Skip to Content

OVESTIN 1MG CREAM

Active substance(s): ESTRIOL

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Ovestin® 1mg Cream
(estriol)

The full name of your medicine is Ovestin 1mg vaginal cream. It is called
Ovestin throughout the remainder of this 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

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.

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.

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.

Endometrial cancer (cancer of the lining of the womb)

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.

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

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).

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.

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.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

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

Hide