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ESTRIOL 0.1% VAGINAL CREAM

Active substance: ESTRIOL

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S1521 LEAFLET 20120721

3.3 If you use more Ovestin than you should or if you swallow it
accidentally

6. Further Information

If someone has swallowed some cream by accident, or too much
cream is applied at any time, there is no need to worry. However,
you should talk to your doctor. The person may feel sick or be sick.
Women may have some vaginal bleeding after a few days.



Each gram of cream contains 1mg of estriol.



The other ingredients are: eutanol G, lactic acid, sodium
hydroxide, purified water, sorbitan monostearate, cetyl
palmitate, glycerol, stearyl alcohol, cetyl alcohol, polysorbate 60
and chlorhexidine hydrochloride.



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.

3.5 If you stop using Ovestin
Keep using this medicine as prescribed by your doctor. Keep using
Ovestin, even if you seem to be better. If you stop too early or too
suddenly your problem may return.
4. Possible side effects
Like all medicines, Ovestin can cause side effects, although not
everybody gets them.
 See your doctor straight away, if you notice any of the
following serious side effects – your doctor may decide to
stop you using the cream:


your blood pressure rises



you suddenly have migraine-type headaches (see Section 2.4
above)



you have signs of a blood clot (see Section 2.4 above)



Before you start taking HRT



Ovestin Cream is a white cream.

Read all of this leaflet carefully before you start using this
medicine.



There are 15 gm of cream in each tube.



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

 Tell your doctor if you have any medical problems or illnesses.



The pack contains a clear plastic applicator



If you have any further questions, ask your doctor or pharmacist.

Regular check-ups



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

Once you have started on HRT, see your doctor for regular checkups (at least once a year). At these check-ups, your doctor may
discuss the benefits and risks of continuing to take HRT.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Make sure that you:

What Ovestin looks like and contents of the pack

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.

Your medicine is called Ovestin Cream but will be referred to as
Ovestin throughout the following patient information leaflet.



go for regular breast screening and cervical smear tests



regularly check your breasts for any changes such as
dimpling of the skin, changes in the nipple, or any lumps you
can see or feel.

Manufacturer
This product is manufactured by Organon (Ireland) Ltd, Swords,
Ireland.
POM

In this leaflet:
1. What Ovestin is and what it is used for

2.1 Do not use Ovestin if:

2. Before you use Ovestin



you are allergic (hypersensitive) to any of the ingredients of
Ovestin (listed in Section 6)



you have had a disease caused by blood clots in the arteries
such as angina, stroke or a heart attack (myocardial infarction)



you have had a blood clot (thrombosis)



you have had breast cancer or suspect that you have breast
cancer

1. What Ovestin is and what it is used for

PL No: 19488/1521

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



®

OVESTIN CREAM
(estriol)

As well as benefits, HRT has some risks that you need to consider
when you’re deciding whether to start taking it, or whether to carry
on taking it. This is especially important if you are more than 60
years old.
Your doctor should ask about you and your family’s medical history.
Your doctor may decide to examine your breasts or your stomach
and may do an internal examination. They will only do this if it is
necessary for you or you have any special concerns. Your doctor
will tell you how often these tests should be performed

3.4 If you forget to use Ovestin


2. Before you use Ovestin

PACKAGE LEAFLET: INFORMATION FOR THE USER

What Ovestin cream contains



Ovestin contains a medicine called estriol. It belongs to a group of
medicines called Hormone Replacement Therapy (HRT).

you have had cancer of other sex organs – such as cancer of
the womb lining or ovary



you have vaginal bleeding that has not been explained by your
doctor

Ovestin is used:



you have excessive thickening of the womb lining



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



you have had a liver disease, and your liver is still not working
properly



you have a rare blood problem called ‘porphyria’.

3. How to use Ovestin
4. Possible side effects

Leaflet revision date: 21 July 2012

5. How to store Ovestin
6. Further information

you have any of the problems listed in Section 2.1 above.

