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CLOMIFENE CITRATE 50MG TABLETS

Active substance(s): CLOMIFENE CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CLOMID®

Do not take this medicine and tell your doctor if:


50MG TABLETS

(clomifene 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.
2.
3.
4.
5.
6.

What Clomid 50mg Tablets are and what they are used
for
What you need to know before you take Clomid 50mg
Tablets
How to take Clomid 50mg Tablets
Possible side effects
How to store Clomid 50mg Tablets
Contents of the pack and other information

1. What Clomid 50mg Tablets are and what
they are used for
Clomid 50mg Tablets contain a medicine called clomifene
citrate. This belongs to a group of medicines called ovulation
stimulants. It works by stimulating the release of eggs from
the ovary (ovulation).







You are allergic (hypersensitive) to clomifene or any of
the other ingredients of Clomid 50mg Tablets (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 Clomid 50mg
Tablets.

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

Take special care with Clomid 50mg Tablets
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 hypertriglyceridaemia (an excess of fats in the
blood) or a family history of hypertriglyceridaemia.

Your doctor should check for any other causes of fertility
problems before starting treatment with Clomid 50mg
Tablets.

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.

Clomid 50mg Tablets contain 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
Clomid 50mg Tablets.

3. How to take Clomid 50mg Tablets
Always take Clomid 50mg Tablets 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

Clomid 50mg Tablets are used for some types of infertility, in
women who are not ovulating properly.

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Clomid 50mg
Tablets.



2. What you need to know before you take
Clomid 50mg Tablets

Taking other medicines

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

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 Clomid 50mg Tablets.
You should talk to your doctor about the possible risks before
you take Clomid 50mg Tablets.


Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
you buy without a prescription, including herbal medicines.
This is because Clomid 50mg Tablets can affect the way some
other medicines work. Also some medicines can affect the
way Clomid 50mg Tablets work.

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. Clomid 50mg
Tablets can lower the amount of milk produced.

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

Page 1 of 2

If you take more Clomid 50mg Tablets than you
should

If you take more Clomid 50mg Tablets 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 Clomid 50mg Tablets

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 Clomid 50mg Tablets

Keep taking Clomid 50mg Tablets 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.

4. Possible side effects
Like all medicines, Clomid 50mg Tablets can cause side
effects, although not everybody gets them.

Stop taking Clomid 50mg Tablets 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 Clomid 50mg Tablets 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 Clomid 50mg Tablets
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 clomifene
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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Clomid 50mg Tablets










KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
Do not use after the expiry date printed on the carton
label or blister strip. The expiry date refers to the last
day of that month.
Do not store above 25°C. Protect from light and
moisture.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any signs of
deterioration, you should ask your pharmacist who will
advise you what to do.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

Page 2 of 2

6. Contents of the pack and other
information
What Clomid 50mg Tablets contain

Each tablet contains 50mg of the active ingredient, clomifene
citrate.
Clomid 50mg Tablets also contain the following inactive
ingredients: sucrose, lactose, soluble maize starch,
magnesium stearate, maize starch and yellow iron oxide
(E172).

What Clomid 50mg Tablets look like and contents of
the pack
Clomid 50mg Tablets are beige tablets coded with 'M' logo.

They are available as blister packs of 10 tablets or 30 tablets.

Manufacturer

Manufactured by: Doppel Farmaceutici S.R.L., Stradone
Farneses, 118 29100 Piacenza, Italy.
Or
DOPPEL Farmaceutici S.r.l., Via Martiri delle Foibe, 1,
29016 Cortemaggiore, Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3
1QR.
Product Licence holder: Doncaster Pharmaceuticals Group
Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0247

POM

Leaflet revision and issue date (Ref.) 03.01.18
Clomid® is a registered trademark of Aventis Pharma Ltd.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the following
information:
Product name: Clomid 50mg Tablets
Reference No: 04423/0247

PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not take this medicine and tell your doctor if:


CLOMIFENE CITRATE 50MG TABLETS
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.
2.
3.
4.
5.
6.

