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ETHINYLESTRADIOL TABLETS BP 1 MG

Active substance(s): ETHINYLESTRADIOL

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Patient Information Leaflet: Ethinylestradiol Tablets BP, 10 micrograms,
50 micrograms and 1 mg, Tablets Ethinylestradiol

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Read all of this leaflet carefully before you
start taking Ethinylestradiol.
• 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.
• In this leaflet, Ethinylestradiol Tablets BP
10 micrograms, 50 micrograms and 1 mg
will be called Ethinylestradiol.
In this leaflet:
1. What Ethinylestradiol is for
2. Before you take Ethinylestradiol
3. How to take Ethinylestradiol
4. Possible side effects
5. How to store Ethinylestradiol
6. Further information

1. What Ethinylestradiol is for
Ethinylestradiol belongs to a group of
medicines called oestrogens (female sex
hormones). Ethinylestradiol is a synthetic
(man-made) oestrogen.

Oestrogens are a group of naturally occurring
hormones which have a wide range of actions
in the body. These include effects on the
development of the body and maintaining the
menstrual cycle (periods) in women.
During the menopause (sometimes called “the
change of life”) a woman’s body slowly
produces less oestrogen. This may cause hot
flushes, night sweats, mood swings and
dryness in the vagina. Over a long time it may
also cause a thinning of the bones, which may
be more likely to then break (osteoporosis).
Ethinylestradiol is used for:
• Hormone Replacement Therapy (HRT) This is the most common use of
Ethinylestradiol. The tablets replace the
naturally occurring oestrogen if not enough
is being produced. This can be in older
women going through, or after the
menopause or in younger women whose
ovaries have not developed properly.
• Period Problems – You may be prescribed
Ethinylestradiol if you are suffering from
problems associated with your periods. If
you still have your womb and are
prescribed an oestrogen, such as
Ethinylestradiol, then your doctor should
normally prescribe a progestogen as well.
• Osteoporosis - Women who have passed
through the menopause and are at a high
risk of future fractures may be prescribed
Ethinylestradiol if they are unable to take
other medicines for this condition.
• Prostate Cancer – Oestrogen is also a
naturally occurring hormone in men and
Ethinylestradiol may be prescribed to treat
men suffering from prostate cancer.

2. Before you take Ethinylestradiol
Do not take Ethinylestradiol if:
• You are allergic to ethinylestradiol
• You are allergic to any of the other
ingredients in Ethinylestradiol (see section 6)
• You have ever had heart disease or any
problems with your heart or circulation.
This includes any blood clots (thrombosis),
problems with your blood (e.g. sickle cell,
polycythaemia or porphyria), varicose
veins, migraine, high blood pressure, heart
attack, stroke or angina
• You have or have had breast cancer
• You have or have had a tumour that may
be affected by oestrogen e.g. endometrial
cancer (cancer or the womb)
• You suffer from a condition where the
lining of the womb builds up more than
usual (endometrial hyperplasia)
• You suffer from unexplained vaginal
bleeding
• You have ever had liver or gall bladder
disease. This includes gallstones or jaundice
due to pregnancy or the contraceptive pill
If any of the above applies to you talk to your
doctor or pharmacist.
Check with your doctor before taking
Ethinylestradiol if:
• You still have your womb. If this is the case
the ethinylestradiol should normally be
taken with another type of hormone tablet
to reduce the risk of cancer in the lining of
the womb. If you suffer from fibroids
(growths in the womb) they may be made
worse by ethinylestradiol

• You are diabetic – Ethinylestradiol may
effect how your body controls sugar and
therefore your diabetic treatment may need
adjusting
• You have had any problems with your
kidneys
• You have ever suffered from hearing loss
• You suffer from asthma
• You wear contact lenses
• You have been told by your doctor that
you suffer from increased blood lipids
Safety of HRT
As well as benefits, HRT has some risks
which you may wish to discuss with your
doctor when you are deciding whether to start
HRT, or whether to carry on taking it.
Medical check-ups
Before you start using HRT, your doctor
should ask you about your own and your
family’s medical history. Your doctor may
decide to examine your breasts and/or your
abdomen and may do an internal examination
- but only if these examinations are necessary
for you, or if you have any special concerns.
Once you have started on HRT, you should
see your doctor for regular check-ups (at least
once a year). At these check-ups, your doctor
may discuss with you the benefits and risks of
continuing to take HRT.
Be sure to:
• Go for regular breast screening and cervical
smear tests
• Regularly check your breasts for any
changes such as dimpling of the skin,
changes in the nipple, or any lumps you
can see or feel

Effects on your heart or circulation
- Heart disease
HRT is not recommended for women who
have or have recently had heart disease. If you
have ever had heart disease, talk to your
doctor to see if you should be taking HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing
conjugated oestrogen plus the progestogen
MPA) have shown that women may be
slightly more likely to get heart disease during
the first year of taking the medication. For
other types of HRT, the risk is likely to be
similar, although this is not yet certain.
If you get:
A pain in your chest that spreads to your
arm or neck. See a doctor as soon as
possible and do not take any more HRT
until your doctor says you can. This pain
could be a sign of heart disease.

