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CLOMIFENE 50MG TABLETS

Active substance(s): CLOMIFENE CITRATE / CLOMIFENE CITRATE / CLOMIFENE CITRATE

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Package leaflet: Information for the user

Clomifene 50mg Tablets
Clomifene Citrate

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Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or nurse.
- This medicine has been prescribed for 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 doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4
What is in this leaflet:
1. What Clomifene Tablets is and what it is used for
2. What you need to know before you take Clomifene Tablets
3. How to take Clomifene Tablets
4. Possible side effects
5. How to store Clomifene Tablets
6. Contents of the pack and other information

1. What Clomifene Tablets is and what it is
used for

Clomifene 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 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 Tablets

Before taking this 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
Tablets. You should talk to your doctor about the
possible risks before you take Clomifene Tablets.
Do not take Clomifene Tablets:
• if you are allergic to clomifene or any of the other
ingredients of this medicine (listed in section 6)
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue
• if you have or ever had liver disease
• if you have unusual menstrual bleeding where the cause
is not known
• if you have a type of cancer that is made worse by hormones
• if you have a cyst on your ovary

• if you are pregnant. You should have a test to make sure
you are not pregnant before you take Clomifene Tablets
Do not take this medicine if any of the above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Clomifene Tablets:
• if you are having an early menopause or have been told
you are infertile
• if you have stopped having periods because you are
under-weight
• if you have had fits or seizures in the past
• if you have ‘fibroids’ in your womb
• if you have ‘polycystic’ ovaries
• if your ovaries are swollen
• if 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 Clomifene Tablets.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Clomifene Tablets.
Other medicines and Clomifene Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This includes medicines you buy with a prescription,
including herbal medicines. This is because Clomifene
Tablets can affect the way some other medicines work. Also
some medicines can affect the way Clomifene 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
Tablets 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.
Clomifene Tablets contain lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

3. How to take Clomifene Tablets

Always take this medicine exactly as your doctor has told you.
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

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Clomifene 50mg - 30 Tablets
Wockhardt UK
FP2186
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- 8TH JULY 2016
- 8TH JULY 2016
- 11TH JULY 2016
- 13TH DEC. 2016
- 3RD MARCH 2017

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6. Contents of the pack and other information

What Clomifene Tablets contain
The active substance is clomifene citrate.
Each tablet contains 50mg of clomifene citrate.
The other ingredients are lactose, maize starch and
magnesium stearate.
What Clomifene Tablets look like and contents of the pack
Clomifene tablets are white, round tablets with HG C50 on
one side and a breakline on the other side.
They are available in packs of 30 tablets.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print
or audio please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Reference number
Clomifene 50mg Tablets
29831/0037
This is a service provided by the Royal National Institute of
Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
This leaflet was last revised in 03/2017

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5. How to store Clomifene Tablets

Keep this medicine out of the sight and reach of
children
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last day
of that month.
Do not store above 25°C. Store in the original package.
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.

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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.
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 this leaflet. You can also report side effects directly via
the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Clomifene Tablets and 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 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 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 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
• Raised red skin patches with blisters surrounded by rings,
sores on the lips, eyes or mouth and fever (erythema
multiforme), red or purple skin patches (ecchymosis)
• Feeling or being sick








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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 than you should
If you take more clomifene 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 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 Tablets
Keep taking Clomifene 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
medicine, ask your doctor or pharmacist.

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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