Ovestin is a registered trade mark of NV Organon, The Netherlands.

These side effects are rare.
Other side effects include:



irritation or itching of the skin in or around your vagina when you
start to use Ovestin. This usually gets better after a few weeks.
increased vaginal discharge, bleeding or spotting

S1521 LEAFLET 20120721

What is Ovestin used for



gall bladder problems



For vaginal problems caused by having too little ‘oestrogen’



skin problems such as a rash or an allergy to the sun



Before or after vaginal surgery to help wound healing.



breasts become swollen, tender or painful



headaches

How Ovestin works



feeling sick or being sick.

Estriol (the medicine in Ovestin) is one of the natural oestrogens.

 If you have any of these side effects tell your doctor.



Oestrogens are female sex hormones.

They may decide to stop your treatment for a while.



They are produced in the ovaries.

Dementia



They cause sexual development in women and control the
menstrual cycle during the child-bearing years.

HRT will not prevent memory loss. The risk of memory loss may be
somewhat higher in women who start using HRT after the age of 65.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

When women get older the ovaries gradually produce less
oestrogen.
If the ovaries are removed before the menopause, oestrogen
production stops very suddenly.



Keep out of the sight and reach of children.



Do not store above 30°C.

Shortage of oestrogens may cause the vaginal wall to become thin
and dry. So sexual intercourse may become painful and you may
get vaginal infections.



Do not use this medicine after the expiry date which is stated on
the label and carton. The expiry date refers to the last day of the
month.

These problems can be relieved by using medicines like Ovestin
which contain oestrogen. It may take several days or weeks before
you notice an improvement.





If the medicine shows any other signs of deterioration, you
should seek the advice of your pharmacist who will tell you what
to do.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

2.2 Take special care with Ovestin
Check with your doctor or pharmacist before using your medicine if
you have had:


a problem caused by growth of the womb lining outside the
womb (fibroids or endometriosis)



any problem with your heart or circulation (including high blood
pressure or risk factors for a blood clot – see Section 2.4)



relatives who have had blood clots



asthma



diabetes



migraine or severe headaches



epilepsy (fits)



gallstones



liver or kidney problems



a rare problem called ‘systemic lupus erythematosus’ (SLE)



otosclerosis (a hearing disorder).

This happens at the menopause (usually around the age of 50).


5. How to store Ovestin



 Do not use this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before using
Ovestin.

 If you have any of these, talk to your doctor or pharmacist
before using Ovestin.
Ovestin contains cetyl alcohol and stearyl alcohol. This may cause
local skin reactions (e.g.contact dermatitis).

2.3 Ovestin and the risk of developing cancer

2.4 Ovestin and the heart or circulation

How likely is a blood clot?

3.1 How much to use

Breast cancer

Coronary artery disease (CAD)

Looking at women in their 50s, on average, over 5 years:

For vaginal problems



HRT is not recommended for women who have had heart
disease recently. If you have ever had heart disease, talk to your
doctor to see if you should be taking HRT.



In women not taking HRT: 4 in 1,000 would be expected to get
a blood clot in a vein.



The usual dose is 1 applicator up to the ring (0.5 mg estriol in
0.5 g of cream) a day for the first 2 to 3 weeks.



In women who have been taking HRT for over 5 years, 9 in
1,000 would be expected to get a blood clot.



Then the dose is 1 applicator up to the ring twice a week.

Women who have ever had breast cancer should not take
HRT.

Taking HRT slightly increases the risk of breast cancer. The risk is
also slightly increased if you have a later menopause. The risk after
the menopause for a woman taking oestrogen-only HRT for 5 years
is about the same as for a woman of the same age who is still
having periods over that time and not taking HRT. The risk for a
woman who is taking oestrogen plus progestogen HRT is higher
than for oestrogen-only HRT. However, oestrogen plus progestogen
HRT is beneficial for the endometrium.
For all kinds of HRT, the extra risk of breast cancer goes up the
longer you take it. However, it returns to normal about 5 years after
stopping HRT.

