Elleste Solo MX 80 micrograms Transdermal Patch

Elleste Solo MX 80 micrograms Transdermal Matrix Patch

2.5 mg estradiol (as hemihydrate)

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, please 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.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Elleste Solo is and what it is used for.


• 2. Before you use Elleste Solo


• 3. How to use Elleste Solo


• 4. Possible side effects


• 5. How to store Elleste Solo


• 6. Further information

What Elleste Solo is and what it is used for

Elleste Solo is a transdermal patch containing estradiol as the active ingredient. The estradiol in Elleste Solo is a synthetic version of the body’s natural estrogen. It is made from plant materials.

The estradiol gradually comes out of the sticky side of the patch and goes through your skin while you are wearing it. You will get about 80 micrograms of estradiol a day from Elleste Solo.

Estradiol is one of a group of female hormones called estrogens. During the menopause (sometimes called "the change") a woman’s ovaries will produce less estrogen, and this may lead to symptoms of the menopause (such as hot flushes, night sweats and and dryness in the vagina) which may cause discomfort during sexual intercourse. Elleste Solo replaces estrogen and is used to prevent or relieve these symptoms. Your doctor will aim to give you the lowest dose required to treat your symptoms.

Elleste Solo is not a contraceptive, if you need contraceptive advice you should speak to your doctor.

Before you use Elleste Solo

Elleste Solo may not be suitable for all women.

Before you start using this medicine, please read the following information.

Do not use Elleste Solo if you have or have ever had:

• narrowed or blocked arteries (blood vessels) possibly leading to angina or heart disease


• vaginal bleeding that your doctor cannot find a cause for


• porphyria (a rare inherited blood disease),


• 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").


• endometrial hyperplasia (an overgrowth of the lining of the womb)


• breast or womb cancer;


• liver disease; you cannot use this medicine until your liver is working properly


• an allergic reaction to estradiol or any other of the ingredients in this medicine, listed in Section 6.

Medical check-ups

Before you start taking Hormone Replacement Therapy (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 there may be 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. If you notice any changes tell your doctor as soon as possible.

Take special care with Elleste Solo

Certain conditions may get worse, while you are using Elleste Solo.

You should discuss these with your doctor and he/she may want to monitor you more closely if you suffer from any of the following conditions:

• Family history of cancer, particularly breast cancer


• High blood pressure


• Diabetes (See Taking other medicines)


• Migraine or severe headache


• Uterine fibroids (lumps of fibrous and muscular tissue in your womb)


• Epilepsy


• History of liver disease


• Gallstones


• High levels of lipids in your blood (hypertriglyceridaemia)


• A personal or family history of blood clots


• Systemic Lupus Erythematosus, (SLE; an inflammatory disease affecting the skin and organs)


• History of endometrial hyperplasia (overgrowth of the lining of the womb)


• Endometriosis (where tissue from the womb is found outside the womb)


• Otosclerosis (an inherited form of deafness which sometimes gets worse during pregnancy)


• Asthma.

Blood tests

Elleste Solo may affect the results of certain blood tests, so tell the person taking the sample that you are taking these tablets.

Safety of HRT

As well as benefits, HRT has some risks which you may wish to discuss with your doctor when you’re deciding whether to start HRT, or whether to carry on taking it.

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 estrogen 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 (see Section 2 "Take special care")

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.

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 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 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 estrogen-only HRT at age 50 and take it for 5 years, the figure will be 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 (i.e. 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 notice any 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 will usually prescribe a progestogen as well as estrogen. 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 and 65.

For women who take estrogen-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 estrogen-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.

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.

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.

Taking other medicines with Elleste Solo

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including over-the-counter medicines.

In particular, tell your doctor if you are using any of the following because they may alter the effects of Elleste Solo:

• drugs that treat epilepsy


• some anti-infectives (anti-virals or antibiotics)


• sedatives


• herbal medicines containing St. John’s Wort

If you are taking medicine for diabetes, such as insulin or tablets to reduce blood sugar, tell your doctor or pharmacist as your dose may need to be changed.

If you are using ‘the pill’ or another hormonal contraceptive you will need to use another type of contraception. Please discuss this with your doctor.

Pregnancy and breast-feeding

You should not use Elleste Solo if you are pregnant or breast feeding. If you become pregnant while taking this medicine, you must stop taking it immediately.

Driving and using machines

Elleste Solo is not expected to affect your ability to drive or use machines.

How to use Elleste Solo

Your doctor will aim to give you the lowest dose for the shortest duration that will treat your symptoms.

The usual dose is one Elleste Solo patch twice a week.

If you think that the patch is too strong or that it is not working, talk to your doctor or pharmacist.

Always follow any instructions your doctor gives you. Check with your doctor or pharmacist if you are unsure.

Keep using Elleste Solo as part of your HRT until your doctor tells you to stop.

Starting treatment

If you are having regular periods then you should start your Elleste Solo treatment within 5 days of the start of your bleeding.

If you are not having regular periods then you can start Elleste Solo treatment at any time.

Changing from another type of HRT

If you are changing from a HRT product that gives you a withdrawal bleed (eg a sequential or cyclic product) then you should finish the treatment cycle and start using Elleste Solo within 5 days of the withdrawal bleed starting.

If you are changing from a HRT product that does not give you a withdrawal bleed then you can start using Elleste Solo on any convenient day.

