GYNEST CREAM 0.01% W/W

Active substance: ESTRIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gynest Cream
Estriol
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 you get side effects and they become serious or if you
notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist

1

Gynest contains a medicine called estriol. This is the new
name for oestriol – the medicine itself has not changed.
Estriol is a hormone known as an estrogen. It belongs to a
group of medicines called hormone replacement therapy
(HRT).

What Gynest is used for

Gynest is used for vaginal problems caused by a lack of
the hormone estrogen.
• Gynest replaces the hormone estrogen in the vaginal
area when your body is not producing enough
• This happens most often during or after the menopause
(see right column 'What is the menopause?')

Before you use Gynest

Do not use Gynest if you:












1 What Gynest is and what it is used for
2 Before you use Gynest
3 How to use Gynest
4 Possible side effects
5 How to store Gynest
6 Further information

What Gynest is and what it is used for

The name of your medicine is Gynest cream. It is called
‘Gynest’ in this leaflet.

2

In this leaflet

Are allergic to soya or peanuts. Gynest contains peanut
oil (arachis oil). See right column ‘Important information
about some of the ingredients of Gynest’
Are allergic to any of the other ingredients in Gynest
(listed in section 6 below)
Have ever had or think you may have breast cancer
Have a cancer that is made worse by estrogens such as
cancer of the lining of the womb (endometrial cancer)
Have ever had blood clots (thrombosis)
Have an abnormality of your clotting system that makes
you more prone to develop blood clots
Have or have recently had blocked arteries (arterial
thrombo-embolic disease) that gave you angina or a
heart attack
Have a blood problem called ‘porphyria’
Have abnormal vaginal bleeding which has not been
explained
Have thickening of the lining of your womb (endometrial
hyperplasia) which has not been treated
Have acute liver disease or a history of liver disease which
is not completely resolved

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 Gynest.
Check with your doctor or pharmacist before using Gynest
if:
• You are using a ‘barrier’ method of contraception. This
includes condoms or diaphragms. This is because
Gynest can damage the rubber and stop them working
properly. Talk to your doctor about using another type
of contraception while you are using this medicine.

Medical check-ups

Before 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 if you have any special concerns.
Once you have started on HRT, see your doctor for regular
check-ups (every three months). 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

Tell your doctor if you have ever had any of the
following. You may need to have the above
medical check-ups more often.

• A problem caused by growth of the womb lining:
- Inside the womb (fibroids)
- Outside the womb (endometriosis)
• Increased risk of blood clots (see right column 'Blood
clots')
• An increased risk of cancers related to estrogens e.g. a
family history of breast cancer (see ‘Breast cancer’ below)
• High blood pressure (hypertension)
• Liver problems
• Diabetes
• Gallstones
• Migraine or severe headaches
• Systemic lupus erythematosus (SLE). This is an allergic
condition that causes joint pain, skin rashes and fever
• Epilepsy
• Asthma
• Bone formation in the ear (otosclerosis)
• Heart or kidney problems
• High levels of fats called ‘triglycerides’ in your blood
(hypertriglyceridaemia)
Tell your doctor if these illnesses return or get worse while
you are using Gynest.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines that you buy without a prescription or herbal
medicines.
In particular, tell your doctor or pharmacist if you are taking
any of the following:
• Medicines for epilepsy such as phenobarbital, phenytoin
or carbamazepine
• Medicines for infections such as rifampicin, rifabutin,
nevirapine or efavirenz
• Medicines for HIV infection called ritonavir and nelfinavir
• Bosentan – for high blood pressure in the blood vessels
of the lungs
• St John’s Wort – for depression
Taking these medicines with Gynest can stop Gynest from
working as well as it should and may cause unusual
bleeding from your womb.
• A medicine for epilepsy called lamotrigine. Using Gynest
with lamotrigine could affect control of your epilepsy.

