VAGIFEM 10 MICROGRAMS VAGINAL TABLETS

Active substance: ESTRADIOL HEMIHYDRATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Vagifem®
10 micrograms
vaginal tablets
Estradiol
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 local Hormone
Replacement Therapy (HRT).
It 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 after 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. This may relieve discomfort
in the vagina.
The experience of treating women
older than 65 years is limited.

2. Before you use
Vagifem®
Medical history and regular
check-ups
The use of HRT carries risks which
need to be considered when
deciding whether to start taking it,
or whether to carry on taking it.
Before you start (or restart) HRT,
your doctor will ask about your own
and your family’s medical history.
Your doctor may decide to perform
a physical examination. This may
include an examination of your
breasts and/or internal examination,
if necessary.
Go for regular breast screening as
recommended by your doctor.
Do not use Vagifem®:
If any of the following apply to you.
If you are not sure about any of the
points below, talk to your doctor
before using Vagifem®.

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Do not use Vagifem® if
• You are allergic (hypersensitive)
to estradiol or any of the other
ingredients of Vagifem® (listed in
Section 6 Further information)
• You have or have ever had breast
cancer, or you are suspected of
having it
• You have or have ever had
cancer which is sensitive to
oestrogens, such as cancer of
the womb lining (endometrium),
or you are suspected of having it
• You have any unexplained
vaginal bleeding
• You have excessive thickening of
the womb lining (endometrial
hyperplasia) that is not being
treated
• You have or have ever had a
blood clot in a vein
(thrombosis), such as in the legs
or lungs (deep venous
thrombosis) or the lungs
(pulmonary embolism)
• You have a blood clotting
disorder (such as protein C,
protein S, or antithrombin
deficiency)
• You have or have recently had a
disease caused by blood clots in
the arteries, such as a heart
attack, stroke or angina
• You have or have ever had a liver
disease and your liver function
tests have not returned to normal
• You have a rare blood problem
called “porphyria”, which is
passed down in families
(inherited).
If any of the above conditions
appear for the first time while using
Vagifem®, stop using it at once and
consult your doctor immediately.
When to take special care with
Vagifem®
Tell your doctor if you have or have
ever had any of the following
problems before you start the
treatment. If so, you should see
your doctor more often for checkups. Vagifem®, as opposed to
systemic oestrogen, is for local
treatment in the vagina, and the
absorption into the blood is very
low. It is therefore less likely that the
conditions mentioned below will get
worse or come back during
treatment with Vagifem®.
• Asthma
• Epilepsy
• Diabetes
• Gallstones
• High blood pressure
• Migraines or severe headaches
• A liver disorder, such as a benign
liver tumour
• Growth of womb lining outside
your womb (endometriosis) or a
history of excessive growth of the
womb lining (endometrial
hyperplasia)
• A disease affecting the eardrum
and hearing (otosclerosis)
• A disease of the immune system
that affects many organs of the
body (systemic lupus
erythematosus, SLE)
• Increased risk of getting an
oestrogen-sensitive cancer (such
as having a mother, sister or
grandmother who has had breast
cancer)
• Increased risk of developing
blood clots (see “Blood clots in a
vein (thrombosis)”)
• Fibroids inside your womb
• A very high level of fat in your
blood (triglycerides)
• Fluid retention due to cardiac or
kidney problems.

