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VIVELLEDOT 75 MICROGRAMS/24 HOURS TRANSDERMAL PATCHES

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Common (affects 1 to 10 users in 100):
Depression, nervousness, mood changes, sleeplessness, nausea (feeling
sick), indigestion, diarrhoea, abdominal pain, bloated feeling, acne, rash,
dry skin, itching, pruritus, breast enlargement, heavy menstrual periods, a
white or yellowish discharge from the vagina, irregular vaginal bleeding,
severe uterine contractions, inflammation of the vagina, abnormal growth of
the womb lining (endometrial hyperplasia), pain, back pain, weakness, fluid
retention (oedema) in the extremities (hands and feet), weight changes.
Uncommon (affects 1 to 10 users in 1,000):
Migraine, dizziness, increase in blood pressure, vomiting (being sick), skin
discolouration, impaired liver function tests.
Rare (affects 1 to 10 users in 10,000):
Tingling or numbness of hand and feet, blood clot, gallstones, hair loss,
muscular weakness, benign smooth muscle growth in uterus, cysts close to
uterine tubes, polyps (small growths) in the uterine cervix (neck of the
womb), changes in sexual desire, hypersensitivity, allergic reactions such as
rash.
Very rare (affects less than 1 user in 10,000):
Hives, signs of serious allergic reaction such as sudden trouble breathing,
tightness of the chest, general rash, swelling or itching, decreased
carbohydrate tolerance, involuntary movements which may affect the eyes,
head and neck, contact lens discomfort, dry eyes, tear film composition
changes, severe skin lesions, excessive hair growth.
Not known (can not be estimated from the available data):
Breast cancer, embolism, pain in extremity, liver function test abnormal.






The active substance is estradiol (as hemihydrate).
The other ingredients in the adhesive layer of the patch are acrylic
adhesive, silicone adhesive, oleyl alcohol, dipropylene glycol,
povidone (E1201).
The backing layer is composed of: ethylene/vinyl acetate copolymer,
polyethylene, vinylidene/vinyl chloride copolymer, polyethylene,
ethylene/vinyl acetate copolymer co-extruded film, silicon dioxide/titanium
dioxide.
The release liner (to be removed before application) is a fluoropolymercoated polyester film.

What Estradot looks like and contents of the pack
Estradot is a 7.5 cm2 rectangular patch with rounded corners, comprising a
pressure-sensitive adhesive layer containing estradiol, with a translucent
polymeric backing on one side and protective liner on the other.
Estradot comes in boxes of 8 patches.
Marketing Authorisation Holder and Manufacturer
This medicine is manufactured by Novartis Pharma S.A.S, 26 Rue de La
Chapelle, 68330 Huningue, France and is procured from within the EU.
Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon
(UK) Limited, Redditch, B98 0RE.

PL Number: 33723/0043

Estradot ® 75 micrograms/24 hours transdermal patch

6

Ref:LTT0043/140812/1/F

(estradiol hemihydrate)

Patient Information Leaflet
Your medicine is called Estradot 75 micrograms/24 hours transdermal
patches, and will be referred to as Estradot throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.



In
1
2
3
4
5

POM

this leaflet:
What Estradot is and what it is used for
Before you use Estradot
How to use Estradot
Possible side effects
How to store Estradot
Further information









if you have abnormal growth of the womb lining (endometrial
hyperplasia) and you have not been treated for this yet;
if you have, or have ever had a blood clot in your veins. This may cause
blockage of a blood vessel in the legs (deep vein thrombosis), leading to
thromboembolism e.g. in the lungs (pulmonary embolism) or other organs;
if you have thrombophilic disorders (e.g. protein C, protein S or
antithrombin deficiency);
if you have, or have ever had a heart attack, stroke or severe chest
pain due to angina (angina pectoris);
if you have, or have ever had a liver disease and your liver function has
not returned to normal;
if you have porphyria (red blood pigment in your urine);
if you are allergic to estradiol or any of the other ingredients of Estradot.

Tell your doctor if any of these applies to you. You should not receive
Estradot.
Take special care with Estradot
Estradot is not a transdermal contraceptive nor a fertility treatment. If you are
still capable of becoming pregnant you must not use any hormone
replacement therapy.

Estradot is a registered trademark of Novartis AG.
Leaflet revision date: 14/08/12

Other side effects that have been linked to HRT:
Hard painful lumps looking like bruises on the legs, skin eruptions (redness,
spots and sometimes blistering, possibly also affecting the inside of the
mouth) and decline in memory or mental ability (possible
dementia), gallbladder disease.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

1

Estradot is a hormone replacement therapy. You need to be aware of the
general risks when using HRT.

