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Active substance(s): ESTRADIOL HEMIHYDRATE

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Package leaflet: Information for the user
1.53 mg/spray transdermal spray, solution


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
–– 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
–– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Lenzetto is and what it is used for
What you need to know before you use Lenzetto
How to use Lenzetto
Possible side effects
How to store Lenzetto
Contents of the pack and other information

1. What Lenzetto is and what it is used for

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 using 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.

Lenzetto is a Hormone Replacement Therapy (HRT). It contains a female hormone,
from the group of oestrogens. Lenzetto is used in postmenopausal women with at least
6 months since their last natural period.
Lenzetto contains a higher dose of oestrogens than other oestrogen-only HRT
Lenzetto can also be used in women who have had surgery to remove their ovaries
products. The risk of endometrium cancer when using Lenzetto together with a
as this causes instant menopause.
progestogen is not known.

Lenzetto is a spray solution which contains small amounts of a medicine called
Unexpected bleeding
estradiol. When sprayed onto the skin as directed, it passes through the skin into your You will have a bleed once a month (so-called withdrawal bleed) while using Lenzetto
if it is combined with sequentially dosed progestagen product. But, if you have
unexpected bleeding or drops of blood (spotting) besides your monthly bleeding,
Lenzetto is used for:
–– carries on for more than the first 6 months;
Relief of symptoms occurring after menopause
–– starts after you have been using Lenzetto more than 6 months;
During the menopause, the amount of the oestrogen produced by a woman’s body
–– carries on after you have stopped using Lenzetto;
drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”).
see your doctor as soon as possible.
Lenzetto alleviates these symptoms after menopause. You will only be prescribed
Lenzetto if your symptoms seriously hinder your daily life.
Breast cancer
Evidence suggests that using combined oestrogen-progestogen and possibly also
Lenzetto is indicated to treat oestrogen deficiency symptoms after menopause; when oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how
menstruation has ceased following menopause. Symptoms of oestrogen deficiency
long you take HRT. The additional risk becomes clear within a few years. However, it
include hot flushes (sudden waves of heat and sweating in the whole body), sleeping returns to normal within a few years (at most 5) after stopping treatment.
problems, irritability and dryness of the vagina.
For women who have had their womb removed and who are using oestrogen-only
HRT for 5 years, little or no increase in breast cancer risk is shown.
The experience in treating women older than 65 years is limited.
Women aged 50 to 79 who are not using HRT, on average, 9 to 14 in 1000 will be
Lenzetto is not a contraceptive.
diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who
are using oestrogen-progestogen HRT over 5 years, there will be 13 to 20 cases in
1000 users (i.e. an extra 4 to 6 cases).
2. What you need to know before you use Lenzetto
Regularly check your breasts. See your doctor if you notice any changes such as:
Medical history and regular check-ups
–– dimpling of the skin
The use of HRT carries risks which need to be considered when deciding whether to –– changes in the nipple
start using it, or whether to carry on using it.
–– any lumps you can see or feel.
The experience in treating women with a premature menopause (due to ovarian
Additionally, you are advised to join mammography screening programs when
failure or surgery) is limited. If you have a premature menopause the risks of using HRT offered to you. For mammogram screening, it is important that you inform the nurse/
may be different. Please talk to your doctor.
healthcare professional who is actually taking the x-ray that you use HRT, as this
medication may increase the density of your breasts which may affect the outcome of
Before you start (or restart) HRT, your doctor will ask you about your own and your
the mammogram. Where the density of the breast is increased, mammography may
family’s medical history. Your doctor may decide to perform a physical examination.
not detect all lumps.
This may include an examination of your breasts and/or an internal examination, if
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported
Once you have started on Lenzetto you should see your doctor for regular check-ups in women using HRT for at least 5 to 10 years.
(at least once a year). At these check-ups, discuss with your doctor the benefits and
risks of continuing with Lenzetto.
Women aged 50 to 69 who are not using HRT, on average about 2 women in
1000 will be diagnosed with ovarian cancer over a 5-year period. For women
Go for regular breast screening, as recommended by your doctor.
who have been using HRT for 5 years, there will be between 2 and 3 cases per
1000 users (i.e. up to 1 extra case).
Do not use Lenzetto
if any of the following applies to you. If you are not sure about any of the points
Effect of HRT on heart and circulation
below, talk to your doctor before taking Lenzetto.
Blood clots in a vein (thrombosis)
Do not use Lenzetto
The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in
–– if you have or have ever had breast cancer, or if you are suspected of having it; non-users, especially during the first year of using it.
–– if you have or have ever had any cancer which is sensitive to oestrogens, such
as cancer of the lining of your womb (endometrium), or if you are suspected of
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain,
having it;
breathlessness, fainting or even death.
–– if you have any unexplained vaginal bleeding;
–– if you have excessive thickening of the lining of your womb
You are more likely to get a blood clot in your veins as you get older and if
(endometrial hyperplasia) that is not being treated;
any of the following applies to you. Inform your doctor if any of these situations
–– if you have or have ever had a blood clot in your vein (thrombosis), such as in
applies to you:
the legs (deep venous thrombosis) or the lungs (pulmonary embolism);
–– you are unable to walk for a long time because of major surgery, injury or illness
–– if you have a blood clotting disorder (such as protein C, protein S or
(see also section 3, If you need to have surgery).
antithrombin deficiency);
–– you are seriously overweight (BMI >30 kg/m2).
–– if you have, or recently have had a disease caused by blood clots in the arteries, –– you have any blood clotting problem that needs long-term treatment with a
such as heart attack, stroke or angina;
medicine used to prevent blood clots.
–– if you have, or have ever had, a liver disease and your liver function tests have
–– if any of your close relatives has ever had a blood clot in the leg, lung or another
not returned to normal;
–– if you have a rare blood problem called “porphyria” which passes down in
–– you have systemic lupus erythematosus (SLE).
families (is inherited);
–– you have cancer.
–– if you are allergic to estradiol or any of the other ingredients of this medicine (listed
in the section 6.).
For signs of a blood clot, see “Stop using Lenzetto and see a doctor immediately”.

