ESTRIOL 0.1% VAGINAL CREAM
Active substance(s): 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
S1521 LEAFLET 20170421
PACKAGE LEAFLET: INFORMATION FOR THE USER
OVESTIN® 1mg VAGINAL CREAM
(estriol)
Your medicine is called Ovestin 1mg Vaginal Cream but will be
referred to as Ovestin throughout the following patient information
leaflet.
2. Before you use Ovestin
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.
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 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.
flu-like symptoms
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
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.
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.
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.
PL: 19488/1521
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.
you have had angina or a heart attack (myocardial infarction)
3. How to use Ovestin
you have had a blood clot (thrombosis)
4. Possible side effects
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
you have a rare blood problem called ‘porphyria’.
5. How to store Ovestin
Leaflet revision date: 21 April 2017
6. Further information
Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD or
Braille.
1. What Ovestin is and what it is used for
Ovestin is a registered trade mark of NV Organon, The Netherlands.
How Ovestin works
The name of your medicine is Ovestin 1 mg cream. Ovestin contains
a medicine called estriol. It belongs to a group of medicines called
Hormone Replacement Therapy (HRT).
What is Ovestin used for
Ovestin is used:
For vaginal problems caused by having too little ‘oestrogen’
Before or after vaginal surgery to help wound healing.
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
Estriol (the medicine in Ovestin) is one of the natural oestrogens.
5. How to store Ovestin
Keep out of the sight and reach of children.
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. Before you use Ovestin
Aspen Bad Oldesloe GmbH, lndustriestrasse 32-36, D-23843
Bad Oldesloe, Germany.
By reporting side effects, you can help provide more information on
the safety of this medicine.
go for regular breast screening and cervical smear tests
you are allergic (hypersensitive) to any of the ingredients of
Ovestin (listed in Section 6)
1. What Ovestin is and what it is used for
They may decide to stop your treatment for a while.
Dementia
Organon (Ireland) Ltd, Swords, Ireland.
In this leaflet:
POM
Make sure that you:
2.1 Do not use Ovestin if:
This product is manufactured by:
Regular check-ups
S1521 LEAFLET 20170421
Oestrogens are female sex hormones.
They are produced in the ovaries.
They cause sexual development in women and control the
menstrual cycle during the child-bearing years.
When women get older the ovaries gradually produce less
oestrogen.
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
This happens at the menopause (usually around the age of 50).
If the ovaries are removed before the menopause, oestrogen
production stops very suddenly.
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 Ovestin
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 Ovestin.
Tell your doctor if you have Hepatitis C and you are taking the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir. Taking the combination of these drugs with some
oestrogen-containing products may cause increases in liver function
blood test results (increase in ALT liver enzyme); the risk of this
happening with Ovestin is currently unknown.
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.
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.
Ovestin comes in a pack together with a clear plastic applicator.
getting older
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.
high blood pressure
smoking
drinking too much alcohol
an uneven heartbeat
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.
How likely is a stroke?
Your risk of breast cancer is also higher if:
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.
Looking at women in their 50s, on average, over 5 years
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.
you have a close relative (mother, sister or grandmother) who
has had breast cancer
you are seriously overweight.
Looking at women in their 60s, on average, over 5 years
How likely is breast cancer?
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:
Tell your doctor or pharmacist if you are taking any of the
following:
medicines for epilepsy - such as barbiturates, hydantoins and
carbamezapine.
medicines for infections - such as griseofulvin and rifamycins.
medicines for viral infections - such as nevirapine, efavirenz,
ritonavir or nelfinavir.
herbal preparations containing St John’s wort (Hypericum
perforatum) - a herbal medicine used for depression.
one of the following medicines: corticosteroids,
succinylcholine,theophyllines or troleandomycin.
Tell your doctor if you have Hepatitis C and you are taking the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir. Taking the combination of these drugs with some
oestrogen-containing products may cause increases in liver function
blood test results (increase in ALT liver enzyme); the risk of this
happening with Ovestin is currently unknown.
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 have a vaginal infection, your doctor may also prescribe a
medicine to treat the infection.
Blood clots
2.6 Operations
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.
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.
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:
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.
