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ESTRIOL 0.1% VAGINAL CREAM

Active substance: ESTRIOL

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4. Possible side effects

6. Further Information

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

What Ovestin cream contains


Each gram of cream contains 1mg of estriol.

 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:



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.



your blood pressure rises

2. Before you use Ovestin

S1521 LEAFLET 20150202

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

OVESTIN CREAM
(estriol)
Your medicine is called Ovestin Cream but will be referred to as
Ovestin throughout the following patient information leaflet.

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



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

What Ovestin looks like and contents of the pack


Ovestin Cream is a white cream.



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

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



There are 15 gm of cream in each tube.



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

Regular check-ups



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



The pack contains a clear plastic applicator



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.

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



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.

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.

HRT will not prevent memory loss. In one study of women who
started using combined HRT after the age of 65, a small increase in
the risk of dementia was observed.
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.

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.

PL No: 19488/1521

1. What Ovestin is and what it is used for



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



you have had angina 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



Ovestin 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



you have excessive thickening of the womb lining

What is Ovestin used for



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

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

Leaflet revision date: 02 February 2015

4. Possible side effects
5. How to store Ovestin

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

6. Further information

S1521 LEAFLET 20150202

Ovestin is used:


For vaginal problems caused by having too little ‘oestrogen’



Before or after vaginal surgery to help wound healing.

How Ovestin works



Keep out of the sight and reach of children.

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



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.



go for regular breast screening and cervical smear tests



In this leaflet:

5. How to store Ovestin





1. What Ovestin is and what it is used for

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

Make sure that you:
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.
2.1 Do not use Ovestin if:

Manufacturer

They may decide to stop your treatment for a while.
Dementia



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

 you have a rare blood problem called ‘porphyria’.
 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.
2.2 Take special care with Ovestin



Oestrogens are female sex hormones.

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



They are produced in the ovaries.





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

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



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

When women get older the ovaries gradually produce less
oestrogen.

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



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



asthma

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



diabetes



migraine or severe headaches



epilepsy (fits)



gallstones



liver or kidney problems



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

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 Ovestin
which contain oestrogen. It may take several days or weeks before
you notice an improvement.

 otosclerosis (a hearing disorder).
 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
Breast cancer


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.
Your risk of breast cancer is also higher if:


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

 you are seriously overweight.
How likely is breast cancer?

Stroke

2.5 Taking other medicines

3.2 How to apply the cream

Research suggests that HRT slightly increases the risk of having a
stroke. Other things that can increase the risk of stroke include:

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

Ovestin comes in a pack together with a clear plastic applicator.



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

1

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

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.
How likely is a stroke?



medicines for infections - such as griseofulvin and rifamycins.

2

Screw the end of the applicator onto the tube



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

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



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



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



In women not taking HRT: 3 in 1,000 would be expected to
have a stroke.



In women taking HRT: 4 in 1,000 would be expected to have a
stroke.
Looking at women in their 60s, on average, over 5 years


In women not taking HRT: 11 in 1,000 would be expected to
have a stroke.
In women taking HRT: 15 in 1,000 would be expected to have a
stroke.

Looking at women aged 50, on average, by the time they reach 65:


In women not taking HRT: 32 in 1,000 will get breast cancer.





In women who start taking oestrogen-only HRT at age 50 and
take it for 5 years: between 33 and 34 in 1,000 will get breast
cancer. This means an extra 1 to 2 cases.

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

In women taking oestrogen-only HRT for 10 years: 37 in 1,000
will get breast cancer. This means an extra 5 cases.

 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.



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:
 Make an appointment to see your doctor straight away.
Endometrial cancer (cancer of the lining of the womb)
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.
You do not need to take a separate progestogen with Ovestin.
If you get breakthrough bleeding or spotting, it is usually nothing to
worry about, but you should:
 Talk to your doctor. It could be a sign that your endometrium
has become thicker.
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. Some studies have shown that taking
oestrogen-only HRT for more than 5 years may increase the risk of
ovarian cancer. It is not yet known whether other kinds of HRT
increase the risk in the same way.

Blood clots
HRT may increase the risk of blood clots in the veins (also called
deep vein thrombosis, or DVT). 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 more likely to get a blood clot if:

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

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


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.

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



you are very overweight



you have had a blood clot before

3. How to use Ovestin



any of your close family have had blood clots



you have ever had a miscarriage



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

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.



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



you have a rare problem called SLE.

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



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.

Heart disease

How likely is a blood clot?

3.1 How much to use

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.
HRT will not help to prevent heart disease.

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

For vaginal problems



In women not taking HRT: 3 in 1,000 would be expected to get
a blood clot.





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.



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



For other types of HRT (like Ovestin), the risk is likely to be similar.
However this is not yet certain. If you get a pain in your chest that
spreads to your arm or neck:

In women not taking HRT: 8 in 1,000 would be expected to get
a blood clot.

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 taking HRT: 17 in 1,000 would be expected to get a
blood clot.

Before or after vaginal surgery

 See a doctor as soon as possible

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



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.

 See a doctor straight away



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

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

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.
 Follow these instructions:

If you have a vaginal infection, your doctor may also prescribe a
medicine to treat the infection.

2.4 Ovestin and the heart or circulation

Studies with one type of HRT (containing a progestogen, and a
different oestrogen to the one in Ovestin) have shown that women
may be slightly more likely to get heart disease during the first year
of taking that type of HRT.

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

In women taking HRT: 7 in 1,000 would be expected to get a
blood clot.
Looking at women in their 60s, on average, over 5 years:

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

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.

Ovestin is easy to remove with water.
3.3 If you use more Ovestin than you should or if you swallow it
accidentally
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.
3.4 If you forget to use Ovestin


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

6. Further Information

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

What Estriol cream contains


Each gram of cream contains 1mg of estriol.

