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VAGIFEM 10 MICROGRAMS VAGINAL TABLETS

Active substance(s): ESTRADIOL HEMIHYDRATE / ESTRADIOL HEMIHYDRATE / ESTRADIOL HEMIHYDRATE

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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.
Do not use Vagifem®:
If any of the following apply to you. If
you are not sure about any of the

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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.

Additionally, you are advised to join
mammography screening programs
when offered to you. For mammogram
screening, it is important that you
inform the nurse/healthcare professional who is actually taking the x-ray
that you use HRT, as this medication
may increase the density of your
breasts which may affect the outcome
of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer is rare – much rarer
than breast cancer. The use of oestrogenonly or combined oestrogen-progestagen
HRT has been associated with a slightly
increased risk of ovarian cancer.
Compare
The risk of ovarian cancer varies
with age. For example, in women
aged 50 to 54 who are not taking
HRT, about 2 women in 2,000 will
be diagnosed with ovarian cancer
over a 5-year period. For women
who have been taking HRT for
5 years, there will be about 3 cases
per 2,000 users (i.e. about 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 (see also section 3, If
you need to have surgery)
• 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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Code: 100% Direction
Length: Max. 29 mm (100%)

Insert size: 210x297-023
Current: 4

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.

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Regulatory Operations

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

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therapy there is no increased risk of
developing a heart disease.

Code start
Code: 100% Direction
Length: Max. 29 mm (100%)

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.
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®
Some medicines may interfere with the
effect of Vagifem®. This might lead to
irregular bleeding. This applies to the
following medicines:
• Medicines for epilepsy (such as
phenobarbital, phenytoin and
carbamazepin);
• Medicines for tuberculosis (such as
rifampicin, rifabutin);
• Medicines for HIV infection (such
as nevirapine, efavirenz, ritonavir
and nelfinavir);
• Herbal remedies containing
St John’s Wort (Hypericum
perforatum)
Please tell your doctor or pharmacist if
you are using or have recently used any
other medicines, including medicines
obtained without a prescription, herbal
medicines or other natural products.
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.

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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
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 need to have surgery
The following applies to HRT medicines
which circulate in the blood. It is not
known how this applies to locally
administered treatments such as
Vagifem®.
If you are going to have surgery, tell
the surgeon that you are using
Vagifem®. You may need to stop
using Vagifem® about 4 to 6 weeks
before the operation to reduce the risk
of a blood clot (see section 2, Blood
clots in a vein). Ask your doctor when
you can start using Vagifem® again.
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.
The following diseases are reported
more often in women using HRT
compared to women not using HRT:
• breast cancer;
• abnormal growth or cancer of the
lining of the womb (endometrial
hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs
or lungs (venous thromboembolism);
• heart disease;
• stroke;
• probable memory loss if HRT is
started over the age of 65;
For more information about these side
effects, see Section 2.
Common: may affect up to
1 in 10 people
• Headache
• Stomach pain
• Vaginal bleeding, discharge or
discomfort.
Uncommon: may affect up to
1 in 100 people
• An infection of the genitals caused
by a fungus
• Feeling sick (nausea)
• Rash
• Weight increase
• Hot flush
• Hypertension.
Very rare: may affect up to
1 in 10,000 people
• Diarrhoea
• Fluid retention
• Migraine aggravated
• Generalised 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).

USER INSTRUCTIONS
How to use Vagifem®

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.

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.
This medicine may cause risk to the
aquatic environment.

6. Contents of the pack
and other information

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).

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: 01/2017

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 registered
trademark owned by
Novo Nordisk Health Care AG,
Switzerland
© 2017
Novo Nordisk A/S

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Expand Transcript

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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