What Estradot is and what it is used for

Estradot is a hormone replacement therapy (HRT) and contains the hormone
oestrogen.
Estradot comes as a patch that is applied to the skin. The patch releases
small amounts of estradiol, which pass directly through the skin into your
bloodstream. Estradiol is identical to the natural hormone oestrogen that is
produced by the ovaries until the menopause (the time when your
menstrual periods stop).
Estradot is used for:

5 How to store Estradot









Relief of symptoms of the menopause
During the menopause, the amount of oestrogen produced by a woman’s
body drops. For some women this can cause unpleasant symptoms such as
hot face, neck and chest (“hot flushes”), sleep problems, irritability and
depression. Some women also have problems with dryness of the vagina,
which may cause discomfort during or after sexual intercourse. Estradot can
reduce or stop these symptoms after the menopause.

Keep out of the sight and reach of children.
Once opened or once the protective pouch has been removed, the patch
should be applied to the skin immediately.
Do not refrigerate or freeze Estradot.
Do not use Estradot after the expiry date which is stated on the carton and
patch after ‘EXP’. The expiry date refers to the last date of the month.
Do not use any Estradot pack that is damaged or shows signs of
tampering.
If your medicine become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

Prevention of osteoporosis (for Estradot 50, 75 and 100 only)
Reduced oestrogen can increase the risk of osteoporosis.
Osteoporosis is a thinning of the bones that makes them weaker and more
likely to break. Taking oestrogens after the menopause slows down bone loss
and can help to prevent osteoporosis.
Estradot may be used to prevent osteoporosis after the menopause in
women who are at an increased risk of fractures but who are unable to use
other drugs approved for the prevention of osteoporosis. Your doctor should
discuss all the available options with you.

6 Further information

If you have or have ever had any of the following conditions, you need
to let your doctor know. They may come back or get worse during
treatment with Estradot:
• Benign tumours of the womb (e.g. myoma), endometrial hyperplasia
(abnormal growth of the womb lining) or endometriosis (endometrial
growths outside the uterus): Using HRT products containing only
oestrogens (such as Estradot) for a long period can increase the risk of
abnormal growth of the womb lining (the endometrium) and endometrial
cancer. Adding a progestogen for at least 12 days every month / 28 day
cycle greatly decreases this risk. During the first months of treatment,
irregular bleeding may occur.
Contact your doctor immediately:
– if unexpected bleeding or spotting (breakthrough bleeding) occurs after
having used Estradot for some time or if this continues after you stop
treatment
– if you have painful menstrual periods.
Your doctor should examine what the cause is.
• If your womb has not been removed, you should also use the hormone
progestogen for 12-14 days a month / 28 day cycle, in addition to
Estradot, as directed by your doctor.
• Blood clots (thrombosis, lung embolism): You should not use Estradot
if you have ever had a blood clot in your veins. HRT may increase the
risk of blood clots, especially during the first year of treatment.
Stop using Estradot and contact your doctor immediately if you get:
– painful swelling and redness of the legs
– sudden chest pain
– difficulty in breathing.

The experience treating women older than 65 years is limited.

What Estradot contains
Estradot 75 micrograms/24 hours transdermal patch contains estradiol
hemihydrate corresponding to 1.17 mg estradiol and releases about 75
micrograms estradiol per 24 hours.

2

Before you use Estradot

Do not use Estradot
• If you have, or have ever had breast cancer, or think you might have it;
• if you have, or have ever had any cancer which is sensitive to
oestrogens, such as cancer of the lining of the womb (endometrium), or
think you might have it;
if you have vaginal bleeding of unknown cause;



Page 4

These symptoms may be signs of a blood clot.
Tell your doctor if any of the following applies to you:
– if you are extremely overweight (BMI>30)
– if you have had a blood clot before or if you or someone in your close
family has had blood clots
– if you have any blood-clotting problem needing treatment with a medicine
(anticoagulant)
– if you have had more than one miscarriage
– if you are off your feet for a long time because of surgery, injury or illness
– if you are about to have an operation; it is best to stop treatment 4 to 6
weeks before surgery.
Page 1

Any of these will make your risk of a blood clot higher.
• High blood pressure: Stop using Estradot and contact your doctor
immediately,
– if an increase in blood pressure occurs while using Estradot.
• Liver problems: You need to let your doctor know if you have ever had
liver problems, such as a benign tumour in the liver (liver adenoma).
Stop using Estradot and contact your doctor immediately,
– if you get yellowing of the eyes and face (jaundice); this could be a sign of
liver problems.
• Migraine or severe headache: Some studies with HRT have shown a
slightly increased risk of ischaemic stroke.
Stop using Estradot and contact your doctor immediately,
– if you get unexplained migraine-like headaches, with or without disturbed
vision. Headaches like these can be an early sign of a stroke. If you have
already had a stroke, talk with your doctor about whether the benefits of
the treatment outweigh the possibly increased risk.

