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ORTHO-GYNEST 0.5MG PESSARIES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ortho-Gynest® pessaries
Estriol
Ortho-Gynest is a registered trademark

Read all of this leaflet carefully before you start using this
medicine medicine because it contains important information for
you.





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 only. Do not pass it on to others. It
may harm them, even if their symptoms 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

In this leaflet
1.
2.
3.
4.
5.
6.
7.

What Ortho-Gynest pessaries are and what they are used for
What you need to know before you use Ortho-Gynest pessaries
Safety of HRT
How to use Ortho-Gynest pessaries
Possible side effects
How to store Ortho-Gynest pessaries
Contents of the pack and other information

1. What Ortho-Gynest pessaries are and what they are used for
The name of your medicine is Ortho-Gynest pessaries. This pack contains 15
pessaries.
Ortho-Gynest pessaries are solid, bullet-shaped pessaries (vaginal
suppositories). When inserted into the vagina they release a medicine called
estriol.
Estriol is a female hormone known as an oestrogen. It belongs to a group of
medicines called hormone replacement therapy (HRT).
What Ortho Gynest pessaries are used for
Ortho-Gynest pessaries are used for vaginal problems caused by a lack of the
hormone estrogen.
• Ortho-Gynest pessaries replace the hormone estrogen in the vaginal area
when your body is not producing enough
• This happens most often during or after the menopause (see ‘What is the
menopause?’ below)
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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’.
Ortho-Gynest is not a contraceptive. If it is less than 12 months since your last
menstrual period or you are under 50 years old, you may still need to use
additional contraception to prevent pregnancy. Speak to your doctor for advice

2. What you need to know before you use Ortho-Gynest
pessaries
Do not use Ortho-Gynest pessaries if:






You are allergic to anything in Ortho-Gynest pessaries (listed in section 7
below)
You have, or have ever had, or think you may have,breast cancer
You have, or are suspected of having a cancer that is made worse by
oestrogens (such as endometrial cancer)
You have a thickening of the lining of the womb which has not been treated

Page 2 of 12










You have ever had vaginal bleeding which you could not explain
You have ever had blood clots in a vein (thrombosis) or a blood clot that has
travelled to your lung (pulmonary embolism)
You have problems with your blood which increases the likelihood of developing
a blood clot (thrombosis) (such as protein C, protein S or antithrombin
deficiency)
You have ever had blocked arteries (arterial thrombo-embolic disease) that
gave you angina or a heart attack or resulted in a stroke
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)
You are pregnant or breast feeding

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 Ortho-Gynest pessaries. Stop using
Ortho-Gynest at once if any of the above appears for the first time and talk to your
doctor immediately.
Ortho-Gynest pessaries should not be used by children.
Warnings and precautions
Check with your doctor or pharmacist before using this medicine if:


You are using a ‘barrier’ method of contraception. This includes condoms or
diaphragms. This is because Ortho-Gynest pessaries 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 tummy, 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 (at least
every 6 to 12 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
these checks more often.
• A problem caused by growth of the womb lining:
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inside the womb (fibroids)
outside the womb (endometriosis)
thickening of the lining of the womb (endometrial hyperplasia)
Increased risk of blood clots (see ‘Blood clots’ in section 3 below)
A family history of increased risk of cancers related to estrogens (such as
having a mother, sister or grandmother who has had breast cancer) (see
‘Breast cancer’ in section 3 below)
High blood pressure (hypertension)
Diabetes
Gallstones
Migraine or severe headaches
Systemic lupus erythematosus (SLE). This is an allergic condition that causes
joint pain, skin rashes and fever
Epilepsy
Any breast problems
Asthma
A disease affecting the eardrum and hearing (otosclerosis)
Liver. heart or kidney problems
High levels of fat (triglycerides) in your blood as you may have a higher risk of
pancreatitis (inflammation of the pancreas, which causes severe pain in the
abdomen and back)
















Tell your doctor if these illnesses return or get worse while you are using OrthoGynest pessaries.
If you have had a premature menopause the risk of using HRT may be different.
Talk to your doctor about the risks.
Other medicines and Ortho Gynestl
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
Medicine for Hepatitis C infection called telaprevir
Bosentan - for high blood pressure in the blood vessels of the lungs
St. John’s Wort - for depression

