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ESTRADIOL 1MG GEL

Active substance(s): ESTRADIOL HEMIHYDRATE

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S0736 LEAFLET Sadrena 20140613

During the first few months of treatment, breakthrough bleeding,
spotting and breast tenderness or enlargement can occur. These
are usually temporary and normally disappear after continued
treatment.

S0736 LEAFLET Sadrena 20140613



gall bladder disease



probable dementia over the age of 65



various skin disorders:

Other side effects
Common (affects up to 1 in 10 people):


itching of the skin, rash, pain, increased sweating, swollen feet
and lower legs



discolouration of the skin especially of the face or neck
known as “pregnancy patches” (chloasma)



rash with target-shaped reddening or sores (erythema
multiforme)



purpura due to loss of integrity or function of the vessels
(vascular purpura)



breasts become tender or painful



increase or decrease in your weight



headache, dizziness

Reporting of side effects



tummy pains, feeling sick or being sick, flatulence



bleeding or spotting, menstrual disorder



depression, nervousness, lethargy

If you get any side effects, talk to your doctor or pharmacist. This
includes any 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.



hot flushes.



if you have any unexplained vaginal bleeding

SANDRENA 1mg GEL
(estradiol hemihydrate)



if you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated



Information for other strength of Sandrena may also be present in
this leaflet

if you have or have ever had a blood clot in a vein
(thrombosis), such as in the legs (deep venous thrombosis) or
the lungs (pulmonary embolism)



Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

if you have a blood clotting disorder (such as protein C,
protein S, or antithrombin deficiency)



if you have or recently have had a disease caused by blood
clots in the arteries, such as a heart attack, stroke or angina



if you have or have ever had a liver disease and your liver
function tests have not returned to normal



if you have a rare blood problem called “porphyria” which is
passed down in families (inherited)



if you are allergic to estradiol or any of the other ingredients of
this medicine Sandrena (listed in section 6).

Your medicine is known as to Sandrena 1mg Gel but will be
referred to Sandrena throughout the following leaflet.



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.

By reporting side effects you can help provide more information on
the safety of this medicine.

What is in this leaflet

Uncommon (affects up to 1 in 100 people):


PACKAGE LEAFLET: INFORMATION FOR THE USER

The following side effects have been reported with other HRTs:

If any of the above conditions appear for the first time while using
Sandrena, stop using it at once and consult your doctor
immediately.

1. What Sandrena is and what it is used for

changes to sex drive and mood, anxiety, sleeplessness, apathy,
emotional instability, impaired concentration,euphoria, agitation

5. How to store Sandrena

2. What you need to know before you use Sandrena

Warnings and precautions





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

migraine, delusion, trembling

3. How to use Sandrena





Do not store above 25°C.

visual impairment, dry eye

4. Possible side effects





hypertension, superficial phlebitis, purpura

Do not use after the expiry date printed on the carton or sachet
label.

5. How to store Sandrena



Talk to your doctor or pharmacist before using Sandrena. 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 Sandrena. If so, you should see your doctor
more often for check-ups:

shortness of breath, rhinitis





benign breast or endometrial tumour



increased appetite, high level of cholesterol in the blood

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



increased heart rate





Sandrena is a Hormone Replacement Therapy (HRT). It contains
the female hormone oestrogen.

constipation, digestive disturbance, diarrhoea, rectal disorder

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



acne, alopecia, dry skin, nail disorder, skin nodule, excessive
growth of hair, urticaria (a raised, itchy rash that appears on the
skin), painful reddish skin nodules (erythema nodosum)

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 protect
the environment.

Sandrena is used for:



joint disorders, muscle cramps



increased urinary frequency/urgency, loss of bladder control,
urinary tract infection, urine discoloration, haematuria



tender or swollen breast, abnormal growth of the lining of the
womb, uterine disorder



tiredness, abnormal laboratory test, weakness, fever, flu
syndrome, general feeling of ill health



allergic (hypersensitivity) reaction.



6. Contents of the pack and other information
What Sandrena contain



2. What you need to know before you use Sandrena

What Sandrena looks like and contents of the pack



alterations in liver function and biliary flow



Sandrena is a smooth opalescent alcohol-based gel.



contact lense intolerance





menstrual pain

Sandrena is available in boxes of 28 sachets of 1g gel or 91
sachets of 1g gel.



pre-menstrual like syndrome.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA0 1DX.



uterine fibroids



hereditary angioedema

Manufacturer



cerebral circulatory disorder



bloating

This product is manufactured by Orion Corporation, PO Box 425
FIN-02101 Turku, Finland.



liver disease causing yellowing of the skin

 contact rash, eczema
If you have any of these side effects tell your doctor. The doctor
may decide to stop your treatment for a while.
Dementia
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 advice.