HRT will not help to prevent heart disease.
Women taking oestrogen-progestagen HRT are slightly more likely
to get heart disease during the first year of taking that type of HRT
than those not taking any HRT. For other types of HRT (like
Ovestin), the risk is likely to be similar. However this is not yet
certain. As the risk of heart disease strongly depends on age, the
number of extra cases of heart disease due to use of estrogenprogestagen HRT is very low in healthy women close to
menopause, but will rise with more advanced age.
If you get a pain in your chest that spreads to your arm or neck:

Your risk of breast cancer is also higher if:

 See a doctor as soon as possible



you have a close relative (mother, sister or grandmother) who
has had breast cancer

Do not use any more HRT until a doctor says you can. This pain
could be a sign of heart disease.



you are seriously overweight.

Stroke

How likely is breast cancer?
Looking at women aged 50 to 65, on average, over a 5-year period:


In women not taking HRT: 9 to 12 in 1,000 will get breast
cancer.



In women taking oestrogen-progestagen HRT: 15 to 18 in
1,000 will get breast cancer. This means an extra 6 cases, on
average.

Looking at women aged 50 to 79, on average, over a
5-year period:


In women not taking HRT: 14 in 1,000 will get breast cancer.



In women taking oestrogen-progestagen HRT: 18 in 1,000
will get breast cancer. This means an extra 4 cases.

If you notice any changes in your breast, such as: dimpling of your
skin, changes in your nipple or any lumps you can see or feel:

 See a doctor straight away
Do not use any more HRT until a doctor says you can.
These may be signs of a blood clot.

Before or after vaginal surgery


2.5 Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines obtained
without a prescription, including herbal medicines. This is because
Ovestin can affect the way some other medicines work. Also some
other medicines can affect the way Ovestin works.

Before surgery - the dose is 1 applicator up to the ring (0.5 mg
estriol in 0.5 g of cream) a day for 2 weeks before the operation.



After surgery - do not use the cream again for at least 2 weeks.
Then use 1 applicator up to the ring twice a week.

3.2 How to apply the cream
Ovestin comes in a pack together with a clear plastic applicator.

Combined oestrogen-progestagen and oestrogen-only HRT
increase the risk of stroke up to 1.5-fold. The comparable risk for
users, versus non-users, does not change with age or time since
menopause.

 Tell your doctor or pharmacist if you are taking any of the
following:


medicines for epilepsy - such as barbiturates, hydantoins and
carbamezapine.

However, because the risk of stroke is strongly agerelated, the
overall general risk of stroke in women, who use HRT, will increase
with age.



The applicator has a ring marked on the body. Fill the applicator up
to the ring mark with Ovestin cream to get the correct dose.

medicines for infections - such as griseofulvin and rifamycins.

 Follow these instructions:



1

Other things that can increase the risk of stroke include:

medicines for viral infections - such as nevirapine, efavirenz,
ritonavir or nelfinavir.

Remove the cap from the tube and turn the cap upside down.
Then use the sharp point to open the tube.



herbal peparations containing St John’s wort (Hypericum
perforatum) - a herbal medicine used for depression.

2

Screw the end of the applicator onto the tube



one of the following medicines: corticosteroids,
succinylcholine,theophyllines or troleandomycin.

3

Squeeze the tube to fill the applicator with the cream up to the
red ring mark (the plunger will stop at the red ring mark).

Ask your doctor or pharmacist for advice before taking any
medicine, if you are pregnant or breast-feeding.

4

Unscrew the applicator from the tube and put the cap back on
the tube.

Driving and using machines

5

To apply the cream, lie down, put the end of the applicator deep
into your vagina and slowly push the plunger all the way in.



getting older



high blood pressure



smoking



drinking too much alcohol



an uneven heartbeat

 Make an appointment to see your doctor straight away.