Do not use Ovestin if you are pregnant or might become
pregnant. This is because it may affect the baby.
you are very overweight
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 have had a blood clot before
any of your close family have had blood clots
you have ever had a miscarriage
Ovarian cancer
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
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.
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.
2.4 Ovestin and the heart or circulation
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.
Cleaning the applicator
3. How to use Ovestin
After use, pull the plunger out of the barrel.
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.
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.
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.
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.
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.
HRT will not help to prevent heart disease.
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.
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 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.
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 taking HRT: 17 in 1,000 would be expected to get a
blood clot.
Then the dose is 1 applicator up to the ring twice a week.
See a doctor as soon as possible
If you get painful swelling in your leg, sudden chest pain or have
problems breathing:
3.1 How much to use
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.
For vaginal problems
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.
Do not use any more HRT until a doctor says you can.
These may be signs of a blood clot.
2. Screw the end of the applicator onto the tube.
Ovestin has no or little effect on the ability to drive or use machines.
How likely is a blood clot?
See a doctor straight away
1. Remove the cap from the tube and turn the cap upside down.
Then use the sharp point to open the tube.
2.8 Driving and using machines
Heart disease
Do not use any more HRT until a doctor says you can. This pain
could be a sign of heart disease.
Follow these instructions:
2.7 Pregnancy and breast-feeding
Talk to your doctor. It could be a sign that your endometrium
has become thicker.
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.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Ovestin.
You are more likely to get a blood clot if:
Use the applicator to apply the cream in the vagina. A good time to
do this is before going to bed.
Before or after vaginal surgery
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.
3.4 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 20170421
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.
flu-like symptoms
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
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.
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.
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.
2.1 Do not use Estriol if:
Aspen Bad Oldesloe GmbH, lndustriestrasse 32-36, D-23843
Bad Oldesloe, Germany.
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
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
you have a rare blood problem called ‘porphyria’.
POM
PL: 19488/1521
2. Before you use Estriol
Leaflet revision date: 21 April 2017
6. Further information
Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD or
Braille.
1. What Estriol is and what it is used for
The name of your medicine is Estriol 1 mg cream. Estriol contains a
medicine called estriol. It belongs to a group of medicines called
Hormone Replacement Therapy (HRT).
What is Estriol used for
Estriol is used:
For vaginal problems caused by having too little ‘oestrogen’
Before or after vaginal surgery to help wound healing.
Estriol (the medicine in Estriol) is one of the natural oestrogens.
2.2 Take special care with Estriol
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.
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.
They cause sexual development in women and control the
menstrual cycle during the child-bearing years.
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.
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.
How Estriol works
Keep out of the sight and reach of children.
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.
1. What Estriol is and what it is used for
If the medicine shows any other signs of deterioration, you
should seek the advice of your pharmacist who will tell you what
to do.
go for regular breast screening and cervical smear tests
In this leaflet:
S1521 LEAFLET Estriol 20170421
Organon (Ireland) Ltd, Swords, Ireland.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Estriol
Make sure that you:
This product is manufactured by:
They may decide to stop your treatment for a while.
Dementia
Regular check-ups
When women get older the ovaries gradually produce less
oestrogen.
This happens at the menopause (usually around the age of 50).
If the ovaries are removed before the menopause, oestrogen
production stops very suddenly.
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.
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).
If you have any of these, talk to your doctor or pharmacist
before using Estriol.
Tell your doctor if you have Hepatitis C and you are taking the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir. Taking the combination of these drugs with some
oestrogen-containing products may cause increases in liver function
blood test results (increase in ALT liver enzyme); the risk of this
happening with Estriol is currently unknown.
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.
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.
Estriol comes in a pack together with a clear plastic applicator.
getting older
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.
high blood pressure
smoking
drinking too much alcohol
an uneven heartbeat
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.
How likely is a stroke?
Your risk of breast cancer is also higher if:
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.
Looking at women in their 50s, on average, over 5 years
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.
you have a close relative (mother, sister or grandmother) who
has had breast cancer
you are seriously overweight.
Looking at women in their 60s, on average, over 5 years
How likely is breast cancer?