During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face,
neck and chest (“hot flushes”). Sandrena alleviates these symptoms
after menopause. You will only be prescribed Sandrena if your
symptoms seriously hinder your daily life.

Sandrena also contains the following inactive ingredients:
carbomer 974P, trolamine, propylene glycol, ethanol 96% and
purified water.

venous thromboembolism

POM

Medical history and regular check-ups
The use of HRT carries risks which need to be considered when
deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor.
Before you start (or restart) HRT, your doctor will ask about your
own and your family’s medical history. Your doctor may decide to
perform a physical examination. This may include an examination of
your breasts and/or an internal examination, if necessary.
Once you have started on Sandrena you should see your doctor for
regular check-ups (at least once a year). At these check-ups,
discuss with your doctor the benefits and risks of continuing with
Sandrena.
Regularly check your breasts for any changes (see ‘Breast
cancer’ below). Go for regular breast screening, as recommended
by your doctor.

PL No. 19488/0736

Leaflet revision date: 13 June 2014

Do not use Sandrena:

Sandrena is a registered trade mark of Orion Corporation, Finland.
S0736 LEAFLET Sadrena 20140613



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 a 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 headaches



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



hereditary angioedema.

Relief of symptoms occurring after menopause

You must talk to your doctor if you do not feel better or if you feel
worse.



(cannot be estimated from the available data):

1. What Sandrena is and what it is used for

Each gram of gel contains 1.0mg of the active ingredient,
estradiol (as the hemihydrate).

Rare (affects up to 1 in 1,000 people):

Adverse events reported post marketing with frequency not known

6. Contents of the pack and other information

if any of the following applies to you. If you are not sure about any
of the points below, talk to your doctor before using Sandrena.
Do not use Sandrena:


if you have or have ever had breast cancer, or if you are
suspected of having it



if you have cancer which is sensitive to oestrogens, such as
cancer of the womb lining (endometrium), or if you are
suspected of having it

Stop using Sandrena and see a doctor immediately
If you notice any of the following when taking HRT:


any of the conditions mentioned in the “Do not use Sandrena”
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, dizziness)



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)’.
Note: Sandrena 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)
Taking oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
Taking a progestagen in addition to oestrogen for at least 12 days
of each 28 day cycle protects you from this extra risk. So your
doctor will prescribe a progestagen 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 progestagen.
In women who still have a womb and who are not taking HRT, on
average, 5 in 1,000 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 1,000 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.
Unexpected bleeding
If your doctor has prescribed you progestagen tablets in addition to
Sandrena, you will usually have a bleed once a month (so-called
withdrawal bleed). But, if you have unexpected bleeding or drops of
blood (spotting) besides your monthly bleeding, which:


carries on for more than the first 6 months



starts after you have been taking Sandrena more than 6 months

You are more likely to get a blood clot in your veins as you get older
and if any of the following applies to you. Inform your doctor if any
of these situations applies to you:


you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, If you need to have
surgery)



you are seriously overweight (BMI > 30 kg/m2)



you have or have had any blood clotting problem that needs
long-term treatment with a medicine used to prevent blood clots



if any of your close relatives has ever had a blood clot in the
leg, lung or another organ



you have systemic lupus erythematosus (SLE)

 you have cancer.
For signs of a blood clot, see “Stop using Sandrena and see a
doctor immediately”.

Looking at women in their 50s who are not taking HRT, on average,
over a 5 year period, 4 to 7 in 1,000 would be expected to get a
blood clot in a vein.
For women in their 50s who have been taking oestrogen progestagen HRT for over 5 years, there will be 9 to 12 cases in
1,000 users (i.e. an extra 5 cases).
For women in their 50s who have had their womb removed and
have been taking oestrogen-only HRT for over 5 years, there will be
5 to 8 cases in 1,000 users (i.e. 1 extra case).
Heart disease (heart attack)

Breast cancer

Women over the age of 60 years who use oestrogen-progestagen
HRT are slightly more likely to develop heart disease than those not
taking any HRT.

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.

