Patient Leaflet Updated 27-Sep-2024 | Theramex UK Limited
Evorel 75 Patches
Evorel®
Estradiol
Evorel is a registered trademark
1. What Evorel is and what it is used for
2. What you need to know before you use Evorel
3. How to use Evorel
4. Possible side effects
5. How to store Evorel
6. Contents of the pack and other information
The name of your medicine is Evorel. It is a Hormone Replacement Therapy (HRT).
Evorel contains an oestrogen (estradiol) which is a female hormone. It comes in 4 different sizes: Evorel 25, Evorel 50, Evorel 75 and Evorel 100.
Evorel comes in a ‘memory pack’. This can be used to help you remember when to change your patches. Each pack contains eight patches. Evorel 50 also comes in packs of two and twenty-four patches.
The hormone is spread evenly in each patch. It passes slowly into your body through the skin.
Women produce oestrogen hormones from their ovaries throughout their adult life. These hormones are important in sexual development and control of the menstrual cycle.
The menopause happens when the level of hormones produced by the ovaries goes down. This is a gradual process. During this time the levels of oestrogen can go up and down. This can cause:
You may get the same symptoms if you have had your ovaries taken out in an operation.
During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Evorel alleviates these symptoms after menopause. You will only be prescribed Evorel if your symptoms seriously hinder your daily life.
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Evorel to prevent osteoporosis after menopause.
Evorel patches replace the oestrogen that is normally released by the ovaries. However, in women who still have a womb, taking an oestrogen hormone regularly may cause the lining of your womb to build up and get thicker.
Evorel is not a contraceptive.
The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.
Once you have started on Evorel you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Evorel.
Go for regular breast screening, as recommended by your doctor.
If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Evorel
If any of the above conditions appear for the first time while taking Evorel, stop taking it at once and consult your doctor immediately.
Evorel should not be used by children.
Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Evorel. If so, you should see your doctor more often for check-ups:
Make sure that you:
If you notice any of the following when taking HRT:
For more information, see ‘Blood clots in a vein (thrombosis)’
Note: Evorel is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.
As well as benefits, HRT has some risks. Consider the following when deciding to take or continue HRT.
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).
Taking a progestogen in addition to the oestrogen for at least 12 days of each 28-day cycle protects you from this extra risk. So, your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen.
In women who still have a womb 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 aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.
Evorel 100 contains a higher dose of oestrogens than other oestrogen-only HRT products. The risk of endometrium cancer when using Evorel 100 together with a progestogen is not known.
Breast cancer
Evidence shows that taking combined oestrogen-progestogen or oestrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The additional risk becomes clear within a 3 years of use. After stopping HRT the extra risk will decrease with time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.
Compare
Women aged 50 to 54 who are not taking HRT, on average 13 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 who start taking oestrogen-only HRT for 5 years, there will be 16-17 cases in 1000 users (i.e. an extra 0 to 3 cases).
For women aged 50 who start taking oestrogen-progestogen HRT for 5 years, there will be 21 cases in 1000 users (i.e.an extra 4-8 cases).
Women aged 50 to 59 who are not taking HRT, on average, 27 in 1000 will be diagnosed with breast cancer over a 10-year period.
For women aged 50 who start taking oestrogen-only HRT for 10 years, there will be 34 cases in 1000 users (i.e. an extra 7 cases)
For women aged 50 who start taking oestrogen-progestogen HRT for 10 years, there will be 48 cases in 1000 users (i.e. an extra 21 cases).
Regularly check your breasts. See your doctor if you notice any changes such as:
Make an appointment to see your doctor as soon as possible.
Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare, much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case).
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you:
For signs of a blood clot, see “Stop using Evorel and see a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e.an extra 5 cases).
For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.
For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease.
Stroke
The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.
Compare
Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).
If you get migraine-type headaches which you cannot explain
These headaches may be an early warning sign of a stroke
If you have brown patches on your face or body (chloasma) or have a history of them, you may need to keep out of the sun or away from sunbeds (these patches may not completely disappear again)
Evorel and medicines like it will not stop memory loss (dementia). Women who start using medicines like Evorel after the age of 65 may have a small increase in the risk of dementia.
Some medicines may interfere with the effect of Evorel. This might lead to irregular bleeding. This applies to the following medicines:
HRT can affect the way some other medicines work:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products. Your doctor will advise you.
Tell your doctor if you are going to have surgery. 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.
If you visit a hospital or your family doctor for a blood or urine test, tell them that you are taking Evorel. This is because this medicine may affect the results of the tests.