• Breast cancer: You should not use Estradot if you have ever had
breast cancer. There is an increased risk of breast cancer related
to HRT. The risk increases the longer the treatment lasts and decreases
when treatment is stopped. Five years after stopping treatment, the risk
returns to that of women who have never used HRT. The risk of breast
cancer seems to be higher for women using oestrogen in combination with
progestogen than for women who use products containing only oestrogen
(such as Estradot).
Contact your doctor if you notice any changes to your breasts, such as:
– dimpling of the breast skin
– changes in the nipple
– lumps that you can see or feel.
Your doctor may advise you to have regular breast check-ups, including
mammography. You need to let your doctor know if you have a history of
breast cancer or other oestrogen-sensitive cancers in your immediate family
(mother, sister or daughter).
• Heart disease: You should not use Estradot if you have ever had a
heart attack or chest pain (angina pectoris). Studies with HRT tablets
have shown that women may be slightly more likely to get heart disease
during the first year of treatment. For Estradot, it is not certain whether the
risk is similar.
Stop using Estradot and contact a doctor immediately,
– if you get pain in your chest that spreads to your arm or neck.
This pain may be a sign of heart disease.
• Ischaemic Stroke: You should not use Estradot if you have ever had
an ischaemic stroke.
See “migraine or severe headache”. These can be warning signs of an
ischaemic stroke.
• Cancer of the ovaries: Some studies have shown that using hormone
therapy with oestrogens alone (such as Estradot) for 5–10 years may lead
to a slightly increased risk of cancer of the ovaries compared to women
never treated with HRT. It is suggested that long - term use of combined
HRTs may confer a similar, or slightly smaller risk.
• Hypothyroidism: A condition in which your thyroid gland fails to produce
enough thyroid hormone and for which you are treated with thyroid
hormone replacement therapy.
• Angioedema: Oestrogens may induce or exacerbate symptoms of
angioedema (episodes of rapid swelling of hands, feet, face, lips, eyes,
tongue, throat or digestive tract), in particular in women with hereditary
angioedema.
• High fat levels in your blood which in rare cases may cause
inflammation of the pancreas.
• Diabetes
• Gallstones
• Systemic lupus erythematosus (SLE), an autoimmune disorder
• Epilepsy
• Asthma
• Hearing loss due to otosclerosis (a problem with the bones in your
ear)
• Kidney problems
Tell your doctor before taking Estradot if you have ever had any of the
conditions above.

Medical check-ups
Before you start using Estradot your doctor should ask you about your own
and your family’s medical history. Your doctor should examine your breasts
and your abdomen and may do an internal examination. He/she should tell
you what kind of changes in the breast you should report to the doctor and
may advise you to have a breast X-ray (a mammogram). Once you have
started Estradot, you should see your doctor for regular check-ups (at least
once a year). At these check-ups your doctor should discuss with you the
benefits and risks of continuing to take Estradot.
Effects on laboratory tests
Using oestrogens may influence the results of certain laboratory results.
Tell your doctor that you use Estradot before undergoing a blood test.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. Some
medicines may increase or decrease the effect of Estradot, such as
medicines containing:
phenobarbital, phenytoin or carbamazepine (used to treat epilepsy),
rifampicin, rifabutin (used to treat tuberculosis),
nevirapine, efavirenz, ritonavir, nelfinavir (used to treat HIV infection),
St John’s Wort (herbal medicine used to treat depression).






Pregnancy and breast-feeding
You should not use Estradot if you are pregnant or can still become pregnant
or while you are breast-feeding.
Stop using Estradot and contact your doctor immediately if you become
pregnant during Estradot treatment. Ask your doctor or pharmacist for advice
before taking any medicine.

If the patch does not stick completely to your skin, use a new patch.
No matter what day this happens, go back to changing this patch on the
same days as your original schedule.

Women with a uterus
Your doctor should give you another hormone called progestogen in addition
to Estradot to reduce the risk of cancer of the uterus.
While Estradot is applied continuously without a break, the progestogen
tablet should be taken for at least 12-14 days every month / 28 day cycle.
Check the risks to be aware of with HRT in general in section 2, Take special
care with Estradot.

Further useful information:
Bathing, swimming, showering or exercising should not affect the patch if it
has been correctly applied. If a patch falls off, e.g. during bathing or
showering, shake it to remove the water. After careful drying and cooling
down of the skin, reapply the same patch on a different area of the lower
abdomen (see ‘Where to apply Estradot’).

Women without a uterus
The Estradot patch is applied continuously without a break.
Additional use of another type of hormone called progestogen is not required,
unless you have a condition where the lining of the uterus also grows outside
the uterus (endometriosis). Check the risks to be aware of with HRT in
general in section 2, Take special care with Estradot.

