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CLIMAVAL 2MG TABLETS

Active substance(s): ESTRADIOL VALERATE / ESTRADIOL VALERATE / ESTRADIOL VALERATE

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S283-84 LEAFLET Climavel 20150820

S283-84 LEAFLET Climavel 20150820

Other side effects

6. Content of the pack and other information

In addition, the following side effects have been reported with
Climaval:

What Climaval contains



Breast tension and pain, breast cancer.



Discharge from the vagina.



Headache, dizziness, vertigo, changes in sexual desire,
depression.



Increased blood pressure, palpitations (sensation of fluttering in
the chest), fast heart beat or other heart symptoms, tender or
painful veins (signs of thrombophlebitis), fluid retention, nose
bleeds.



Indigestion, wind, nausea, vomiting, abdominal pain and
bloating, problems with your gall bladder (biliary stasis).



General itching, hair loss, hives and skin rash.



Glucose intolerance which can make you sweat or feel faint
after eating.



Weight gain.



Hypersensitivity reaction such as rash, itching, hives.

The following side effects have been reported with other HRTs:


Gall bladder disease



Various skin disorders:



The active substance in Climaval is Estradiol. Each Climaval
1mg film coated tablet contains 1mg of estradiol valerate. Each
Climaval 2mg film coated tablet contains 2mg of estradiol
valerate.
The other ingredients are: lactose, corn starch, FD & C Blue No.
2 (E132), povidone (grade 30), purified water, talc (sterile,
white), magnesium stearate, hypromellose, propylene glycol,
Opaspray blue M-1-6517 (E171, E132 and E464).

What Climaval looks like and contents of the pack
Climaval 1mg Tablets are pale blue round tablets marked OC on
one side and CG on the other.
Climaval 2mg Tablets are blue round tablets marked OD on one
side and CG on the other.
Climaval is available as calendar blister packs of 28 or 84 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



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

Manufacturer



painful reddish skin nodules (erythema nodosum),

This product is manufactured by either:



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



Novartis Pharmaceuticals UK Ltd, Horsham UK or



Novartis Farmaceutica, S.A., Ronda Santa Maria, 158, 08210Barbera del Valles, Barcelona, Spain.



Decline in memory or mental ability



Diarrhoea



Migraine,



Fibroids (benign growths in the uterus)





Pain in extremity

• Dry eyes and contact lens discomfort
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Climaval

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

CLIMAVAL 1mg TABLETS
CLIMAVAL 2mg TABLETS
(estradiol valerate)
Your medicine is known by any of the above name but will be
referred to as Climaval throughout the following patient information
leaflet.
Read all of this leaflet carefully, before you start taking this
medicine because it contains important information for you.

Leaflet revision date: 20 August 2015
Climaval is a registered trade mark of Novartis AG, Switzerland.
S283-84 LEAFLET Climavel 20150820



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 severe kidney disease;

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 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 (hypersensitive) to oestradiol valerate or any
of the other ingredients of Climaval (listed in section 6);



If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.

What is in this leaflet
1. What Climaval is and what it is used for
2. What you need to know before you take Climaval
3. How to take Climaval
4. Possible side effects
5. How to store Climaval

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

6. Content of the pack and other information
When to take special care with Climaval
1. What Climaval is and what it is used for
Climaval is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen.
Oestradiol valerate is identical to the natural female hormone
oestrogen. This hormone is produced by the ovaries before the
menopause.
Climaval is used for:
Relief of symptoms occurring after menopause
Menopause occurs naturally in all women, usually between the
ages of 45 and 55 years. It occurs also in younger women who
have their ovaries removed by surgery. 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”), sleep problems, irritability, and depression. Some women
also have problems with urine control or dryness of the vagina,
which may cause discomfort during or after sexual intercourse.
Climaval alleviates these symptoms after menopause. You will only
be prescribed Climaval if your symptoms seriously hinder your daily
life.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store your tablets above 25°C.



Store in the original package.



Protect from light and moisture. Store in a dry place.



Do not use Climaval after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.

2. What you need to know before you take Climaval

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.

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.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

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

Keep this leaflet. You may need to read it again.













If any of the following applies to you. If you are not sure about any
of the points below, talk to your doctor before taking Climaval,



PL. 19488/0283 Climaval 1mg Tablets
PL. 19488/0284 Climaval 2mg Tablets

Do not take Climaval

Medical history and regular check-ups

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) Climaval, 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. He/she
should tell you what kind of changes in the breast you should look
out for and may advise you to have a breast X-ray (a mammogram).
Once you have started on Climaval, 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
Climaval.
Go for regular breast screening, as recommended by your doctor.