Putting on a patch

You should stick the patch on dry, unbroken areas of your skin below the waistline such as your lower back or buttocks. Place your new patch on a fresh area of skin, away from the place you have just used.

Do not put the patch on or near your breasts

When you have chosen the areas where you want to put the patch make sure the area is not red or irritated. Before you apply the patch, wash and dry the area where you are going to put it.

Do not put powder or oil on your skin before you stick on the patch as this might prevent it from sticking properly.

• Take one pack out of the carton and open the pouch.


• Take out the patch.


• Next, take off the smaller piece of shiny backing covering the sticky side of the patch and put the patch on the area of skin you have chosen.


• Gently peel off the rest of the backing while you flatten the surface of the patch with your other hand as you pull. This should give a smooth and wrinkle-free surface. Pressing it for a few seconds will make it stick firmly.

Changing your patch

You should take off each patch after 3 or 4 days, so that you use two each week and you always change them on the same two days. For example, if you start your first patch on Monday, change to your next one on Thursday then change it again on the next Monday and so on.

As long as you have stuck the patch on correctly, it should not come off in the bath or shower. If your patch comes off before the day you regularly change it and you cannot stick it back on, you should put a new patch on. You should change this patch on your usual day and carry on as before.

When the time comes to change the patch, take off the old one and fold it up, with the sticky side inwards, and put it back into an empty pack, and dispose of it safely.

Remember to keep your new and/or used patches where children cannot see or reach them as they still contain medicine.

Do you need to take anything else while using Elleste Solo?

If you have had a hysterectomy (your womb taken out) your HRT will be Elleste Solo only.

If you have not had your womb taken out your doctor will normally also give you a progestogen treatment (another hormone replacement treatment which balances the effect of estradiol on your womb). You will take this for two weeks of each monthly cycle.

This is part of your HRT. For more information see "Section 2:Endometrial cancer (cancer of the lining of the womb)".

While you are using Elleste Solo and a progestogen treatment you will probably have either a "period" or some regular bleeding each month. This is quite normal.

If you use more Elleste Solo than you should

It is almost impossible to get an overdose of estradiol from Elleste Solo if you are using the patches properly. However if you are at all worried, take off your patch and see a doctor.

If you forget to use Elleste Solo

If you forget to change your patch at the right time you should change it as soon as possible. But remember to follow your normal schedule for sticking on your next one. You may experience some breakthrough bleeding or spotting.

Possible side effects

Like all medicines, Elleste Solo can cause side effects, although not everybody gets them.

Reasons to stop using Elleste Solo

Stop using Elleste Solo and see your doctor immediately, if you develop any of the conditions listed in "Do not use Elleste Solo" in Section 2 or if any of the following occur:

• Painful swelling in your leg, sudden chest pain or difficulty breathing. These may be signs of a blood clot.


• Jaundice, (yellowing of the skin or eyes).


• New migraine or severe headache.


• You are pregnant or think you may be pregnant.

Also, your doctor may advise you to stop taking your HRT if your blood pressure increases.

Very common side effects, occurring in more than 1 in 10 people using Elleste Solo are:

• Tender breasts.


• Headaches.


• Breakthrough bleeding.

Less than 1 in 10 people might have a mild redness and itching where the patch has been. When this does happen it usually disappears within 3 or 4 days of taking the patch off. If the skin reaction is worse or lasts for longer than this you should tell your doctor.

In general these side-effects do not usually last long. If they do last for a long time or become serious you should tell your doctor or pharmacist.

Other side effects that have been reported while using Estrogen therapy include:

• Tenderness to breasts, or unexpected secretions.


• Unexpected vaginal bleeding, itching, discomfort/pain or unpleasant discharge.


• Increased awareness of, or size, of fibroids, aggravation of endometriosis.


• Breast cancer, (See Section 2: "Effects on your risk of developing cancer").


• Stroke.


• Blood clot formation, e.g. in the legs or lungs.


• Liver tumours.


• Liver disorders.


• Nausea (feeling sick)or vomiting (being sick).


• Stomach cramp, bloating.


• Skin discolouration or rash.


• Excessive general itching.


• Hair loss, or abnormal distribution of hair growth.


• Muscular cramp or twitching.


• Migraine, serious headache, dizziness.


• Mood change (elation/depression).


• Nervous disorders (such as twitching of arms and legs).


• Dementia.


• Loss of sex drive.


• Visual disturbances.


• Intolerance of contact lenses.


• Change in body weight, water or sodium retention.


• Reduced tolerance to glucose (sugar).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Elleste Solo

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

If your doctor decides to stop treating you, return any unused patches to the pharmacist who will dispose of them safely.

Do not take Elleste Solo after the ’expiry date’ shown on the box.

Further information

What Elleste Solo patches contain

The active ingredient in each patch is 2.5 mg estradiol (as hemihydrate).

The patch also contains other ingredients which are: acrylic adhesive, diethyltoluamide, polyester laminate and metalised polyester.

What Elleste Solo Transdermal patches look like and contents of the pack

Elleste Solo Transdermal Patches are rectangular in shape with rounded corners. They are packed in a box containing 8, individually wrapped patches.

An additional pack containing two patches may be available. Not all pack sizes are marketed.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

UK

Patch Manufacturer

LTS Lohmann Therapie Systeme AG

Lohmannstrasse 2, D56626

Andernach

Germany

If you have any comments on the way this leaflet is written, please write to

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

UK

This leaflet was last approved in November 2008.

Elleste Solo is a registered trademark.