Operations or tests

Tell your doctor if you are going to have surgery. You may
need to stop taking HRT about 4 to 6 weeks before the
operation to reduce the risk of blood clot. Your doctor will
tell you when you can start taking HRT again.
If you visit a hospital or your family doctor for a blood or
urine test, tell them that you are using Gynest. This is
because this medicine may affect the result of the test.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant, think you may
be pregnant or might become pregnant. This is because it
may affect the baby. Do not use this medicine if you are
breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.

What is the menopause?

Women produce estrogen hormones from their ovaries
throughout their adult life. These hormones are important in
sexual development and control of the menstrual cycle.
The menopause happens when the level of hormones
produced by the ovaries goes down. This is a gradual
process. During this time the levels of estrogen can go up
and down. This can cause the following symptoms:
• Vaginal dryness or itching
• Uncomfortable or painful sexual intercourse
You may get the same symptoms if you have had your
ovaries taken out in an operation. This is called a ‘surgical
menopause’.

Driving or using machines

There is no information about whether Gynest affects your
ability to drive or use machines. See how this medicine
affects you before you drive or use any tools or machines.

Important information about some of the
ingredients of Gynest

• Gynest contains peanut oil (arachis oil). Do not use
Gynest if you are allergic to peanuts or soya. See ‘Do not
use Gynest if’ above.
• Gynest also contains benzoic acid (E210). This can irritate
your skin, eyes, eyelids, mouth and nostrils if it comes
into contact with them.
As well as benefits, HRT has some risks. Consider the
following when deciding to take or continue HRT.

HRT will not help to prevent heart disease

Studies have shown that there was no increase in heart
disease in women without a womb using estrogen-only HRT.
If you get a pain in your chest that spreads to your arm and
neck
• See a doctor as soon as possible
• Do not use any more HRT until your doctor says you can
This pain may be a sign of heart disease.

Stroke

The risk of having a stroke due to a blood clot is up to 1.5
times higher with HRT. Other things that increase the risk of
stroke include:
• Getting older
• High blood pressure
• Smoking
• Drinking too much alcohol
• An irregular 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 – 8 in 1000 would be expected
to have a stroke
• In women taking HRT – 11 in 1000 would be expected to
have a stroke (i.e. an extra 3 cases)
If you get migraine-type headaches which you cannot explain
• See a doctor as soon as possible
• Do not use any more HRT until your 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), by up to 3 times,
especially during the first year of taking it.
These blood clots are not always serious. However, if a clot
travels to the lungs, it can cause chest pain, breathlessness,
collapse or even death. This is called pulmonary embolism
or PE.
The risk of a blood clot increases with age. In addition 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 are pregnant or just had a baby
• You have had one or more miscarriages
• 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 illness called SLE
• You have cancer
If any of these things apply to you, talk to your doctor to see
if you should take HRT.

How likely is a blood clot?

Looking at women in their 50s, on average, over 5 years:
• In women not taking HRT – 7 in 1000 would be expected
to get a blood clot
• In women taking estrogen-only HRT tablets – 8 in 1000
would be expected to get a blood clot (i.e. an extra 1
case)
If you get painful swelling in your leg, sudden chest pain or
have difficulty breathing
• See a doctor as soon as possible
• Do not use any more HRT until your doctor says you can
These may be signs of a blood clot.

2

Before you use Gynest (continued)

Breast cancer

Women who have breast cancer or are suspected of
having breast cancer, or have had breast cancer in the
past should not take HRT.
Studies have found a small increase in the risk of breast
cancer in users of estrogen-only HRT.
The extra risk of breast cancer goes up the longer you take
it. However, it 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
• You are very overweight

How likely is breast cancer?

Looking at women between the ages of 50 and 65, on
average, over 5 years:
• In women not taking HRT – 9-12 in 1000 will get breast
cancer
• In women taking estrogen-only HRT, there will be
around an extra 1-2 cases per 1,000
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)

increase the risk of cancer of the lining of the womb (the
endometrium). It is possible there may be a similar risk with
estrogen cream used for repeated treatments or over a
long time. You do not need to take a separate progestogen
with Gynest.
If you get breakthrough bleeding or spotting, it is usually
nothing to worry about, especially in the first few months of
taking HRT. However, if it carries on for more than a few
months, or starts after you have been using Gynest for a
while, or carries on after you have stopped using Gynest,
you should make an appointment to see your doctor. It
could be a sign that your endometrium has become
thicker.