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 Climaval. If so, you should see
your doctor more often for check-ups.


Fibroids inside your womb



Growth of womb lining outside your womb (endometriosis)
or a history of excessive growth of the womb lining (endometrial
hyperplasia)



Increased risk of developing blood clots (see “Blood clots in
a vein (thrombosis)”)



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



High blood pressure



A liver disorder, such as a benign liver tumour (liver adenoma)



Diabetes



Gallstones



Migraine or severe headaches



A disease of the immune system that affects many organs of
the body (Systemic lupus erythematosus,SLE), an
autoimmune disorder



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



Hypothyroidism (a condition in which your thyroid gland fails to
produce enough thyroid hormone and for which you are treated
with thyroid hormone replacement therapy)



Hereditary angioedema or episodes of rapid swelling of the
hands, feet, face, lips, eyes, tongue, throat (airway blockage) or
digestive tract.

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

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


dimpling of the skin

Other medicines and Climaval

How long to take Climaval

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

From time to time, you will need to discuss with your doctor the
possible risks and benefits associated with Climaval and whether
you still need the treatment. It is important that you take the lowest
possible effective dose and only as long as needed.



Any of the conditions mentioned in the ‘Do Not take Climaval’
section



Yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease



Ovarian cancer

A large rise in your blood pressure (symptoms may be
headache, tiredness, dizziness)

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.



medicines for epilepsy (such as phenobarbital, phenytoin,
carbamazepine),



Migraine-like headaches which happen for the first time, with or
without disturbed vision. Headaches like these can be an early
sign of a stroke. If you have already had a stroke, talk with your
doctor about whether the benefits of the treatment outweigh the
possibly increased risk.

Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1000 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 1000 users (i.e. up to 1 extra
case).



medicines for tuberculosis (such as rifampicin, rifabutin),



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

If you forget to take a tablet at your usual time, try to take it within
12 hours. If this is not possible, leave the forgotten tablet and
continue to take the remaining tablets at the usual time.



Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)

herbal remedies containing St John’s wort (Hypericum
perforatum),

If you need to have surgery

If you get pain in your chest that spreads to your arm or neck.
This pain may be a sign of heart disease.



other anti-infective medicines (such as ketoconazole,
erythromycin).




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)’.
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 progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. So your
doctor will prescribe a progestogen separately if you still have your
womb. If you have had your womb removed (a hysterectomy),
discuss with your doctor whether you can safely take this product
without a progestogen.
In women who still have a womb and who are not taking HRT, on
average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra
cases), depending on the dose and for how long it is taken.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed)
while taking Climaval. 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 Climaval for more than 6
months



carries on after you have stopped taking Climaval



change in the nipple



any lump you can see or feel

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

Climaval has no known effects on the ability to drive and use
machines.
Climaval contains lactose



you have 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 an other organ



you have systemic lupus erythematosus (SLE)

3. How to take Climaval



you have cancer.

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure. Your
doctor will aim to prescribe the lowest dose to treat your symptom
for as short as necessary. Speak to your doctor if you think this
dose is too strong or not strong enough. During the treatment your
doctor may adjust the dose according to your individual needs.
When to start treatment

For signs of a blood clot, see “Stop taking Climaval 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 1000 would be expected to get a
blood clot in a vein.
For women in their 50s who have been taking oestrogenprogestogen HRT for over 5 years, there will be 9 to 12 cases in
1000 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 1000 users (i.e. 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.

Breast cancer

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

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17
in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestogen
HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an
extra 4 to 6 cases).

Not applicable, because Climaval is only indicated in women
without a uterus.
Driving and using machines

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

− if you have painful menstrual periods
See your doctor as soon as possible.

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

If you need a blood test, tell your doctor or the laboratory staff that
you are taking Climaval, because this medicine can affect the
results of some tests.
Pregnancy and breast-feeding



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

Evidence suggests that taking combined oestrogen-progestogen
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

The risk of getting stroke is about 1.5 times higher in HRT users
than in non-users. The number of extra cases of stroke due to use
of HRT will increase with age.
Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 would be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases
in 1000 users, over 5 years (i.e. an extra 3 cases).
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.

Lactose is a form of sugar. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking Climaval.



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



If you are changing from a cyclic or sequential HRT
treatment (where the progestogen is added for 12–14 days of
the cycle), you should start to take Climaval on the day after
you complete your previous cycle.
How to take Climaval
Take one tablet each day by following the sequence of
numbers and arrows on the calendar pack.
Swallow your tablets whole with a glass of water.
The pack has been designed specifically to help you take the
tablets correctly.

If you take more Climaval than you should
Contact your doctor or pharmacist immediately if you have taken
too much Climaval.
If you forget to take Climaval

If you are going to have surgery, tell the surgeon that you are taking
Climaval. You may need to stop taking Climaval 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 taking
Climaval again.
If you stop taking Climaval
Stopping Climaval may increase the risk of breakthrough bleeding
or spotting. If this occurs after you stop treatment, contact your
doctor immediately. Your doctor will need to work out the reasons
for this.
After a long treatment break, consult your doctor before starting to
take Climaval again.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
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.
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Some effects could be serious
These symptoms need immediate medical attention.


Unexpected vaginal bleeding or spotting (breakthrough
bleeding) after taking Climaval for some time, or after you stop
treatment



Painful menstrual periods



Painful swelling and redness of the legs



Sudden chest pain



Difficulty in breathing

Write the name of the day you take your first tablet in the box below.
For example, if you start your tablets on a Wednesday, then write
“Wednesday” in the box. This day will also be the day on which you
will take tablets 8, 15 and 22. This will help you check that you
have taken each tablet on the right day.



Pain in your chest that spreads to your arm or neck



Yellowing of the eyes and face (jaundice)



Rapid increase in your blood pressure



Unexplained migraine-like headaches

Write your start day here:



Breast changes, including dimpling of the breast skin, changes
in the nipple, lumps that you can see or feel.

When you finish one blister pack, start the new one the next day
whether or not you experience bleeding. This will normally be the
same day of the week as you started the previous blister pack. Do
not take a break between blister packs unless your doctor tells you.

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

The tablets are best taken at the same time every day; try to get
into a routine.
Follow your doctor’s instructions as to how and when you should
take Climaval tablets and never change the dose yourself, however
well you feel.
If you are unsure about how much medicine to take or when to take
it, ask your doctor or pharmacist.

S283-84 LEAFLET Climavel 20150820

S283-84 LEAFLET Estadiol 20150820

S283-84 LEAFLET Estadiol 20150820

Other side effects

6. Content of the pack and other information

In addition, the following side effects have been reported with
Estradiol Tablets:

What Estradiol Tablets contain



Breast tension and pain, breast cancer.



Discharge from the vagina.



Headache, dizziness, vertigo, changes in sexual desire,
depression.



Increased blood pressure, palpitations (sensation of fluttering in
the chest), fast heart beat or other heart symptoms, tender or
painful veins (signs of thrombophlebitis), fluid retention, nose
bleeds.



Indigestion, wind, nausea, vomiting, abdominal pain and
bloating, problems with your gall bladder (biliary stasis).



General itching, hair loss, hives and skin rash.



Glucose intolerance which can make you sweat or feel faint
after eating.



Weight gain.



Hypersensitivity reaction such as rash, itching, hives.

The following side effects have been reported with other HRTs:


Gall bladder disease



Various skin disorders:





The active substance in Estradiol Tablets is Estradiol. Each
Estradiol Valerate 1mg film coated tablet contains 1mg of
estradiol valerate. Each Estradiol Valerate 2mg film coated
tablet contains 2mg of estradiol valerate.
The other ingredients are: lactose, corn starch, FD & C Blue No.
2 (E132), povidone (grade 30), purified water, talc (sterile,
white), magnesium stearate, hypromellose, propylene glycol,
Opaspray blue M-1-6517 (E171, E132 and E464).

What Estradiol Tablets looks like and contents of the pack
Estradiol Valerate 1mg Tablets are pale blue round tablets marked
OC on one side and CG on the other.
Estradiol Valerate 2mg Tablets are blue round tablets marked OD
on one side and CG on the other.
Estradiol Tablets are available as calendar blister packs of 28 or 84
tablets.

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESTRADIOL VALERATE 1mg TABLETS
ESTRADIOL VALERATE 2mg TABLETS


Your medicine is known by any of the above name but will be
referred to as Estradiol Tablets throughout the following patient
information leaflet.

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;

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



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 severe kidney disease;



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 (hypersensitive) to oestradiol valerate or any
of the other ingredients of Estradiol Tablets (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.

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

What is in this leaflet
1. What Estradiol Tablets are and what they are used for

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



painful reddish skin nodules (erythema nodosum),

Manufacturer

2. What you need to know before you take Estradiol Tablets
3. How to take Estradiol Tablets



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

This product is manufactured by either:

4. Possible side effects



Novartis Pharmaceuticals UK Ltd, Horsham UK or



Novartis Farmaceutica, S.A., Ronda Santa Maria, 158,
08210-Barbera del Valles, Barcelona, Spain.

5. How to store Estradiol Tablets
6. Content of the pack and other information

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

PL. 19488/0283 Estradiol Valerate 1mg Tablets

1. What Estradiol Tablets are and what they are used for

When to take special care with Estradiol Tablets

PL. 19488/0284 Estradiol Valerate 2mg Tablets

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

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 Tablets. If so, you
should see your doctor more often for check-ups.

Decline in memory or mental ability



Diarrhoea



Migraine,



Fibroids (benign growths in the uterus)



Pain in extremity

• Dry eyes and contact lens discomfort
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Estradiol Tablets


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store your tablets above 25°C.



Store in the original package.

POM

Oestradiol valerate is identical to the natural female hormone
oestrogen. This hormone is produced by the ovaries before the
menopause.

Leaflet revision date: 20 August 2015
S283-84 LEAFLET Estadiol 20150820

Estradiol Tablets are used for:
Relief of symptoms occurring after menopause
Menopause occurs naturally in all women, usually between the
ages of 45 and 55 years. It occurs also in younger women who
have their ovaries removed by surgery. 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”), sleep problems, irritability, and depression. Some women
also have problems with urine control or dryness of the vagina,
which may cause discomfort during or after sexual intercourse.
Estradiol Tablets alleviates these symptoms after menopause. You
will only be prescribed Estradiol Tablets if your symptoms seriously
hinder your daily life.



Protect from light and moisture. Store in a dry place.



Do not use Estradiol Tablets after the expiry date which is
stated on the carton and blister strip. The expiry date refers to
the last day of that month.

2. What you need to know before you take Estradiol Tablets

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.

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.



If any of the following applies to you. If you are not sure about any
of the points below, talk to your doctor before taking Estradiol
Tablets,







Do not take Estradiol Tablets

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Medical history and regular check-ups



Fibroids inside your womb



Growth of womb lining outside your womb (endometriosis)
or a history of excessive growth of the womb lining (endometrial
hyperplasia)



Increased risk of developing blood clots (see “Blood clots in
a vein (thrombosis)”)



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



High blood pressure



A liver disorder, such as a benign liver tumour (liver adenoma)



Diabetes



Gallstones



Migraine or severe headaches



A disease of the immune system that affects many organs of
the body (Systemic lupus erythematosus,SLE), an
autoimmune disorder



Epilepsy

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.



Asthma



A disease affecting the eardrum and hearing (otosclerosis)



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

Before you start (or restart) Estradiol Tablets, 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. He/she should tell you what kind of changes in the
breast you should look out for and may advise you to have a breast
X-ray (a mammogram). Once you have started on Estradiol Tablets,
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 Tablets.



Fluid retention due to cardiac or kidney problems



Hypothyroidism (a condition in which your thyroid gland fails to
produce enough thyroid hormone and for which you are treated
with thyroid hormone replacement therapy)



Hereditary angioedema or episodes of rapid swelling of the
hands, feet, face, lips, eyes, tongue, throat (airway blockage) or
digestive tract.

Go for regular breast screening, as recommended by your doctor.

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

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


dimpling of the skin

Other medicines and Estradiol Tablets

How long to take Estradiol Tablets

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

From time to time, you will need to discuss with your doctor the
possible risks and benefits associated with Estradiol Tablets and
whether you still need the treatment. It is important that you take the
lowest possible effective dose and only as long as needed.



Any of the conditions mentioned in the ‘Do Not take Estradiol
Tablets’ section



Yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease



Ovarian cancer

A large rise in your blood pressure (symptoms may be
headache, tiredness, dizziness)

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.



medicines for epilepsy (such as phenobarbital, phenytoin,
carbamazepine),



Migraine-like headaches which happen for the first time, with or
without disturbed vision. Headaches like these can be an early
sign of a stroke. If you have already had a stroke, talk with your
doctor about whether the benefits of the treatment outweigh the
possibly increased risk.

Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1000 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 1000 users (i.e. up to 1 extra
case).



medicines for tuberculosis (such as rifampicin, rifabutin),



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

If you forget to take a tablet at your usual time, try to take it within
12 hours. If this is not possible, leave the forgotten tablet and
continue to take the remaining tablets at the usual time.



Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)

herbal remedies containing St John’s wort (Hypericum
perforatum),

If you need to have surgery

If you get pain in your chest that spreads to your arm or neck.
This pain may be a sign of heart disease.



other anti-infective medicines (such as ketoconazole,
erythromycin).




