SANDRENA 1.0 MG GEL

Active substance: ESTRADIOL

View full screen / Print PDF » Download PDF ⇩

Transcript
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.
Other side effects
Common (affects up to 1 in 10 people):
- itching of the skin, rash, pain, increased
sweating, swollen feet and lower legs
- breasts become tender or painful
- increase or decrease in your weight
- - headache, dizziness
- tummy pains, feeling sick or being sick,
flatulence
- bleeding or spotting, menstrual disorder
- depression, nervousness, lethargy
- hot flushes.
Uncommon (affects up to 1 in 100 people):
- changes to sex drive and mood, anxiety,
sleeplessness, apathy, emotional instability,
impaired concentration,euphoria, agitation
- migraine, delusion, trembling
- visual impairment, dry eye
- hypertension, superficial phlebitis, purpura
- shortness of breath, rhinitis
- benign breast or endometrial tumour
- increased appetite, high level of cholesterol in
the blood
- increased heart rate
- constipation, digestive disturbance, diarrhoea,
rectal disorder
- 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)
- 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.
Rare (affects up to 1 in 1,000 people):
- venous thromboembolism
- alterations in liver function and biliary flow
- contact lense intolerance
- menstrual pain
- pre-menstrual like syndrome.
Adverse events reported post marketing with
frequency not known (cannot be estimated from
the available data):
- uterine fibroids
- hereditary angioedema
- cerebral circulatory disorder
- , bloating
- 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.
The following side effects have been reported with
other HRTs:
- gall bladder disease
- probable dementia over the age of 65
- various skin disorders:
- 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)

Reporting of side effects
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.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Sandrena

• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.

• Do not store above 25°C.
• Do not use this medicine after the expiry date
shown on the carton or sachet label.

• If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
6. Contents of the pack and other information
What Sandrena contains
Estradiol is one of the female hormones your body
makes. Sandrena sachets contain 1.0 milligrams
of estradiol in each sachet.
Sandrena gel also contains carbomer 974P,
trolamine, propylene glycol, ethanol 96% and
purified water.
What Sandrena looks like and contents of the
pack
Sandrena is a smooth, opalescent, alcohol-based
gel. The active ingredient in Sandrena is
estradiol.
This is the new name for oestradiol. The ingredient
has not changed.
Sandrena is supplied in packs of 28 or 91 sachets
Manufacturer and Licence Holder
This medicine is manufactured by Orion
Corporation, PO BOX 425, FIN-02101, Turku,
Finland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1178 - Sandrena 1.0mg Gel

Sandrena is a registered trademark of Orion
Corporation.
Leaflet revision date: 11/03/14

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

PATIENT INFORMATION LEAFLET

Ref: 1178/110314/1/F

®

Sandrena 1.0mg Gel
(estradiol)
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.
Your medicine is called Sandrena 1.0mg Gel and
will be referred to as Sandrena throughout the rest
of this leaflet. Please note that the leaflet also
contains information about other strengths of the
medicine, Sandrena 0.5mg Gel.
What is in this leaflet:
1. What Sandrena is and what it is used for
2. What you need to know before you use
Sandrena
3. How to use Sandrena
4. Possible side effects
5. How to store Sandrena
6. Contents of the pack and other information
1. What Sandrena is and what it is used for
Sandrena is a Hormone Replacement Therapy
(HRT). It contains the female hormone oestrogen.
Sandrena is used for:
Relief of symptoms occurring after menopause
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.
You must talk to your doctor if you do not feel
better or if you feel worse.

2. What you need to know before you use
Sandrena
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.
Do not use Sandrena:
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

- if you have any unexplained vaginal bleeding
- if you have excessive thickening of the womb
lining (endometrial hyperplasia) that is not being
treated
- 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)
- 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).
If any of the above conditions appear for the first
time while using Sandrena, stop using it at once
and consult your doctor immediately.
Warnings and precautions
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:
- 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.
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)

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

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).

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.

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
• carries on after you have stopped using
Sandrena
see your doctor as soon as possible.
Breast cancer
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.
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.
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 oestrogenprogestagen 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
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.
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 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.

For signs of a blood clot, see “Stop using
Sandrena and see a doctor immediately”.
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)
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart
attack.
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.
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
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).

Laboratory tests
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.
Pregnancy, breast-feeding and fertility
Sandrena is for use in postmenopausal women
only. If you become pregnant, stop using
Sandrena and contact your doctor.
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.
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.
How much to use
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.
Each pack of Sandrena 1 mg gel contains only
1 g sachets.
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.
- 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.

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

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.
How to apply the gel
Sandrena should be rubbed gently on dry and
clean skin. It should not be swallowed.
Where to apply the gel
- Do not apply the gel to your breasts, face or on
irritated skin.
- Apply the gel to your lower body or thighs.
- Apply the gel to a different side of your body
each day.

Follow these instructions:
1. Apply the gel once a day to the skin on your
lower body or thighs.
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.
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.
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
If you use more gel than you should, talk to your
doctor or pharmacist.
You may feel bloated, anxious or irritable, or your
breasts may feel tender. Nausea, vomiting and
withdrawal bleeding may also occur in some
women.
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)
- ovarian cancer
- blood clots in the veins of the legs or lungs
(venous thromboembolism)
- heart disease
- stroke
- probable memory loss if HRT is started over the
age of 65.
For more information about these side effects, see
section 2.