How likely is endometrial cancer?

Looking at women who still have a uterus and who are not
taking HRT – on average 5 in 1,000 will be diagnosed with
endometrial cancer.
For women who take estrogen-only HRT, the number will
be 2-12 times higher, depending on the dose and how long
they take it. Even after they stop taking estrogen-only HRT,
they will be at higher risk for at least 10 years.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is
serious. It can be difficult to diagnose. This is because
there are often no obvious signs of the disease. Some
studies have suggested that taking estrogen-only HRT for
more than 5 years may slightly increase the risk of ovarian
cancer by 1 extra case per 2,500 women. It is not yet
known whether Gynest increases the risk in the same way.

Taking estrogen-only HRT tablets for a long time can

3

How to use Gynest

Gynest should be used in the vagina of adult women.
Always use this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Gynest comes with 16 disposable plastic applicators that
you screw on to the tube. It will help you to put the right
amount into your vagina.
Unless your doctor tells you otherwise, you should:
• Start by using one applicator of Gynest each evening
When your symptoms improve, your doctor may
recommend that you:
• Use one applicator of Gynest twice a week

How to apply the cream

1. Remove the cap from the tube. Use the top of the cap
to pierce the metal seal on the tube
2. One end of the applicator has a plunger. Screw the
other end of the applicator onto the tube
3. Squeeze the tube so that the applicator barrel is
completely filled with cream. This will push the plunger
out

8. Keep the plunger firmly pressed down. Grip the
applicator by the barrel and remove the empty
applicator
9. Wash your hands afterwards
10. Use a sanitary towel to stop your clothes getting
stained

After each use



Dispose of the used applicator
Use a new applicator for your next dose

When to stop using Gynest



See your doctor after 3 months to see if you need to
continue treatment
Gynest should be used at the lowest dose and for the
shortest period of time for your symptoms

If you swallow Gynest

If a large amount of the cream is eaten or swallowed,
talk to a doctor or go to the nearest hospital casualty
department straight away.

If you forget a dose

Apply the missed dose when you remember. Do not use
Gynest more than once on any one day.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Unscrew the filled applicator and replace the cap on
the tube
5. Lie down with your knees bent and spread apart
6. Gently insert the open end of the applicator well into
your vagina
7. Push the plunger firmly but gently. Empty the cream
into your vagina by pushing the plunger as
far as it will go

4

Wash out the cream. Too much estrogen therapy may
cause breast pain or tenderness, nausea, spotting,
abdominal cramps and/or bloating. If you are worried or
have any unusual symptoms you should contact your
doctor.

Possible side effects

Like all medicines, Gynest can cause side effects, although
not everybody gets them.
Stop using Gynest and tell your doctor straight away if
you notice or suspect any of the following as you may
need urgent medical treatment.
• Sudden swelling of the face or throat which may cause
difficulty in swallowing or breathing. Hives (also known
as nettle rash or urticaria), severe irritation, reddening
or blistering of your skin. These may be signs of a
severe allergic reaction. This only happens in a small
number of people
• Blood clots (thrombosis), a heart attack or stroke (see
section 2 ‘Before you use Gynest’)
• New or unusual migraine-type headaches, with or
without disturbed vision
• Yellowing of the skin or whites of the eyes (jaundice), or
worsening of liver problems
• A significant increase in your blood pressure
• Breast cancer, endometrial cancer or ovarian cancer
(see section 2 ‘Before you use Gynest’)
• Pregnancy
• If you start to have any of the conditions listed above
under ‘Do not use Gynest if:’.

