Elleste Solo

]INFORMATION FOR THE PATIENT
Elleste Solo™ 1mg and 2mg
estradiol hemihydrate
Please read this leaflet carefully before you start to take your medicine. The leaflet cannot tell you everything about your medicine. So if you have any questions or are not sure about anything, ask your doctor or pharmacist.

Some information about Elleste Solo

The name of your medicine is Elleste Solo.

Who makes Elleste Solo?

There are three blister strips in each pack. Each strip contains 28 tablets.
Elleste Solo 1mg tablets are white and contain 1 milligram estradiol (as hemihydrate).
Elleste Solo 2mg tablets are orange and contain 2 milligrams estradiol (as hemihydrate).
Estradiol hemihydrate is the active ingredient. The estradiol hemihydrate used to make Elleste Solo does not come from animals.
The tablets also contain lactose monohydrate, maize starch, povidone, talc, magnesium stearate, macrogol 400, titanium dioxide (E171), and hydroxypropylmethyl cellulose (E464). Elleste Solo 2mg has the extra ingredient sunset yellow (E110).

Who supplies Elleste Solo?

Elleste Solo is supplied by:
Pfizer Limited, Sandwich, Kent CT13 9NJ
for:
Shire Pharmaceutical Contracts Ltd, Basingstoke, RG24 8EP, UK

Who makes Elleste Solo?

Elleste Solo is made by:
Pharmacia Limited, Whalton Road, Morpeth,
Northumberland, NE61 3YA; or
Celltech Manufacturing Services Limited, Vale of Bardsley, Ashton-Under-Lyne, Lancashire OL7 9RR

What is Elleste Solo?

Elleste Solo is a form of hormone replacement therapy (HRT).
It contains the hormone estradiol hemihydrate, and is one of a group of medicines called estrogen-only preparations. It is not an oral contraceptive.

Why has your doctor given you Elleste Solo?

Elleste Solo treats the symptoms of the menopause (change of life). It is usually given to women who have had a hysterectomy (had their womb removed).
As you approach the menopause, your ovaries gradually produce fewer hormones. This may cause unpleasant symptoms such as hot flushes and sweating. Elleste Solo replaces a hormone which you lose during the menopause and prevents or relieves any unpleasant symptoms.
Other changes in your bones may also take place over a longer time. These changes can lead to an increased risk of your bones breaking or cracking. If you are at an increased risk of fractures due to osteoporosis (thinning of the bones)
but are unable to take other treatments or if other therapies prove to be ineffective, Elleste Solo 2 mg may also be used for this purpose. Your doctor should discuss all the available options with you.

Before you take Elleste Solo

Elleste Solo may not be suitable for all women. Read the checklist below. Do not take Elleste Solo, if you have, or have ever had:

a blood clot in a vein in your leg or anywhere else (a “deep vein thrombosis”);
a blood clot that has travelled to your lung or another part of the body (an “embolus”);
heart disease;
breast or womb cancer;
vaginal bleeding which your doctor could not find the cause of;
liver problems, for example jaundice (yellowing of the skin or eyes);
porphyria (a rare inherited blood disease);
endometrial hyperplasia (an increase in the number of cells of the inner lining of the womb) which has not been treated.

Also do not take Elleste Solo if you:

are pregnant or think you could be pregnant;
are breast-feeding; or
have ever had an allergic reaction to any of the
ingredients in Elleste Solo.

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.

Medical check-ups

Before you start taking HRT, your doctor should ask 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’ve 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 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 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
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’re 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 17 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 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 estrogen-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 estrogen plus progestogen HRT is higher than for estrogen-only HRT (but estrogen 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.
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, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.
For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (ie an extra 1-2 cases).
If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (ie an extra 5 cases).
For women who start taking estrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (ie an extra 6 cases).
If they take estrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (ie an extra 19 cases).
If you noticeany changes in your breast, 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 estrogen-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 estrogen helps to lower the extra risk.
If you still have your womb, your doctor may prescribe a progestogen as well as estrogen. 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 estrogen 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 estrogen.
Your product, Elleste Solo is an estrogen-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 50-65).
For women who take estrogen-only HRT for 5 years, the figure will be 9 in 1000 (ie an extra 4 cases).
If they take estrogen-only HRT for 10 years, the figure will be 15 in 1000 (ie an extra 10 cases).
The addition of a progestogen to estrogen-only HRT
substantially reduces the risk of endometrial cancer.
If you getbreakthrough bleeding or spotting, it’s usually nothing to worry about, especially 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 estrogen-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.
Certain diseases sometimes get worse when you are taking hormone replacement therapy. Your doctor may need to check you more closely if you have any of the following.