Taking these medicines with Ortho-Gynest pessaries can stop the pessaries from
working as well as they should. This might lead to irregular bleeding
Page 4 of 12



A medicine for epilepsy called lamotrigine. Using Ortho-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 a 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 Ortho-Gynest pessaries. This is because this medicine may affect
the results 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. If you become
pregnant, stop taking Ortho-Gynest and contact your doctor
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.
Driving or using machines
There is no information about whether Ortho-Gynest pessaries affect your ability
to drive or use machines. See how this medicine affects you before you drive or
use any tools or machines.
Ortho-Gynest pessaries contain benzoic acid (E210) and butylated
hydroxytoluene (E321)
• . These can irritate your skin, eyes, eyelids, mouth and nostrils if they come
into contact with them

3. Safety of HRT
As well as benefits, HRT has some risks. You should consider the following
when deciding to take or continue HRT.
Heart disease
HRT is not recommended for women who have had heart disease recently. If
you have ever had heart disease, talk to your doctor to see if you should be
taking HRT.

Page 5 of 12

HRT will not help to prevent heart disease.
There is no evidence that HRT will prevent a heart attack. Women over the age
of 60 years who use oestrogen-progestogen 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.
If you get a pain in your chest that spreads to your arm and neck



See a doctor as soon as possible
Do not take any more HRT until your doctor says you can

This pain may be a sign of heart disease.
Stroke
Research suggests that HRT slightly increases the risk of having a stroke, about
1.5 times higher in HRT users than non-users. Other things that can 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 aged 50-59 years, 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 (an
extra 3 cases)

If you get migraine-type headaches which you cannot explain



See a doctor as soon as possible
Do not take any more HRT until your doctor says you can

These headaches may be an early warning sign of a stroke.

Page 6 of 12

Blood clots
HRT may increase the risk of blood clots in the veins, the risk is about 1.3 to 3
times higher (also called deep vein thrombosis, or DVT), 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.
You are more likely to get a blood clot if:












You are very overweight (BMI above 30 kg/m2)
You are taking medicine containing an oestrogen
You are getting older
You have cancer
You have just had a baby
You have had a blood clot before
Any of your close family have had blood clots 
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

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 aged 50-59 years, on average, over 5 years:




In women not taking HRT – between 4 and 7 in 1000 would be expected to
get a blood clot
In women who have had their womb removed taking oestrogen-only HT –
between 3 and 10 in 1000 would be expected to get a blood clot (an extra 1
case)
In women taking oestrogen-progestogen HRT – between 1 and 13 in 1000
would be expected to get a blood clot (an extra 5 cases)

If you get painful swelling in your leg, sudden chest pain or have difficulty
breathing
• See a doctor as soon as possible
• Do not take any more HRT until your doctor says you can

Page 7 of 12

These may be signs of a blood clot.
Breast cancer
Women who have breast cancer, or have had breast cancer in the past,
should not take HRT.
Taking HRT increases the risk of breast cancer. The risk is also slightly
increased if you have a later menopause.
• Postmenopausal women taking estrogen-only HRT for 5 years - the risk is
about the same as for a woman of the same age who is still having periods
over that time, and not taking HRT
For all kinds of 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 aged 50 to 79, on average, over the next 5 years:



In women not taking HRT – between 9 and 17 in 1000 will get breast cancer
In women taking estrogen-progestogen HRT at age 50 to 79 and take it for
5 years, between 13 and 23 in 1000 will get breast cancer (an extra 4-6
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 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 estrogen pessaries used for repeated treatments or over a
long time.
If you get breakthrough bleeding or spotting, it is usually nothing to worry
about, but you should:

Page 8 of 12

Make an appointment to see your doctor as soon as possible. It could be a
sign that your endometrium has become thicker.
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare, but it is serious. It can be difficult
to diagnose. This is because there are often no obvious signs of the disease.
There is a slightly increased risk of ovarian cancer has been reported in women
taking HRT for at least 5 to 10 years.
Dementia
Ortho-Gynest and medicines like it will not stop memory loss (dementia). Women
who start using medicines like Ortho-Gynest after the age of 65 may have a
small increase in the risk of dementia. Speak to your doctor for advice.