Ref: 1178/110314/1/B

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.
Other side effects
Common (affects up to 1 in 10 people):
- itching of the skin, rash, pain, increased
sweating, swollen feet and lower legs
- breasts become tender or painful
- increase or decrease in your weight
- - headache, dizziness
- tummy pains, feeling sick or being sick,
flatulence
- bleeding or spotting, menstrual disorder
- depression, nervousness, lethargy
- hot flushes.
Uncommon (affects up to 1 in 100 people):
- changes to sex drive and mood, anxiety,
sleeplessness, apathy, emotional instability,
impaired concentration,euphoria, agitation
- migraine, delusion, trembling
- visual impairment, dry eye
- hypertension, superficial phlebitis, purpura
- shortness of breath, rhinitis
- benign breast or endometrial tumour
- increased appetite, high level of cholesterol in
the blood
- increased heart rate
- constipation, digestive disturbance, diarrhoea,
rectal disorder
- 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)
- 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.
Rare (affects up to 1 in 1,000 people):
- venous thromboembolism
- alterations in liver function and biliary flow
- contact lense intolerance
- menstrual pain
- pre-menstrual like syndrome.
Adverse events reported post marketing with
frequency not known (cannot be estimated from
the available data):
- uterine fibroids
- hereditary angioedema
- cerebral circulatory disorder
- , bloating
- 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.
The following side effects have been reported with
other HRTs:
- gall bladder disease
- probable dementia over the age of 65
- various skin disorders:
- 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)

Reporting of side effects
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.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Estradiol

• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.

• Do not store above 25°C.
• Do not use this medicine after the expiry date
shown on the carton or sachet label.

• If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
6. Contents of the pack and other information
What Estradiol contains
Estradiol is one of the female hormones your body
makes. Estradiol sachets contain 1.0 milligrams of
estradiol in each sachet.
Estradiol gel also contains carbomer 974P,
trolamine, propylene glycol, ethanol 96% and
purified water.
What Estradiol looks like and contents of the
pack
Estradiol is a smooth, opalescent, alcohol-based
gel. The active ingredient in Estradiol is
estradiol.
This is the new name for oestradiol. The ingredient
has not changed.
Estradiol is supplied in packs of 28 or 91 sachets
Manufacturer and Licence Holder
This medicine is manufactured by Orion
Corporation, PO BOX 425, FIN-02101, Turku,
Finland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1178 - Estradiol 1.0mg Gel

Leaflet revision date: 11/03/14

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

PATIENT INFORMATION LEAFLET

Ref: 1178/110314/2/F

Estradiol
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. 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.
Your medicine is called Estradiol 1.0mg Gel and
will be referred to as Estradiol throughout the rest
of this leaflet. Please note that the leaflet also
contains information about other strengths of the
medicine, Estradiol 0.5mg Gel.
What is in this leaflet:
1. What Estradiol is and what it is used for
2. What you need to know before you use
Estradiol
3. How to use Estradiol
4. Possible side effects
5. How to store Estradiol
6. Contents of the pack and other information
1. What Estradiol is and what it is used for
Estradiol is a Hormone Replacement Therapy
(HRT). It contains the female hormone oestrogen.
Estradiol is used for:
Relief of symptoms occurring after menopause
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.
You must talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before you use
Estradiol
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 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.
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.
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

- if you have any unexplained vaginal bleeding
- if you have excessive thickening of the womb
lining (endometrial hyperplasia) that is not being
treated
- 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)
- 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).
If any of the above conditions appear for the first
time while using Estradiol, stop using it at once
and consult your doctor immediately.
Warnings and precautions
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:
- 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.
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)

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

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).

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.

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
• carries on after you have stopped using
Estradiol
see your doctor as soon as possible.
Breast cancer
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.
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.
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 oestrogenprogestagen 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
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.
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 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.

For signs of a blood clot, see “Stop using Estradiol
and see a doctor immediately”.
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)
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart
attack.
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.
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
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).

Laboratory tests
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.
Pregnancy, breast-feeding and fertility
Estradiol is for use in postmenopausal women
only. If you become pregnant, stop using Estradiol
and contact your doctor.
Driving and using machines
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
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 Estradiol
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:
- 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.
How much to use
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.
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.
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.
- 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.

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 Estradiol.
Other medicines and Estradiol
Some medicines may interfere with the effect of
Estradiol. 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,
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.

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.
How to apply the gel
Estradiol should be rubbed gently on dry and
clean skin. It should not be swallowed.
Where to apply the gel
- Do not apply the gel to your breasts, face or on
irritated skin.
- Apply the gel to your lower body or thighs.
- Apply the gel to a different side of your body
each day.

Follow these instructions:
1. Apply the gel once a day to the skin on your
lower body or thighs.
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.
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.
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.
If you use more Estradiol gel than you should
If you use more gel than you should, talk to your
doctor or pharmacist.
You may feel bloated, anxious or irritable, or your
breasts may feel tender. Nausea, vomiting and
withdrawal bleeding may also occur in some
women.
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 Estradiol
If you swallow Estradiol there is no need to worry.
However, you should talk to your doctor.
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
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)
- ovarian cancer
- blood clots in the veins of the legs or lungs
(venous thromboembolism)
- heart disease
- stroke
- probable memory loss if HRT is started over the
age of 65.
For more information about these side effects, see
section 2.

Ref: 1178/110314/2/B

Expand view ⇕

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.

Hide
(web4)