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VAGIFEM

Active substance: ESTRADIOL

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Insert size: 210x297-012
Current: 4.0
Colour: PMS 280C

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Vagifem®
25 micrograms
film-coated
vaginal tablets
Estradiol hemihydrate
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 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 get
serious, or if you notice any side
effects not listed in this leaflet
please tell your doctor or
pharmacist.
In this leaflet:
1. What Vagifem® is and what it is
used for
2. Before you use Vagifem®
3. How to use Vagifem®
4. Possible side effects
5. How to store Vagifem®
6. Further information
1. WHAT VAGIFEM® IS AND
WHAT IT IS USED FOR
Vagifem® contains estradiol
• Estradiol is a female sex hormone
• It belongs to a group of
hormones called oestrogens
• It is exactly the same as the
estradiol produced by the ovaries
of women.
Vagifem® belongs to a group of
medicines called Hormone
Replacement Therapy (HRT).
It is intended for postmenopausal women and is used
to relieve menopausal symptoms in
the vagina such as dryness or
irritation. In medical terms this is
known as ‘vaginal atrophy’. It is
caused by a drop in the levels of
oestrogen in your body. This
happens naturally around the
menopause.
Vagifem® works by replacing the
oestrogen which is normally
produced in the ovaries of women.
It is inserted into your vagina, so the
hormone is released where it is
needed.
The experience of treating women
older than 65 years is limited.
2. BEFORE YOU USE VAGIFEM®
Medical check-ups
Before you start using Vagifem®,
your doctor will tell you about the
risks and benefits of the treatment
(see also Section 4). Before you start
using Vagifem® and regularly during
treatment, your doctor will check
whether Vagifem® is the right
treatment for you. Once you’ve
started on HRT, your doctor will tell
you how often to go for regular
check-ups. At these check-ups, your
doctor may discuss with you the
benefits and risks of continuing to
take HRT.
If you have a close relative (e.g.
mother, sister, maternal or paternal
grandmother), who has suffered
from any serious illness such as
blood clots or breast cancer, you
might be at a higher risk for serious

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illness. Always tell your doctor
about any close relative(s) suffering
from serious illness.
As well as regular check-ups with
your doctor, you should:
• Regularly examine your breasts
for any changes, such as dimpling
or sinking of the skin, changes in
the nipple, or any lumps you can
see or feel. Tell your doctor if you
notice any changes.
• Go for regular breast screening
(mammography) and cervical
smear tests.
Do not use Vagifem® if:
• You are allergic (hypersensitive) to
estradiol or any of the other
ingredients of Vagifem® (listed in
Section 6 below)
• You have or have ever had, or
think you might have breast
cancer
• You have or have had a hormone
dependent tumour (e.g. cancer of
the lining of the womb)
• You have unusual vaginal
bleeding which you have not told
your doctor about
• You have thickening of the lining
of the womb (endometrial
hyperplasia) and you are not
being treated for it
• You have or previously have had a
blood clot inside the blood vessels
of the legs or lungs (deep vein
thrombosis or pulmonary
embolism)
• You have porphyria. This is a rare
disease which affects the
production of some of your blood
pigments.
• You have active or recent arterial
thromboembolic disease (e.g.
angina, myocardial infarction)
• You have acute liver disease or
history of liver disease as long as
liver function tests have failed to
return to normal
Do not use Vagifem® if any of the
above applies to you. If you are not
sure, talk to your doctor or
pharmacist before using this
medicine.
Take special care with Vagifem®
Check with your doctor before
using Vagifem® if you have or have
ever had any of the illnesses in the
list below. He or she may want to
follow you more closely.
• Asthma
• Epilepsy
• Diabetes
• Gallstones
• High blood pressure
• Migraines or severe headaches
• Liver problems such as ‘liver
adenoma’ (a benign tumour)
• Endometrial hyperplasia
(thickening of the lining of your
womb)
• Otosclerosis. This is when you lose
your hearing over a period of time
• Systemic lupus erythematosus (a
disease affecting the skin, joints
and kidneys)
• Blood clots or risk factors for
blood clots (see Section 4 ‘Other
side effects of systemic HRT’)
• Leiomyoma (benign tumours of
the womb) or endometriosis
(growth of the womb lining
outside the womb)
If any of the above applies to you,
or if you are not sure, talk to your
doctor or pharmacist before using
Vagifem®.
Using other medicines
Please tell your doctor or pharmacist
if you are using or have recently
used any other medicines, including
medicines obtained without a
prescription.