Stop using Vagifem® and see a
doctor immediately
If you notice any of the following
when using HRT:
• Migraine-like headaches which
happen for the first time
• Yellowing of your skin or the
whites of your eyes (jaundice).
These may be signs of a liver
disease
• A large rise in your blood pressure
(symptoms may be headache,
tiredness, dizziness)
• Any of the conditions mentioned
in the ‘Do not use Vagifem®’
section
If you become pregnant
If you notice signs of a blood clot,
such as:
-painful swelling and redness of
the legs
-sudden chest pain
-difficulty in breathing
For more information, see ‘Blood
clots in a vein (thrombosis)’.
The following risks apply to HRT
medicines which circulate in the
blood. It is not known how these
risks apply to locally administered
treatments such as Vagifem®.
HRT and cancer
Excessive thickening of the
lining of the womb (endometrial
hyperplasia) and cancer of the
lining of the womb (endometrial
cancer)
Taking oestrogen-only HRT tablets
for a long time can increase the risk
of developing cancer of the womb
lining (the endometrium). It is
uncertain whether long term (more
than one year) or repeated use of
local vaginally administered
oestrogen products possess a similar
risk.
Vagifem® has been shown to have
very low systemic absorption initially
during treatment, and the addition
of a progestagen is therefore not
necessary.
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.
Breast cancer
Evidence suggests that taking
combined oestrogen-progestagen
and possibly also oestrogen-only
HRT increases the risk of breast
cancer. The extra risk depends on
how long you take HRT. The
additional risk becomes clear within
a few years. However, it returns to
normal within a few years (at most
5) after stopping treatment.
For women who have had their
womb removed and who are using
oestrogen-only HRT for 5 years, little
or no increase in breast cancer risk is
shown.
Compare
Women aged 50 to 79 who are
not taking HRT, on average, 9 to
14 in 1000 will be diagnosed with
breast cancer over a 5-year period.
For women aged 50 to 79 who
are taking oestrogen-progestagen
HRT over 5 years, there will be
13 to 20 cases in 1000 users
(i.e. an extra 4 to 6 cases).
Regularly check your breasts.
See your doctor if you notice
any changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel

Ovarian cancer
Ovarian cancer is rare. A slightly
increased risk of ovarian cancer has
been reported in women taking HRT
for at least 5 to 10 years.
Women aged 50 to 69 who are not
taking HRT, on average about 2
women in 1000 will be diagnosed
with ovarian cancer over a 5-year
period. For women who have been
taking HRT for 5 years, there will be
between 2 and 3 cases per 1000
users (i.e. up to 1 extra case).
Effect of HRT on heart and
circulation
Blood clots in a vein
(thrombosis)
The risk of blood clots in the veins
is about 1.3 to 3- times higher in
HRT users than in non-users,
especially during the first year of
taking it.
Blood clots can be serious, and if
one travels to the lungs, it can cause
chest pain, breathlessness, fainting
or even death.
You are more likely to get a blood
clot in your veins as you get older
and if any of the following apply to
you. Inform your doctor if any of
these situations apply to you:
• you are unable to walk for a long
time because of major surgery,
injury or illness
• you are seriously overweight
(BMI >30 kg/m2)
• you have any blood clotting
problem that needs long-term
treatment with a medicine used
to prevent blood clots
• if any of your close relatives has
ever had a blood clot in the leg,
lung or an other organ
• you have systemic lupus
erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop
taking Vagifem® and see a doctor
immediately”.
Compare
Looking at women in their
50s who are not taking HRT, on
average, over a 5-year period, 4 to
7 in 1000 would be expected to
get a blood clot in a vein.
For women in their 50s who have
been taking oestrogenprogestagen HRT for over 5 years,
there will be 9 to 12 cases in
1000 users (i.e. 5 extra cases)
For women in their 50s who have
had their womb removed and
have been taking oestrogen-only
HRT for over 5 years, there will be
5 to 8 cases in 1000 users
(i.e. 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will
prevent a heart attack.
Women over the age of 60 years
who use oestrogen-progestagen
HRT are slightly more likely to
develop heart disease than those
not taking any HRT.
For women who have had their
womb removed and are taking
oestrogen-only therapy there is no
increased risk of developing a heart
disease.

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Stroke
The risk of getting stroke is about
1.5 times higher in HRT users than
in non-users. The number of extra
cases of stroke due to use of HRT
will increase with age.