Some medicines may interfere with the effect of Lenzetto. This might lead to irregular
bleeding. This applies to the following medicines:
–– medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine)
–– medicines for tuberculosis (such as rifampicin, rifabutin)
–– medicines for HIV infection (such as nevirapine, ritonavir, nelfinavir or efavirenz)
–– (traditional) herbal medicines containing St John’s Wort (Hypericum perforatum).
Ask your doctor or pharmacist for advice before taking any medicine.
Laboratory Tests
If you need a blood test, tell your doctor or the laboratory staff that you are using
Lenzetto because this medicine can affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Lenzetto is for post-menopausal women only. If you become pregnant, stop using
Lenzetto immediately and contact your doctor.
Do not use Lenzetto while you are breast-feeding.
Driving and using machines
Lenzetto has no known effect on the ability to drive or use machines.
Lenzetto contains alcohol
Alcohol-based liquids are flammable. Avoid fire, flame or smoking until the spray has
3. How to use Lenzetto
Always use this medicine exactly as your doctor 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. During the treatment your doctor may adjust the dose according to your
individual needs. Speak to your doctor if you think this dose is too strong or not strong
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. Your doctor will explain to you how to take these tablets. Withdrawal
bleeding may occur at the end of the progestogen treatment period. (See section
“Unexpected bleeding”.)
Where to apply Lenzetto
The spray should be applied to the inner forearm. Do not apply Lenzetto to the
breasts or any area near to the breasts.
How to apply Lenzetto
Before spraying the first dose from a new container onto your dry and healthy
skin, the applicator should be prepared for use by spraying three times with the
cover on.
The container should be held upright as shown in Figure 1. With the cover on, press
the button right down three times with your thumb or index finger.
The medicine is now ready to use.
Do not prepare the applicator before each dose; only prepare the applicator once
before using a new container.

If any of the above conditions appear for the first time while using Lenzetto, stop using Looking at women in their 50s who are not using HRT, on average, over a 5-year
it at once and consult your doctor immediately.
period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
Warnings and precautions
Talk to your doctor or pharmacist before using Lenzetto.