Other side effects of estrogen treatment:
In the reproductive and urinary system
• Break-through bleeding
• Vaginal discharge

5

If you take more than the dose recommended
by this leaflet or your doctor




Needing to pass urine more often or pain on passing
urine (cystitis)
Pre-menstrual tension syndrome (PMT)

In the breasts
• Breast tenderness and pain
In the stomach
• Feeling sick (nausea), being sick (vomiting)
• Feeling bloated, stomach pain or stomach cramps
• Problems with a gland on the underside of the liver
called the ‘gallbladder’
In the skin
• Patches of darkened skin, small red marks on the skin,
red painful swellings or bruising on the legs
In the nervous system and brain
• Migraine or severe headaches made worse
• Depression
• Dementia (loss of memory) over the age of 65
In other parts of the body
• Fast or irregular heartbeats (palpitations)
• Leg pain
If any of the side effects gets serious, or if you notice
any other side effects not listed in this leaflet, please
tell your doctor or pharmacist.

How to store Gynest

Keep out of the reach and sight of children.

Do not use Gynest if you notice that the tube seal is
missing or broken.

Do not store above 25°C.
Do not use Gynest after the expiry date which is stated on
the pack. The expiry date refers to the last day of that
month.

6

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
protect the environment.

Further Information

What Gynest contains
The active substance in Gynest is estriol.
Gynest contains 0.01% estriol.

The product licence is held by:
Marlborough Pharmaceuticals, 35A High Street,
Marlborough, Wiltshire, SN8 1LW.

The other ingredients are benzoic acid (E210), glyceryl
monostearate, arachis oil (peanut oil), glycerine, glutamic
acid, purified water.

Gynest is made by:
PHARBIL Waltrop GmbH, Im Wirringen 12, D-45731,
Waltrop, Germany

What Gynest looks like and contents of the pack
Gynest is a white to yellowish-white cream. It comes in
tubes of 80g.

For information in large print,
tape, CD or Braille,
telephone 01672 514187.

This leaflet was last revised in September 2012

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gynest Cream
Estriol
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 you get side effects and they become serious or if you
notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist

1

Gynest contains a medicine called estriol. This is the new
name for oestriol – the medicine itself has not changed.
Estriol is a hormone known as an estrogen. It belongs to a
group of medicines called hormone replacement therapy
(HRT).

What Gynest is used for

Gynest is used for vaginal problems caused by a lack of
the hormone estrogen.
• Gynest replaces the hormone estrogen in the vaginal
area when your body is not producing enough
• This happens most often during or after the menopause
(see right column 'What is the menopause?')

Before you use Gynest

Do not use Gynest if you:












1 What Gynest is and what it is used for
2 Before you use Gynest
3 How to use Gynest
4 Possible side effects
5 How to store Gynest
6 Further information

What Gynest is and what it is used for

The name of your medicine is Gynest cream. It is called
‘Gynest’ in this leaflet.

2

In this leaflet

Are allergic to soya or peanuts. Gynest contains peanut
oil (arachis oil). See right column ‘Important information
about some of the ingredients of Gynest’
Are allergic to any of the other ingredients in Gynest
(listed in section 6 below)
Have ever had or think you may have breast cancer
Have a cancer that is made worse by estrogens such as
cancer of the lining of the womb (endometrial cancer)
Have ever had blood clots (thrombosis)
Have an abnormality of your clotting system that makes
you more prone to develop blood clots
Have or have recently had blocked arteries (arterial
thrombo-embolic disease) that gave you angina or a
heart attack
Have a blood problem called ‘porphyria’
Have abnormal vaginal bleeding which has not been
explained
Have thickening of the lining of your womb (endometrial
hyperplasia) which has not been treated
Have acute liver disease or a history of liver disease which
is not completely resolved

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 Gynest.
Check with your doctor or pharmacist before using Gynest
if:
• You are using a ‘barrier’ method of contraception. This
includes condoms or diaphragms. This is because
Gynest can damage the rubber and stop them working
properly. Talk to your doctor about using another type
of contraception while you are using this medicine.