Migraine or severe headache
Asthma
Gallstones
Epilepsy
High blood pressure
A personal or family history of blood clots
Diabetes
Liver problems
Heart or kidney problems
Overgrowth of the endometrial lining
Fibroids in your womb
Endometriosis (where tissue from your womb is found outside the womb)
A history of breast cancer in your family
Systemic lupus erythematosus (a chronic inflammatory disease affecting the skin and organs)
Otosclerosis (an inherited form of deafness which sometimes gets worse during pregnancy)
High levels of lipids in your blood (hypertriglyceridaemia)

Elleste Solo may affect the result of certain laboratory tests, so tell the person taking the sample that you are on Elleste Solo.

If you have fibroids (lumps of fibrous and muscular tissue) in your womb, these may increase in size when you are taking Elleste Solo. See your doctor if you have pain or swelling in your abdomen.
If you are a diabetic, you may need to change the amount of insulin you take. Check your blood glucose level more often until it is steady.

Do I need contraception while I am taking Elleste Solo?

It is important to remember that Elleste Solo is not a
contraceptive (the pill).
If you are using the pill or another hormonal contraceptive you will need to use another type of contraceptive. Please discuss this with your doctor.

Other medicines and Elleste Solo

Some medicines may stop Elleste Solo from working properly.
These include some drugs that treat diabetes, epilepsy, and some antibiotics and sedatives. If your doctor does not know that you are taking these other medicines, tell him or her before you start taking Elleste Solo. You should also tell your
doctor if you are taking any herbal medicines containing St. John's Wort.

How to take Elleste Solo

If you are still having regular periods, take your first tablet on the first day of bleeding.
If you are not having regular periods, you can start straight away.
Take one tablet each day. You can take the tablet at a time of the day that suits you. But it is best to take it about the same time each day. Swallow the tablets whole, with some water.
All the tablets are the same. The days of the week are marked on the strip to help you to remember to take one each day.
Follow the direction of the arrows on the pack and take a tablet each day until the pack is empty. When you finish a foil strip, start a new strip on the next day.

Changing from another type of HRT

If you are changing from another type of HRT, start taking Elleste Solo when you finish the pack of HRT you are taking at the moment.
If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

What do I do if I forget to take a tablet?

Take the tablet as soon as you remember, and take the next one at the normal time. But if you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. If you have not had a hysterectomy you may experience breakthrough bleeding or spotting.

What if I take too many tablets at once?

There should be no problems, but if you are worried contact your doctor. Take the usual tablet the following day.

Will I have periods?

If you have not had a hysterectomy, and you are also taking a progestogen, you will probably have a monthly bleed. In the first few months you may get irregular bleeding. However, if this carries on you should tell your doctor.

Does Elleste Solo have side effects?

All medicines can sometimes cause problems. If you are worried about side effects, ask your doctor.
During the first few months you may feel like being sick, have headaches, or your breasts may be painful or increase in size.
These side effects should become less of a problem as your body gets used to the medicine.
You may also get the following side effects.
Common: feeling sick, stomach cramps, headache, an increase in size of fibroids in the womb, breakthrough bleeding, changes in weight, oedema (swelling) of legs, breast tenderness and enlargement, mood changes, changes in sex drive.
Uncommon: indigestion, being sick, flatulence, gallstones and gallbladder disease, feeling dizzy, migraine, vaginal thrush, increase in blood pressure, leg cramps, breast cancer (please refer to the earlier section on breast cancer).
Rare: loss of hair from the scalp, increase in body and facial hair, itchiness, rashes, thromboembolic disease (please refer to the earlier section on the effects of HRT on the heart and circulation).
Very rare: heart disease (please refer to the earlier section on the effects of HRT on the heart and circulation), stroke, chloasma (brown patches on the skin), red swellings on the skin.

Reasons to stop taking Elleste Solo

Stop taking the tablets at once and tell your doctor if :

you become jaundiced (get yellowing of the skin or eyes)
you have itching all over your body;
you have an unusual, severe or prolonged headache;
your sight is affected in any way;
you find it difficult to speak; or
any part of your body suddenly feels weak or numb.

Also stop taking the tablets at once if there is a chance that you could be or could become pregnant.

How to store Elleste Solo

Do not store above 25°C. Store in the original package.
Keep your Elleste Solo tablets where children cannot see or reach them.
Don't take Elleste Solo after the 'expiry date' shown on the box.
If your tablets are out of date, take them to your pharmacist who will get rid of them safely.
This leaflet was revised in December 2003.
If you have any comments on the way this leaflet is written, please write to Medical Information at Pharmacia Limited,
Davy Avenue, Milton Keynes MK5 8PH.
5012/PIL2
5013/PIL2