Evorel
(Estradiol)

Prescription Settings Edit

Brand Name Choices

Evorel 25 1.6mg (25mcg/24Hr)
Evorel 25 1.6mg (25mcg/24Hr) Extended Release Patches

Manufactured by Janssen-Cilag Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Evorel 50 3.2mg (50mcg/24Hr)
Evorel 50 3.2mg (50mcg/24Hr) Extended Release Patches

Manufactured by Janssen-Cilag Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Evorel 75 4.8mg (75mcg/24Hr)
Evorel 75 4.8mg (75mcg/24Hr) Extended Release Patches

Manufactured by Janssen-Cilag Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Evorel 100 6.4mg (100mcg/24Hr)
Evorel 100 6.4mg (100mcg/24Hr) Extended Release Patches

Manufactured by Janssen-Cilag Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Generic Choices

No generic medication is available for Evorel (Estradiol)

What Evorel is and what it is used for

The name of your medicine is Evorel. It belongs to a group of medicines called 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. Evorel is used for
• The symptoms of the menopause (see ‘What is the menopause?’)Evorel 50, 75 and 100 can also be used to
• Prevent osteoporosis (fragile bones) in women who have had the menopause and are most likely to have bone problems. Evorel 50, 75 and 100 are only used if other medicines for osteoporosis have been tried first and they have not worked What is the menopause? 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:
• Hot flushes, night sweats or mood swings
• Vaginal problems such as dryness or itching
• Uncomfortable or painful sexual intercourse You may get the same symptoms if you have had your ovaries taken out in an operation. How Evorel works 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.
• This means it is necessary to add a progestogen hormone to the oestrogen
• This helps shed the lining of the womb and stop any problems happening Evorel is not a contraceptive.

How to take Evorel

Always use Evorel 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. When to start using Evorel You may put an Evorel patch on at any time if:
• You have not used HRT before your menopause and no longer have menstrual periods
• Your menstrual cycles are not regular and you are not pregnant
• You are changing from HRT that does not give you a withdrawal bleed Put an Evorel patch on within 5 days of the start of bleeding if:
• You are not currently using HRT and still having regular periods Put an Evorel patch on at the end of a treatment cycle or one week after you finish using another HRT product if:
• You are changing from an HRT medicine that gives you a withdrawal bleed If you are using another type of HRT:
• The day you start will depend on the type of HRT you have been using Talk to your doctor if you are not sure which type of HRT you are using. Using the patches 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.
•9 - Changing your patches
• You must change the patches twice a week to give your body a steady supply of hormones. There is enough hormone in each patch to last for several days
• Change your patch on the same two days every week. This will mean that one patch is on for three days and the next patch for four days
• For example, if you apply your first patch on a Monday, change it on Thursday and again on the following Monday. You can work out your two days from the following table, starting from the first day of use: 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 Tue Wed Thur Fri Sat Sun Thur Fri Sat Sun Mon Tue Wed Where to apply the patch 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 apply on or near the breasts
• Do not put it on top of cuts, spots or anywhere the skin is irritated
• Do not use cream, moisturiser or talc before applying the patch
• Do not apply the patch on the same area of skin twice in a row
• It can be worn under loose areas of clothing.
• Do not wear a patch under elasticated areas or a tight waistband
• Apply the patch to clean, dry, cool skin as soon as you open the protective pouch
•10 - Putting a patch on Do not use a patch if its protective pouch is already open. Step 1: Open and Peel
• Using the notches as a guide, tear along two edges of the pouch. Remove the patch
• With the protective backing facing you, bend and peel off half the backing. Don’t touch the sticky side
•it may not stick properly Step 2: Apply and Press
• Apply the open half of the patch to your skin
• Remove the remaining backing and press down the rest of the patch
• Press the patch with the palm of your hand to make sure it is firmly stuck Removing a patch
• Peel an edge of the patch smoothly away from the skin
• Fold the patch in half, so that the sticky side sticks to itself
• Put it in with the household rubbish, safely out of the reach of children and pets
• Do not flush used patches down the toilet 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. If a patch falls off 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. If you forget to change the 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.
•11 - If you use more Evorel than you should 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:
• Tender or painful breasts
• Feeling sick (nausea) or being sick
• Unexpected vaginal bleeding
• Stomach pain or bloating 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. Contraception while using Evorel 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
• You can have a bath or shower as normal. Do not scrub too hard as this can loosen the edges of the patch
• You can go swimming. The patch will not be affected
• You can exercise and play sports. However, do not wear the patch under tight clothing or waist bands
• You can sunbathe. However, keep the patch covered, out of direct sunlight If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Evorel 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. The following diseases are reported more often in women using HRT compared to women not using HRT:
• breast cancer;
• abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• heart disease;
• stroke;
• probable memory loss if HRT is started over the age of 65; For more information about these side effects, see Section 3. Take off the patch and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.
• Sudden swelling of the face or throat which may cause difficulty in swallowing or breathing. This may be a sign of an allergic reaction. This only happens in a small number of people
•12 -
• Blood clots (thrombosis), a heart attack or stroke
• Yellowing of the skin or whites of the eyes (jaundice), or other liver problems
• Migraine-type headaches for the first time or more frequent (affects less than 1 in 10 people)
• An increase in blood pressure
• Breast or ovarian cancer, endometrial cancer or hyperplasia (long, heavy or irregular vaginal bleeding)
• Convulsions or fits (frequency not known) Tell your doctor if you notice any of the following side effects while using Evorel:

Very common (affects more than 1 in 10 people)
• Irritated, itchy skin and rash where the patch is applied

Common (affects less than 1 in 10 people)
• Red, puffy skin where the patch is applied
• Breast pain
• Rash or feeling itchy
• Feeling dizzy
• Feeling depressed
• Headache
• Feeling sick or having stomach pains
• Diarrhoea
• Pain, including pain in joints
• Break through bleeding, spotting or periods
• Weight gain

Uncommon (affects less than 1 in 100 people)
• Vaginal thrush
• Wind
• Being aware of your heart beat (palpitations)
• Fuller breasts
• Painful periods
• Swelling of hands and feet (peripheral oedema)
• Water retention or build-up of fluid under the skin (oedema)
• Muscle pain
• Allergic reactions (hypersensitivity)

Rare (affects less than 1 in 1,000 people)
• Bloated feeling
• Gallstones

The following side effects have been reported with other HRTs:
•13 -

Common (affects less than 1 in 10 people)
• Weight decrease
• Feeling sick

Uncommon (affects less than 1 in100 people)
• Problems with sight
• Indigestion
• Painful reddish skin nodules (erythema nodosum)
• Tender breasts

Rare (affects less than 1 in 1,000 people)
• Feeling anxious
• Increase or loss in sex drive
• Being sick
• Contact lenses may feel uncomfortable
• Excess hair growth
• Acne
• Muscle cramps
• Discharge from the vagina, premenstrual syndrome (PMS)
• Feeling tired

The following side effects have been reported in association with oestrogen/progestogen treatment
• Gall bladder disease
• Brown patches on your face or body (chloasma)
• Rash with target -shaped reddening or sores (erythema multiforme)
• Bruising on the legs
• Loss of memory (Dementia) (see section 3)

Reporting of side effects 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.

How to Store Evorel

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.

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