For women in their 50s who have been using oestrogen-progestogen HRT for over
5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

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 Lenzetto.
If so, you should see your doctor more often for check-ups:
–– fibroids inside your womb;
–– growth of womb lining outside your womb (endometriosis ) or a history of
excessive growth of the womb lining (endometrial hyperplasia);
–– increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”);
–– increased risk of getting an oestrogen-sensitive cancer (such as having a mother,
sister or grandmother who has had breast cancer);
–– high blood pressure;
–– a liver disorder such as a benign liver tumour;
–– diabetes;
–– gallstones;
–– migraine or severe headache;
–– a disease of the immune system that affects many organs of the body (systemic
lupus erythematosus, SLE);
–– epilepsy;
–– asthma;
–– a disease affecting the eardrum and hearing (otosclerosis);
–– a very high level of fat in your blood (triglycerides);
–– fluid retention due to cardiac or kidney problems.

For women in their 50s who have had their womb removed and have been using
oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users
(i.e. 1 extra case).

Stop using Lenzetto and see a doctor immediately
If you notice any of the following when using HRT:
–– any of the conditions mentioned in the “Do not use Lenzetto” section
–– yellowing of your skin or the whites of your eyes (jaundice). These may be signs of
a liver disease;
–– a large rise in your blood pressure (symptoms may be headache, tiredness,
–– migraine-like headaches which happen for the first time;
–– if you become pregnant;
–– if you notice signs of a blood clot, such as:
–– painful swelling and redness of the legs;
–– sudden chest pain;
–– difficulty in breathing.
For more information, see “Blood clots in a vein (thrombosis)”.

Other conditions
HRT will not prevent memory loss. There is some evidence of a higher risk of memory
loss in women who start using HRT after the age of 65. Speak to your doctor for

Note: Lenzetto 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.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the lining of the womb (endometrial cancer).

Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.

Make sure that the skin where you want to spray the medicine is clean and dry.
How to apply your daily dose.

Women over the age of 60 years who use oestrogen-progestogen HRT are slightly
more likely to develop heart disease than those not using any HRT.
For women who have had their womb removed and are using 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 using 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 using HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra
3 cases).

Oestrogen in Lenzetto spray can be accidentally transfered to other people from the
area of skin where it was sprayedon. Do not allow others, especially children, to
come into contact with the exposed area of your skin.. If a child comes in contact
with the part of the arm where Lenzetto was sprayed, wash the child’s skin with soap
and water as soon as possible. Young children who accidentally came into contact
with the area where Lenzetto was sprayed on, may show signs of puberty that are not
expected (for example, breast budding).
Call your healthcare provider right away if you see any signs and symptoms (breast
development or other sexual changes) in a child that may have occurred through
accidental exposure to Lenzetto. In most cases the child’s breasts will go back to
normal when they are no longer exposed to Lenzetto.
Do not allow pets to lick or touch the arm where Lenzetto was sprayed. Small pets
may be especially sensitive to the oestrogen in Lenzetto.
Contact a veterinarian if your pet exhibits mammary/nipple enlargement and/or
vulvar swelling, or any other sign of illness.

To apply your daily dose, take off the plastic cover, hold the container upright and
rest the plastic cone flat against the skin. (Figure 2)
You may need to move your arm or move the cone part of the container on the arm
so that the cone is flat against your skin and there are no gaps between the cone and
your dry and healthy skin.
Press the button right down one time.
If another spray is needed, move the cone along your arm so that it is beside the area
you have already sprayed. Press the button right down one time.

Using oestrogen-only HRT will increase the risk of excessive thickening of the lining of the Other medicines and Lenzetto
If a third spray is needed, move the cone along your arm again and press the button
womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).
Tell your doctor if you are using, have recently used or might use any other medicines. right down one time.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
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
–– Ovarian cancer;
–– Blood clots in the veins of the legs or lung (venous thromboembolism);
–– Heart attack;
–– Stroke;
–– Gallbladder disease;
–– High blood pressure;
–– Liver problems;
–– High blood sugar;
–– Probable memory loss if HRT is started over the age of 65.