What Clomifene Citrate 50mg Tablets are and what they
are used for
What you need to know before you take Clomifene
Citrate 50mg Tablets
How to take Clomifene Citrate 50mg Tablets
Possible side effects
How to store Clomifene Citrate 50mg Tablets
Contents of the pack and other information

1. What Clomifene Citrate 50mg Tablets are
and what they are used for
Clomifene Citrate 50mg Tablets contain a medicine called
clomifene citrate. This belongs to a group of medicines called
ovulation stimulants. It works by stimulating the release of
eggs from the ovary (ovulation).
Clomifene Citrate 50mg Tablets are used for some types of
infertility, in women who are not ovulating properly.

2. What you need to know before you take
Clomifene Citrate 50mg Tablets
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 Clomifene Citrate
50mg Tablets. You should talk to your doctor about the
possible risks before you take Clomifene Citrate 50mg
Tablets.





You are allergic (hypersensitive) to clomifene or any of
the other ingredients of Clomifene Citrate 50mg Tablets
(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 Clomifene Citrate
50mg Tablets

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

Take special care with
Clomifene Citrate 50mg Tablets
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 hypertriglyceridaemia (an excess of fats in the
blood) or a family history of hypertriglyceridaemia.

Your doctor should check for any other causes of fertility
problems before starting treatment with Clomifene Citrate
50mg Tablets.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Clomifene Citrate
50mg Tablets.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
you buy without a prescription, including herbal medicines.
This is because Clomifene Citrate 50mg Tablets can affect the
way some other medicines work. Also some medicines can
affect the way Clomifene Citrate 50mg Tablets work.

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. Clomifene
Citrate 50mg Tablets can lower the amount of milk
produced.

Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Page 1 of 2

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.

Clomifene Citrate 50mg Tablets contain 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
Clomifene Citrate 50mg Tablets.

3. How to take Clomifene Citrate 50mg
Tablets
Always take Clomifene Citrate 50mg Tablets 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 Clomifene Citrate 50mg Tablets
than you should

If you take more Clomifene Citrate 50mg Tablets 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 Clomifene Citrate 50mg
Tablets

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 Clomifene Citrate 50mg Tablets

Keep taking Clomifene Citrate 50mg Tablets 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.

4. Possible side effects
Like all medicines, Clomifene Citrate 50mg Tablets can cause
side effects, although not everybody gets them.

Stop taking Clomifene Citrate 50mg Tablets 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 Clomifene Citrate 50mg Tablets 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
Clomifene Citrate 50mg Tablets
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 clomifene
may increase this risk. Therefore the recommended duration
of treatment should not be exceeded.

6. Contents of the pack and other
information

What Clomifene Citrate 50mg Tablets contain

Each tablet contains 50mg of the active ingredient, clomifene
citrate.
Clomifene Citrate 50mg Tablets also contain the following
inactive ingredients: sucrose, lactose, soluble maize starch,
magnesium stearate, maize starch and yellow iron oxide
(E172).

What Clomifene Citrate 50mg Tablets look like and
contents of the pack

Clomifene Citrate 50mg Tablets are beige tablets coded with
'M' logo.
They are available as blister packs of 10 tablets or 30 tablets.

Manufacturer

Manufactured by: Doppel Farmaceutici S.R.L., Stradone
Farneses, 118 29100 Piacenza, Italy. Or
DOPPEL Farmaceutici S.r.l., Via Martiri delle Foibe, 1,
29016 Cortemaggiore, Italy.

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.

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3
1QR.

Reporting of side effects

Product Licence holder: Doncaster Pharmaceuticals Group
Ltd., Kirk Sandall, Doncaster, DN3 1QR.

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Clomifene Citrate 50mg
Tablets










KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
Do not use after the expiry date printed on the carton
label or blister strip. The expiry date refers to the last
day of that month.
Do not store above 25°C. Protect from light and
moisture.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any signs of
deterioration, you should ask your pharmacist who will
advise you what to do.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

Page 2 of 2

PL No: 04423/0247

POM

Leaflet revision and issue date (Ref.) 03.01.18

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the following
information:
Product name:
Clomifene Citrate 50mg Tablets
Reference No: 04423/0247

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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