If you are worried about any of these things, or if you have had a
stroke in the past, talk to your doctor to see if you should take HRT.

Endometrial cancer (cancer of the lining of the womb)

How likely is a stroke?

Taking oestrogen-only HRT tablets for a long time can increase
the risk of developing cancer of the lining of the womb. It is
possible there may be a similar risk with oestrogen cream used
directly in the vagina for repeated treatments or over a long time.

Looking at women in their 50s, on average, over 5 years

You do not need to take a separate progestogen with Ovestin.

If you get painful swelling in your leg, sudden chest pain or have
problems breathing:

Your doctor will prescribe the lowest dose that relieves your
symptoms. Your doctor may want you to stop from time to time
(every 2 to 3 months for a period of 4 weeks). This is to check if you
still need treatment.



In women not taking HRT: 8 in 1,000 would be expected to
have a stroke.



In women taking HRT: 11 in 1,000 would be expected to have a
stroke.

Use the applicator to apply the cream in the vagina. A good time to
do this is before going to bed.

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Ovestin.
If you have a vaginal infection, your doctor may also prescribe a
medicine to treat the infection.
2.6 Operations
 Tell your doctor you are using Ovestin if you are going to have
surgery. You may need to stop using HRT about 4 to 6 weeks
before the operation to reduce the risk of a blood clot. Your
doctor will tell you when you can start taking HRT again.
2.7 Pregnancy and breast-feeding

If you get breakthrough bleeding or spotting, it is usually nothing to
worry about, but you should:

If you get an unexpected migraine-type headache, with or without
disturbed vision:



 Talk to your doctor. It could be a sign that your endometrium
has become thicker.

 See a doctor straight away and do not use any more HRT until
a doctor says you can. These headaches may be an early
warning sign of a stroke.

Do not use Ovestin if you are pregnant or might become
pregnant. This is because it may affect the baby.



Do not breast-feed if you are using this medicine.

Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious.
It can be difficult to diagnose, because there are often no obvious
signs of the problem. Ovarian cancer is much rarer than breast
cancer. ‘Long-term (at least 5 to 10 years) use of oestrogen-only
HRT products is thought to carry a slightly increased risk of ovarian
cancer. Some studies suggest the long-term use of combined HRT
may carry a similar, or slightly smaller risk. It is not yet known
whether Ovestin increases the risk in the same way.

Blood clots

For women who have been taking HRT for over 5 years there will be
one extra case per 2500 users.

You are more likely to get a blood clot if:

HRT increases the risk of blood clots in the veins (also called deep
vein thrombosis, or DVT) 1.3 to 3-fold. This is especially during the
first year of taking it.
These blood clots are not always serious. However, if a clot
travels to your lungs, it can cause chest pain, feeling breathless,
collapse or even death. This is called a pulmonary embolism or PE.


you are older



you have ever had a miscarriage



you are very overweight



you have had a blood clot before in the leg, lung or other organ




Always use Ovestin exactly as your doctor or pharmacist has told
you. You should check with your doctor or pharmacist if you are not
sure.

if you use oestrogens



3. HOW TO USE OVESTIN

if you get pregnant or have recently had a baby



Ovestin has no or little effect on the ability to drive or use machines



If you have had your womb and ovaries removed, you can start
using Ovestin straight away.



If you have never used HRT before or if you are changing over
from a period-free HRT, you can also use Ovestin straight away.



If you are changing over from another type of HRT where you
have a period, start taking Ovestin one week after you finish the
other HRT.

Cleaning the applicator


After use, pull the plunger out of the barrel.

any of your close family have had blood clots



Wash the plunger and barrel in hand hot, soapy water.

you have any blood clotting problem that needs treatment with
a medicine such as warfarin



Do not use detergents. Rinse well with clean water afterwards.
Do not put the applicator in boiling water.





you are off your feet for a long time because of major surgery,
injury or illness

Ovestin is easy to remove with water.



you have a rare problem called SLE.



you have cancer

 If any of these things apply to you, talk to your doctor to see if
you should take HRT.

