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CLOMIFENE CITRATE 50MG TABLETS

Active substance(s): CLOMIFENE CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not take this medicine and tell your doctor if:
ƒ

CLOMID® 50MG TABLETS
(clomifene citrate)

Read all of this leaflet carefully before you
start taking this medicine
ƒ
ƒ
ƒ

ƒ

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 for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Clomid 50mg Tablets are and what they are used for
Before you take Clomid 50mg Tablets
How to take Clomid 50mg Tablets
Possible side effects
How to store Clomid 50mg Tablets
Further 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).
Clomid 50mg Tablets are used for some types of infertility, in
women who are not ovulating properly.

2. Before you take Clomid 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)
ƒ
Pregnancies where the baby grows outside of the womb
(ectopic)
ƒ
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.
ƒ

ƒ
ƒ
ƒ
ƒ
ƒ

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:
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

You are having an early menopause or have been told you
are infertile
You have stopped having periods because you are underweight
You have had fits or seizures in the past
You have ‘fibroids’ in your womb
You have ‘polycystic’ ovaries
Your ovaries are swollen

Important information about some of the
ingredients of Clomid 50mg Tablets

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
ƒ
ƒ
ƒ
ƒ
ƒ

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:
ƒ
ƒ

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

ƒ

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

ƒ

Taking other medicines

Please 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
ƒ
ƒ

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.

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.

ƒ

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 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.

Page 1 of 2

4. Possible side effects

5. How to store Clomid 50mg Tablets

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

ƒ
ƒ

Stop taking Clomid 50mg Tablets and see your
doctor or go to a hospital straight away if:
ƒ

ƒ

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

ƒ
ƒ

ƒ

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.

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:

ƒ

ƒ

6. Further Information

ƒ

ƒ
ƒ
ƒ

Over-stimulation of the ovary. This can lead to pain in the
pelvis, stomach or calf, 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
ƒ
Pain in the lower part of the stomach. This could be a sign of
endometriosis or worsening of endometriosis, ovarian cancer
or enlarged ovaries
ƒ
Cloudy lenses in the eye (cataracts)
ƒ
Fits, feeling faint, dis-orientated or more tense than normal.
Also, balance problems or feeling dizzy (vertigo)
ƒ
Feeling tired or difficulty in sleeping (insomnia), depression
or change in moods or behaviour
ƒ
Speech problems
ƒ
Skin rash or itching
ƒ
Feeling or being sick
ƒ
Flushing of the skin
ƒ
Headaches
ƒ
Swelling of the face, around the eyes, lips or tongue
ƒ
Painful breasts
ƒ
Hair loss or thinning
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.
ƒ

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.

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.) 09.10.12
Clomid® is a registered trademark of Aventis Pharma Ltd.

Other formats

To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information
Product name
Clomid 50mg Tablets
Reference number
04423/0247
Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not take this medicine and tell your doctor if:
ƒ

CLOMIFENE CITRATE 50MG TABLETS
Read all of this leaflet carefully before you
start taking this medicine
ƒ
ƒ
ƒ

ƒ

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 for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Clomifene Citrate 50mg Tablets are and what they are
used for
Before you take Clomifene Citrate 50mg Tablets
How to take Clomifene Citrate 50mg Tablets
Possible side effects
How to store Clomifene Citrate 50mg Tablets
Further 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. 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)
ƒ
Pregnancies where the baby grows outside of the womb
(ectopic)
ƒ
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.
ƒ

ƒ
ƒ
ƒ
ƒ
ƒ

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

Important information about some of the
ingredients of Clomifene Citrate 50mg Tablets

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.

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

Taking this medicine

Take special care with
Clomifene Citrate 50mg Tablets
Check with your doctor or pharmacist before taking
your medicine if:

ƒ
ƒ
ƒ

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

You are having an early menopause or have been told you
are infertile
You have stopped having periods because you are underweight
You have had fits or seizures in the past
You have ‘fibroids’ in your womb
You have ‘polycystic’ ovaries
Your ovaries are swollen

ƒ
ƒ

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:
ƒ
ƒ

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

ƒ

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.

ƒ

Taking other medicines

Please 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
ƒ
ƒ

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.

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.

Page 1 of 2

ƒ

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:
ƒ

ƒ

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:
ƒ

ƒ

ƒ
ƒ
ƒ

Over-stimulation of the ovary. This can lead to pain in the
pelvis, stomach or calf, 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:
ƒ
ƒ

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

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
Cloudy lenses in the eye (cataracts)
Fits, feeling faint, dis-orientated 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
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

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.

5. How to store Clomifene Citrate 50mg
Tablets
ƒ
ƒ

ƒ
ƒ

ƒ

ƒ

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.

6. Further 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.
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
Page 2 of 2

Leaflet revision and issue date (Ref.) 09.10.12

Other formats

To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information
Product name
Clomifene Citrate 50mg Tablets
Reference number
04423/0247

Expand view ⇕

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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