There is no evidence that HRT will prevent a heart attack.

For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.
Stroke
The risk of getting a 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.

Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17
in 1,000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestagen
HRT over 5 years, there will be 13 to 23 cases in 1,000 users (i.e.
an extra 4 to 6 cases).


Regularly check your breasts. See your doctor if you notice
any changes such as:


dimpling of the skin



changes in the nipple



any lumps you can see or feel

Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1,000 will be diagnosed with ovarian cancer over a 5 year
period. For women who have been taking HRT for 5 years, there
will be between 2 and 3 cases per 1,000 users (i.e. up to 1 extra
case).
Effects of HRT on heart and circulation

Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death.

2. Spread the gel over an area 1–2 times the size of your hand.
3. Allow the gel to dry for a few minutes.

Pregnancy, breast-feeding and fertility
Sandrena is for use in postmenopausal women only. If you become
pregnant, stop using Sandrena and contact your doctor.

4. Wash your hands after applying the gel. Avoid contact of the gel
with your eyes. The gel may irritate your eyes.
5. Do not wash the area where you have applied the gel for at
least one hour.

Driving and using machines
No studies on the effects of Sandrena on the ability to drive and use
machines have been performed.
Sandrena contains propylene glycol
Sandrena contains propylene glycol, which may cause skin
irritation.

If you need to have surgery
If you are going to have surgery, tell the surgeon that you are using
Sandrena. You may need to stop using Sandrena about 4 to 6
weeks before the operation to reduce the risk of a blood clot (see
section 2, Blood clots in a vein). Ask your doctor when you can start
using Sandrena again.
If you use more Sandrena gel than you should

3. How to use Sandrena
Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
When to start using Sandrena
You can start using Sandrena straight away if:


You have never used HRT before



You are changing over from a period-free HRT.

Wait for your period to end if:


You are changing over from another type of HRT where you
have a period.

If you have not had your womb removed, your doctor will
normally also prescribe another medicine containing the
hormone progestagen. This is normally a tablet taken for 12 to 14
days in each monthly cycle. After each course of progestagen you
will usually have a withdrawal bleed, like a period.

Sandrena comes in sachets of 0.5 mg estradiol in 0.5 g of gel, or in
sachets of 1 mg estradiol in 1g of gel.
Each pack of Sandrena 0.5 mg gel contains only 0.5 g sachets.

Looking at women in their 50s who are not taking HRT, on average,
8 in 1,000 would be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases
in 1,000 users, over 5 years (i.e. an extra 3 cases).

Use the amount of Sandrena gel that your doctor has prescribed.
Your doctor will aim to prescribe the lowest dose to treat your
symptom for as short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.

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 advice.
Women with a tendency to discoloration of the skin (chloasma)
should minimise exposure to the sun or ultraviolet radiation
whilst using Sandrena.

Other medicines and Sandrena
Some medicines may interfere with the effect of Sandrena. This
might lead to irregular bleeding. This applies to the following
medicines:



The recommended dose is between 0.5 mg and 1.5 mg of
estradiol a day.



Use the following number of 0.5 g or 1 g sachets depending on
the dose, and the pack size prescribed by your doctor:

For a 0.5 mg daily dose: Use one 0.5 g sachet.
For a 1 mg daily dose: There are two options. Use one 1 g sachet
or use two 0.5 g sachets.
For a 1.5 mg daily dose: There are two options. Use three 0.5 g
sachets or use one 0.5 g sachet with one 1 g sachet.
If you are also taking progestagen tablets, take them as your doctor
has told you. You will normally have a withdrawal bleed after each
course of progestagen.

Overdosage is unlikely with transdermal application. Treatment is
symptomatic. The gel should be washed. The symptoms disappear
when the treatment is stopped or when the dose is reduced.
If you swallow Sandrena
If you swallow Sandrena there is no need to worry. However, you
should talk to your doctor.
If you forget to use Sandrena


Apply the missed dose when you remember, unless you are
more than 12 hours late.



If you are more than 12 hours late just skip the missed dose.



Missed doses may cause some bleeding between your periods.
This is called breakthrough bleeding.