S1521 LEAFLET Estriol 20120721

3.3 If you use more Estriol than you should or if you swallow it
accidentally

6. Further Information

If someone has swallowed some cream by accident, or too much
cream is applied at any time, there is no need to worry. However,
you should talk to your doctor. The person may feel sick or be sick.
Women may have some vaginal bleeding after a few days.



Each gram of cream contains 1mg of estriol.



The other ingredients are: eutanol G, lactic acid, sodium
hydroxide, purified water, sorbitan monostearate, cetyl
palmitate, glycerol, stearyl alcohol, cetyl alcohol, polysorbate 60
and chlorhexidine hydrochloride.

PACKAGE LEAFLET: INFORMATION FOR THE USER

What Estriol contains

3.4 If you forget to use Estriol


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.

3.5 If you stop using Estriol
Keep using this medicine as prescribed by your doctor. Keep using
Estriol, even if you seem to be better. If you stop too early or too
suddenly your problem may return.
4. Possible side effects
Like all medicines, Estriol can cause side effects, although not
everybody gets them.
 See your doctor straight away, if you notice any of the
following serious side effects – your doctor may decide to
stop you using the cream:


your blood pressure rises



you suddenly have migraine-type headaches (see Section 2.4
above)



Estriol Cream is a white cream.



There are 15 gm of cream in each tube.



The pack contains a clear plastic applicator

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.

This product is manufactured by Organon (Ireland) Ltd, Swords,
Ireland.

Other side effects include:

Read all of this leaflet carefully before you start using this
medicine.

POM

As well as benefits, HRT has some risks that you need to consider
when you’re deciding whether to start taking it, or whether to carry
on taking it. This is especially important if you are more than 60
years old.
Before you start taking HRT
Your doctor should ask about you and your family’s medical history.
Your doctor may decide to examine your breasts or your stomach
and may do an internal examination. They will only do this if it is
necessary for you or you have any special concerns. Your doctor
will tell you how often these tests should be performed
 Tell your doctor if you have any medical problems or illnesses.



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

Regular check-ups



If you have any further questions, ask your doctor or pharmacist.



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

Once you have started on HRT, see your doctor for regular checkups (at least once a year). At these check-ups, your doctor may
discuss the benefits and risks of continuing to take HRT.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Make sure that you:


go for regular breast screening and cervical smear tests



regularly check your breasts for any changes such as
dimpling of the skin, changes in the nipple, or any lumps you
can see or feel.

PL No: 19488/1521

In this leaflet:

2.1 Do not use Estriol if:

1. What Estriol is and what it is used for

you have any of the problems listed in Section 2.1 above.

These side effects are rare.

Your medicine is called Estriol 0.1% Vaginal Cream but will be
referred to as Estriol throughout the following patient information
leaflet.

Manufacturer

you have signs of a blood clot (see Section 2.4 above)





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



What Estriol looks like and contents of the pack

ESTRIOL 0.1% VAGINAL CREAM
(estriol)

2. Before you use Estriol



you are allergic (hypersensitive) to any of the ingredients of
Estriol (listed in Section 6)



you have had a disease caused by blood clots in the arteries
such as angina, stroke or a heart attack (myocardial infarction)



you have had a blood clot (thrombosis)



you have had breast cancer or suspect that you have breast
cancer



you have had cancer of other sex organs – such as cancer of
the womb lining or ovary

2. Before you use Estriol
3. How to use Estriol

Leaflet revision date: 21 July 2012

4. Possible side effects
5. How to store Estriol
6. Further information
S1521 LEAFLET Estriol 20120721

1. What Estriol IS and what it is used for



irritation or itching of the skin in or around your vagina when you
start to use Estriol. This usually gets better after a few weeks.

