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OVESTIN 1 MG CREAM

Active substance(s): ESTRIOL

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Page:
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New Item Code:
16-0319
Replacement:
N/A

Read all of this leaflet carefully before you
start using this medicine.
• 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.
• 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.
In this leaflet:
1. What Ovestin is and what it is used for
2. Before you use Ovestin
3. How to use Ovestin
4. Possible side effects
5. How to store Ovestin
6. Further information

1. What Ovestin is and
what it is used for
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.
How Ovestin works
Estriol (the medicine in Ovestin) is one of the
natural oestrogens.
• Oestrogens are female sex hormones.
• They are produced in the ovaries.
• They cause sexual development in women and
control the menstrual cycle during the childbearing years.
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 Ovestin which
contain oestrogen. It may take several
days or weeks before you notice an improvement.

2.2 Take special care with Ovestin

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.

Check with your doctor or pharmacist before
using your medicine if you have had:
• a problem caused by growth of the womb lining
outside the womb (fibroids or endometriosis)
• any problem with your heart or circulation
(including high blood pressure or risk factors for
a blood clot – see Section 2.4)
• relatives who have had blood clots
• asthma
• diabetes
• migraine or severe headaches
• epilepsy (fits)
• gallstones
• liver or kidney problems
• a rare problem called ‘systemic lupus
erythematosus’ (SLE)
• otosclerosis (a hearing disorder).

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

➔If you have any of these, talk to your doctor or
pharmacist before using Ovestin.

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

Ovestin contains cetyl alcohol and stearyl alcohol.
This may cause local skin reactions (e.g.contact
dermatitis).

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.

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.

2.1 Do not use Ovestin if:
• you are allergic (hypersensitive) to any of the
ingredients of Ovestin (listed in Section 6)
• you have had angina or a heart attack

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 oestrogenonly 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 oestrogenonly 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?
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.
• In women taking oestrogen-only HRT for
10 years: 37 in 1,000 will get breast cancer.
This means an extra 5 cases.
If you notice any changes in your breast, such
as: dimpling of your skin, changes in your nipple
or any lumps you can see or feel:
➔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.

2.4 Ovestin and the heart or
circulation
Heart disease
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.
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. 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:
➔See a doctor as soon as possible
Do not use any more HRT until a doctor says you
can. This pain could be a sign of heart disease.
Stroke
Research suggests that HRT slightly increases
the risk of having a stroke. Other things that can
increase the risk of stroke include:
• getting older
• high blood pressure
• smoking
• drinking too much alcohol
• an uneven heartbeat
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?
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.
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.
If you get an unexpected migraine-type
headache, with or without disturbed vision:
➔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.

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:
• you are very overweight
• you have had a blood clot before
• 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
• 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.
How likely is a blood clot?
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:
• 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.
If you get painful swelling in your leg,
sudden chest
pain or have problems breathing:
➔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.

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

Market:
United Kingdom
Product Name:
Ovestin Cream 1mg/g
Number of Colours:
2
Black PMS 2607

Manufacturing Site:
ABO

160 mm Measuring Bar

ESTRIOL 1mg in 1g of cream

(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
• 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’.
➔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.

Drawing Ref. Number:
BE80_425x243
Drawing Version:
03
Originated by:
Aidan Collins
Originated at:
APTL
Originated on:
13 Jun 2016
Amended on:
N/A

ASPEN Artwork Panel • May 2013 • Version 5

PACKAGE LEAFLET: INFORMATION FOR THE USER

ASPEN Artwork Panel
AW Version:
1

If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using Ovestin.
If you have a vaginal infection, your doctor may
also prescribe a medicine to treat the infection.

2.6 Operations
➔Tell your doctor you are using Ovestin if you
are going to have surgery. You may need to
stop using HRT about 4 to 6 weeks before the
operation to reduce the risk of a blood clot. Your
doctor will tell you when you can start taking
HRT again.

2.7 Pregnancy and breast-feeding
• 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.

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

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).

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.
• 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.

3.2 How to apply the cream
Ovestin comes in a pack together with a clear
plastic applicator.
Use the applicator to apply the cream in the
vagina. A good time to do this is before
going to bed.
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:
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.

3.5 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
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
• 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.

Like all medicines, Ovestin can cause side effects,
although not everybody gets them.
➔See your doctor straight away, if you notice
any of the following serious side effects – your
doctor may decide to stop you using the cream:
• your blood pressure rises
• your skin or the whites of your eyes go yellow
(jaundice)
• you suddenly have migraine-type headaches
(see Section 2.4 above)
• you have signs of a blood clot (see Section
2.4 above)
• you have any of the problems listed in Section
2.1 above.
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. They may decide to stop your treatment
for a while.
Dementia
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.

5. How to store Ovestin
Keep out of the reach and sight of children.
Do not use this medicine after the “use by” date
on the pack.

Do not store above 25°C. Do not freeze.
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 protect
the environment.

6. Further information
What Ovestin contains
• The active substance is estriol. Each gram of
cream contains 1 milligram of estriol.
• The other ingredients are chlorhexidine
dihydrochloride, octyldodecanol, cetyl
palmitate, glycerin, cetyl alcohol, stearyl
alcohol, polysorbate 60, sorbitan stearate, lactic
acid, sodium hydroxide and purified water.
What Ovestin cream looks like and the
contents of the pack
• Ovestin is a white cream.
• There are 15 gm of cream in each tube.
• The pack contains a clear plastic applicator

Replacement:
N/A
Market:
United Kingdom
Product Name:
Ovestin Cream 1mg/g
Number of Colours:
2
Black PMS 2607

Manufacturing Site:
ABO
Drawing Ref. Number:
BE80_425x243
Drawing Version:
03

The Marketing authorisation holder is:
Aspen Pharma Trading Limited,
3016 Lake Drive, Citywest Business Campus,
Dublin 24, Ireland
The manufacturer is:
Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36,
D-23843 Bad Oldesloe, Germany

Originated by:
Aidan Collins

This leaflet was last updated in June 2016

Amended on:
N/A

To listen to or request a copy of this leaflet in
Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name: Ovestin 1 mg cream
Reference Number: PL 39699/0058
This is a service provided by the Royal National
Institute for Blind People

160 mm Measuring Bar

➔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.

New Item Code:
16-0319

Originated at:
APTL
Originated on:
13 Jun 2016

ASPEN Artwork Panel • May 2013 • Version 5

00000000000000

Page:
2 of 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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