation of pre-existing endometriosis during Clomiphene Citrate 50mg Tablets therapy.

Multiple pregnancies, including simultaneous intrauterine and extrauterine pregnancies, have been reported. There is an increased chance of ectopic pregnancy in women who conceive following Clomiphene Citrate 50mg 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 aggravation. Ovarian cancer: see section 4.4.

Central nervous system: Convulsions have been reported; patients with a history of seizures may be predisposed, transient paraesthesia (frequency not known), dizziness (frequency not known). In investigational patients, CNS symptoms/signs, conditions of dizziness, light-headedness/vertigo (0.9%), nervous tension/insonmia (0.8%) and fatigue/depression (0.7%) were reported. After prescription availability, there were isolated additional reports of these conditions and also reports of other conditions such as syncope/fainting, cerebrovascular accident, cerebral thrombosis, psychotic reactions including paranoid psychosis, neurologic impairment, disorientation 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: Dermatitis and rash were reported by investigational patients. Conditions such as rash and urticaria were the most common ones reported after prescription availability but also reported were conditions such as allergic reaction, erythema multiforme, ecchymosis and angioneuroticoedema. Hair thinning (alopecia) has been reported very rarely.

Liver function: Bromsulphalein (BSP) retention of greater than 5% was reported in 32 of 141 patients in whom it was measured, including 5 of 43 patients who took approximately the dose of Clomiphene Citrate 50mg Tablets now recommended. Retention was usually minimal unless associated with prolonged continuous Clomiphene Citrate 50mg Tablets administration or with apparently unrelated liver disease. Other liver function tests were usually normal. In a later study in which patients were given 6 consecutive monthly courses of Clomiphene Citrate 50mg Tablets (50 or 100mg daily for 3 days) or matching placebo, BSP tests were done on 94 patients. Values in excess of 5% retention were recorded in 11 patients, 6 of whom had taken drug and 5 placebo.

In a separate report, one patient taking 50mg of Clomiphene Citrate 50mg Tablets daily developed jaundice on the 19th day of treatment; liver biopsy revealed bile stasis without evidence of hepatitis.

Metabolism Disorders: Hypertriglyceridemia (frequency: not known), 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.

Cardiac disorders: Tachycardia, (frequency not known) palpitations (frequency not known)

Hepatobiliary disorders: Increased Transaminases

Gastrointestinal disorders: Pancreatitis (frequency not known)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

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

Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: ovulation stimulants, synthetic

Mechanism of action:

The ovulatory response to cyclic Clomiphene Citrate 50mg 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:

Clomiphene Citrate 50mg 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 anovulatory women.

5.2 Pharmacokinetic properties

Orally administered ¹⁴C labelledClomiphene citrate was readily absorbed when administered to humans. Cumulative excretion of the ¹⁴C 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 ¹⁴C dose after 31 days to 35 days and 0.45% per day of the ¹⁴C dose after 42 days to 45 days was seen in faecal and urine samples collected from 6 subjects for 14 to 53 days after Clomiphene citrate ¹⁴C administration. The remaining drug/metabolites may be slowly excreted from a sequestered enterohepatic recirculation pool.

5.3 Preclinical safety data

Carcinogenicity

Prolonged use of Clomiphene Citrate 50mg Tablets may increase the risk of developing ovarian cancer.

Long term toxicity studies in animals have not been performed to evaluate the carcinogenic potential of Clomiphene Citrate 25mg Tablets.

Mutagenicity

Mutagenic potential of Clomiphene Citrate 50mg Tablets has not been evaluated.

Pharmaceutical particulars

6.1 List of excipients

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Blister pack:

Base: 250 micron PVC

Foil: 20 micron hard-tempered aluminium

(in cardboard cartons)

Pack sizes: 30 and 100 tablets.

6.6 Special precautions for disposal and other handling

None.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Clomiphene Citrate Tablets BP 25mg Taj Pharma
Clomiphene Citrate Tablets BP 50mg Taj Pharma
Clomiphene Citrate Tablets BP 100mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clomiphene citrate 25mg Tablets

Clomiphene citrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed to you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet:

1. What Clomiphene citrate is and what it is used for
2. What you need to know before you take Clomiphene citrate
3. How to take Clomiphene citrate
4. Possible side effects
5. How to store Clomiphene citrate
6. Contents of the pack and other information

What Clomiphene citrate is and what it is used for

Clomiphene citrate contains a medicine called Clomiphene citrate. This belongs to a group of medicines called ovulation stimulants. It works by stimulating the release of eggs from the ovary (ovulation). Clomiphene citrate is used for some types of infertility, in women who are not ovulating properly.

What you need to know before you take Clomiphene citrate

Before you take the medicine 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)
A possible increased risk of ovarian cancer Any pregnancy could lead to birth defects or miscarriage. This can happen even if you are not taking Clomiphene citrate . You should talk to your doctor about the possible risks before you take Clomiphene citrate .

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to Clomiphene or any of the other ingredients of Clomiphene citrate (listed in Section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
You have or ever had liver disease
You have unusual menstrual bleeding where the cause is not known
You have a type of cancer that is made worse by hormones
You have a cyst on your ovary
You are pregnant. You should have a test to make sure you are not pregnant before you take Clomiphene citrate

Do not take this medicine if any of the above apply to you.