Where to apply Estradot
Apply the patch to the lower abdomen, below the waistline. Avoid the
waistline itself, since clothing may cause the patch to rub off. Do not apply
the patch to the breasts or any area near to the breasts.
When changing your patch, based on your twice-a-week schedule, apply
your new patch to a different site. Do not apply a new patch to that same
area for at least one week.
Before you apply Estradot, make sure that your skin is:
clean, dry and cool,
free of any powder, oil, moisturiser, or lotion,
free of cuts and/or irritation.





How to apply Estradot
Each patch is individually sealed in a protective pouch.
Tear open this pouch at the indentation and remove the
patch (do not use scissors to open the pouch as this
could damage the patch).

Driving and using machines
Estradot has no known effect on the ability to drive and use machines.

3

How to use Estradot

A stiff protective backing covers the sticky side of the patch. This backing
must be removed before the patch is stuck to the skin.
Apply the patch immediately after opening the pouch and removing the
protective backing.

Always use Estradot exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure. During the treatment your
doctor may adjust the dose according to your individual needs.
How long to use Estradot
It is important that you use the lowest possible effective dose and only as
long as needed.
From time to time, you should discuss with your doctor whether you still need
the treatment.

Hold the patch with the protective backing facing you.
Peel off one side of the protective backing and discard
it. Try to avoid touching the sticky side of the patch
with your fingers.

Holding the other half of the backing, apply the sticky side of the
patch to a dry area of your lower abdomen. Press the sticky side to
the skin and smooth down. Fold back the remaining side of the patch.

When to start treatment
• If you are currently not using any form of HRT (patches or tablets), or if
you have been using a continuous combined HRT product (where
oestrogen and the progestogen are given every day without interruption),
you can start to use Estradot on any convenient day.



Grasp the straight edge of the protective backing and
pull it off the patch.

Press the sticky remaining side of the patch to the skin
and smooth down. Press the patch firmly in place with
the palm of your hand for about 10 seconds.

If you are changing from a cyclic or sequential HRT treatment (where
the progestogen is added for 12–14 days of the cycle), you should start to
use Estradot on the day after you complete your previous cycle.

When to apply Estradot
• An Estradot patch should be replaced twice weekly (every 3 to 4 days). It
is best to always replace it on the same two days of the week (e.g.
Monday and Thursday). Your Estradot pack contains a calendar checklist
on the back to help you remember your schedule. Mark the twice-a-week
schedule that you plan to follow. Always change the patch on the two days
of the week you have marked.
• Estradot should be worn continuously until it is time to replace it with a
new patch.

When sunbathing or using a solarium, the patch should be covered.
When swimming, the patch can be worn under your bathing suit.
If you have used more Estradot than you should
Remove the patch if you have used too much Estradot. Symptoms of
overdose are usually tenderness of the breasts and/or vaginal bleeding.
Acute overdose is unlikely due to the way Estradot is used (patch). If
symptoms persist contact your doctor.
If you forget to use Estradot
If you forget to change the patch, change the patch as soon as you
remember. No matter what day this happens, go back to changing the newly
applied patch on the same days as your original schedule.
Do not use a double dose to make up for the forgotten patch.
If you stop using Estradot
Stopping use of Estradot 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 product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Estradot patches can cause side effects, although not
everybody gets them.
Some effects could be serious
These symptoms need immediate medical attention:
• Sudden chest pain
• Pain in your chest that spreads to your arm or neck
• Difficulty in breathing
• Painful swelling and redness of the legs
• Yellowing of the eyes and face (jaundice), darkening of urine, itchy skin
• Unexpected vaginal bleeding or spotting (breakthrough bleeding) after
using Estradot for some time, or after you stop treatment
• Breast changes, including dimpling of the breast skin, changes in the
nipple, lumps that you can see or feel.
Painful menstrual periods
Unexplained migraine-like headaches




Stop using Estradot and tell your doctor immediately if you get any of the
effects mentioned above. Check the risks to be aware of with HRT in general
in section 2, Take special care with Estradot.

Very common (affects more than 1 user in 10):
Headache, skin reactions at the patch application site (redness, rash,
itching), erythema, breast tension and pain, menstrual pains, menstrual
disorders.

When changing the patch, peel it off, fold it with
the sticky side inside, and discard it with normal
household waste.

Other side effects
In addition, the following side effects have been reported with Estradot. If any
of these gets severe, tell your doctor or pharmacist.

Make sure that the patch sticks properly to your skin
and go over the edges with your finger to ensure good
contact between the patch and skin.