 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:



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.



your blood pressure rises

S1521 LEAFLET Estriol 20150202

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESTRIOL 0.1% VAGINAL CREAM
(estriol)
Your medicine is called Estriol 0.1% Vaginal Cream but will be
referred to as Estriol throughout the following patient information
leaflet.

2. Before you use 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.
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 skin or the whites of your eyes go yellow (jaundice)



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

What Estriol looks like and contents of the pack


Estriol Cream is a white cream.

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



There are 15 gm of cream in each tube.

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

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




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



The pack contains a clear plastic applicator



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 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.

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 Estriol. This usually gets better after a few weeks.



increased vaginal discharge, bleeding or spotting



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.

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

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.

In this leaflet:

2.1 Do not use Estriol if:

1. What Estriol is and what it is used for



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

3. How to use Estriol



you have had angina or a heart attack (myocardial infarction)

4. Possible side effects

PL No: 19488/1521



you have had a blood clot (thrombosis)

5. How to store Estriol



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



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



you have excessive thickening of the womb lining



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

2. Before you use Estriol
Leaflet revision date: 02 February 2015

They may decide to stop your treatment for a while.
Dementia

Regular check-ups

S1521 LEAFLET Estriol 20150202

HRT will not prevent memory loss. In one study of women who
started using combined HRT after the age of 65, a small increase in
the risk of dementia was observed.
Reporting of side effects

6. Further information

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.

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

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



For vaginal problems caused by having too little ‘oestrogen’



Before or after vaginal surgery to help wound healing.

5. How to store Estriol

1. What Estriol is and what it is used for

Estriol is used:

How Estriol works

 you have a rare blood problem called ‘porphyria’.
 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.



Keep out of the sight and reach of children.



Do not store above 30°C.





Oestrogens are female sex hormones.

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.



They are produced in the ovaries.



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

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



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)





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.

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

When women get older the ovaries gradually produce less
oestrogen.

2.2 Take special care with Estriol



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





relatives who have had blood clots

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



asthma



diabetes



migraine or severe headaches



epilepsy (fits)



gallstones



liver or kidney problems



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

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.

 otosclerosis (a hearing disorder).
 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
Breast cancer


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.
Your risk of breast cancer is also higher if:


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

 you are seriously overweight.
How likely is breast cancer?

Stroke

2.5 Taking other medicines

3.2 How to apply the cream

Research suggests that HRT slightly increases the risk of having a
stroke. Other things that can increase the risk of stroke include:

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

Estriol comes in a pack together with a clear plastic applicator.



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

1

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

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.
How likely is a stroke?



medicines for infections - such as griseofulvin and rifamycins.

2

Screw the end of the applicator onto the tube



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

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



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



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



In women not taking HRT: 3 in 1,000 would be expected to
have a stroke.



In women taking HRT: 4 in 1,000 would be expected to have a
stroke.
Looking at women in their 60s, on average, over 5 years


In women not taking HRT: 11 in 1,000 would be expected to
have a stroke.
In women taking HRT: 15 in 1,000 would be expected to have a
stroke.

Looking at women aged 50, on average, by the time they reach 65:


In women not taking HRT: 32 in 1,000 will get breast cancer.





In women who start taking oestrogen-only HRT at age 50 and
take it for 5 years: between 33 and 34 in 1,000 will get breast
cancer. This means an extra 1 to 2 cases.

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

In women taking oestrogen-only HRT for 10 years: 37 in 1,000
will get breast cancer. This means an extra 5 cases.

 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.



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:
 Make an appointment to see your doctor straight away.
Endometrial cancer (cancer of the lining of the womb)
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.
You do not need to take a separate progestogen with Estriol.
If you get breakthrough bleeding or spotting, it is usually nothing to
worry about, but you should:
 Talk to your doctor. It could be a sign that your endometrium
has become thicker.
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. Some studies have shown that taking
oestrogen-only HRT for more than 5 years may increase the risk of
ovarian cancer. It is not yet known whether other kinds of HRT
increase the risk in the same way.

Blood clots
HRT may increase the risk of blood clots in the veins (also called
deep vein thrombosis, or DVT). 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.

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.



you are very overweight

2.8 Driving and using machines



you have had a blood clot before

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



any of your close family have had blood clots



you have ever had a miscarriage

3. How to use Estriol



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

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.



you have a rare problem called SLE.

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

Heart disease



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



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.



How likely is a blood clot?

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.
HRT will not help to prevent heart disease.

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.

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


In women not taking HRT: 3 in 1,000 would be expected to get
a blood clot.



In women taking HRT: 7 in 1,000 would be expected to get a
blood clot.
Looking at women in their 60s, on average, over 5 years:


For other types of HRT (like Estriol), the risk is likely to be similar.
However this is not yet certain. If you get a pain in your chest that
spreads to your arm or neck:

In women not taking HRT: 8 in 1,000 would be expected to get
a blood clot.



In women taking HRT: 17 in 1,000 would be expected to get a
blood clot.

 See a doctor as soon as possible

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

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

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.
 Follow these instructions:

You are more likely to get a blood clot if:

2.4 Estriol and the heart or circulation

Studies with one type of HRT (containing a progestogen, and a
different oestrogen to the one in Estriol) have shown that women
may be slightly more likely to get heart disease during the first year
of taking that type of HRT.

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

 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.

3.1 How much to use
For vaginal problems


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.



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.

Estriol is easy to remove with water.
3.3 If you use more Estriol than you should or if you swallow it
accidentally
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.

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

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.

3.4 If you forget to use Estriol

Before or after vaginal surgery

3.5 If you stop using Estriol



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.



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.

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.

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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