Patient Leaflet Updated 27-Sep-2024 | Theramex UK Limited
Evorel Sequi
Evorel Sequi®
Estradiol (as hemihydate), norethisterone acetate
Evorel is a registered trademark
1. What Evorel Sequi is and what it is used for
2. What you need to know before you use Evorel Sequi
3. How to use Evorel Sequi
4. Possible side effects
5. How to store Evorel Sequi
6. Contents of the pack and other information
The name of your medicine is Evorel Sequi. It belongs to a group of medicines called hormone replacement therapy (HRT).
Evorel Sequi contains two medicines:
They are both female hormones.
Evorel Sequi comes in a ‘memory pack’. This can be used to help you remember when to change your patches. Each pack contains eight patches.
The hormones are spread evenly in each patch. They pass 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 Sequi alleviates these symptoms after menopause. You will only be prescribed Evorel Sequi 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 Sequi to prevent osteoporosis after menopause.
Evorel Sequi is known as ‘continuous sequential’ HRT. This is because two hormones are used one after another:
Evorel Sequi patches replace the oestrogen that is normally released by the ovaries. However, taking an oestrogen hormone regularly may cause the lining of your womb to build up and get thicker.
The shedding of the lining of the womb will probably give a ‘withdrawal bleed’. This will be like having a period each month. The withdrawal bleed will start during week 4, before you finish an Evorel Sequi pack.
Evorel Sequi 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.
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 Sequi 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 Sequi.
Go for regular breast screening, as recommended by your doctor.
You are allergic to estradiol hemihydrate norethisterone acetate or any of the other ingredients of this medicine (listed in section 6).
If any of the above conditions appear for the first time while taking Evorel Sequi, stop taking it at once and consult your doctor immediately.
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 Sequi. If so, you should see your doctor more often for check-ups:
You may still be able to use Evorel Sequi, but you should discuss this with your doctor first. Also tell your doctor if these illnesses return or get worse while you are using Evorel Sequi.
If you have had a premature menopause the risk of using HRT may be different. Talk to your doctor about the risks.
Make sure that you:
If you notice any of the following when using Evorel Sequi
For more information, see ‘Blood clots in a vein (thrombosis)
Note: Evorel Sequi 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).
The progestogen in Evorel Sequi protects you from this extra risk.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed) while taking Evorel Sequi. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:
see your doctor as soon as possible
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 have had your womb removed because of endometriosis, any endometrium left in your body may be at risk of cancer. This means your doctor may prescribe HRT that includes a progestogen as well as an oestrogen.
Your product, Evorel Sequi, contains a progestogen. Evorel Sequi is only used in women who still have a womb (see Section 1 ‘What Evorel Sequi is used for’).
Compare
Looking at women aged 50 to 65 who still have a womb, on average:
The addition of a progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.
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 mammography 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 oestrogenonly 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.
These blood clots can be serious, and if a clot travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This is called pulmonary embolism, or PE.
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:
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, on average, over 5 years:
If you get painful swelling in your leg, sudden chest pain or have difficulty breathing
These may be signs of a blood clot.
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.
If you get a pain in your chest that spreads to your arm and neck
This pain may be a sign of heart disease.
Stroke
Research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:
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
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.
Looking at women in their 50s, on average, over 5 years:
If you get migraine-type headaches which you cannot explain
These headaches may be an early warning sign of a stroke.
Other conditions
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.
Some medicines may interfere with the effect of Evorel Sequi. This might lead to irregular bleeding. This applies to the following medicines:
Taking these medicines with Evorel Sequi can stop it from working as well. Because of this you may get some bleeding, like a period, when you are not expecting it.
HRT can affect the way some other medicines work:
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 Sequi. This is because this medicine may affect the results of the tests.
Evorel Sequi should not be used by children.
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.
Evorel Sequi is for use in postmenopausal women only. If you become pregnant, remove the patch and contact your doctor.
Do not use this medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
There is no information about whether Evorel Sequi 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. Your doctor will aim to reduce your symptoms with the lowest possible dose for the shortest amount of time.
You may put an Evorel Sequi patch on at any time if:
Put an Evorel 50 patch on within 5 days of the start of bleeding if:
Put an Evorel 50 patch on at the end of a treatment cycle or one week after you finish using another HRT product if:
Talk to your doctor if you are not sure which type of HRT you are using.
The patches need to be changed twice a week. You must use the patches in the right order.
Weeks 1 and 2
Use the four Evorel 50 patches one at a time.
Weeks 3 and 4
Use the four Evorel Conti patches one at a time. As soon as you remove your fourth Evorel 50 patch, replace it with the first Evorel Conti patch.
Start a new pack of Evorel Sequi 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 the new patch.
It is always useful to keep a spare pack that you can use to replace patches that have fallen off.
Talk to your doctor if you need more patches.
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.
It is unlikely that you will have too much of the hormones in Evorel Sequi. The most common symptoms of having too much oestrogen or progestogen 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.
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 taking Evorel Sequi. You may need to stop taking Evorel Sequi 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 taking Evorel Sequi again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are reported more often in women using HRT compared to women not using HRT:
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)
Frequency not known
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)
Very Rare (affects less than 1 in 10,000 people)
Frequency not known
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. It should be stored at room temperature (do not store above 25°C).
Do not use Evorel Sequi 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 open.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substances in Evorel Sequi are estradiol hemihydrate and norethisterone acetate.
Each Evorel 50 patch contains 3.2 mg of estradiol hemihydrate. Each Evorel 50 patch delivers 50 micrograms of estradiol a day.
Each Evorel Conti patch contains 3.2 mg of estradiol hemihydrate and 11.2 mg of norethisterone acetate. Each Evorel Conti patch delivers 50 micrograms of estradiol and 170 micrograms of norethisterone a day.
The other ingredients are Duro-Tak 387-2287 (this makes the patches sticky), guar gum and Hostaphan MN19 (backing film).
Evorel Sequi comes in a memory pack containing four Evorel 50 patches (marked CE50) and four Evorel Conti patches (marked CEN1).
Both types of patch 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 and has a surface area of 16 sq cm.
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