If your second or third spray will not fit the same inner forearm, or if you have trouble
putting the cone on your inner forearms as shown in Figure 3 or if you have difficulty
to use on the forearm, you can also spray onto your other inner forearm or to the inner For more information about these side effects, see Section 2.
surface of your thigh.
Some side effects can be serious.
When you have finished using Lenzetto, always put the cover back on the container. The following symptoms need immediate medical attention:
–– Sudden chest pain;
Let the spray dry for at least 2 minutes before getting dressed and at least 60 minutes –– Pain in your chest that spreads to your arm or neck;
before bathing or washing. If you get Lenzetto spray on another area of your skin like –– Breathing difficulties;
your hands, wash that area of your skin with soap and water right away.
–– Painful swelling and redness in the legs;
–– Yellowing of the eyes and face (jaundice);
Lenzetto should not be used on broken or damaged skin.
–– Unexpected vaginal bleeding (breakthrough bleeding) or spotting after using
Lenzetto for some time or after you stop treatment;
Do not massage or rub Lenzetto into the skin.
–– Breast changes including dimpling of the breast skin, changes in the nipple, lumps
that you can see or feel;
Do not allow other people to touch the area of skin you have sprayed for at least –– Painful menstrual periods;
60 minutes afterwards. If another person (special care for children) accidentally
–– Dizziness and faintness;
touches the area of your skin where you sprayed Lenzetto, tell that person to wash the –– Changes in speech;
area of their skin with soap and water right away.
–– Changes in vision;
–– Unexplained migraine-like headaches.
How much Lenzetto you should use
Your doctor will probably start you on the lowest dose (one spray per day) and
If any of the side effects get serious, or if you notice any side effects not listed in this
you should talk with your doctor about how well the medicine is working for you. If
leaflet, please tell your doctor or pharmacist.
necessary, your doctor may increase your dose to two sprays per day. The maximum
daily dose is 3 sprays.
The following side effects below have been reported with Lenzetto:
How often you will use Lenzetto
The total number of sprays (dose(s)) that your doctor has prescribed for you should be
applied at the same time each day.

Common side effects (may affect up to 1 in 10 people)
Headache, abdominal pain, nausea, rash, pruritis (itching), irregular uterine bleeding
or vaginal bleeding including spotting, weight increase or weight decrease.

The period of time you will continue to use Lenzetto
Talk to your doctor every 3‑6 months about how long you should use Lenzetto for.
You should only use Lenzetto for as long as you need it to provide relief from hot
flushes associated with menopause.

Uncommon side effects (may affect up to 1 in 100 people)
Hypersensitivity reactions, depressed mood, insomnia (difficulty sleeping), dizziness,
vertigo (a feeling of dizziness or “spinning”) , visual disturbances, palpitations (feeling
your heartbeat), diarrhoea, dyspepsia (indigestion), increased blood pressure,
erythema nodosum (characterized by painful reddish skin nodules), hives (general
or localised rash or lumps), skin irritation, swelling due to fluid retention (oedema),
muscle pain, breast tenderness, breast pain, breast discolouration, breast discharge,
polyps (small growths) in the uterine or cervix, endometrial hyperplasia, ovary cyst,
inflammation of genitals (vaginitis), increased liver enzymes and blood cholesterol,
underarm pain.

Other useful information
Sunscreens can alter the absorption of oestrogen from Lenzetto.
Avoid using sunscreen on the part of the skin where you intend to spray the product
for at least 1 hour before or after you use Lenzetto.
Lenzetto should be used with caution under extreme temperature conditions, such as
sauna or sunbathing.
There is limited data suggesting that the rate and extent of absorption of Lenzetto
can be reduced in overweight and obese women. Please talk to your doctor.
During the treatment your doctor may adjust the dose according to your individual
If you use more Lenzetto than you should
If you use more Lenzetto than you should, or if children have been using the medicine
by accident, please contact your doctor or the hospital to get an opinion of the risk
and advice on action to be taken.
If you use more Lenzetto than you should, you may feel sick, vomit and have
withdrawal bleeding (unusual vaginal bleeding).
If you forget to use Lenzetto
If you forget to use Lenzetto at your normal time, spray the medicine on as soon as
you remember, and then use it as you normally would the next day. If it is almost time
for your next dose, just wait and apply the next dose as you normally would. Do not
use a double dose to make up for a forgotten dose.
If you have any further questions about how to use this product, ask your doctor or
If you stop using Lenzetto
Your doctor will also explain how to stop using this medicine when your treatment is