Pregnancy and breast-feeding
• Do not use Vagifem® if you think
you might be pregnant, or if you
are breast-feeding
• If you get pregnant while you are
using Vagifem®, stop using it and
see a doctor straight away.
Driving and using machines
No known effect.
3. HOW TO USE VAGIFEM®
Always use Vagifem® exactly as your
doctor has told you. You should
check with your doctor or
pharmacist if you are not sure.
Using this medicine
• You can start using Vagifem® on
any day which is best for you
• Insert the vaginal tablet into your
vagina with the applicator.
The ’USER INSTRUCTIONS’ at the
end of the leaflet tell you how to do
this. Read the instructions carefully
before using Vagifem®.
How much to use
• Use one vaginal tablet each day
for the first 2 weeks
• Then use one vaginal tablet twice
a week. Leave 3 or 4 days
between each dose.
If you use more Vagifem® than
you should
• If you have used more Vagifem®
than you should, talk to a doctor
or pharmacist.
• An overdose of oestrogen could
make you feel sick or vomit.
If you forget to use Vagifem®
• If you forget a dose, use the
medicine as soon as you remember.
• Do not use a double dose to
make up for a forgotten dose.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.
General information about
treating symptoms of the
menopause
• When using medicines for any
menopausal symptoms, use the
lowest dose that works. Also, use
the medicine for as short a time
as you need to.
Only continue treatment if the
benefit is more than the risk.
Talk to your doctor about this.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Vagifem® can
cause side effects, although not
everybody gets them.
Stop using Vagifem® and see a
doctor straight away if you notice
any of the following side effects:
• A migraine-type headache you
have not had before
• Yellow colouring of your skin or
eyes (jaundice) or other liver
problems
• A big increase in blood pressure
• Blood clots called ‘deep vein
thrombosis’ (see also ‘Other side
effects of systemic HRT’)
• If you develop any of the illnesses
listed in Section 2, ’Do not use
Vagifem®’
• You become pregnant
Tell your doctor or pharmacist if
any of the following side effects
get serious or last longer than a
few days:
Common (may affect more than
1 in 100 women)
• Headache
• Passing wind (flatulence)
• Feeling sick (nausea) or being sick
(vomiting)
• Indigestion
• Stomach pain, discomfort or
distension

• Swelling of arms or legs (oedema)
• Vaginal bleeding, discharge or
discomfort
• An infection of the genitals
caused by a fungus or inflamed
vagina
• Breast oedema or breast
enlargement, breast pain or
breast tenderness.
Very rare (may affect less than
1 in 10000 women)
• Breast cancer
• Cancer of the lining of the womb
(endometrial cancer)
• Thickening of the lining of your
womb (endometrial hyperplasia)
• Blood clots called ‘deep vein
thrombosis’
Other side effects of systemic
HRT are:
• Allergic reaction (hypersensitivity)
• Diarrhoea
• Weight increase
• Fluid retention
• Being unable to sleep (insomnia)
• Feeling depressed
• Worsening of existing migraine
• Rash, including itchy, lumpy rash
called ‘hives or urticaria’
• Itching of the genitals
• Vaginal pain, irritation of the
vagina, painful spasm of the vagina
(vaginismus) or vaginal ulcers
• Increase in blood oestrogen
(shown in blood test)
• Drug ineffective.
Important information on the
side effects of HRT
Vagifem® is used for local treatment
in the vagina and contains only a
small amount of estradiol. This
means that the chances of getting
the diseases described below are
less likely than with HRT products
used for systemic treatment
(treatment that affects the body as a
whole).
As well as benefits, HRT has some
risks which you need to consider
when you’re deciding whether to
take it, or whether to carry on
taking it.
Effects on your heart or circulation
Heart disease
HRT is not recommended for
women who have heart disease,
or 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 conjugated oestrogen
plus the progestogen MPA) have
shown that women may be slightly
more likely to get heart disease
during the first year of taking the
medication. For other types of HRT,
the risk is likely to be similar,
although 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 and do not take any
more HRT until your doctor says
you can. This pain could be a sign
of heart disease.

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Stroke
Recent research suggests that
systemic 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 irregular heartbeat