Any adhesive that might remain on your skin can be easily rubbed off. Then
place the new Estradot patch onto a different area of skin.
Ref:LTT0043/140812/1/B

Page 3

Page 2

Common (affects 1 to 10 users in 100):
Depression, nervousness, mood changes, sleeplessness, nausea (feeling
sick), indigestion, diarrhoea, abdominal pain, bloated feeling, acne, rash,
dry skin, itching, pruritus, breast enlargement, heavy menstrual periods, a
white or yellowish discharge from the vagina, irregular vaginal bleeding,
severe uterine contractions, inflammation of the vagina, abnormal growth of
the womb lining (endometrial hyperplasia), pain, back pain, weakness, fluid
retention (oedema) in the extremities (hands and feet), weight changes.
Uncommon (affects 1 to 10 users in 1,000):
Migraine, dizziness, increase in blood pressure, vomiting (being sick), skin
discolouration, impaired liver function tests.
Rare (affects 1 to 10 users in 10,000):
Tingling or numbness of hand and feet, blood clot, gallstones, hair loss,
muscular weakness, benign smooth muscle growth in uterus, cysts close to
uterine tubes, polyps (small growths) in the uterine cervix (neck of the
womb), changes in sexual desire, hypersensitivity, allergic reactions such as
rash.
Very rare (affects less than 1 user in 10,000):
Hives, signs of serious allergic reaction such as sudden trouble breathing,
tightness of the chest, general rash, swelling or itching, decreased
carbohydrate tolerance, involuntary movements which may affect the eyes,
head and neck, contact lens discomfort, dry eyes, tear film composition
changes, severe skin lesions, excessive hair growth.
Not known (can not be estimated from the available data):
Breast cancer, embolism, pain in extremity, liver function test abnormal.






The active substance is estradiol (as hemihydrate).
The other ingredients in the adhesive layer of the patch are acrylic
adhesive, silicone adhesive, oleyl alcohol, dipropylene glycol,
povidone (E1201).
The backing layer is composed of: ethylene/vinyl acetate copolymer,
polyethylene, vinylidene/vinyl chloride copolymer, polyethylene,
ethylene/vinyl acetate copolymer co-extruded film, silicon dioxide/titanium
dioxide.
The release liner (to be removed before application) is a fluoropolymercoated polyester film.

What Vivelldot looks like and contents of the pack
Vivelldot is a 7.5 cm2 rectangular patch with rounded corners, comprising a
pressure-sensitive adhesive layer containing estradiol, with a translucent
polymeric backing on one side and protective liner on the other.
Vivelldot comes in boxes of 8 patches.
Marketing Authorisation Holder and Manufacturer
This medicine is manufactured by Novartis Pharma S.A.S, 26 Rue de La
Chapelle, 68330 Huningue, France and is procured from within the EU.
Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon
(UK) Limited, Redditch, B98 0RE.

PL Number: 33723/0043

Vivelldot ® 75 micrograms/24 hours transdermal patch

6

Ref:LTT0043/140812/2/F

(estradiol hemihydrate)

Patient Information Leaflet
Your medicine is called Vivelldot 75 micrograms/24 hours transdermal
patches, and will be referred to as Vivelldot throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.



In
1
2
3
4
5

POM

this leaflet:
What Vivelldot is and what it is used for
Before you use Vivelldot
How to use Vivelldot
Possible side effects
How to store Vivelldot
Further information









if you have abnormal growth of the womb lining (endometrial
hyperplasia) and you have not been treated for this yet;
if you have, or have ever had a blood clot in your veins. This may cause
blockage of a blood vessel in the legs (deep vein thrombosis), leading to
thromboembolism e.g. in the lungs (pulmonary embolism) or other organs;
if you have thrombophilic disorders (e.g. protein C, protein S or
antithrombin deficiency);
if you have, or have ever had a heart attack, stroke or severe chest
pain due to angina (angina pectoris);
if you have, or have ever had a liver disease and your liver function has
not returned to normal;
if you have porphyria (red blood pigment in your urine);
if you are allergic to estradiol or any of the other ingredients of Vivelldot.

Tell your doctor if any of these applies to you. You should not receive
Vivelldot.
Take special care with Vivelldot
Vivelldot is not a transdermal contraceptive nor a fertility treatment. If you are
still capable of becoming pregnant you must not use any hormone
replacement therapy.

Vivelldot is a registered trademark of Novartis AG.
Leaflet revision date: 14/08/12

Other side effects that have been linked to HRT:
Hard painful lumps looking like bruises on the legs, skin eruptions (redness,
spots and sometimes blistering, possibly also affecting the inside of the
mouth) and decline in memory or mental ability (possible dementia),
gallbladder disease.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

1

Vivelldot is a hormone replacement therapy. You need to be aware of the
general risks when using HRT.