Rare side effects (may affect up to 1 in 1000 people)
Anxiety, decrease or increase in sexual drive, migraine, intolerance to contact
lenses, bloating, vomiting, increased body hair, acne, muscle cramps, painful
menstruation, vaginal bleeding, premenstrual like syndrome, breast enlargement,
Other side effects, with frequency “not known” have been reported with Lenzetto
during post-marketing surveillance: hair loss (alopecia), chloasma (golden brown
pigment patches, so called “pregnancy patches”, especially on the face), skin

for Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
By reporting side effects you can help provide more information on the safety of this
5. How to store Lenzetto
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label
on the container. The expiry date refers to the last day of that month.
Use within 56 days of first use.
Do not refrigerate or freeze this medicine.
Do not store above 25°C.
Contains ethanol which is flammable. Store away from heaters or naked flames.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other information
What Lenzetto contains
–– The active ingredient is estradiol (as estradiol hemihydrate). Each spray contains
1.53 mg estradiol (equivalent to 1.58 mg estradiol hemihydrate).
–– The other ingredients are octisalate and ethanol 96%.
What Lenzetto looks like and contents of the pack
Lenzetto is a transdermal spray containing a solution of estradiol and octisalate in
ethanol. It is provided with a metered dose pump.
Lenzetto is supplied as a plastic container with a plastic cover. There is a glass
container inside. One container is filled with 8.1 mL of solution and is designed to
deliver 56 sprays. Each spray contains 1.53 mg estradiol.
Do not use each Lenzetto container for more than the labelled number of sprays even
though the bottle may not be completely empty.
Pack sizes:
One plastic container 8.1 ml (56 sprays)
Three plastic containers 3x8.1 ml (3x56 sprays)
Not all pack sizes may be marked.
Marketing Authorisation Holder:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Gedeon Richter România S.A.
Cuza Vodă street 99-105
Romania - 540306
This leaflet was revised in February 2016.

The following side effects have been reported with other HRT-s:
serious allergic reaction which causes swelling of the face or throat (angioedema),
anaphylactoid/anaphylactic reactions (serious allergic reaction which causes
difficulty in breathing or dizziness), glucose intolerance, depression, mood
disturbances, irritability, exacerbation of chorea (St. Vitus’s dance), exacerbation
of epilepsy, dementia, exacerbation of asthma, yellowing of the skin (jaundice),
inflammation of the pancreas, benign neoplasm of the smooth muscle of the
womb, discolouration of the skin especially of the face or neck known as
“pregnancy patches” (chloasma or melasma) - that may persist when drug
is discontinued; painful reddish skin nodules (erythema nodosum); rash with
target-shaped reddening or sores (erythema multiforme), haemorrhagic eruption,
loss of hair, pain in a joint, secretion of milk from the breast, lumpiness in the
breasts, increase in size of benign neoplasm of the smooth muscle of the womb,
changes in the secretion and the inner lining of the cervix (“neck” of the womb),
inflammation of the vagina, fungal infections in the vagina (vaginal candidiasis),
abnormally low level of calcium in the blood.

If you need to have surgery
Reporting of side effects
If you are going to have surgery, tell the surgeon that you are using Lenzetto. You may If you get any side effects, talk to your doctor or pharmacist. This includes any
need to stop using Lenzetto about 4 to 6 weeks before the operation to reduce the
possible side effects not listed in this leaflet. You can also report side effects directly:
risk of a blood clot. Ask your doctor when you can start using Lenzetto again.
for United Kingdom
If you have any further questions on the use of this medicine, ask your doctor or
Yellow Card Scheme


1.53 mg/spray transdermal spray, solution



1.53 mg/spray transdermal spray, solution






P Black
9 pt
T.Eszter/vm 16.02.


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