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:
Tell your doctor or pharmacist if you are taking any of the
following:
medicines for epilepsy - such as barbiturates, hydantoins and
carbamezapine.
medicines for infections - such as griseofulvin and rifamycins.
medicines for viral infections - such as nevirapine, efavirenz,
ritonavir or nelfinavir.
herbal preparations containing St John’s wort (Hypericum
perforatum) - a herbal medicine used for depression.
one of the following medicines: corticosteroids,
succinylcholine,theophyllines or troleandomycin.
Tell your doctor if you have Hepatitis C and you are taking the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir. Taking the combination of these drugs with some
oestrogen-containing products may cause increases in liver function
blood test results (increase in ALT liver enzyme); the risk of this
happening with Estriol is currently unknown.
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 have a vaginal infection, your doctor may also prescribe a
medicine to treat the infection.
Blood clots
2.6 Operations
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.
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.
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:
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 have had a blood clot before
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
Talk to your doctor. It could be a sign that your endometrium
has become thicker.
any of your close family have had blood clots
you have ever had a miscarriage
Ovarian cancer
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
you have a rare problem called SLE.
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.
If any of these things apply to you, talk to your doctor to see if
you should take HRT.
2.4 Estriol and the heart or circulation
Heart disease
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.
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.
HRT will not help to prevent heart disease.
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.
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:
In women not taking HRT: 8 in 1,000 would be expected to get
a blood clot.
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:
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.
In women taking HRT: 17 in 1,000 would be expected to get a
blood clot.
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.
Follow these instructions:
1. Remove the cap from the tube and turn the cap upside down.
Then use the sharp point to open the tube.
2. Screw the end of the applicator onto the tube.
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.
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.
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.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Estriol.
You are more likely to get a blood clot if:
Use the applicator to apply the cream in the vagina. A good time to
do this is before going to bed.
2.8 Driving and using machines
Estriol has no or little effect on the ability to drive or use machines.
3. How to use Estriol
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 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.
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.
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.
3.1 How much to use
3.4 If you forget to use Estriol
For vaginal problems
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.
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.
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.
Before or after vaginal surgery
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.
3.5 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.
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
S1521 LEAFLET 20170421
PACKAGE LEAFLET: INFORMATION FOR THE USER
OVESTIN® 1mg VAGINAL CREAM
(estriol)
Your medicine is called Ovestin 1mg Vaginal Cream but will be
referred to as Ovestin throughout the following patient information
leaflet.
2. Before you use Ovestin
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.
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 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.
flu-like symptoms
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
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.
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.
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.
PL: 19488/1521
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.
you have had angina or a heart attack (myocardial infarction)
3. How to use Ovestin
you have had a blood clot (thrombosis)
4. Possible side effects
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
you have a rare blood problem called ‘porphyria’.
5. How to store Ovestin
Leaflet revision date: 21 April 2017
6. Further information
Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD or
Braille.
1. What Ovestin is and what it is used for
Ovestin is a registered trade mark of NV Organon, The Netherlands.
How Ovestin works
The name of your medicine is Ovestin 1 mg cream. Ovestin contains
a medicine called estriol. It belongs to a group of medicines called
Hormone Replacement Therapy (HRT).
What is Ovestin used for
Ovestin is used:
For vaginal problems caused by having too little ‘oestrogen’
Before or after vaginal surgery to help wound healing.
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
Estriol (the medicine in Ovestin) is one of the natural oestrogens.
5. How to store Ovestin
Keep out of the sight and reach of children.
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. Before you use Ovestin
Aspen Bad Oldesloe GmbH, lndustriestrasse 32-36, D-23843
Bad Oldesloe, Germany.
By reporting side effects, you can help provide more information on
the safety of this medicine.
go for regular breast screening and cervical smear tests
you are allergic (hypersensitive) to any of the ingredients of
Ovestin (listed in Section 6)
1. What Ovestin is and what it is used for
They may decide to stop your treatment for a while.
Dementia
Organon (Ireland) Ltd, Swords, Ireland.
In this leaflet:
POM
Make sure that you:
2.1 Do not use Ovestin if:
This product is manufactured by:
Regular check-ups
S1521 LEAFLET 20170421
Oestrogens are female sex hormones.
