The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00101/0488 .
Estraderm MX 25, 50, 75 and 100
oestradiol (as hemihydrate)
1. What Estraderm MX is and what it is used for
2. What you need to know before you use Estraderm MX
3. How to use Estraderm MX
4. Possible side effects
5. How to store Estraderm MX
6. Contents of the pack and other information
Estraderm MX is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen.
Estraderm MX is used in postmenopausal women with at least 12 months since their last natural period.
Estraderm MX is a patch that is applied to the skin. The patch contains a supply of oestradiol which is released from the patch and absorbed through the skin into your blood stream. This is called a transdermal patch.
Estraderm MX is used for:
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). Estraderm MX alleviates these symptoms after menopause. You will only be prescribed Estraderm MX 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 Estraderm MX to prevent osteoporosis after menopause.
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 Estraderm MX 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 Estraderm MX.
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 Estraderm MX,
Do not take Estraderm MX
If any of the above conditions appear for the first time while taking Estraderm MX, stop taking it at once and consult your doctor immediately.
Take special care with Estraderm MX
If you experience:
Stop using Estraderm MX and tell 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 Estraderm MX. If so, you should see your doctor more often for check-ups:
If you notice any of the following when taking HRT:
For more information, see ‘Blood clots in a vein (thrombosis)’
Note: Estraderm MX 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.
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.
Estraderm MX 75 and Estraderm MX 100 contains a higher dose of oestrogens than other oestrogen-only HRT products. The risk of endometrium cancer when using Estraderm MX together with a progestogen is not known.
Evidence shows that taking combined oestrogen-progestogen and possibly or oestrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The risk is much lower in women taking oestrogen-only HRT than in those taking oestrogen-progestogen combinations. The extra risk depends on how long you use HRT. The additional risk becomes clear within 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.
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 to 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).
Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestagen 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 taking Estraderm MX and see a doctor immediately’.
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.
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 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).
Some medicines may interfere with the effect of Estraderm MX. This might lead to irregular bleeding.
This applies to the following medicines:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.
If you need a blood test, tell your doctor or the laboratory staff that you are taking Estraderm MX, because this medicine can affect the results of some tests. Some laboratory tests, such as tests for glucose tolerance or thyroid function, may be affected by Estraderm MX therapy.
Estraderm MX is for use in postmenopausal women only. If you become pregnant, stop taking Estraderm MX and contact your doctor.
Estraderm MX should not be used during breast-feeding.
Estraderm MX has no known effect on the ability to drive and use machines.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary.
Speak to your doctor if you think this dose is too strong or not strong enough.
If you have not had a hysterectomy, your doctor will give you tablets containing another hormone called progestogen to offset the effects of oestrogens on the lining of the womb. (See the section above on ovarian cancer.) Your doctor will explain to you how to take these tablets. Withdrawal bleeding may occur at the end of the progestogen treatment period. Tell your doctor if you get irregular and/or heavy bleeding (see ovarian cancer).
It is important that you use the lowest possible effective dose and only as long as needed. You should apply a new patch twice a week i.e. every 3 or 4 days.
From time to time, you should discuss with your doctor whether you still need the treatment
Stick the patch on to a hairless area of skin below the waist. Most patients find that the buttock is the best place. Choose an area of the buttock where the skin is not inflamed, broken, or irritated. You could also try the lower back, hip or abdomen.
Never put a patch on or near the breasts.
Choose a clean, dry area of skin. To help the patch stick, the skin should be clean, dry, and free of creams, lotions, oil, or powder. You should use a different area of skin each time. Wait a week before using the same area again. Avoid skin which is red or irritated.
Do not expose the patch to direct sunlight.
Each Estraderm MX patch is sealed in an airtight sachet. Tear open one of the sachets at the notch (do not use scissors) and take out the patch. Don’t take the patch out of the sachet until immediately before you intend to use it.
Removing the lining
A stiff, transparent protective lining covers the sticky side of the patch, i.e. the side that will be placed against your skin. First remove the smaller piece of the transparent liner. Then peel off the larger piece. Try to avoid touching the adhesive and remember not to allow the patch to become folded so that the sticky surfaces come in contact with each other. Now apply the patch.
Applying the patch
With the palm of your hand press the sticky side of the patch firmly onto the spot you have chosen.
Hold it there for about 10-20 seconds. Make sure that it sticks well, especially around the edges, but once the patch is in place do not pull at it to test that it is sticking properly.
The patches should be changed twice a week on the same two days of the week, e.g. Mondays and Thursdays. Choose two days which you are likely to remember.
You will find a table at the end of this leaflet for you to fill in to jog your memory. Tick the day of the week on which you are starting the treatment and keep this leaflet somewhere safe so that you can refer back to it if you need to.
When the time comes to change the patch, peel it off and fold it in half with the sticky side inside.
Dispose of the patch carefully (see Section 5), making sure that it is kept out of the reach of children because it will still contain some medication. Stick a new patch onto a different area of skin.
If a patch falls off it will not stick to your skin again. Use another patch on a different area of your skin (see Where to apply the patch). Make sure you choose a clean, dry, lotion-free area of the skin.
No matter what day this happens, go back to changing the patch on the same days as usual.
Remove the patch if you have used too much Estraderm MX. Symptoms of overdose are usually tenderness of the breasts and/or vaginal bleeding. Acute overdose is unlikely due to the way Estraderm is used (patch). If symptoms persist contact your doctor.
If you forget to apply a patch, apply a new patch as soon as you remember. No matter what day that happens, go back to changing this patch on the same day as you usually do. There is an increased chance of breakthrough bleeding or spotting if there is a break in treatment. Do not use a double dose to make up for the forgotten patch.
Stopping use of Estraderm MX may increase the risk of breakthrough bleeding or spotting. Talk to your doctor if this occurs. After a long break in treatment, consult your doctor before starting to use the patch again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you are going to have surgery, tell the surgeon that you are taking Estraderm MX. You may need to stop taking Estraderm MX 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 Estraderm MX again.
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, may affect more than 1 in 10 people:
Common, may affect up to 1 in 10 people:
Uncommon, may affect up to 1 in 100 people:
Rare, may affect up to 1 in 1,000 people:
Very rare, may affect up to 1 in 10,000 people:
Not known: frequency cannot be estimated from the available data
If any of these apply to you and are severe, tell your doctor.
The following side effects have been reported with other HRTs:
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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Estraderm MX 25 contains 0.75 mg oestradiol releasing about 25 micrograms of oestradiol a day.
Estraderm MX 50 contains 1.5 mg oestradiol releasing about 50 micrograms of oestradiol a day.
Estraderm MX 75 contains 2.25 mg oestradiol releasing about 75 micrograms of oestradiol a day.
Estraderm MX 100 contains 3.0 mg oestradiol releasing about 100 micrograms of oestradiol a day.
Estraderm MX is a square-shaped, self-adhesive, transparent, transdermal patch for application to the skin surface. Each patch comprises an impermeable polyester backing film, an adhesive matrix containing oestradiol and an oversized protective liner which is removed prior to application of the patch to the skin.
Estraderm MX is available in four different strengths: 25, 50, 75 and 100 micrograms/ day.
Not all strengths may be marketed.
Estraderm MX is available in cartons of 8 patches (1 month pack) and 24 patches (3 months pack).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in 12/2023.
Fill this in to remind you when to change your patch. Please tick the box for the days of the week when you should change your patch.
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Merus Labs Luxco, telephone number 0800 198 5000.
ESTRADERM MX is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited