Evorel Sequi
(Estradiol Hemihydrate/Norethisterone Acetate)

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Brand Name Choices

Evorel Sequi 3.2mg, 3.2mg/11.2mg (50mcg/24Hr, 50/170mcg/24Hr)
Evorel Sequi 3.2mg, 3.2mg/11.2mg (50mcg/24Hr, 50/170mcg/24Hr) Patches

Estradiol Hemihydrate/Norethisterone Acetate

Manufactured by Theramex UK Limited

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

* Each 8-pack of Evorel Sequi patches containes 4 Evorel 50 patches and 4 Evorel Conti patches. The Evorel 50 patch is to be worn continuously for the first 14 days followed by the Evorel Conti patch for the next 14 days. Patches are to be changed twice weekly.

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Generic Choices

No generic medication is available for Evorel Sequi (Estradiol Hemihydrate/Norethisterone Acetate)

What Evorel Sequi is and what it is used for

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:
• An oestrogen (estradiol)
• A progestogen (norethisterone) 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:
• Four ‘Evorel 50’ patches marked CE50 (containing estradiol only)
• Four ‘Evorel Conti’ patches marked CEN1 (containing estradiol and norethisterone) The hormones are spread evenly in each patch. They pass slowly into your body through the skin What Evorel Sequi is used for Evorel Sequi is used:
• For the symptoms of the menopause (see ‘What is the menopause?’). It is only used in women who still have a womb. It is suitable for women who have had the menopause (postmenopausal) or who are around the time of the menopause (perimenopausal)
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• To prevent osteoporosis (fragile bones) in women who have had the menopause and are most likely to have bone problems. Evorel Sequi is 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 Sequi works Evorel Sequi is known as ‘continuous sequential’ HRT. This is because two hormones are used one after another:
• Estradiol is used by itself for two weeks
• Then estradiol and norethisterone are used together for the next two weeks 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.
• 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 Conti patches used during weeks 3 and 4 contain this progestogen 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.

How to take Evorel Sequi

Always use Evorel Sequi 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. When to start using Evorel Sequi You may put an Evorel 50 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 50 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 50 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
•10 - 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. 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. 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
•11 - 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, moisturizer 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 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 if you do 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
•12 - 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 of the same type. 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. 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. If you use more Evorel Sequi than you should 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:
• Tender breasts
• Feeling sick (nausea) or being sick
• Unexpected vaginal bleeding
• Feeling depressed
• Tiredness
• Acne
• Growth of body or facial hair Removing the patch can reverse the effects of too much oestrogen and/or progestogen. Talk to your doctor or pharmacist before using any more patches. Contraception while using Evorel Sequi 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, 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:
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• 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, rapid swelling of the hands and feet and stomach cramps
• Blood clots (thrombosis), or stroke (frequency not known)
• 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 (affects less than 1 in 10 people)
• Breast or ovarian cancer, endometrial cancer or hyperplasia (long, heavy or irregular vaginal bleeding)Widespread rash with peeling skin and blistering in the mouth, eyes and genitals (Stevens-Johnson syndrome) (frequency not known)
• Convulsions or fits (frequency not known) Tell your doctor if you notice any of the following side effects while using Evorel Sequi:

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

Common (affects less than 1 in 10 people)
• Feeling depressed or nervous
• Inappropriate signs of emotion
• Being unable to sleep
• Headache
• Itchy skin or red rash
• Feeling sick (nausea), or having stomach pain wind or other stomach upsets
• Diarrhoea
• Pain including pain in the back, muscles, joints
• Breast pain
• Feeling generally unwell
• Weight gain
• Heavy vaginal bleeding, painful periods
• Water retention or build-up of fluid under the skin (oedema)
•14 -

Uncommon (affects less than 1 in 100 people)
• Concentration problems
• Feeling dizzy
• More or less interest in sex than usual
• Allergic reaction (hypersensitivity)
• A fungal infection called thrush
• Feeling tired
• Being aware of your heartbeat (palpitations)
• Numb or tingling hands or feet, less skin sensitivity
• Breast lumps (non-cancerous)
• Fuller breasts
• Irregular vaginal bleeding
• Thickening of the lining of the womb Frequency not known
• Mood swings
• Bloated feeling
• Gallstones
• Swelling of the hands and feet (peripheral oedema)
• Puffy skin where the patch is applied

The following side effects have been reported with other combined HRTs:

Very common (affects more than 1 in 10 people)
• Tender breasts

Common (affects less than 1 in 10 people)
• Indigestion
• Acne
• Dry skin
• Pain in extremity (e.g. back pain, arms, legs, wrists, ankles)
• Severe contractions of the uterus
• Vaginal infection or discharge (white or yellowish discharge from the vagina)

Uncommon (affects less than 1 in100 people)
• Dizziness
• Varicose veins
• Being sick
• Skin discolouration
• Abnormal liver function tests

Rare (affects less than 1 in 1,000 people)
• Gallstones
• Muscle weakness
• Benign growths in the uterus smooth muscle
• Cysts close to the Fallopian tube
• Cervical polyps
•15 - Very

Rare (affects less than 1 in 10,000 people)
• Yellowing of the skin, itching, dark coloured urine Frequency not known
• Hair loss

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 painful reddish skin nodules(eythema nodosum)
• Rash with target shaped reddening or sores (erythema multiforme)
• Rash with red or purple coloured spots (vascular purpura)
• Loss of memory (Dementia) (see section 2)
• Dry eyes
• Change to composition of tears

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. 6. How to store Evor

How to Store Evorel Sequi

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.

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