They are produced in the ovaries.
They cause sexual development in women and control the
menstrual cycle during the child-bearing years.
When women get older the ovaries gradually produce less
oestrogen.
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
This happens at the menopause (usually around the age of 50).
If the ovaries are removed before the menopause, oestrogen
production stops very suddenly.
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 Ovestin
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 Ovestin.
Tell your doctor if you have Hepatitis C and you are taking the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir. Taking the combination of these drugs with some
oestrogen-containing products may cause increases in liver function
blood test results (increase in ALT liver enzyme); the risk of this
happening with Ovestin is currently unknown.
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.
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.
Ovestin comes in a pack together with a clear plastic applicator.
getting older
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.
high blood pressure
smoking
drinking too much alcohol
an uneven heartbeat
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.
How likely is a stroke?
Your risk of breast cancer is also higher if:
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.
Looking at women in their 50s, on average, over 5 years
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.
you have a close relative (mother, sister or grandmother) who
has had breast cancer
you are seriously overweight.
Looking at women in their 60s, on average, over 5 years
How likely is breast cancer?
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:
Tell your doctor or pharmacist if you are taking any of the
following:
medicines for epilepsy - such as barbiturates, hydantoins and
carbamezapine.
medicines for infections - such as griseofulvin and rifamycins.
medicines for viral infections - such as nevirapine, efavirenz,
ritonavir or nelfinavir.
herbal preparations containing St John’s wort (Hypericum
perforatum) - a herbal medicine used for depression.
one of the following medicines: corticosteroids,
succinylcholine,theophyllines or troleandomycin.
Tell your doctor if you have Hepatitis C and you are taking the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir. Taking the combination of these drugs with some
oestrogen-containing products may cause increases in liver function
blood test results (increase in ALT liver enzyme); the risk of this
happening with Ovestin is currently unknown.
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 have a vaginal infection, your doctor may also prescribe a
medicine to treat the infection.
Blood clots
2.6 Operations
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.
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.
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:
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.
Do not use Ovestin if you are pregnant or might become
pregnant. This is because it may affect the baby.
you are very overweight
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 have had a blood clot before
any of your close family have had blood clots
you have ever had a miscarriage
Ovarian cancer
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
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.
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.
2.4 Ovestin and the heart or circulation
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.
Cleaning the applicator
3. How to use Ovestin
After use, pull the plunger out of the barrel.
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.
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.
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.
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.
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.
HRT will not help to prevent heart disease.
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.
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 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.
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 taking HRT: 17 in 1,000 would be expected to get a
blood clot.
Then the dose is 1 applicator up to the ring twice a week.
See a doctor as soon as possible
If you get painful swelling in your leg, sudden chest pain or have
problems breathing:
3.1 How much to use
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.
For vaginal problems
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.
Do not use any more HRT until a doctor says you can.
These may be signs of a blood clot.
2. Screw the end of the applicator onto the tube.
Ovestin has no or little effect on the ability to drive or use machines.
How likely is a blood clot?
See a doctor straight away
1. Remove the cap from the tube and turn the cap upside down.
Then use the sharp point to open the tube.
2.8 Driving and using machines
Heart disease
Do not use any more HRT until a doctor says you can. This pain
could be a sign of heart disease.
Follow these instructions:
2.7 Pregnancy and breast-feeding
Talk to your doctor. It could be a sign that your endometrium
has become thicker.
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.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Ovestin.
You are more likely to get a blood clot if:
Use the applicator to apply the cream in the vagina. A good time to
do this is before going to bed.
Before or after vaginal surgery
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.
3.4 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 20170421
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.
flu-like symptoms
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
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.
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.
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.
2.1 Do not use Estriol if:
Aspen Bad Oldesloe GmbH, lndustriestrasse 32-36, D-23843
Bad Oldesloe, Germany.
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
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
you have a rare blood problem called ‘porphyria’.
POM
PL: 19488/1521
2. Before you use Estriol
Leaflet revision date: 21 April 2017
6. Further information
Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD or
Braille.