If you stop using Sandrena
Keep using this medicine as prescribed by your doctor. Keep using
Sandrena, even if you seem to be better. If you stop too early or too
suddenly your problem may return.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop using the gel and see your doctor straight away, if you
notice any of the following serious side effects:


your blood pressure rises



your skin or the whites of your eyes go yellow (jaundice)



you suddenly have migraine-type headaches (see section 2)



you have signs of a blood clot (see section 2)

 you get any of the problems listed in section 2.
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)

Sandrena should be rubbed gently on dry and clean skin. It should
not be swallowed.



ovarian cancer



blood clots in the veins of the legs or lungs (venous
thromboembolism)

Where to apply the gel



heart disease



Do not apply the gel to your breasts, face or on irritated skin.



stroke



Apply the gel to your lower body or thighs.



probable memory loss if HRT is started over the age of 65.



Apply the gel to a different side of your body each day.

For more information about these side effects, see section 2.

Medicines for epilepsy (such as phenobarbital, phenytoin and
carbamazepine)



Medicines for tuberculosis (such as rifampicin, rifabutin)

How to apply the gel



Medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir)
Herbal remedies containing St John’s Wort (Hypericum
perforatum).

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines including medicines obtained
without a prescription, herbal medicines or other natural products.

You may feel bloated, anxious or irritable, or your breasts may feel
tender. Nausea, vomiting and withdrawal bleeding may also occur
in some women.







If you use more gel than you should, talk to your doctor or
pharmacist.

How much to use

Compare

Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3 times higher
in HRT users than in non-users, especially during the first year of
taking it.

1. Apply the gel once a day to the skin on your lower body or
thighs.

Each pack of Sandrena 1 mg gel contains only 1 g sachets.

Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer
has been reported in women taking HRT for at least 5 to 10 years.

Follow these instructions:

If you need a blood test, tell your doctor or the laboratory staff that
you are using Sandrena, because this medicine can affect the
results of some tests.

Compare

 carries on after you have stopped using Sandrena
see your doctor as soon as possible.

Evidence suggests that taking combined oestrogen-progestagen
and possibly also oestrogen-only HRT increases the risk of breast
cancer. The extra risk depends on how long you take HRT. The
additional risk becomes clear within a few years. However, it returns
to normal within a few years (at most 5) after stopping treatment.

Laboratory tests

S0736 LEAFLET Sadrena 20140613

S0736 LEAFLET Estradiol 20140613

During the first few months of treatment, breakthrough bleeding,
spotting and breast tenderness or enlargement can occur. These
are usually temporary and normally disappear after continued
treatment.

S0736 LEAFLET Estradiol 20140613



gall bladder disease



probable dementia over the age of 65



various skin disorders:

Other side effects
Common (affects up to 1 in 10 people):


itching of the skin, rash, pain, increased sweating, swollen feet
and lower legs



discolouration of the skin especially of the face or neck
known as “pregnancy patches” (chloasma)



rash with target-shaped reddening or sores (erythema
multiforme)



purpura due to loss of integrity or function of the vessels
(vascular purpura)



breasts become tender or painful



increase or decrease in your weight



headache, dizziness

Reporting of side effects



tummy pains, feeling sick or being sick, flatulence



bleeding or spotting, menstrual disorder



depression, nervousness, lethargy

If you get any side effects, talk to your doctor or pharmacist. This
includes any 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.



hot flushes.

changes to sex drive and mood, anxiety, sleeplessness, apathy,
emotional instability, impaired concentration,euphoria, agitation



if you have any unexplained vaginal bleeding

ESTRADIOL 1mg GEL
(estradiol hemihydrate)



if you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated

Your medicine is known as to Estradiol 1mg Gel but will be referred
to Estradiol throughout the following leaflet.



Information for other strength of Estradiol may also be present in
this leaflet

if you have or have ever had a blood clot in a vein
(thrombosis), such as in the legs (deep venous thrombosis) or
the lungs (pulmonary embolism)



Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

if you have a blood clotting disorder (such as protein C,
protein S, or antithrombin deficiency)



if you have or recently have had a disease caused by blood
clots in the arteries, such as a heart attack, stroke or angina



if you have or have ever had a liver disease and your liver
function tests have not returned to normal



if you have a rare blood problem called “porphyria” which is
passed down in families (inherited)



if you are allergic to estradiol or any of the other ingredients of
this medicine Estradiol (listed in section 6).



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.

By reporting side effects you can help provide more information on
the safety of this medicine.

If any of the above conditions appear for the first time while using
Estradiol, stop using it at once and consult your doctor immediately.

