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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.

-    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 women 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

•    You have had a blood clot before

•    Any of your close family have had blood clots

•    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.

If you get:

•    painful swelling in your leg

•    sudden chest pain

•    difficulty breathing.

You must 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

-    Surgery

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 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 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 it, but returns to normal within about 5 years after 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

•    are seriously overweight.

Compare:

-    Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 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 33 and 34 in 1000 (i.e. an extra 1-2 cases).

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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).

- 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 oestrogen-only 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.

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.

You must 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.

- 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)

•    Medicines for epilepsy (e.g. phenytoin, phenobarbitol, carbamazepine and lamotrigine)

•    Medicines for narcolepsy (e.g. modafinil)

•    Medicines for the treatment of depression (e.g. imipramine or St John’s Wort)

•    Any other medicine, including medicines obtained without a prescription.

Pregnancy and breast-feeding Do not take Ethinylestradiol if you are pregnant or breast feeding. If you become pregnant whilst taking Ethinylestradiol you should stop taking your tablets immediately and talk to your doctor.

Warnings about the ingredients in Ethinylestradiol

Ethinylestradiol contains lactose. It is not suitable for people who are unable to tolerate a 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.

5. How to store Ethinylestradiol Tablets

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.

6. Further information

What Ethinylestradiol contain

The active substance is ethinylestradiol (10 or 50 micrograms or 1 mg).

The other ingredients are lactose, starch maize and magnesium stearate.

What Ethinylestradiol looks like

Ethinylestradiol are white tablets. 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

This leaflet was last updated May 2015.

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 11001278