What Vivelldot is and what it is used for

Vivelldot is a hormone replacement therapy (HRT) and contains the hormone
oestrogen.
Vivelldot comes as a patch that is applied to the skin. The patch releases
small amounts of estradiol, which pass directly through the skin into your
bloodstream. Estradiol is identical to the natural hormone oestrogen that is
produced by the ovaries until the menopause (the time when your
menstrual periods stop).
Vivelldot is used for:

5 How to store Vivelldot









Relief of symptoms of the menopause
During the menopause, the amount of oestrogen produced by a woman’s
body drops. For some women this can cause unpleasant symptoms such as
hot face, neck and chest (“hot flushes”), sleep problems, irritability and
depression. Some women also have problems with dryness of the vagina,
which may cause discomfort during or after sexual intercourse. Vivelldot can
reduce or stop these symptoms after the menopause.

Keep out of the sight and reach of children.
Once opened or once the protective pouch has been removed, the patch
should be applied to the skin immediately.
Do not refrigerate or freeze Vivelldot.
Do not use Vivelldot after the expiry date which is stated on the carton and
patch after ‘EXP’. The expiry date refers to the last date of the month.
Do not use any Vivelldot pack that is damaged or shows signs of
tampering.
If your medicine become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

Prevention of osteoporosis (for Vivelldot 50, 75 and 100 only)
Reduced oestrogen can increase the risk of osteoporosis.
Osteoporosis is a thinning of the bones that makes them weaker and more
likely to break. Taking oestrogens after the menopause slows down bone loss
and can help to prevent osteoporosis.
Vivelldot may be used to prevent osteoporosis after the menopause in
women who are at an increased risk of fractures but who are unable to use
other drugs approved for the prevention of osteoporosis. Your doctor should
discuss all the available options with you.

6 Further information

If you have or have ever had any of the following conditions, you need
to let your doctor know. They may come back or get worse during
treatment with Vivelldot:
• Benign tumours of the womb (e.g. myoma), endometrial hyperplasia
(abnormal growth of the womb lining) or endometriosis (endometrial
growths outside the uterus): Using HRT products containing only
oestrogens (such as Vivelldot) for a long period can increase the risk of
abnormal growth of the womb lining (the endometrium) and endometrial
cancer. Adding a progestogen for at least 12 days every month / 28 day
cycle greatly decreases this risk. During the first months of treatment,
irregular bleeding may occur.
Contact your doctor immediately:
– if unexpected bleeding or spotting (breakthrough bleeding) occurs after
having used Vivelldot for some time or if this continues after you stop
treatment
– if you have painful menstrual periods.
Your doctor should examine what the cause is.
• If your womb has not been removed, you should also use the hormone
progestogen for 12-14 days a month / 28 day cycle, in addition to
Vivelldot, as directed by your doctor.
• Blood clots (thrombosis, lung embolism): You should not use Vivelldot
if you have ever had a blood clot in your veins. HRT may increase the
risk of blood clots, especially during the first year of treatment.
Stop using Vivelldot and contact your doctor immediately if you get:
– painful swelling and redness of the legs
– sudden chest pain
– difficulty in breathing.

The experience treating women older than 65 years is limited.

What Vivelldot contains
Vivelldot 75 micrograms/24 hours transdermal patch contains estradiol
hemihydrate corresponding to 1.17 mg estradiol and releases about 75
micrograms estradiol per 24 hours.

2

Before you use Vivelldot

Do not use Vivelldot
• If you have, or have ever had breast cancer, or think you might have it;
• if you have, or have ever had any cancer which is sensitive to
oestrogens, such as cancer of the lining of the womb (endometrium), or
think you might have it;
if you have vaginal bleeding of unknown cause;



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These symptoms may be signs of a blood clot.
Tell your doctor if any of the following applies to you:
– if you are extremely overweight (BMI>30)
– if you have had a blood clot before or if you or someone in your close
family has had blood clots
– if you have any blood-clotting problem needing treatment with a medicine
(anticoagulant)
– if you have had more than one miscarriage
– if you are off your feet for a long time because of surgery, injury or illness
– if you are about to have an operation; it is best to stop treatment 4 to 6
weeks before surgery.
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Any of these will make your risk of a blood clot higher.
• High blood pressure: Stop using Vivelldot and contact your doctor
immediately,
– if an increase in blood pressure occurs while using Vivelldot.
• Liver problems: You need to let your doctor know if you have ever had
liver problems, such as a benign tumour in the liver (liver adenoma).
Stop using Vivelldot and contact your doctor immediately,
– if you get yellowing of the eyes and face (jaundice); this could be a sign of
liver problems.
• Migraine or severe headache: Some studies with HRT have shown a
slightly increased risk of ischaemic stroke.
Stop using Vivelldot and contact your doctor immediately,
– if you get unexplained migraine-like headaches, with or without disturbed
vision. Headaches like these can be an early sign of a stroke. If you have
already had a stroke, talk with your doctor about whether the benefits of
the treatment outweigh the possibly increased risk.