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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.
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Compare
Looking at women in their 50s
who are not taking HRT - on
average, over a 5-year period,
3 in 1000 would be expected to
have a stroke.
For women in their 50s who are
taking HRT, the figure would be
4 in 1000.
Looking at women in their 60s
who are not taking HRT - on
average, over a 5-year period,
11 in 1000 would be expected to
have a stroke.
For women in their 60s who are
taking HRT, the figure would be
15 in 1000.
If you get:
• unexplained migraine-type
headaches, with or without
disturbed vision
►See a doctor as soon as
possible and do not take any
more HRT until your doctor says
you can. These headaches may be
an early warning sign of a stroke.
Blood clots
Systemic HRT may increase the risk
of blood clots in the veins (also
called deep vein thrombosis, or
DVT), especially during the first year
of taking it.
These blood clots are not always
serious, but if one travels to the
lungs, it can cause chest pain,
breathlessness, collapse or even
death. This condition is called
pulmonary embolism, or PE. DVT
and PE are examples of a condition
called venous thromboembolism,
or VTE.
You are more likely to get a blood
clot:
• if you are seriously overweight
• if you have had a blood clot before
• if any of your close family have
had blood clots
• if you have had one or more
miscarriages
• if you have any blood clotting
problem that needs treatment
with a medicine such as warfarin
• if you’re off your feet for a long
time because of major surgery,
injury or illness
• if you have a rare condition called
SLE
If any of these things apply to
you, talk to your doctor to see if
you should take HRT.
Compare
Looking at women in their 50s
who are not taking HRT - on
average, over a 5-year period,
3 in 1000 would be expected to
get a blood clot.
For women in their 50s who are
taking HRT, the figure would be
7 in 1000.
Looking at women in their 60s
who are not taking HRT - on
average, over a 5-year period,
8 in 1000 would be expected to
get a blood clot.
For women in their 60s who are
taking HRT, the figure would be
17 in 1000.
If you get:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing
►See a doctor as soon as
possible and do not take any
more HRT until your doctor says
you can. These may be signs of a
blood clot.

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If you’re going to have surgery,
make sure your doctor knows about
it. You may need to stop taking 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.
Effects on your risk of
developing cancer
Breast cancer
Women who have breast cancer,
or have had breast cancer in the
past, should not take HRT
Taking HRT slightly increases the risk
of breast cancer; so does having a
later menopause. The risk for a
post-menopausal woman taking
oestrogen-only HRT for 5 years is
about the same as for a woman of
the same age who’s still having
periods over that time and not
taking HRT.
The extra risk of breast cancer goes
up the longer you take it, but
returns to normal within 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
• if you are seriously overweight
Compare
Looking at women aged 50 who
are not taking HRT - on average,
32 in 1000 will be diagnosed with
breast cancer by the time they
reach the age of 65.
For women who start taking
oestrogen-only HRT at age 50
and take it for 5 years, the
figure will be between 33 and 34
in 1000 (i.e. an extra 1-2 cases).
If they take oestrogen-only HRT
for 10 years, the figure will be 37
in 1000 (i.e. an extra 5 cases).
If you notice
any changes in your breast, such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
►Make an appointment to see
your doctor as soon as possible.
Endometrial cancer (cancer of
the lining of the womb)
Taking oestrogen-only HRT
tablets orally for a long time can
increase the risk of developing
cancer of the lining of the womb
(the endometrium). It is possible
there may be a similar risk with
oestrogen cream/rings/tablets used
directly in the vagina for repeated
treatments or over a long time.
If you get breakthrough bleeding
or spotting, it’s usually nothing to
worry about, but you should
►Make an appointment to see 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 disease.
Some studies have indicated 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.

5. HOW TO STORE VAGIFEM®
Keep out of the reach and sight of
children.
Do not store above 25°C. Do not
refrigerate. Keep the blisters in the
outer carton in order to protect
from light.
Do not use Vagifem® after the
expiry date which is stated on the
carton. The expiry date refers to the
last day of that month.
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.

USER INSTRUCTIONS
How to use Vagifem®

6. FURTHER INFORMATION
What Vagifem® contains
• The active substance is estradiol
25 micrograms (as estradiol
hemihydrate)
• Other ingredients are:
hypromellose, lactose
monohydrate, maize starch and
magnesium stearate
• The film-coating contains:
hypromellose and Macrogol
6000.

1. Tear off one single blister pack.
Open the end as shown in the
picture.

What Vagifem® looks like and
content of the pack
Each Vagifem® comes in an
applicator which is used once only.
There are 15 applicators with
vaginal tablets in each box.
Vagifem® is engraved with
NOVO 279.
Marketing Authorisation Holder
Novo Nordisk A/S
Novo Alle
DK-2880 Bagsvaerd
Denmark

2. Insert the applicator carefully into
the vagina.
Stop when you can feel some
resistance.

The registered office in the UK is:
Novo Nordisk Limited
Broadfield Park
Crawley
West Sussex
RH11 9RT
Tel: (01293) 613555
This leaflet was last approved in:04/2010
Detailed information on this
medicine is available on the web site
of www.emc.medicines.org.uk

3. To release the tablet, gently press
the push button until you feel a
click.
The tablet will stick to the wall of
the vagina straight away.
It will not fall out if you stand up or
walk.

4. Take out the applicator and
throw it away

Vagifem® is a trademark owned by
Novo Nordisk Femcare AG,
Switzerland.
© 1995/2008
Novo Nordisk A/S

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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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