Medical check-ups

Before 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 if you have any special concerns.
Once you have started on HRT, see your doctor for regular
check-ups (every three months). 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

Tell your doctor if you have ever had any of the
following. You may need to have the above
medical check-ups more often.

• A problem caused by growth of the womb lining:
- Inside the womb (fibroids)
- Outside the womb (endometriosis)
• Increased risk of blood clots (see right column 'Blood
clots')
• An increased risk of cancers related to estrogens e.g. a
family history of breast cancer (see ‘Breast cancer’ below)
• High blood pressure (hypertension)
• Liver problems
• Diabetes
• Gallstones
• Migraine or severe headaches
• Systemic lupus erythematosus (SLE). This is an allergic
condition that causes joint pain, skin rashes and fever
• Epilepsy
• Asthma
• Bone formation in the ear (otosclerosis)
• Heart or kidney problems
• High levels of fats called ‘triglycerides’ in your blood
(hypertriglyceridaemia)
Tell your doctor if these illnesses return or get worse while
you are using Gynest.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines that you buy without a prescription or herbal
medicines.
In particular, tell your doctor or pharmacist if you are taking
any of the following:
• Medicines for epilepsy such as phenobarbital, phenytoin
or carbamazepine
• Medicines for infections such as rifampicin, rifabutin,
nevirapine or efavirenz
• Medicines for HIV infection called ritonavir and nelfinavir
• Bosentan – for high blood pressure in the blood vessels
of the lungs
• St John’s Wort – for depression
Taking these medicines with Gynest can stop Gynest from
working as well as it should and may cause unusual
bleeding from your womb.
• A medicine for epilepsy called lamotrigine. Using Gynest
with lamotrigine could affect control of your epilepsy.

Operations or tests

Tell your doctor if you are going to have surgery. You may
need to stop taking HRT about 4 to 6 weeks before the
operation to reduce the risk of blood clot. Your doctor will
tell you when you can start taking HRT again.
If you visit a hospital or your family doctor for a blood or
urine test, tell them that you are using Gynest. This is
because this medicine may affect the result of the test.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant, think you may
be pregnant or might become pregnant. This is because it
may affect the baby. Do not use this medicine if you are
breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.

What is the menopause?

Women produce estrogen hormones from their ovaries
throughout their adult life. These hormones are important in
sexual development and control of the menstrual cycle.
The menopause happens when the level of hormones
produced by the ovaries goes down. This is a gradual
process. During this time the levels of estrogen can go up
and down. This can cause the following symptoms:
• Vaginal dryness or itching
• Uncomfortable or painful sexual intercourse
You may get the same symptoms if you have had your
ovaries taken out in an operation. This is called a ‘surgical
menopause’.

Driving or using machines

There is no information about whether Gynest affects your
ability to drive or use machines. See how this medicine
affects you before you drive or use any tools or machines.

Important information about some of the
ingredients of Gynest

• Gynest contains peanut oil (arachis oil). Do not use
Gynest if you are allergic to peanuts or soya. See ‘Do not
use Gynest if’ above.
• Gynest also contains benzoic acid (E210). This can irritate
your skin, eyes, eyelids, mouth and nostrils if it comes
into contact with them.
As well as benefits, HRT has some risks. Consider the
following when deciding to take or continue HRT.

HRT will not help to prevent heart disease

Studies have shown that there was no increase in heart
disease in women without a womb using estrogen-only HRT.
If you get a pain in your chest that spreads to your arm and
neck
• See a doctor as soon as possible
• Do not use any more HRT until your doctor says you can
This pain may be a sign of heart disease.