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)’.
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 progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. So your
doctor will prescribe a progestogen separately if you still have your
womb. If you have had your womb removed (a hysterectomy),
discuss with your doctor whether you can safely take this product
without a progestogen.
In women who still have a womb and who are not taking HRT, on
average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra
cases), depending on the dose and for how long it is taken.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed)
while taking Estradiol Tablets. 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 Tablets for more
than 6 months



carries on after you have stopped taking Estradiol Tablets



change in the nipple



any lump you can see or feel

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

Estradiol Tablets have no known effects on the ability to drive and
use machines.
Estradiol Tablets contain lactose



you have 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 an other organ



you have systemic lupus erythematosus (SLE)

3. How to take Estradiol Tablets



you have cancer.

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure. Your
doctor will aim to prescribe the lowest dose to treat your symptom
for as short as necessary. Speak to your doctor if you think this
dose is too strong or not strong enough. During the treatment your
doctor may adjust the dose according to your individual needs.
When to start treatment

For signs of a blood clot, see “Stop taking Estradiol Tablets 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 1000 would be expected to get a
blood clot in a vein.
For women in their 50s who have been taking oestrogenprogestogen HRT for over 5 years, there will be 9 to 12 cases in
1000 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 1000 users (i.e. 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.

Breast cancer

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

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17
in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestogen
HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an
extra 4 to 6 cases).

Not applicable, because Estradiol Tablets are only indicated in
women without a uterus.
Driving and using machines

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

− if you have painful menstrual periods
See your doctor as soon as possible.

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

If you need a blood test, tell your doctor or the laboratory staff that
you are taking Estradiol Tablets, because this medicine can affect
the results of some tests.
Pregnancy and breast-feeding



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

Evidence suggests that taking combined oestrogen-progestogen
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

The risk of getting stroke is about 1.5 times higher in HRT users
than in non-users. The number of extra cases of stroke due to use
of HRT will increase with age.
Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 would be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases
in 1000 users, over 5 years (i.e. an extra 3 cases).
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.

Lactose is a form of sugar. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking Estradiol Tablets.



If you are currently not taking any form of HRT (patches or
tablets), or if you have been taking a continuous combined
HRT product (where oestrogen and the progestogen are given
every day without interruption), you can start to take Estradiol
Tablets on any convenient day.



If you are changing from a cyclic or sequential HRT
treatment (where the progestogen is added for 12–14 days of
the cycle), you should start to take Estradiol Tablets on the day
after you complete your previous cycle.
How to take Estradiol Tablets
Take one tablet each day by following the sequence of
numbers and arrows on the calendar pack.

Swallow your tablets whole with a glass of water.
The pack has been designed specifically to help you take the
tablets correctly.

If you take more Estradiol Tablets than you should
Contact your doctor or pharmacist immediately if you have taken
too much Estradiol Tablets.
If you forget to take Estradiol Tablets

If you are going to have surgery, tell the surgeon that you are taking
Estradiol Tablets. You may need to stop taking Estradiol Tablets
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 taking Estradiol Tablets again.
If you stop taking Estradiol Tablets
Stopping Estradiol Tablets may increase the risk of breakthrough
bleeding or spotting. If this occurs after you stop treatment, contact
your doctor immediately. Your doctor will need to work out the
reasons for this.
After a long treatment break, consult your doctor before starting to
take Estradiol Tablets again.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
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.
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Some effects could be serious
These symptoms need immediate medical attention.


Unexpected vaginal bleeding or spotting (breakthrough
bleeding) after taking Estradiol Tablets for some time, or after
you stop treatment



Painful menstrual periods



Painful swelling and redness of the legs



Sudden chest pain



Difficulty in breathing

Write the name of the day you take your first tablet in the box below.
For example, if you start your tablets on a Wednesday, then write
“Wednesday” in the box. This day will also be the day on which you
will take tablets 8, 15 and 22. This will help you check that you
have taken each tablet on the right day.



Pain in your chest that spreads to your arm or neck



Yellowing of the eyes and face (jaundice)



Rapid increase in your blood pressure



Unexplained migraine-like headaches

Write your start day here:



Breast changes, including dimpling of the breast skin, changes
in the nipple, lumps that you can see or feel.

When you finish one blister pack, start the new one the next day
whether or not you experience bleeding. This will normally be the
same day of the week as you started the previous blister pack. Do
not take a break between blister packs unless your doctor tells you.

Stop taking Estradiol Tablets and tell your doctor immediately
if you get any of the effects mentioned above. Check the risks to be
aware of with HRT in general in section 2, When to take special
care with Estradiol Tablets.

The tablets are best taken at the same time every day; try to get
into a routine.
Follow your doctor’s instructions as to how and when you should
take Estradiol tablets and never change the dose yourself, however
well you feel.
If you are unsure about how much medicine to take or when to take
it, ask your doctor or pharmacist.

S283-84 LEAFLET Estadiol 20150820

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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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