What is in this leaflet

Uncommon (affects up to 1 in 100 people):


PACKAGE LEAFLET: INFORMATION FOR THE USER

The following side effects have been reported with other HRTs:

5. How to store Estradiol

1. What Estradiol is and what it is used for

Warnings and precautions

2. What you need to know before you use Estradiol



migraine, delusion, trembling





Do not store above 25°C.

visual impairment, dry eye

4. Possible side effects





hypertension, superficial phlebitis, purpura

Do not use after the expiry date printed on the carton or sachet
label.

5. How to store Estradiol

Talk to your doctor or pharmacist before using Estradiol. 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 Estradiol. If so, you should see your doctor
more often for check-ups:



shortness of breath, rhinitis



6. Contents of the pack and other information



fibroids inside your womb



benign breast or endometrial tumour





increased appetite, high level of cholesterol in the blood

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



increased heart rate



Estradiol is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen.





constipation, digestive disturbance, diarrhoea, rectal disorder

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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)”)



acne, alopecia, dry skin, nail disorder, skin nodule, excessive
growth of hair, urticaria (a raised, itchy rash that appears on the
skin), painful reddish skin nodules (erythema nodosum)



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 protect
the environment.

Estradiol is used for:



increased risk of getting a oestrogen-sensitive cancer (such as
having a mother, sister or grandmother who has had breast
cancer)

During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face,
neck and chest (“hot flushes”). Estradiol alleviates these symptoms
after menopause. You will only be prescribed Estradiol if your
symptoms seriously hinder your daily life.



high blood pressure



a liver disorder, such as a benign liver tumour



diabetes



gallstones

Each gram of gel contains 1.0mg of the active ingredient,
estradiol (as the hemihydrate).

You must talk to your doctor if you do not feel better or if you feel
worse.



migraine or severe headaches



Estradiol also contains the following inactive ingredients:
carbomer 974P, trolamine, propylene glycol, ethanol 96% and
purified water.

a disease of the immune system that affects many organs of the
body (systemic lupus erythematosus, SLE)

2. What you need to know before you use Estradiol



epilepsy

Medical history and regular check-ups



asthma

The use of HRT carries risks which need to be considered when
deciding whether to start taking it, or whether to carry on taking it.



a disease affecting the eardrum and hearing (otosclerosis)

The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor.



a very high level of fat in your blood (triglycerides)



fluid retention due to cardiac or kidney problems



hereditary angioedema.



joint disorders, muscle cramps



increased urinary frequency/urgency, loss of bladder control,
urinary tract infection, urine discoloration, haematuria





tender or swollen breast, abnormal growth of the lining of the
womb, uterine disorder
tiredness, abnormal laboratory test, weakness, fever, flu
syndrome, general feeling of ill health



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

3. How to use Estradiol

6. Contents of the pack and other information
What Estradiol contain



allergic (hypersensitivity) reaction.

Rare (affects up to 1 in 1,000 people):


venous thromboembolism

What Estradiol looks like and contents of the pack



alterations in liver function and biliary flow



Estradiol is a smooth opalescent alcohol-based gel.



contact lense intolerance





menstrual pain

Estradiol is available in boxes of 28 sachets of 1g gel or 91
sachets of 1g gel.



pre-menstrual like syndrome.

Adverse events reported post marketing with frequency not known
(cannot be estimated from the available data):

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA0 1DX.



uterine fibroids



hereditary angioedema

Manufacturer



cerebral circulatory disorder



bloating

This product is manufactured by Orion Corporation, PO Box 425
FIN-02101 Turku, Finland.



liver disease causing yellowing of the skin

 contact rash, eczema
If you have any of these side effects tell your doctor. The doctor
may decide to stop your treatment for a while.

POM

Relief of symptoms occurring after menopause

Before you start (or restart) HRT, your doctor will ask about your
own and your family’s medical history. Your doctor may decide to
perform a physical examination. This may include an examination of
your breasts and/or an internal examination, if necessary.
Once you have started on Estradiol you should see your doctor for
regular check-ups (at least once a year). At these check-ups,
discuss with your doctor the benefits and risks of continuing with
Estradiol.
Regularly check your breasts for any changes (see ‘Breast
cancer’ below). Go for regular breast screening, as recommended
by your doctor.

PL No. 19488/0736

Leaflet revision date: 13 June 2014

Do not use Estradiol:
if any of the following applies to you. If you are not sure about any
of the points below, talk to your doctor before using Estradiol.

Dementia
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 advice.