Estriol contains a medicine called estriol. It belongs to a group of
medicines called Hormone Replacement Therapy (HRT).



you have vaginal bleeding that has not been explained by your
doctor



increased vaginal discharge, bleeding or spotting

What is Estriol used for



you have excessive thickening of the womb lining

Estriol is used:



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



you have had a liver disease, and your liver is still not working
properly



you have a rare blood problem called ‘porphyria’.



gall bladder problems



skin problems such as a rash or an allergy to the sun



breasts become swollen, tender or painful



headaches



feeling sick or being sick.

 If you have any of these side effects tell your doctor.
They may decide to stop your treatment for a while.
Dementia
HRT will not prevent memory loss. The risk of memory loss may be
somewhat higher in women who start using HRT after the age of 65.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, tell your doctoror pharmacist.
5. How to store Estriol


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Do not use this medicine after the expiry date which is stated on
the label and carton. The expiry date refers to the last day of the
month.





If the medicine shows any other signs of deterioration, you
should seek the advice of your pharmacist who will tell you what
to do.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.



for vaginal problems caused by having too little ‘oestrogen’



before or after vaginal surgery to help wound healing.

How Estriol works


Oestrogens are female sex hormones.

 Do not use this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before using
Estriol.



They are produced in the ovaries.

2.2 Take special care with Estriol



They cause sexual development in women and control the
menstrual cycle during the child-bearing years.

Check with your doctor or pharmacist before using your medicine if
you have had:

Estriol (the medicine in Estriol) is one of the natural oestrogens.

When women get older the ovaries gradually produce less
oestrogen.



a problem caused by growth of the womb lining outside the
womb (fibroids or endometriosis)



This happens at the menopause (usually around the age of 50).





If the ovaries are removed before the menopause, oestrogen
production stops very suddenly.

any problem with your heart or circulation (including high blood
pressure or risk factors for a blood clot – see Section 2.4)



relatives who have had blood clots



asthma



diabetes



migraine or severe headaches



epilepsy (fits)



gallstones



liver or kidney problems



a rare problem called ‘systemic lupus erythematosus’ (SLE)



otosclerosis (a hearing disorder).

Shortage of oestrogens may cause the vaginal wall to become thin
and dry. So sexual intercourse may become painful and you may
get vaginal infections.
These problems can be relieved by using medicines like Estriol
which contain oestrogen. It may take several days or weeks before
you notice an improvement.

 If you have any of these, talk to your doctor or pharmacist
before using Estriol.
Estriol contains cetyl alcohol and stearyl alcohol. This may cause
local skin reactions (e.g.contact dermatitis).

2.3 Estriol and the risk of developing cancer

2.4 Estriol and the heart or circulation

How likely is a blood clot?

3.1 How much to use

Breast cancer

Coronary artery disease (CAD)

Looking at women in their 50s, on average, over 5 years:

For vaginal problems



HRT is not recommended for women who have had heart
disease recently. If you have ever had heart disease, talk to your
doctor to see if you should be taking HRT.



In women not taking HRT: 4 in 1,000 would be expected to get
a blood clot in a vein.



The usual dose is 1 applicator up to the ring (0.5 mg estriol in
0.5 g of cream) a day for the first 2 to 3 weeks.



In women who have been taking HRT for over 5 years, 9 in
1,000 would be expected to get a blood clot.



Then the dose is 1 applicator up to the ring twice a week.

Women who have ever had breast cancer should not take
HRT.

Taking HRT slightly increases the risk of breast cancer. The risk is
also slightly increased if you have a later menopause. The risk after
the menopause for a woman taking oestrogen-only HRT for 5 years
is about the same as for a woman of the same age who is still
having periods over that time and not taking HRT. The risk for a
woman who is taking oestrogen plus progestogen HRT is higher
than for oestrogen-only HRT. However, oestrogen plus progestogen
HRT is beneficial for the endometrium.
For all kinds of HRT, the extra risk of breast cancer goes up the
longer you take it. However, it returns to normal about 5 years after
stopping HRT.

