Evorel Conti
(Estradiol Hemihydrate/Norethisterone Acetate)

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Brand Name Choices

Evorel Conti 3.2mg/11.2mg (50/170mcg/24Hr)
Evorel Conti 3.2mg/11.2mg (50/170mcg/24Hr) 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 Conti (Estradiol Hemihydrate/Norethisterone Acetate)

What Evorel Conti is and what it is used for

The name of your medicine is Evorel Conti. It belongs to a group of medicines called hormone replacement therapy (HRT). Evorel Conti contains two medicines:
• An oestrogen (estradiol)
• A progestogen (norethisterone) They are both female hormones. Evorel Conti comes in a ‘memory pack’. This can be used to help you remember when to change your patches. Each pack contains eight or twenty-four patches. The hormones are spread evenly in each patch. They pass slowly into your body through the skin.What Evorel Conti is used for Evorel Conti is used:
• For the symptoms of the menopause (see ‘What is the menopause?’). It is suitable for women who have not had a period (menstrual bleed) for at least 18 months
• To prevent osteoporosis (fragile bones) in women who have had the menopause and are most likely to have bone problems. Evorel Conti is only used if other medicines for osteoporosis have been tried first and they have not worked
•2 - 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 Conti works Evorel Conti is known as ‘continuous combined’ HRT. This is because both hormones in the patch are released all the time. Evorel Conti 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 Most women do not have a regular monthly period with Evorel Conti. However, bleeding or spotting does often occur in the first few months until treatment settles down. Evorel Conti 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 Conti

Always use Evorel Conti 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 Conti You may put an Evorel Conti patch on at any time if:
• You have not been using another type of HRT Put an Evorel Conti 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 Conti 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
•10 - 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 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
•11 - 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 a shower, wait until your skin cools before applying the 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. If you use more Evorel Conti than you should It is unlikely that you will have too much of the hormones in Evorel Conti. 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 Conti 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
•12 - 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:
• 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) (affects less than 1 in 1000 people) 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 100 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 periods)
• Widespread rash with peeling skin and blistering in the mouth, eyes and genitals (Stevens-Johnson syndrome) (frequency not known)
• Convulsions or fits (affects less than 1 in 1,000 people) Tell your doctor if you notice any of the following side effects while using Evorel Conti:

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

Common (affects less than 1 in 10 people)
• Allergic reaction (hypersensitvity)
• Being unable to sleep
• Feeling depressed, nervous or anxious
•13 -
• Headache
• Being aware of your heartbeat (palpitations)
• Varicose veins
• Flushing, skin reddening
• Breast pain
• Numb or tingling hands or feet
• Feeling sick (nausea)
• Diarrhoea
• Stomach ache
• Pain including pain in the back or joints
• Painful periods
• Discharge from the vagina
• Irregular, heavy or prolonged bleeding from the vagina, including after sex
• Water retention or build-up of fluid under the skin (oedema)
• Feeling tired
• Weight gain

Uncommon (affects less than 1 in 100 people)
• Vaginal infections such as thrush
• Less interest in sex than usual
• Wind
• Itchy skin
• Rash
• Swelling of the hands and feet (peripheral oedema)
• Muscle pain Frequency not known
• Mood swings
• Feeling dizzy
• Bloated feeling
• Gallstones
• Fuller breasts

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)
• Mood changes
• Indigestion
• Acne
• Dry skin
• Pain in extremity (e.g. back pain, arms, legs, wrists, ankles)
• Severe contractions of the uterus
• Vaginal infection (white or yellowish discharge from the vagina)

Uncommon (affects less than 1 in100 people)
• Dizziness
•14 -
• 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 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

How to Store Evorel Conti

Keep this medicine out of the sight and reach of children. It should be stored at room temperature (at or below 25°C). Keep in the original pouch and carton. Do not use Evorel Conti 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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