1. What Estradiol is and what it is used for

S0736 LEAFLET Estradiol 20140613

Do not use Estradiol:


if you have or have ever had breast cancer, or if you are
suspected of having it



if you have cancer which is sensitive to oestrogens, such as
cancer of the womb lining (endometrium), or if you are
suspected of having it

Stop using Estradiol and see a doctor immediately
If you notice any of the following when taking HRT:


any of the conditions mentioned in the “Do not use Estradiol”
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, dizziness)



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)’.
Note: Estradiol 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)
Taking oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
Taking a progestagen in addition to oestrogen for at least 12 days
of each 28 day cycle protects you from this extra risk. So your
doctor will prescribe a progestagen 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 progestagen.
In women who still have a womb and who are not taking HRT, on
average, 5 in 1,000 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 1,000 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.
Unexpected bleeding
If your doctor has prescribed you progestagen tablets in addition to
Estradiol, you will usually have a bleed once a month (so-called
withdrawal bleed). But, if you have unexpected bleeding or drops of
blood (spotting) besides your monthly bleeding, which:


carries on for more than the first 6 months



starts after you have been taking Estradiol more than 6 months

You are more likely to get a blood clot in your veins as you get older
and if any of the following applies to you. Inform your doctor if any
of these situations applies to you:


you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, If you need to have
surgery)



you are seriously overweight (BMI > 30 kg/m2)



you have or have had any blood clotting problem that needs
long-term treatment with a medicine used to prevent blood clots



if any of your close relatives has ever had a blood clot in the
leg, lung or another organ



you have systemic lupus erythematosus (SLE)

 you have cancer.
For signs of a blood clot, see “Stop using Estradiol and see a doctor
immediately”.

Laboratory tests

Follow these instructions:

If you need a blood test, tell your doctor or the laboratory staff that
you are using Estradiol, because this medicine can affect the results
of some tests.

1. Apply the gel once a day to the skin on your lower body or
thighs.
3. Allow the gel to dry for a few minutes.

Pregnancy, breast-feeding and fertility
Estradiol is for use in postmenopausal women only. If you become
pregnant, stop using Estradiol and contact your doctor.

No studies on the effects of Estradiol on the ability to drive and use
machines have been performed.
Estradiol contains propylene glycol
Estradiol contains propylene glycol, which may cause skin irritation.
3. How to use Estradiol

If you use more Estradiol gel than you should

Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

If you use more gel than you should, talk to your doctor or
pharmacist.

When to start using Estradiol

You may feel bloated, anxious or irritable, or your breasts may feel
tender. Nausea, vomiting and withdrawal bleeding may also occur
in some women.

Compare
Looking at women in their 50s who are not taking HRT, on average,
over a 5 year period, 4 to 7 in 1,000 would be expected to get a
blood clot in a vein.
For women in their 50s who have been taking oestrogen progestagen HRT for over 5 years, there will be 9 to 12 cases in
1,000 users (i.e. an extra 5 cases).
For women in their 50s who have had their womb removed and
have been taking oestrogen-only HRT for over 5 years, there will be
5 to 8 cases in 1,000 users (i.e. 1 extra case).

You can start using Estradiol straight away if:


You have never used HRT before



You are changing over from a period-free HRT.

Wait for your period to end if:

There is no evidence that HRT will prevent a heart attack.



Breast cancer

Women over the age of 60 years who use oestrogen-progestagen
HRT are slightly more likely to develop heart disease than those not
taking any HRT.
For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.



Regularly check your breasts. See your doctor if you notice
any changes such as:


dimpling of the skin



changes in the nipple



any lumps you can see or feel

How much to use

The risk of getting a 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.

Estradiol comes in sachets of 0.5 mg estradiol in 0.5 g of gel, or in
sachets of 1 mg estradiol in 1g of gel.

Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1,000 would be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases
in 1,000 users, over 5 years (i.e. an extra 3 cases).
Other conditions




Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1,000 will be diagnosed with ovarian cancer over a 5 year
period. For women who have been taking HRT for 5 years, there
will be between 2 and 3 cases per 1,000 users (i.e. up to 1 extra
case).
Effects of HRT on heart and circulation

Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death.

Women with a tendency to discoloration of the skin (chloasma)
should minimise exposure to the sun or ultraviolet radiation
whilst using Estradiol.

Use the amount of Estradiol gel that your doctor has prescribed.
Your doctor will aim to prescribe the lowest dose to treat your
symptom for as short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.