Compare:
- Looking at women in their 50s who are not
taking HRT - on average, over a 5-year
period, 3 in 1000 would be expected to have
a stroke.
- For women in their 50s who are taking
HRT, the figure would be 4 in 1000.
- Looking at women in their 60s who are not
taking HRT - on average, over a 5-year period,
11 in 1000 would be expected to have a stroke.
- For women in their 60s who are taking
HRT, the figure would be 15 in 1000.

• You have had one or more miscarriages
• You have any blood clotting problem that
needs treatment with a medicine such as
warfarin
• You’re off your feet for a long time because
of major surgery, injury or illness
• You have a rare condition called SLE
If any of these things apply to you, talk to
your doctor to see if you should take HRT.
Compare:
- Looking at women in their 50s who are not
taking HRT - on average, over a 5-year period,
3 in 1000 would be expected to get a blood clot.
- For women in their 50s who are taking
HRT, the figure would be 7 in 1000.
- Looking at women in their 60s who are not
taking HRT - on average, over a 5-year period,
8 in 1000 would be expected to get a blood clot.
- For women in their 60s who are taking
HRT, the figure would be 17 in 1000.

Effects on your risk of developing cancer
- Breast cancer
Women who have breast cancer, or have had
breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of
breast cancer; so does having a later
menopause. The risk for a post-menopausal
woman taking oestrogen-only HRT for 5
years is about the same as for a woman of the
same age who is still having periods over that
time and not taking HRT. The risk for a
woman who is taking oestrogen plus
progestogen HRT is higher than for
If you get:
oestrogen-only HRT (but oestrogen plus
Unexplained migraine-type headaches, with
progestogen HRT is beneficial for the
or without disturbed vision.
endometrium, see ‘Endometrial cancer’
See a doctor as soon as possible and do not
below).
take any more HRT until your doctor says
For all kinds of HRT, the extra risk of breast
you can. These headaches may be an early
cancer goes up the longer you take it, but
warning sign of a stroke.
returns to normal within about 5 years after
- Blood clots
stopping HRT.
If
you
get:
HRT may increase the risk of blood clots in
- Stroke
Your risk of breast cancer is also higher if
the veins (also called deep vein thrombosis, or • painful swelling in your leg
Recent research suggests that HRT slightly
you:
• sudden chest pain
DVT), especially during the first year of
increases the risk of having a stroke. Other
• have a close relative (mother, sister or
taking
it.
• difficulty breathing.
things that can increase the risk of stroke
grandmother) who has had breast cancer
include:
These blood clots are not always serious, but
You must see a doctor as soon as possible
• are seriously overweight.
if one travels to the lungs, it can cause chest
and do not take any more HRT until your
• Getting older
Compare:
pain, breathlessness, collapse or even death.
doctor says you can. These may be signs of
• High blood pressure
- Looking at women aged 50 who are not
This
condition
is
called
pulmonary
embolism,
a blood clot
• Smoking
taking HRT - on average, 32 in 1000 will be
or PE.
- Surgery
• Drinking too much alcohol
diagnosed with breast cancer by the time they
DVT and PE are examples of a condition
If you’re going to have surgery, make sure
reach the age of 65.
• An irregular heartbeat.
called venous thromboembolism, or VTE.
your doctor knows about it. You may need to - For women who start taking oestrogen-only
If you are worried about any of these things,
You are more likely to get a blood clot if:
stop taking HRT about 4 to 6 weeks before
HRT at age 50 and take it for 5 years, the
or if you have had a stroke in the past, talk to
• You are seriously overweight
the operation, to reduce the risk of a blood
figure will be 33 and 34 in 1000 (i.e. an extra
your doctor to see if you should take HRT.
• You have had a blood clot before
clot. Your doctor will tell you when you can
1-2 cases).
• Any of your close family have had blood clots start taking HRT again.

