Ethintlestradiol

ETHINYLOESTRADIOL Tablets BP
10 micrograms, 50 micrograms, 1mg
CELLTECH

PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before you start to take your tablets. It contains important information.
If you are not sure about anything or you want to know more ask your doctor or a pharmacist. Keep this leaflet safe as you may want to read it again.

About your tablets
Your tablets are called ethinyloestradiol. They are part of a group of drugs called oestrogens (female sex hormones).

What is in your tablets
Each tablet contains:

Ethinyloestradiol BP 10 micrograms, 50 micrograms or 1 milligram (active ingredient) and
Lactose, starch maize, magnesium stearate (inactive ingredients).

Who makes your tablets
The marketing authorisation holder and manufacturer is Celltech Manufacturing Services Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR, UK.
Ethinyloestradiol tablets 10 micrograms are available in packs of 21, 100 and 500, 50 micrograms in packs of 21 and 100, and 1mg in packs of 28 and 100.

What your tablets do
Ethinyloestradiol is a synthetic oestrogen. Oestrogens are a group of naturally occurring hormones which have a wide range of actions in the body including developmental effects and maintaining the normal menstrual cycle in women. There are different reasons for using ethinyloestradiol. Your doctor should explain to you why he or she has prescribed it for you. The commonest reasons are as hormone replacement therapy to replace the naturally occurring oestrogen if not enough of it is being produced. This could be in older women going through or after the menopause or in younger women to ensure proper development. It can also be used to treat some period problems. If you still have your womb and are prescribed an oestrogen your doctor should normally also prescribe a progestogen. Oestrogens are also naturally occurring hormones in men and ethinyloestradiol may also be used to treat prostate cancer.

Before you take your tablets
Safety of HRT
As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it
Please tell your doctor before you take your tablets if you:

are pregnant, may become pregnant or are breast feeding.
have ever had any heart or circulation problems. This includes any thrombosis (blood clots), problems with your blood (e.g. sickle cell, polycythaemia or porphyia), varicose veins, migraine, high blood pressure, heart attack or angina.[*]have a tumour which may be affected by oestrogen (e.g. some breast cancers).
suffer from untreated endometrial hyperplasia.
suffer from unexplained vaginal bleeding.
have ever had liver or gall bladder disease. This includes gallstones or jaundice due to pregnancy or the contraceptive pill.
are allergic to any of the ingredients listed in the ‘what is in your tablets’ section.

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.

Also tell your doctor if you;

still have your womb. If this is the case the ethinyloestradiol 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 ethinyloestradiol.
are diabetic. Ethinyloestradiol may affect your sugar control and your diabetic treatment may need adjusting.
have had any problems with your kidneys.
have ever suffered from hearing loss.
suffer from asthma
wear contact lenses.
suffer from increased blood lipids

Effects on your heart and circulation
Heart Disease
HRT is not recommended for women who have heart disease, or have had heart disease recently. 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 and 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.

Stroke
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

getting older.
high blood pressure.
smoking.
drinking too much alcohol.
an irregular heartbeat.

If you are worried about any of these things or if you have had a stroke in the past, 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 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 in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get:

unexplained migraine type headaches, with or without disturbed vision.

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood Clots
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT) especially during the first year of taking it.
These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous thromboembolism or VTE.
You are more likely to get a blood clot:

if you are seriously overweight.
if you have had a blood clot before.
if any of your close family have had blood clots.
if you have had one or more miscarriages.
if you have any blood clotting problem that needs treatment with a medicine such as warfarin.
if you are off your feet for a long time because of major surgery, injury or illness.
if 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 l7 in 1000.

If you get:

painful swelling in your leg.
sudden chest pain.
difficulty breathing

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.
If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Effects on your risk of developing cancer

Breast Cancer
Women who have breast cancer, or who 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’s 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 oestrogen only HRT (but oestrogen plus progestogen HRT is beneficial for the endometrium, see ‘endometrial cancer’ below).
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take HRT, but returns to normal within about 5 years of stopping HRT.
Your risk of breast cancer is also higher:

if you have a close relative (mother, sister or grandmother) who has had breast cancer.
if you are seriously overweight.