HRT will not help to prevent heart disease.
Women taking oestrogen-progestagen HRT are slightly more likely
to get heart disease during the first year of taking that type of HRT
than those not taking any HRT. For other types of HRT (like Estriol),
the risk is likely to be similar. However this is not yet certain. As the
risk of heart disease strongly depends on age, the number of extra
cases of heart disease due to use of estrogen-progestagen HRT is
very low in healthy women close to menopause, but will rise with
more advanced age.
If you get a pain in your chest that spreads to your arm or neck:

Your risk of breast cancer is also higher if:

 See a doctor as soon as possible



you have a close relative (mother, sister or grandmother) who
has had breast cancer

Do not use any more HRT until a doctor says you can. This pain
could be a sign of heart disease.



you are seriously overweight.

Stroke

How likely is breast cancer?
Looking at women aged 50 to 65, on average, over a 5-year period:


In women not taking HRT: 9 to 12 in 1,000 will get breast
cancer.



In women taking oestrogen-progestagen HRT: 15 to 18 in
1,000 will get breast cancer. This means an extra 6 cases, on
average.

Looking at women aged 50 to 79, on average, over a
5-year period:


In women not taking HRT: 14 in 1,000 will get breast cancer.



In women taking oestrogen-progestagen HRT: 18 in 1,000
will get breast cancer. This means an extra 4 cases.

If you notice any changes in your breast, such as: dimpling of your
skin, changes in your nipple or any lumps you can see or feel:

Do not use any more HRT until a doctor says you can.
These may be signs of a blood clot.

Before or after vaginal surgery


2.5 Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines obtained
without a prescription, including herbal medicines. This is because
Estriol can affect the way some other medicines work. Also some
other medicines can affect the way Estriol works.

Before surgery - the dose is 1 applicator up to the ring (0.5 mg
estriol in 0.5 g of cream) a day for 2 weeks before the operation.



After surgery - do not use the cream again for at least 2 weeks.
Then use 1 applicator up to the ring twice a week.

3.2 How to apply the cream
Estriol comes in a pack together with a clear plastic applicator.

 Tell your doctor or pharmacist if you are taking any of the
following:


medicines for epilepsy - such as barbiturates, hydantoins and
carbamezapine.

However, because the risk of stroke is strongly agerelated, the
overall general risk of stroke in women, who use HRT, will increase
with age.



The applicator has a ring marked on the body. Fill the applicator up
to the ring mark with Estriol cream to get the correct dose.

medicines for infections - such as griseofulvin and rifamycins.

 Follow these instructions:



1

Other things that can increase the risk of stroke include:

medicines for viral infections - such as nevirapine, efavirenz,
ritonavir or nelfinavir.

Remove the cap from the tube and turn the cap upside down.
Then use the sharp point to open the tube.



herbal peparations containing St John’s wort (Hypericum
perforatum) - a herbal medicine used for depression.

2

Screw the end of the applicator onto the tube



one of the following medicines: corticosteroids,
succinylcholine,theophyllines or troleandomycin.

3

Squeeze the tube to fill the applicator with the cream up to the
red ring mark (the plunger will stop at the red ring mark).

4

Unscrew the applicator from the tube and put the cap back on
the tube.

5

To apply the cream, lie down, put the end of the applicator deep
into your vagina and slowly push the plunger all the way in.



getting older



high blood pressure



smoking



drinking too much alcohol



an uneven heartbeat

 Make an appointment to see your doctor straight away.
Endometrial cancer (cancer of the lining of the womb)

How likely is a stroke?

Taking oestrogen-only HRT tablets for a long time can increase
the risk of developing cancer of the lining of the womb. It is
possible there may be a similar risk with oestrogen cream used
directly in the vagina for repeated treatments or over a long time.

Looking at women in their 50s, on average, over 5 years


In women not taking HRT: 8 in 1,000 would be expected to
have a stroke.