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- If they take oestrogen-only HRT for 10 years,
the figure will be 37 in 1000 (i.e. an extra 5 cases).
- For women who start taking oestrogen plus
progestogen HRT at age 50 and take it for 5
years, the figure will be 38 in 1000 (i.e. an
extra 6 cases).
- If they take oestrogen plus progestogen HRT
for 10 years, the figure will be 51 in 1000 (i.e.
an extra 19 cases).
If you notice any changes in your breast, e.g:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Make an appointment to see your doctor as
soon as possible.
- Endometrial cancer (cancer of the lining of the
womb)
Taking oestrogen-only HRT for a long time can
increase the risk of cancer of the lining of the
womb (the endometrium). Taking a
progestogen as well as the oestrogen helps to
lower the extra risk.
If you still have your womb, your doctor will
usually prescribe a progestogen as well as
oestrogen. These may be prescribed separately,
or as a combined HRT product.
If you have had your womb removed (a
hysterectomy), your doctor will discuss with
you whether you can safely take oestrogen
without a progestogen.
If you’ve had your womb removed because of
endometriosis, any endometrium left in your
body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as
well as an oestrogen.
Ethinylestradiol Tablets is an oestrogen-only
product.

Compare
- Looking at women who still have a uterus
and who are not taking HRT - on average 5 in
1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
- For women who take oestrogen-only HRT,
the number will be 2 to 12 times higher,
depending on the dose and how long you take it.
- The addition of a progestogen to oestrogenonly HRT substantially reduces the risk of
endometrial cancer.
If you get breakthrough bleeding or spotting,
it’s usually nothing to worry about, especially
during the first few months of taking HRT.

- Dementia
HRT will not prevent memory loss. In one
study of women who started using combined
HRT after the age of 65, a small increase in the
risk of dementia was observed.
Tell your doctor if you are taking any of the
following medicines:
• Medicines to thin the blood (e.g. warfarin,
pheninidone or acenocoumarol)
• Medicines for tuberculosis (e.g. rifampicin or
rifabutin)
• Medicines for fungal infections (e.g.
nevirapine, efavirenz, ritonavir or nelfinavir)
• Medicines for your breathing (e.g.
theophylline)
If the bleeding or spotting:
• carries on for more than the first few months • Medicines for epilepsy (e.g. phenytoin,
phenobarbitol, carbamazepine and
• starts after you’ve been on HRT for a while
lamotrigine)
• carries on even after you’ve stopped taking
• Medicines for narcolepsy (e.g. modafinil)
HRT.
• Medicines for the treatment of depression
You must make an appointment to see your
(e.g. imipramine or St John’s Wort)
doctor. It could be a sign that your
• Any other medicine, including medicines
endometrium has become thicker.
obtained without a prescription.
- Ovarian cancer
Pregnancy and breast-feeding
Ovarian cancer (cancer of the ovaries) is very
Do not take Ethinylestradiol if you are
rare, but it is serious. It can be difficult to
pregnant or breast feeding. If you become
diagnose, because there are often no obvious
pregnant whilst taking Ethinylestradiol you
signs of the disease.
should stop taking your tablets immediately
and talk to your doctor.
Some studies have indicated that taking
oestrogen-only HRT for more than 5 years may Warnings about the ingredients in Ethinylestradiol
increase the risk of ovarian cancer. It is not yet Ethinylestradiol contains lactose. It is not
known whether other kinds of HRT increase
suitable for people who are unable to tolerate a
the risk in the same way.
sugar called lactose. This rare condition may
have been passed down from someone in your
family. Tell your doctor or pharmacist before
taking your tablets if this applies to you.

3. How to take Ethinylestradiol
Always take Ethinylestradiol exactly as your
doctor has told you.
IMPORTANT:
Your doctor will choose the dose that is right
for you. Your dose will be shown clearly on the
label that your pharmacist puts on your
medicine. If it does not, or you are not sure,
ask your doctor or pharmacist.
Remember: Your tablets should be taken once a
day and at the same time each day. They should
be swallowed whole with a drink of water.
The dose you have been prescribed will depend
on the condition being treated. The following
are usual doses.
Hormone Replacement Therapy
• 10 to 50 micrograms daily on a cyclical basis
(three weeks on and one week off).
• If you have a womb a progestogen should
normally also be prescribed to lower the risk
of endometrial cancer. Your doctor will
explain this to you if necessary.
Period Disorders
• 20 to 50 micrograms daily from day 5 to day
25 of each cycle.
• A progestogen should be given daily in
addition, either throughout the cycle or from
day 15 to day 25 of the cycle. Your doctor
will explain this to you if necessary.
• As Ethinylestradiol tablets are usually taken
on a cyclical basis direct switching from
other oestrogen-only HRT preparations
taken cyclically is possible.
Prostate Cancer
150 micrograms to 1.5 milligrams daily.