• Breast cancer: You should not use Vivelldot if you have ever had
breast cancer. There is an increased risk of breast cancer related
to HRT. The risk increases the longer the treatment lasts and decreases
when treatment is stopped. Five years after stopping treatment, the risk
returns to that of women who have never used HRT. The risk of breast
cancer seems to be higher for women using oestrogen in combination with
progestogen than for women who use products containing only oestrogen
(such as Vivelldot).
Contact your doctor if you notice any changes to your breasts, such as:
– dimpling of the breast skin
– changes in the nipple
– lumps that you can see or feel.
Your doctor may advise you to have regular breast check-ups, including
mammography. You need to let your doctor know if you have a history of
breast cancer or other oestrogen-sensitive cancers in your immediate family
(mother, sister or daughter).
• Heart disease: You should not use Vivelldot if you have ever had an
heart attack or chest pain (angina pectoris). Studies with HRT tablets
have shown that women may be slightly more likely to get heart disease
during the first year of treatment. For Vivelldot, it is not certain whether the
risk is similar.
Stop using Vivelldot and contact a doctor immediately,
– if you get pain in your chest that spreads to your arm or neck.
This pain may be a sign of heart disease.
• Ischaemic Stroke: You should not use Vivelldot if you have ever had
a ischaemic stroke.
See “migraine or severe headache”. These can be warning signs of an
ischaemic stroke.
• Cancer of the ovaries: Some studies have shown that using hormone
therapy with oestrogens alone (such as Vivelldot) for 5–10 years may lead
to a slightly increased risk of cancer of the ovaries compared to women
never treated with HRT. It is suggested that long - term use of combined
HRTs may confer a similar, or slightly smaller risk.
• Hypothyroidism: A condition in which your thyroid gland fails to produce
enough thyroid hormone and for which you are treated with thyroid
hormone replacement therapy.
• Angioedema: Oestrogens may induce or exacerbate symptoms of
angioedema (episodes of rapid swelling of hands, feet, face, lips, eyes,
tongue, throat or digestive tract), in particular in women with hereditary
angioedema.
• High fat levels in your blood which in rare cases may cause
inflammation of the pancreas.
• Diabetes
• Gallstones
• Systemic lupus erythematosus (SLE), an autoimmune disorder
• Epilepsy
• Asthma
• Hearing loss due to otosclerosis (a problem with the bones in your
ear)
• Kidney problems
Tell your doctor before taking Vivelldot if you have ever had any of the
conditions above.
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Medical check-ups
Before you start using Vivelldot your doctor should ask you about your own
and your family’s medical history. Your doctor should examine your breasts
and your abdomen and may do an internal examination. He/she should tell
you what kind of changes in the breast you should report to the doctor and
may advise you to have a breast X-ray (a mammogram). Once you have
started Vivelldot, you should see your doctor for regular check-ups (at least
once a year). At these check-ups your doctor should discuss with you the
benefits and risks of continuing to take Vivelldot.
Effects on laboratory tests
Using oestrogens may influence the results of certain laboratory results.
Tell your doctor that you use Vivelldot before undergoing a blood test.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. Some
medicines may increase or decrease the effect of Vivelldot, such as
medicines containing:
phenobarbital, phenytoin or carbamazepine (used to treat epilepsy),
rifampicin, rifabutin (used to treat tuberculosis),
nevirapine, efavirenz, ritonavir, nelfinavir (used to treat HIV infection),
St John’s Wort (herbal medicine used to treat depression).






Pregnancy and breast-feeding
You should not use Vivelldot if you are pregnant or can still become pregnant
or while you are breast-feeding.
Stop using Vivelldot and contact your doctor immediately if you become
pregnant during Vivelldot treatment. Ask your doctor or pharmacist for advice
before taking any medicine.

If the patch does not stick completely to your skin, use a new patch.
No matter what day this happens, go back to changing this patch on the
same days as your original schedule.

Women with a uterus
Your doctor should give you another hormone called progestogen in addition
to Vivelldot to reduce the risk of cancer of the uterus.
While Vivelldot is applied continuously without a break, the progestogen
tablet should be taken for at least 12-14 days every month / 28 day cycle.
Check the risks to be aware of with HRT in general in section 2, Take special
care with Vivelldot.

Further useful information:
Bathing, swimming, showering or exercising should not affect the patch if it
has been correctly applied. If a patch falls off, e.g. during bathing or
showering, shake it to remove the water. After careful drying and cooling
down of the skin, reapply the same patch on a different area of the lower
abdomen (see ‘Where to apply Vivelldot’).

Women without a uterus
The Vivelldot patch is applied continuously without a break.
Additional use of another type of hormone called progestogen is not required,
unless you have a condition where the lining of the uterus also grows outside
the uterus (endometriosis). Check the risks to be aware of with HRT in
general in section 2, Take special care with Vivelldot.