Take special care with Clomiphene citrate

Check with your doctor or pharmacist before taking your medicine if:

You are having an early menopause or have been told you are infertile
You have stopped having periods because you are under-weight
You have had fits or seizures in the past
You have ‘fibroids’ in your womb
You have ‘polycystic’ ovaries
Your ovaries are swollen
You have hypertriglyceridemia (an excess of fats in the blood) or a family history of hypertriglyceridemia.

Your doctor should check for any other causes of fertility problems before starting treatment with Clomiphene citrate .

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Clomiphene citrate .

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy with a prescription, including herbal medicines. This is because Clomiphene citrate can affect the way some other medicines work. Also some medicines can affect the way Clomiphene citrate works.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or think you may be pregnant
Talk to your doctor before taking this medicine if you are breast-feeding or planning to breast-feed. Clomiphene citrate can lower the amount of milk produced.

Ask you doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may notice problems with your eyesight such as blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines.

Clomiphene citrate contains lactose and sucrose

This medicine contains lactose and sucrose, which are types of sugar. If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking Clomiphene citrate .

How to take Clomiphene citrate

Always take Clomiphene citrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

Take this medicine by mouth
Swallow the tablets whole with a drink of water.
Do not crush or chew your tablets
Do not take more than two tablets in one day
Do not take the tablets for more than five days at a time
If you feel the effect of your medicine is not working, do not change the dose yourself, but ask your doctor

The usual dose is:

Adult women only:

Your doctor will tell you when in your menstrual cycle to start taking the tablets
For the first course of treatment, take one tablet a day for five days
If you do not have a period after the first course of treatment your doctor will increase your dose to two tablets a day for five days
You should start this second course at least 30 days after the first course
You will not usually take more than three courses of treatment. If ovulation does not happen after three courses talk to your doctor

This medicine should not be taken by children, adolescents, men or women who have already gone through the menopause (post-menopausal).

If you take more Clomiphene citrate than you should

If you take more Clomiphene citrate than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

You are likely to get over-stimulation of your ovary (see section 4 below).

If you forget to take Clomiphene citrate

If you forget a dose, talk to your doctor as you may need to change your treatment cycle. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clomiphene citrate

Keep taking Clomiphene citrate until your doctor tells you to stop. If you stop, the treatment may not work.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side-effects

Like all medicines, Clomiphene citrate can cause side effects, although not everybody gets them.

Stop taking Clomiphene citrate and see your doctor or go to a hospital straight away if:

You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
You have numbness, weakness or paralysis on one side of your body, slurred speech, sudden blurred vision, confusion or unsteadiness. These could be signs of a stroke

Stop taking Clomiphene citrate and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

Over-stimulation of the ovary. This can lead to pain in the pelvis, stomach or calves, swelling or feeling bloated, passing less urine, difficulty in breathing or an increase in weight. If this happens, your doctor may lower your dose of Clomiphene citrate
Blurring of vision or spots or flashes in front of the eyes. These symptoms usually get better but in some cases they may be permanent. Your doctor may send you for an eye examination.
Liver problems that may cause the eyes or skin to go yellow (jaundice)
Sudden and severe headaches
Mental illness such as ‘psychosis’

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Increased pain with periods, heavy periods or bleeding between periods
Pain in the lower part of the stomach. This could be a sign of endometriosis or worsening of endometriosis, ovarian cancer or enlarged ovaries
Thinning of the layer covering the inside of the uterus.
Increased levels of fat in the blood (hypertriglyceridaemia) which may also cause inflammation of the pancreas.
Pain in the upper middle or upper left part of the abdomen. This could be a sign of inflammation of the pancreas (pancreatitis).
Cloudy lenses in the eye (cataracts)
Fits, feeling faint, disorientated or more tense than normal. Also, balance problems or feeling dizzy (vertigo)
Feeling tired or difficulty in sleeping (insomnia), depression or change in moods or behaviour
Rapid or irregular heartbeat
Speech problems
Skin rash or itching
Feeling or being sick
Flushing of the skin
Headaches
Swelling of the face, around the eyes, lips or tongue
Painful breasts
Hair loss or thinning
Increased levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
Numbness or tingling on your skin (paraesthesia)
Feeling anxious
Feeling more nervous than usual.

There have been rare reports of ovarian cancer with fertility drugs. Some studies suggest that prolonged use of Clomiphene may increase this risk. Therefore the recommended duration of treatment should not be exceeded.

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days or if you notice any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the leaflet.

How to store Clomiphene citrate

Keep out of sight and reach of children.

Store in the original container below 25°C.

Do not use Clomiphene citrate after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Clomiphene citrate contains

Each tablet contains 25mg of the active substance, Clomiphene citrate
The other ingredients are sucrose, lactose, soluble starch, maize starch, magnesium stearate, iron oxide yellow, purified water

What Clomiphene citrate looks like and contents of the pack

Clomiphene citrate 50mg Tablets are beige and round.

They are supplied in PVC and aluminium blister packs. Pack sizes 10, 30 or 100 tablets.