Medical check-ups
Once you are taking this medicine:
• Regularly check your breasts for any
changes. If you notice dimpling of the skin,
changes in the nipple, or any lumps you must
see your doctor as soon as possible.
• Go for regular breast screening
• Go for cervical smear tests
• See your doctor for regular check-ups (at
least once a year). At these check-ups, your
doctor will discuss with you the benefits and
risks of continuing to take HRT.
If you take more Ethinylestradiol than you
should
If you have taken too many tablets, contact the
nearest hospital casualty department or your
doctor immediately. Take this leaflet and any
remaining tablets with you to show the doctor.
Taking too many tablets at once may make you
feel sick or be sick. It can also make women
have a period afterwards.
If you forget to take Ethinylestradiol
• Do not take a double dose to make up for a
missed dose. Simply take the next dose as
planned.
• Forgetting a dose may increase the chances
of breakthrough bleeding in woman with an
intact womb.
If you stop taking Ethinylestradiol
Do not stop taking Ethinylestradiol without
first talking to your doctor.
If you have any further questions about the use
of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines Ethinylestradiol can cause
side effects, although not everybody gets them.
If you suffer from any of the following you should
see your doctor as soon as possible and do not take
any more tablets until your doctor tells you too:
• Unexpected migraine, with or without
disturbed vision (these headaches could be an
early warning sign of a stroke)
• Painful swelling in your leg , sudden chest
pain or difficulty breathing (these problems
may be a sign of a blood clot)
• A pain in your chest that spreads to your
arm and neck (this pain could be a sign of
heart disease)
See your doctor as soon as possible if you get
any of the following symptoms:
• If you notice any changes in your breast such
as a lump, dimpling in the skin or the nipple
changing
• If bleeding or spotting carries on for more
than the first few months, or starts after you
have been taking the tablets for a while
• If bleeding or spotting carries on even after
you’ve stopped taking HRT.
Important: All the symptoms in the lists above
are signs that you may be developing a serious
problem. If you ignore these symptoms they
may become worse.
Other possible side effects
• You may feel or be sick
• You may get headaches or migraine
• You may have mood changes
• Your breasts may become tender, enlarge or leak
• Your eyes may hurt if you wear contact lenses
• You may get a skin rash, including skin
discolouration known as chloasma
• You may be more likely to have high blood

pressure, blood clots, gallstones or jaundice
• You may get unexplained pains, particularly
in your calves.
• You may retain fluid and put on weight
• You may have high levels of calcium building
up in the blood, particularly if you have a
malignant tumour
• If you suffer from endometriosis or fibroids
they may become worse
• Men may develop breasts, their testicles may
stop working, may look more female and
become impotent during treatment.
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 Yellow Card
Scheme, Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this
medicine.

What Ethinylestradiol looks like
Ethinylestradiol 10 mcg are white, biconvex,
uncoated tablets, engraved “EVANS 136” on
one side, plain on the reverse.
Ethinylestradiol 50 mcg are white flat bevel
edged uncoated tablets. Breakline on one side
and engraved EVANS 50-137 on the other side.
Ethinylestradiol 1 mg are white flat bevel edged
uncoated tablets. Breakline on one side and
engraved Evans 1-138 on the other side.
The 10 micrograms tablets come in packs of
21, 100 and 500. The 50 micrograms tablets
come in packs of 21 and 100. The 1 mg tablets
come in packs of 28 and 100. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
UCB Pharma Limited, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK
Manufacturer
Recipharm Ltd, Vale of Bardsley,
Ashton-under-Lyne, OL7 9RR, UK

5. How to store Ethinylestradiol Tablets

This leaflet was last updated June 2016.

Keep out of the reach and sight of children.
Do not use Ethinylestradiol after the expiry
date on the container. The expiry date refers to
the last day of that month.
Store below 25°C. Keep your tablets in the
container they came in.
Medicines should not be disposed of via
wastewater or household waste. Return any
medicine you no longer need to your pharmacist.

If this leaflet is difficult to see or
read or you would like it in a
different format, please contact
UCB Pharma Limited, 208 Bath
Road, Slough, Berkshire,
SL1 3WE, UK

6. Further information
What Ethinylestradiol contain
The active substance is ethinylestradiol (10 or
50 micrograms or 1 mg).
The other ingredients are lactose monohydrate,
starch maize and magnesium stearate.

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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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