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Compare
Looking at women in their
50s who are not taking HRT, on
average, 8 in 1000 would be
expected to have a stroke over a
5-year period. For women in their
50s who are taking HRT, there will
be 11 cases in 1000 users, over
5 years (i.e. 3 extra cases).

talking to your doctor. Your doctor
will explain the effects of stopping
treatment. He or she will also
discuss other possibilities for
treatment with you.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

Other conditions
HRT will not prevent memory loss.
There is some evidence of a higher
risk of memory loss in women who
start using HRT after the age of 65.
Speak to your doctor for advice.

Like all medicines, Vagifem® can
cause side effects, although not
everybody gets them.
The frequency of possible side
effects listed below is defined using
the following convention:
Very common (affects more than
1 user in 10)
Common (affects 1 to 10 users
in 100)
Uncommon (affects 1 to 10 users
in 1,000)
Rare (affects 1 to 10 users in
10,000)
Very rare (affects less than 1 user
in 10,000)
Not known (frequency cannot be
estimated from the available data).

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. However, Vagifem® is
not likely to affect other medicines.
This is because Vagifem® is used for
a local treatment in the vagina and
contains a very low dose of
estradiol.
Pregnancy and breast-feeding
Vagifem® is for use in
postmenopausal women only. If you
become pregnant, stop using
Vagifem® and contact your doctor.
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.
General information about
treating symptoms of the
menopause
• When using medicines for any
menopausal symptoms, it is
recommended to use the lowest
dose that works, and to use the
medicine for as short a time as it
is needed.
• Treatment should only be
continued if the benefit is more
than the risk. Talk to your doctor
about this.
If you use more Vagifem® than
you should
• If you have used more Vagifem®
than you should, talk to a doctor
or pharmacist.
• Vagifem® is for local treatment
inside the vagina. The dose of
estradiol is so low that a
considerable number of tablets
would have to be taken to
approach the dose normally used
for treatment taken by mouth.
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 stop using Vagifem®
Do not stop using Vagifem® without

4. Possible side effects

Common
• Headache
• Stomach pain
• Vaginal bleeding, discharge or
discomfort.
Uncommon
• An infection of the genitals
caused by a fungus
• Feeling sick (nausea)
• Rash
• Weight increase
• Hot flush
• Hypertension.

monohydrate, maize starch and
magnesium stearate.
• The film-coating contains:
hypromellose and macrogol
6000.

USER INSTRUCTIONS
How to use Vagifem®

What Vagifem® looks like and
content of the pack
Each white vaginal tablet comes in
an applicator which is used once
only.
Vagifem® is engraved with
NOVO 278 on one side.
Pack sizes:
18 vaginal tablets with applicators.
24 vaginal tablets with applicators.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

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

The registered office in the UK is:Novo Nordisk Limited
Broadfield Park
Brighton Road
Crawley
West Sussex
RH11 9RT
Tel: (01293) 613555
This leaflet was last approved in:
Feb/2012
2. Insert the applicator carefully into
the vagina.
Stop when you can feel some
resistance (8-10 cm).

Very rare
• Diarrhoea
• Fluid retention
• Migraine aggravated
• Generalized hypersensitivity
(e.g. anaphylactic reaction/shock).
The following side effects can
occur with systemic oestrogen
treatment:
• Gall bladder disease
• Various skin disorders:
-discoloration of the skin
especially of the face or neck
known as “pregnancy patches”
(chloasma)
-painful reddish skin nodules
(erythema nodosum)
-rash with target-shaped
reddening or sores (erythema
multiforme)
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.

5. How to store Vagifem®

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.

Keep out of the reach and sight of
children.
Do not refrigerate.
Do not use Vagifem® after the
expiry date which is stated on the
carton label and blister after EXP.
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.

6. Further information
What Vagifem® contains
• The active substance is estradiol
10 micrograms (as estradiol
hemihydrate). Each vaginal tablet
contains 10 micrograms estradiol
(as estradiol hemihydrate).
• Other ingredients are:
hypromellose, lactose

4. Take out the applicator and
throw it away.
Vagifem® is a registered
trademark owned by
Novo Nordisk FemCare AG,
Switzerland
2012
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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