Stroke

The risk of having a stroke due to a blood clot is up to 1.5
times higher with HRT. Other things that increase the risk of
stroke include:
• Getting older
• High blood pressure
• Smoking
• Drinking too much alcohol
• An irregular 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 – 8 in 1000 would be expected
to have a stroke
• In women taking HRT – 11 in 1000 would be expected to
have a stroke (i.e. an extra 3 cases)
If you get migraine-type headaches which you cannot explain
• See a doctor as soon as possible
• Do not use any more HRT until your 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), by up to 3 times,
especially during the first year of taking it.
These blood clots are not always serious. However, if a clot
travels to the lungs, it can cause chest pain, breathlessness,
collapse or even death. This is called pulmonary embolism
or PE.
The risk of a blood clot increases with age. In addition 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 are pregnant or just had a baby
• You have had one or more miscarriages
• 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 illness called SLE
• You have cancer
If any of these things apply to you, talk to your doctor to see
if you should take HRT.

How likely is a blood clot?

Looking at women in their 50s, on average, over 5 years:
• In women not taking HRT – 7 in 1000 would be expected
to get a blood clot
• In women taking estrogen-only HRT tablets – 8 in 1000
would be expected to get a blood clot (i.e. an extra 1
case)
If you get painful swelling in your leg, sudden chest pain or
have difficulty breathing
• See a doctor as soon as possible
• Do not use any more HRT until your doctor says you can
These may be signs of a blood clot.

2

Before you use Gynest (continued)

Breast cancer

Women who have breast cancer or are suspected of
having breast cancer, or have had breast cancer in the
past should not take HRT.

estrogen cream used for repeated treatments or over a
long time. You do not need to take a separate progestogen
with Gynest.

Studies have found a small increase in the risk of breast
cancer in users of estrogen-only HRT.

If you get breakthrough bleeding or spotting, it is usually
nothing to worry about, especially in the first few months of
taking HRT. However, if it carries on for more than a few
months, or starts after you have been using Gynest for a
while, or carries on after you have stopped using Gynest,
you should make an appointment to see your doctor. It
could be a sign that your endometrium has become
thicker.

The extra risk of breast cancer goes up the longer you take
it. However, it 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
• You are very overweight

How likely is breast cancer?

Looking at women between the ages of 50 and 65, on
average, over 5 years:
• In women not taking HRT – 9-12 in 1000 will get breast
cancer
• In women taking estrogen-only HRT, there will be
around an extra 1-2 cases per 1,000
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)

How likely is endometrial cancer?

Looking at women who still have a uterus and who are not
taking HRT – on average 5 in 1,000 will be diagnosed with
endometrial cancer.
For women who take estrogen-only HRT, the number will
be 2-12 times higher, depending on the dose and how long
they take it. Even after they stop taking estrogen-only HRT,
they will be at higher risk for at least 10 years.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is
serious. It can be difficult to diagnose. This is because
there are often no obvious signs of the disease. Some
studies have suggested that taking estrogen-only HRT for
more than 5 years may slightly increase the risk of ovarian
cancer by 1 extra case per 2,500 women. It is not yet
known whether Gynest increases the risk in the same way.

Taking estrogen-only HRT tablets for a long time can
increase the risk of cancer of the lining of the womb (the
endometrium). It is possible there may be a similar risk with

3

How to use Gynest

Gynest should be used in the vagina of adult women.
Always use this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Gynest comes with a plastic applicator that you screw on
to the tube. It will help you to put the right amount into your
vagina.

Cleaning the applicator

After each use:
• Pull the plunger out of the barrel with a sharp tug
• Clean with mild soap and warm water (not boiling
water)
• Rinse well

Unless your doctor tells you otherwise, you should:
• Start by using one applicator of Gynest each evening
When your symptoms improve, your doctor may
recommend that you:
• Use one applicator of Gynest twice a week

How to apply the cream

1. Remove the cap from the tube. Use the top of the cap
to pierce the metal seal on the tube
2. One end of the applicator has a plunger. Screw the
other end of the applicator onto the tube
3. Squeeze the tube so that the applicator barrel is
completely filled with cream. This will push the plunger
out

Putting the applicator back together


Put the tip of the plunger back into the barrel. Push the
plunger firmly
If you lose or break your applicator you can get a new one
from a pharmacist. Ask for the Gynest Vaginal Applicator.