Do not use this medicine if you are pregnant, think you may be pregnant or might become pregnant. This is because it may affect the baby.
If you become pregnant, contact your doctor straight away and remove the patch.
Do not use this medicine if you are breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Evorel is for use in postmenopausal women only. If you become pregnant, stop talking Evorel and contact your doctor.
There is no information about whether Evorel affects your ability to drive or use machines. See how this medicine affects you before you drive or use any tools or machines.
Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Evorel patches are available in 4 different sizes: Evorel 25, Evorel 50, Evorel 75 and Evorel 100. These contain different amounts of the oestrogen hormone, estradiol. Your doctor will aim to reduce your symptoms with the lowest possible dose for the shortest amount of time.
The highest dose you should have is 100 micrograms of estradiol in a day. This is the amount delivered by an Evorel 100 patch each day.
You may put an Evorel patch on at any time if:
Put an Evorel patch on within 5 days of the start of bleeding if:
Put an Evorel patch on at the end of a treatment cycle or one week after you finish using another HRT product if:
If you are using another type of HRT:
The patches need to be changed twice a week.
Start a new pack of Evorel as soon as you finish one. Do not leave a break between packs.
If you put your first patch on: Change on: Change again on:
Monday → Thursday & Monday
Tuesday → Friday & Tuesday
Wednesday → Saturday & Wednesday
Thursday → Sunday & Thursday
Friday → Monday & Friday
Saturday → Tuesday & Saturday
Sunday → Wednesday & Sunday
To help you remember your two “patch change" days, mark them here or on the pack. They are written on the pack like this:
Mon Thur
Tue Fri
Wed Sat
Thur Sun
Fri Mon
Sat Tue
Sun Wed
Stick the patch onto a hairless area of skin below the waist. Most women prefer to wear the patch on the thigh or bottom.
Do not use a patch if its protective pouch is already open.
Step 1: Open and Peel
Step 2: Apply and Press
When you remove the patch some glue may remain on your skin. It will disappear with time, or you can use baby oil to remove it.
Apply a new patch but keep to your original ‘patch change’ days. If you have just had a bath or shower, wait until your skin cools before applying a new patch.
Talk to your doctor if you need more patches.
It is unlikely that you will have too much of the hormones in Evorel. The most common symptoms of having too much oestrogen in your body are:
Removing the patch can reverse the effects of too much oestrogen. Talk to your doctor or pharmacist before using any more patches. Your doctor may decide to change the size of patch.
Change it as soon as you remember and then keep to your original ‘patch change’ days. You may get some bleeding and spotting like a period during this time.
The levels of hormone from the patches are too low to act as a contraceptive. Use non-hormonal contraceptive methods (such as a condom, diaphragm or coil) until your periods have completely stopped.
Everyday activities
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you are going to have surgery, tell the surgeon that you are using Evorel. You may need to stop using Evorel about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start using Evorel again.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may happen more often with the larger size patches.
Some side effects may be due to any progestogen that is being taken at the same time.
For more information about these side effects, see Section 2.
Very common (affects more than 1 in 10 people)
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in 100 people)
Rare (affects less than 1 in 1,000 people)
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in100 people)
Rare (affects less than 1 in 1,000 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard .
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Keep in the original pouch and carton.
Do not use Evorel after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not use a patch if the protective pouch is already open.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Evorel 25 contains 1.6 mg estradiol and delivers 25 micrograms of estradiol a day
Evorel 50 contains 3.2 mg estradiol and delivers 50 micrograms of estradiol a day
Evorel 75 contains 4.8 mg estradiol and delivers 75 micrograms of estradiol a day
Evorel 100 contains 6.4 mg estradiol and delivers 100 micrograms of estradiol a day
Evorel comes in a memory pack containing eight patches.
Evorel 50 also comes in packs of two and twenty four patches.
Evorel 25 is marked CE25 and has a surface area of 8 sq cm
Evorel 50 is marked CE50 and has a surface area of 16 sq cm
Evorel 75 is marked CE75 and has a surface area of 24 sq cm
Evorel 100 is marked CE100 and has a surface area of 32 sq cm
The patches are square with rounded corners. They are clear with a sticky backing that can be stuck to the skin. Each patch comes in a protective sealed pouch.
For information in large print, tape, CD or Braille, telephone 0800 198 5000.
This leaflet was last revised in August 2023.
Theramex HQ UK Ltd, 50 Broadway, 5th Floor, London, SW1H 0BL, UK
0333 0096795
www.theramex.com