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OVESTIN 1MG VAGINAL CREAM

Active substance(s): ESTRIOL

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Ovestin® 1mg Vaginal Cream
(estriol)
PACKAGE LEAFLET: INFORMATION FOR THE USER
The name of your medicine is Ovestin 1mg vaginal cream but will be referred
to as Ovestin throughout the leaflet.
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 1mg 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 child-bearing 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) 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.
Tell your doctor if you have any medical problems or illnesses.
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.
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 (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.

2.2

Take special care with Ovestin

Check with your doctor or pharmacist before using your medicine if you have
had:
• a problem caused by growth of the womb lining outside the womb
(fibroids or endometriosis)
• any problem with your heart or circulation (including high blood pressure
or risk factors for a blood clot – see Section 2.4)
• relatives who have had blood clots
• asthma
• diabetes
• migraine or severe headaches
• epilepsy (fits)
• gallstones
• liver or kidney problems
• a rare problem called ‘systemic lupus erythematosus’ (SLE)
• otosclerosis (a hearing disorder).
If you have any of these, talk to your doctor or pharmacist before using
Ovestin.
Ovestin contains cetyl alcohol and stearyl alcohol. This may cause local skin
reactions (e.g.contact dermatitis).

2.3

Ovestin and the risk of developing cancer

Breast cancer
• Women who have ever had breast cancer should not take HRT.
Taking HRT slightly increases the risk of breast cancer. The risk is also
slightly increased if you have a later menopause. The risk after the
menopause for a woman taking oestrogen-only HRT for 5 years is about the
same as for a woman of the same age who is still having periods over that
time and not taking HRT. The risk for a woman who is taking oestrogen plus
progestogen HRT is higher than for oestrogen-only HRT. However,
oestrogen plus progestogen HRT is beneficial for the endometrium.

For all kinds of HRT, the extra risk of breast cancer goes up the longer you
take it. However, it returns to normal about 5 years after stopping HRT.
Your risk of breast cancer is also higher if:
• you have a close relative (mother, sister or grandmother) who has had
breast cancer
• you are seriously overweight.
How likely is breast cancer?
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.
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.

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.

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.






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 peparations containing St John’s wort (Hypericum perforatum) - a
herbal medicine used for depression.
one of the following medicines: corticosteroids, succinylcholine,
theophyllines or troleandomycin.

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.

3.1

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 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.

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



3.5

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.

If you stop using Ovestin

Keep using this medicine as prescribed by your doctor.
Keep using Ovestin, even if you seem to be better. If you stop too early or
too suddenly your problem may return.

4) Possible side effects
Like all medicines, Ovestin can cause side effects, although not everybody
gets them.
See your doctor straight away, if you notice any of the following
serious side effects – your doctor may decide to stop you using the
cream:
• your blood pressure rises
• 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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5) How to store Ovestin







Keep out of the reach and sight of children.
Do not use this medicine after the expiry 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.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

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 hydrochloride, octyldodecanol,
cetyl esters wax, glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60,
sorbitan monostearate, lactic acid, sodium hydroxide to pH4 and purified
water.
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).

What Ovestin looks like and the contents of the pack
• Ovestin is a homogenous, smooth, white to nearly white cream.
• There are 15 g of cream in each aluminium tube.
• The pack contains a clear plastic applicator (Applicator CE 0344)
PL 10383/2126

Ovestin 1mg Vaginal Cream

POM

Product Licence Holder and Manufacturer
Your medicine is manufactured by Organon Ireland, Ltd., Drynam Road Swords, 2857 - County Dublin, Ireland. Procured from within the EU and
repackaged by the Product Licence holder: Primecrown Ltd., 4/5 Northolt
Trading Estate, Belvue road, Northolt, Middlesex UB5 5QS
Leaflet Date: 22.04.2015
Ovestin is a registered trademark of N.V. Organon, the Netherlands.

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

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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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