When to stop using Gynest



See your doctor after 3 months to see if you need to
continue treatment
Gynest should be used at the lowest dose and for the
shortest period of time for your symptoms

If you swallow Gynest

If a large amount of the cream is eaten or swallowed,
talk to a doctor or go to the nearest hospital casualty
department straight away.

If you forget a dose
4. Unscrew the filled applicator and replace the cap on
the tube
5. Lie down with your knees bent and spread apart
6. Gently insert the open end of the applicator well into
your vagina
7. Push the plunger firmly but gently. Empty the cream
into your vagina by pushing the plunger as
far as it will go

Apply the missed dose when you remember. Do not use
Gynest more than once on any one day.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

If you take more than the dose recommended
by this leaflet or your doctor
Wash out the cream. Too much estrogen therapy may
cause breast pain or tenderness, nausea, spotting,
abdominal cramps and/or bloating. If you are worried or
have any unusual symptoms you should contact your
doctor.

8. Keep the plunger firmly pressed down. Grip the
applicator by the barrel and remove the empty
applicator
9. Wash your hands afterwards
10. Use a sanitary towel to stop your clothes getting
stained

4

Possible side effects

Like all medicines, Gynest can cause side effects, although
not everybody gets them.




Stop using Gynest and tell your doctor straight away if
you notice or suspect any of the following as you may
need urgent medical treatment.
• Sudden swelling of the face or throat which may cause
difficulty in swallowing or breathing. Hives (also known
as nettle rash or urticaria), severe irritation, reddening
or blistering of your skin. These may be signs of a
severe allergic reaction. This only happens in a small
number of people
• Blood clots (thrombosis), a heart attack or stroke (see
section 2 ‘Before you use Gynest’)
• New or unusual migraine-type headaches, with or
without disturbed vision
• Yellowing of the skin or whites of the eyes (jaundice), or
worsening of liver problems
• A significant increase in your blood pressure
• Breast cancer, endometrial cancer or ovarian cancer
(see section 2 ‘Before you use Gynest’)
• Pregnancy
• If you start to have any of the conditions listed above
under ‘Do not use Gynest if:’.

Other side effects of estrogen treatment:
In the reproductive and urinary system
• Break-through bleeding
• Vaginal discharge

5

Needing to pass urine more often or pain on passing
urine (cystitis)
Pre-menstrual tension syndrome (PMT)

In the breasts
• Breast tenderness and pain
In the stomach
• Feeling sick (nausea), being sick (vomiting)
• Feeling bloated, stomach pain or stomach cramps
• Problems with a gland on the underside of the liver
called the ‘gallbladder’
In the skin
• Patches of darkened skin, small red marks on the skin,
red painful swellings or bruising on the legs
In the nervous system and brain
• Migraine or severe headaches made worse
• Depression
• Dementia (loss of memory) over the age of 65
In other parts of the body
• Fast or irregular heartbeats (palpitations)
• Leg pain
If any of the side effects gets serious, or if you notice any
other side effects not listed in this leaflet, please tell your
doctor or pharmacist.

How to store Gynest

Keep out of the reach and sight of children.

Do not use Gynest if you notice that the tube seal is
missing or broken.

Do not store above 25°C.
Do not use Gynest after the expiry date which is stated on
the pack. The expiry date refers to the last day of that
month.

6

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
protect the environment.

Further Information

What Gynest contains
The active substance in Gynest is estriol.
Gynest contains 0.01% estriol.

The product licence is held by:
Marlborough Pharmaceuticals, 35A High Street,
Marlborough, Wiltshire, SN8 1LW.

The other ingredients are benzoic acid (E210), glyceryl
monostearate, arachis oil (peanut oil), glycerine, glutamic
acid, purified water.

Gynest is made by:
PHARBIL Waltrop GmbH, Im Wirringen 12, D-45731,
Waltrop, Germany

What Gynest looks like and contents of the pack
Gynest is a white to yellowish-white cream. It comes in
tubes of 80g.

For information in large print,
tape, CD or Braille,
telephone 01672 514187.
This leaflet was last approved in May 2011

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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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