Where to apply Vivelldot
Apply the patch to the lower abdomen, below the waistline. Avoid the
waistline itself, since clothing may cause the patch to rub off. Do not apply
the patch to the breasts or any area near to the breasts.
When changing your patch, based on your twice-a-week schedule, apply
your new patch to a different site. Do not apply a new patch to that same
area for at least one week.
Before you apply Vivelldot, make sure that your skin is:
clean, dry and cool,
free of any powder, oil, moisturiser, or lotion,
free of cuts and/or irritation.





How to apply Vivelldot
Each patch is individually sealed in a protective pouch.
Tear open this pouch at the indentation and remove the
patch (do not use scissors to open the pouch as this
could damage the patch).

Driving and using machines
Vivelldot has no known effect on the ability to drive and use machines.

3

How to use Vivelldot

A stiff protective backing covers the sticky side of the patch. This backing
must be removed before the patch is stuck to the skin.
Apply the patch immediately after opening the pouch and removing the
protective backing.

Always use Vivelldot exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure. During the treatment your
doctor may adjust the dose according to your individual needs.
How long to use Vivelldot
It is important that you use the lowest possible effective dose and only as
long as needed.
From time to time, you should discuss with your doctor whether you still need
the treatment.

Hold the patch with the protective backing facing you.
Peel off one side of the protective backing and discard
it. Try to avoid touching the sticky side of the patch
with your fingers.

Holding the other half of the backing, apply the sticky side of the
patch to a dry area of your lower abdomen. Press the sticky side to
the skin and smooth down. Fold back the remaining side of the patch.

When to start treatment
• If you are currently not using any form of HRT (patches or tablets), or if
you have been using a continuous combined HRT product (where
oestrogen and the progestogen are given every day without interruption),
you can start to use Vivelldot on any convenient day.



Grasp the straight edge of the protective backing and
pull it off the patch.

Press the sticky remaining side of the patch to the skin
and smooth down. Press the patch firmly in place with
the palm of your hand for about 10 seconds.

If you are changing from a cyclic or sequential HRT treatment (where
the progestogen is added for 12–14 days of the cycle), you should start to
use Vivelldot on the day after you complete your previous cycle.

When to apply Vivelldot
• An Vivelldot patch should be replaced twice weekly (every 3 to 4 days). It
is best to always replace it on the same two days of the week (e.g.
Monday and Thursday). Your Vivelldot pack contains a calendar checklist
on the back to help you remember your schedule. Mark the twice-a-week
schedule that you plan to follow. Always change the patch on the two days
of the week you have marked.
• Vivelldot should be worn continuously until it is time to replace it with a
new patch.

When sunbathing or using a solarium, the patch should be covered.
When swimming, the patch can be worn under your bathing suit.
If you have used more Vivelldot than you should
Remove the patch if you have used too much Vivelldot. Symptoms of
overdose are usually tenderness of the breasts and/or vaginal bleeding.
Acute overdose is unlikely due to the way Vivelldot is used (patch). If
symptoms persist contact your doctor.
If you forget to use Vivelldot
If you forget to change the patch, change the patch as soon as you
remember. No matter what day this happens, go back to changing the newly
applied patch on the same days as your original schedule.
Do not use a double dose to make up for the forgotten patch.
If you stop using Vivelldot
Stopping use of Vivelldot 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 product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Vivelldot patches can cause side effects, although not
everybody gets them.
Some effects could be serious
These symptoms need immediate medical attention:
• Sudden chest pain
• Pain in your chest that spreads to your arm or neck
• Difficulty in breathing
• Painful swelling and redness of the legs
• Yellowing of the eyes and face (jaundice), darkening of urine, itchy skin
• Unexpected vaginal bleeding or spotting (breakthrough bleeding) after
using Vivelldot for some time, or after you stop treatment
• Breast changes, including dimpling of the breast skin, changes in the
nipple, lumps that you can see or feel.
Painful menstrual periods
Unexplained migraine-like headaches




Stop using Vivelldot and tell your doctor immediately if you get any of
the effects mentioned above. Check the risks to be aware of with HRT in
general in section 2, Take special care with Vivelldot.

Very common (affects more than 1 user in 10):
Headache, skin reactions at the patch application site (redness, rash,
itching), erythema, breast tension and pain, menstrual pains, menstrual
disorders.

When changing the patch, peel it off, fold it with
the sticky side inside, and discard it with normal
household waste.

Other side effects
In addition, the following side effects have been reported with Vivelldot. If
any of these gets severe, tell your doctor or pharmacist.

Make sure that the patch sticks properly to your skin
and go over the edges with your finger to ensure good
contact between the patch and skin.

Any adhesive that might remain on your skin can be easily rubbed off. Then
place the new Vivelldot patch onto a different area of skin.
Ref:LTT0043/140812/2/B

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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