Compare
Looking at women aged 50 who are not taking HRT— on average [b]32 in 1000[/b] will be diagnosed with breast cancer by the time they reach the age of 65.
For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).
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 breasts, such as:

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 may prescribe a progestogen as well as oestrogen. If so, 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.
Your product, Ethinyloestradiol 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 for 5 years, the figure will be 9 in 1000 (i.e. an extra 4 cases).
If they take oestrogen-only HRT for 10 years, the figure will be 15 in 1000 (i.e. an extra 10 cases).
The addition of a progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about specially during the first few months of taking HRT.
But if the bleeding or spotting:

carries on for more than the first few months.
starts after you’ve been on HRT for a while
carries on even after you’ve stopped taking HRT

Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian Cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
Some medicines may effect the way in which ethinyloestradiol works. Tell your doctor if you;

are taking medicines to thin the blood such as warfarin, pheninidone or nicoumalone.
are taking rifampicin or rifabutin (for tuberculosis), nevirapine, efavirenz, ritonavir, nelfinavir, (for fungal infections) or theophylline (for your breathing).[*]are epileptic. Some medicines for epilepsy e.g. phenytoin, phenobarbitol and carbamazepine may effect the way your body handles ethinyloestradiol.
are taking drugs for the treatment of depression e.g. imipramine or St Johns Wart (hypericum perforatum).
are taking any other medicines, including ones which you have bought yourself without a prescription..
if you are going to have a thyroid function test, tell the doctor that you are taking ethinyloestradiol as it may effect the result.
if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medical product.

How to take your tablets
You must take your tablets as your doctor has told you to. The label will tell you how much to take and how often to take it. The amount of tablets you take is called the ‘dose’. The dose you have been prescribed will depend upon the condition being treated. The following are usual doses.
Hormone Replacement Therapy (HRT) (pre and post menopausal):
10 — 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 (see above). Your doctor will explain this to you if necessary.
Period Disorders:
20—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 Ethinyloestradiol 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.
Your tablets should be swallowed whole with a drink of water.
They should be taken once a day at the same time each day.
If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before.
Forgetting a dose may increase the likelihood of breakthrough bleeding in women with an intact womb.

What to do if you take too many tablets
It is important not to take too many tablets.
Contact your nearest hospital casualty department or a doctor for advice if you have swallowed too many tablets or if you think a child has swallowed any.
Take this leaflet and any tablets you still have to show the doctor.
Taking too many tablets at once may make you sick. It can also make women have a ‘period’ afterwards.

After taking your Tablets
You may have some side effects while you are taking you tablets. Tell you doctor if you suffer from any of the following;
You may feel or be sick, get headaches or migraine, have mood changes, your breasts may become tender, enlarge or leak. Your eyes may hurt if you wear contact lenses. Skin rashes have been reported, including skin discolouration known as chloasma.
Ethinyloestradiol may make you more to high blood pressure, blood clots, gallstones or jaundice. You should tell your doctor if you get any unexplained pains, particularly in your calves. Some people retain fluid and may put on weight.
It may cause high levels of calcium to build up in the blood, particularly if you have a malignant tumour. If you are taking it cyclically, e.g. three weeks taking it, followed by one week not, you may have a withdrawal bleed during the week you are not taking it. You may bleed between periods or notice more discharge than usual. It may make endometriosis or fibroids worse.
Men may develop breasts, their testicles may stop working, they may look more female and become impotent during treatment.
You may be more likely to suffer from the conditions discussed in the ‘before taking your tablets’ section, e.g. breast cancer, endometrial cancer, ovarian cancer, heart disease, blood clots and stroke.
If you experience any of these side effects or feel unwell in any other way tell your doctor as soon as you can.

Looking after your tablets
Keep your tablets in a safe place where children cannot see or reach them. They may be dangerous to children. Store below 25°C. Keep them in the pack they came in. Do not put them in another container. Do not take the tablets after the ‘use by’ date.
You should take any tablets that are out of date or no longer needed back to your pharmacist.
These tablets are only for you. Only a doctor can prescribe them for you. Never give them to anyone else.
This leaflet only applies to Ethinyloestradiol Tablets 10 mcg, 50 mcg, 1mg.

Date of preparation of leaflet: November 2003. P1026D