In women taking HRT: 11 in 1,000 would be expected to have a
stroke.

If you get breakthrough bleeding or spotting, it is usually nothing to
worry about, but you should:

If you get an unexpected migraine-type headache, with or without
disturbed vision:

 Talk to your doctor. It could be a sign that your endometrium
has become thicker.

 See a doctor straight away and do not use any more HRT until
a doctor says you can. These headaches may be an early
warning sign of a stroke.

Ovarian cancer

 See a doctor straight away

Combined oestrogen-progestagen and oestrogen-only HRT
increase the risk of stroke up to 1.5-fold. The comparable risk for
users, versus non-users, does not change with age or time since
menopause.

If you are worried about any of these things, or if you have had a
stroke in the past, talk to your doctor to see if you should take HRT.

You do not need to take a separate progestogen with Estriol.

If you get painful swelling in your leg, sudden chest pain or have
problems breathing:

Your doctor will prescribe the lowest dose that relieves your
symptoms. Your doctor may want you to stop from time to time
(every 2 to 3 months for a period of 4 weeks). This is to check if you
still need treatment.

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious.
It can be difficult to diagnose, because there are often no obvious
signs of the problem. Ovarian cancer is much rarer than breast
cancer. ‘ Long-term (at least 5 to 10 years) use of oestrogen-only
HRT products is thought to carry a slightly increased risk of ovarian
cancer. Some studies suggest the long-term use of combined HRT
may carry a similar, or slightly smaller risk. It is not yet known
whether Estriol increases the risk in the same way.

Blood clots

For women who have been taking HRT for over 5 years there will be
one extra case per 2500 users.

You are more likely to get a blood clot if:

HRT increases the risk of blood clots in the veins (also called deep
vein thrombosis, or DVT) 1.3 to 3-fold. This is especially during the
first year of taking it.
These blood clots are not always serious. However, if a clot
travels to your lungs, it can cause chest pain, feeling breathless,
collapse or even death. This is called a pulmonary embolism or PE.

Use the applicator to apply the cream in the vagina. A good time to
do this is before going to bed.

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Estriol.
If you have a vaginal infection, your doctor may also prescribe a
medicine to treat the infection.
2.6 Operations
 Tell your doctor you are using Estriol if you are going to have
surgery. You may need to stop using HRT about 4 to 6 weeks
before the operation to reduce the risk of a blood clot. Your
doctor will tell you when you can start taking HRT again.
2.7 Pregnancy and breast-feeding


Do not use Estriol if you are pregnant or might become
pregnant. This is because it may affect the baby.



Do not breast-feed if you are using this medicine.

Ask your doctor or pharmacist for advice before taking any
medicine, if you are pregnant or breast-feeding.
Driving and using machines
Estriol has no or little effect on the ability to drive or use machines
3. How to use Estriol



you are older



Always use Estriol exactly as your doctor or pharmacist has told
you. You should check with your doctor or pharmacist if you are not
sure.

if you get pregnant or have recently had a baby





you have ever had a miscarriage

If you have had your womb and ovaries removed, you can start
using Estriol straight away.



if you use oestrogens





you are very overweight

If you have never used HRT before or if you are changing over
from a period-free HRT, you can also use Estriol straight away.



you have had a blood clot before in the leg, lung or other organ





any of your close family have had blood clots

If you are changing over from another type of HRT where you
have a period, start taking Estriol one week after you finish the
other HRT.



you have any blood clotting problem that needs treatment with
a medicine such as warfarin



you are off your feet for a long time because of major surgery,
injury or illness

Estriol is easy to remove with water.



you have a rare problem called SLE.



you have cancer

 If any of these things apply to you, talk to your doctor to see if
you should take HRT.

Cleaning the applicator


After use, pull the plunger out of the barrel.



Wash the plunger and barrel in hand hot, soapy water.



Do not use detergents. Rinse well with clean water afterwards.



Do not put the applicator in boiling water.

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.

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