4. How to use Ortho-Gynest pessaries
Ortho-Gynest pessaries are for use in the vagina of adult women. The pessaries
melt quickly when placed in the vagina, forming a cream which mixes with the
normal vaginal secretions.
Always use this medicine exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Using the pessary
Unless your doctor tells you otherwise, you should:
• Start by using one Ortho-Gynest pessary in the evening
When your symptoms improve, your doctor may recommend that you:
• Use one Ortho-Gynest pessary every three or four days
Inserting the pessary
• Tear down the groove between two individually wrapped pessaries
• Remove one pessary from the plastic packet using the easy open tab (figure
1)




Lie down with your knees bent and spread apart
Push the pessary with your forefinger as far as you can into your vagina
(figure 2)
Page 9 of 12

2

When to stop using Ortho-Gynest pessaries
• See your doctor after 3 months to see if you need to continue treatment
• Ortho-Gynest pessaries should be used at the lowest dose and for the
shortest period of time for your symptoms
If you swallow Ortho-Gynest pessaries
If a pessary is eaten or swallowed, talk to a doctor or go to the nearest hospital
casualty department straight away.
If you forget to insert a pessary
If you forget to use an Ortho-Gynest pessary, insert one as soon as you
remember. Do not use more than one pessary on any one day.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

5. Possible side effects
Like all medicines, Ortho-Gynest pessaries can cause side effects, although not
everybody gets them.
Stop using Ortho-Gynest pessaries and tell your doctor straight away if
you notice or suspect any of the following. 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
• Blood clots (thrombosis), a heart attack or stroke (see section 3 ‘Safety of
HRT’ above for signs)
• Migraine-type headaches for the first time or more frequent
• Yellowing of the skin or whites of the eyes (jaundice), or other liver problems
• A large rise in your blood pressure (symptoms may be headache, tiredness
and dizziness)
• Breast cancer, endometrial cancer or ovarian cancer (long, heavy or irregular
vaginal bleeding) (see section 3 ‘Safety of HRT’ above)
Tell your doctor if you notice any of the following side effects while using
Ortho Gynest:
Page 10 of 12

Common (affects fewer than 1 in 10 people)











Tender or painful breasts
Feeling sick
Cystitis like symptoms (pain on passing urine)
Stomach pain
Muscle cramps and painful legs and arms
Discharge from the vagina
Vaginal itch
Vaginal burning sensation and discomfort
Being aware of your heart (palpitations)
Feeling depressed

Increased frequency of passing waterThe following side effects have been
reported in association with oestrogen/progestogen treatment
• Gall bladder disease
• Brown patches on your face or body (chloasma)
• Rash with target -shaped reddening or sores (erythema multiforme)
• Appearance of patches of darkened skin, small red marks on the skin, red
painful swellings (erythema nodosum)
• Bruising on the legs
• Loss of memory (Dementia) (see section 4.4)
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. Also tell them if any existing
conditions get worse while you are taking Ortho-Gynest. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
.
By reporting side effects you can help provide more information on the safety of
this medicine

6. How to store Ortho-Gynest pessaries
Keep this medicine out of the sight and reach of children. Store the pessaries in
their original packaging. Do not store above 30°C.
Do not use Ortho-Gynest pessaries:
• After the expiry date which is stated on the pack. The expiry date refers to
the last day of that month
• If the packaging has been damaged

Page 11 of 12

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.

7. Contents of the pack and other information
What Ortho-Gynest contains
Active substance
Each Ortho-Gynest pessary contains 0.5 mg of estriol.
Other ingredients
Ortho-Gynest also contains are benzoic acid (E210), butylated hydroxytoluene
(E321), polyethylene glycol, sorbitan monostearate and Witepsol S 55.
What Ortho-Gynest pessaries look like and contents of the pack
Ortho-Gynest pessaries are yellowish-white and bullet-shaped. They come in
packs of 15 pessaries.
Marketing authorisation holder:
Janssen-Cilag Limited
50 -100 Holmers Farm Way
High Wycombe, Bucks
HP12 4EG, UK
Manufacturer:
Janssen Pharmaceutica NV,
Turnhoutseweg 30,
B-2340 Beerse,
Belgium
OR
McGregor Cory Ltd, Middleton Close, Banbury,
Oxfordshire OX 16 4RS, UK

For information in large print, tape, CD or Braille, telephone 0800
7318450.
This leaflet was last revised in October 2013.

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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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