VAGIFEM 10 MICROGRAMS VAGINAL TABLETS

Active substance: ESTRADIOL HEMIHYDRATE

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Regulatory Operations
Insert size: 210x297-023
Current: 3.0
Colour: PMS 280C

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Vagifem®
10 micrograms
vaginal tablets
Estradiol
Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.
• 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 only. Do not
pass it on to others. It may harm
them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Vagifem® is and what it is
used for
2. What you need to know before
you use Vagifem®
3. How to use Vagifem®
4. Possible side effects
5. How to store Vagifem®
6. Contents of the pack and other
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. What you need to know
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.

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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®.
Do not use Vagifem® if
• You are allergic (hypersensitive)
to estradiol or any of the other
ingredients of Vagifem® (listed in
section 6 ‘Contents of the pack
and other 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
(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.
Warnings and precautions
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 check-ups.
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.
Compare
In women who still have a womb
and who are not taking HRT, on
average, 5 in 1,000 will be
diagnosed with endometrial cancer
between the ages of 50 and 65.
For women aged 50 to 65 who
still have a womb and who take
oestrogen-only HRT, between
10 and 60 women in 1,000 will be
diagnosed with endometrial
cancer (i.e. between 5 and 55 extra
cases), depending on the dose and
for how long it is taken.
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
17 in 1,000 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 23 cases in 1,000 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.
Compare
Women aged 50 to 69 who are
not taking HRT, on average, about
2 women in 1,000 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 1,000 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 another organ
• you have systemic lupus
erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see ‘Stop
using 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 1,000 would be expected to
get a blood clot in a vein.
For women in their 50s who have
been taking oestrogen-progestagen
HRT for over 5 years, there will be
9 to 12 cases in 1,000 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 1,000 users
(i.e. 1 extra case).

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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 oestrogenonly 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 1,000 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 1,000 users,
over 5 years (i.e. 3 extra cases).
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.
Other medicines and Vagifem®
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 this medicine exactly as
your doctor has told you. 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 greater 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.

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If you stop using Vagifem®
Do not stop using Vagifem® without
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 medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
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.
Very rare
• Diarrhoea
• Fluid retention
• Migraine aggravated
• Generalised hypersensitivity
(e.g. anaphylactic reaction/shock).
The frequency of possible side
effects listed above 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).
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).
Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. You can also
report side effects directly via the
Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the
safety of this medicine.

This medicine may cause risk to the
aquatic environment.

USER INSTRUCTIONS
How to use Vagifem®

6. Contents of the pack
and other 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
monohydrate, maize starch and
magnesium stearate.
• The film-coating contains:
hypromellose and macrogol 6000.
What Vagifem® looks like and
contents 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
The registered office in the UK is:Novo Nordisk Limited
3 City Place
Beehive Ring Road
Gatwick
West Sussex
RH6 0PA
Tel: (01293) 613555
This leaflet was last revised in:
06/2014

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

2. Insert the applicator carefully into
the vagina.
Stop when you can feel some
resistance (8-10 cm).

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.

5. How to store Vagifem®
Keep this medicine out of the sight
and reach of children.
Do not refrigerate.
Do not use this medicine 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.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.

4. Take out the applicator and
throw it away.
Vagifem® is a registered
trademark owned by
Novo Nordisk FemCare AG,
Switzerland
© 2014
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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