Medicines for tuberculosis (such as rifampicin, rifabutin)



Medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir)



Herbal remedies containing St John’s Wort (Hypericum
perforatum).

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines including medicines obtained
without a prescription, herbal medicines or other natural products.

If you forget to use Estradiol


Apply the missed dose when you remember, unless you are
more than 12 hours late.



If you are more than 12 hours late just skip the missed dose.



Missed doses may cause some bleeding between your periods.
This is called breakthrough bleeding.

If you stop using Estradiol
Keep using this medicine as prescribed by your doctor. Keep using
Estradiol, even if you seem to be better. If you stop too early or too
suddenly your problem may return.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects



Use the following number of 0.5 g or 1 g sachets depending on
the dose, and the pack size prescribed by your doctor:

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

For a 0.5 mg daily dose: Use one 0.5 g sachet.

If you are also taking progestagen tablets, take them as your doctor
has told you. You will normally have a withdrawal bleed after each
course of progestagen.

Medicines for epilepsy (such as phenobarbital, phenytoin and
carbamazepine)

If you swallow Estradiol
If you swallow Estradiol there is no need to worry. However, you
should talk to your doctor.

The recommended dose is between 0.5 mg and 1.5 mg of
estradiol a day.

Some medicines may interfere with the effect of Estradiol. This
might lead to irregular bleeding. This applies to the following
medicines:


Overdosage is unlikely with transdermal application. Treatment is
symptomatic. The gel should be washed. The symptoms disappear
when the treatment is stopped or when the dose is reduced.



Other medicines and Estradiol

Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3 times higher
in HRT users than in non-users, especially during the first year of
taking it.

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 advice.

Each pack of Estradiol 0.5 mg gel contains only 0.5 g sachets.
Each pack of Estradiol 1 mg gel contains only 1 g sachets.

For a 1 mg daily dose: There are two options. Use one 1 g sachet
or use two 0.5 g sachets.
For a 1.5 mg daily dose: There are two options. Use three 0.5 g
sachets or use one 0.5 g sachet with one 1 g sachet.

Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer
has been reported in women taking HRT for at least 5 to 10 years.

You are changing over from another type of HRT where you
have a period.
If you have not had your womb removed, your doctor will
normally also prescribe another medicine containing the
hormone progestagen. This is normally a tablet taken for 12 to 14
days in each monthly cycle. After each course of progestagen you
will usually have a withdrawal bleed, like a period.

Stroke

Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17
in 1,000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestagen
HRT over 5 years, there will be 13 to 23 cases in 1,000 users (i.e.
an extra 4 to 6 cases).

If you need to have surgery
If you are going to have surgery, tell the surgeon that you are using
Estradiol. You may need to stop using Estradiol about 4 to 6 weeks
before the operation to reduce the risk of a blood clot (see section
2, Blood clots in a vein). Ask your doctor when you can start using
Estradiol again.

Heart disease (heart attack)

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.

4. Wash your hands after applying the gel. Avoid contact of the gel
with your eyes. The gel may irritate your eyes.
5. Do not wash the area where you have applied the gel for at
least one hour.

Driving and using machines

 carries on after you have stopped using Estradiol
see your doctor as soon as possible.

Evidence suggests that taking combined oestrogen-progestagen
and possibly also oestrogen-only HRT increases the risk of breast
cancer. The extra risk depends on how long you take HRT. The
additional risk becomes clear within a few years. However, it returns
to normal within a few years (at most 5) after stopping treatment.

2. Spread the gel over an area 1–2 times the size of your hand.

Stop using the gel and see your doctor straight away, if you
notice any of the following serious side effects:


your blood pressure rises



your skin or the whites of your eyes go yellow (jaundice)



you suddenly have migraine-type headaches (see section 2)



you have signs of a blood clot (see section 2)

 you get any of the problems listed in section 2.
The following diseases are reported more often in women using
HRT compared to women not using HRT:


breast cancer

How to apply the gel



Estradiol should be rubbed gently on dry and clean skin. It should
not be swallowed.

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)

Do not apply the gel to your breasts, face or on irritated skin.



heart disease

Apply the gel to your lower body or thighs.



stroke

Apply the gel to a different side of your body each day.



probable memory loss if HRT is started over the age of 65.

Where to apply the gel




For more information about these side effects, see section 2.
S0736 LEAFLET Estradiol 20140613

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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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