1. What Estriol is and what it is used for
The name of your medicine is Estriol 1 mg cream. Estriol contains a
medicine called estriol. It belongs to a group of medicines called
Hormone Replacement Therapy (HRT).
What is Estriol used for
Estriol is used:
For vaginal problems caused by having too little ‘oestrogen’
Before or after vaginal surgery to help wound healing.
Estriol (the medicine in Estriol) is one of the natural oestrogens.
2.2 Take special care with Estriol
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.
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.
They cause sexual development in women and control the
menstrual cycle during the child-bearing years.
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.
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.
How Estriol works
Keep out of the sight and reach of children.
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.
1. What Estriol is and what it is used for
If the medicine shows any other signs of deterioration, you
should seek the advice of your pharmacist who will tell you what
to do.
go for regular breast screening and cervical smear tests
In this leaflet:
S1521 LEAFLET Estriol 20170421
Organon (Ireland) Ltd, Swords, Ireland.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Estriol
Make sure that you:
This product is manufactured by:
They may decide to stop your treatment for a while.
Dementia
Regular check-ups
When women get older the ovaries gradually produce less
oestrogen.
This happens at the menopause (usually around the age of 50).
If the ovaries are removed before the menopause, oestrogen
production stops very suddenly.
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.
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).
If you have any of these, talk to your doctor or pharmacist
before using Estriol.
Tell your doctor if you have Hepatitis C and you are taking the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir. Taking the combination of these drugs with some
oestrogen-containing products may cause increases in liver function
blood test results (increase in ALT liver enzyme); the risk of this
happening with Estriol is currently unknown.
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.
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.
Estriol comes in a pack together with a clear plastic applicator.
getting older
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.
high blood pressure
smoking
drinking too much alcohol
an uneven heartbeat
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.
How likely is a stroke?
Your risk of breast cancer is also higher if:
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.
Looking at women in their 50s, on average, over 5 years
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.
you have a close relative (mother, sister or grandmother) who
has had breast cancer
you are seriously overweight.
Looking at women in their 60s, on average, over 5 years
How likely is breast cancer?
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:
Tell your doctor or pharmacist if you are taking any of the
following:
medicines for epilepsy - such as barbiturates, hydantoins and
carbamezapine.
medicines for infections - such as griseofulvin and rifamycins.
medicines for viral infections - such as nevirapine, efavirenz,
ritonavir or nelfinavir.
herbal preparations containing St John’s wort (Hypericum
perforatum) - a herbal medicine used for depression.
one of the following medicines: corticosteroids,
succinylcholine,theophyllines or troleandomycin.
Tell your doctor if you have Hepatitis C and you are taking the
combination drug regimen ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir. Taking the combination of these drugs with some
oestrogen-containing products may cause increases in liver function
blood test results (increase in ALT liver enzyme); the risk of this
happening with Estriol is currently unknown.
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 have a vaginal infection, your doctor may also prescribe a
medicine to treat the infection.
Blood clots
2.6 Operations
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.
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.
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:
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 have had a blood clot before
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
Talk to your doctor. It could be a sign that your endometrium
has become thicker.
any of your close family have had blood clots
you have ever had a miscarriage
Ovarian cancer
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
you have a rare problem called SLE.
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.
If any of these things apply to you, talk to your doctor to see if
you should take HRT.
2.4 Estriol and the heart or circulation
Heart disease
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.
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.
HRT will not help to prevent heart disease.
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.
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:
In women not taking HRT: 8 in 1,000 would be expected to get
a blood clot.
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:
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.
In women taking HRT: 17 in 1,000 would be expected to get a
blood clot.
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.
Follow these instructions:
1. Remove the cap from the tube and turn the cap upside down.
Then use the sharp point to open the tube.
2. Screw the end of the applicator onto the tube.
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.
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.
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.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Estriol.
You are more likely to get a blood clot if:
Use the applicator to apply the cream in the vagina. A good time to
do this is before going to bed.
2.8 Driving and using machines
Estriol has no or little effect on the ability to drive or use machines.
3. How to use Estriol
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 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.
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.
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.
3.1 How much to use
3.4 If you forget to use Estriol
For vaginal problems
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.
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.
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.
Before or after vaginal surgery
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.
3.5 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.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
