Before you take Ovestin Tablets
When you must not take it
Do not take Ovestin Tablets if:
you have or have ever had breast cancer, or if you are suspected of having it.
you are pregnant or think you may be pregnant
you have or if it is suspected that you have cancer which is sensitive to oestrogens, such as cancer of the lining of the
you have any unexplained vaginal bleeding, which has not been evaluated by your doctor
you have excessive thickening of the lining of your womb (endometrial hyperplasia) that is not being treated
you have or have had a blood clot (thrombosis in the veins of the legs (deep vein 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 had a disease caused by blood clots in the arteries such a heart attack, stroke or angina
you have or ever have had a liver disease and your liver function tests have not returned to normal
you have had an allergic reaction to oestriol, or any of the other ingredients of Ovestin
you have a rare blood problem called porphyria (an inherited or acquired disorder in the production of blood pigment).
Do not take Ovestin if you have an allergy to:
any medicine containing oestriol
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or troubled breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Take special care with Ovestin Tablets
As well as benefits, Ovestin Tablets have some risks which you need to consider when you are deciding to start or continue
Before you start taking Ovestin, your doctor should ask about your own and your family's medical history. Your doctor may
decide to examine your breasts and/or your abdomen, and may do an internal examination. You will also have periodic check-ups,
especially examinations of the breasts. Your doctor will tell you how often these tests should be performed.
Once you have started taking Ovestin Tablets, you should see your doctor for regular check-ups (at least once every year).
At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take Ovestin
Certain conditions may be made worse by hormone replacement therapy (HRT). If you have or have had any of the following conditions
and/or which were worse during pregnancy or with previous use of hormones tell your doctor who will monitor you closely:
uterine (womb) fibroids
clots in the blood vessels (thrombosis, deep vein thrombosis, lung embolism) or an increased risk of developing this
if anyone in your family has ever had an oestrogen-dependent cancer, such as a close relative who has had breast cancer or
cancer of the lining of the womb
high blood pressure
migraine or (severe) headache
systemic lupus erythematosus (SLE, an immune disorder affecting the skin and other organs)
endometrial hyperplasia (thickening of the lining of the womb)
otosclerosis (inherited deafness)
Tell your doctor if you notice any change in your condition while using Ovestin.
Reasons for immediately stopping Ovestin Tablets:
jaundice (your skin goes yellow)
a sudden increase in blood pressure
if you get a migraine, or severe headaches, for the first time
Effects on your risk of developing cancer
Every woman is at a small risk of getting endometrial cancer (cancer of the lining of the womb), whether or not HRT is used.
The risk of cancer of the lining of the womb increases with the duration of treatment.
Breakthrough bleeding or spotting may occur during the first few months of taking Ovestin.
Tell your doctor if the bleeding or spotting:
carries on for more than the first few months
starts after you have been on Ovestin for a while
carries on even after you have stopped taking Ovestin.
Women who have breast cancer, or have had breast cancer in the past, should not take Ovestin.
Taking oestrogen or oestrogen-progestogen combined HRT or Ovestin for several years slightly increases the risk of breast
cancer. The risk increases with the duration of use and returns to normal within about five years after stopping HRT. Women
using combined HRT have a slightly greater risk of developing breast cancer than women using oestrogen-only HRT.
It is not known whether Ovestin is associated with the same higher risk of breast cancer as other HRT.
Be sure to 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.
Ovarian cancer (cancer of the ovaries) is very rare, but it is a serious condition. It can be difficult to diagnose, because
there are often no obvious signs of the disease.
Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer.
It is not yet known whether other kinds of HRT or Ovestin increase the risk in the same way.
Effects on your heart or circulation
Blood clots (thrombosis)
All women have a very small chance of having a blood clot in the veins of the leg, lungs or other parts of the body. Using
some forms of HRT may slightly increase this small chance. It is unknown if Ovestin increases the risk in the same way.
These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse
or even death. This condition is called pulmonary embolism.
You are more likely to have a blood clot if:
you are older
you are pregnant or have recently had a baby
you have one or more miscarriages
you use oestrogens
you are seriously overweight
you have had a blood clot before in the leg, lung or another organ
blood clots run in your family
you have any blood clotting problem that needs treatment with a medicine such as warfarin
you have systemic lupus erythematosus (a disease of your immune system)
you are unable to move for long periods, for example after a long illness or major operation
you have cancer.
If any of these apply to you, you should talk to your doctor about whether you should use Ovestin Tablets.
If you get a blood clot while you are using Ovestin Tablets you should stop taking it immediately and contact your doctor.
See a doctor as soon as possible if you get:
painful swelling in your leg
sudden chest pain
These may be signs of a blood clot.
Tell your doctor and your surgeon if you are to be hospitalized or undergo surgery.
You may need to stop taking Ovestin about 4-6 weeks before the operation, to reduce the risk of a blood clot. Your doctors
will tell you when you can start using Ovestin again.
Ovestin is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart
disease, talk to your doctor to see if you should be taking Ovestin.
Ovestin will not help to prevent heart disease.
Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly
more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely
to be similar, although this is not yet certain.
If you have symptoms that might indicate that you have a heart disease (such as pain in your chest that spreads to your arm
or neck), see a doctor as soon as possible. Do not take any more HRT until your doctor says you can.
Recent research with one type of HRT (containing conjugated estrogen plus the progestogen MPA) has shown a slight increase
in the risk of having a stroke.
If you have symptoms that might indicate that you have a stroke (such as unexplained migraine-type headaches, with or without
disturbed vision), see a doctor as soon as possible. Do not take any more Ovestin until your doctor says you can.
It is not known if there is an increased risk of dementia when taking Ovestin.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from
your pharmacy, supermarket or health food shop.
Other medicines may influence the effects of oestriol, or oestriol may affect other medicines. These include:
anticoagulants (medicines to stop blood clots);
corticosteroid hormones (includes many anti-asthmatic drugs);
succinylcholine (medicine for muscle relaxation);
theophyllines (medicine for asthma);
medicines for epilepsy (such as barbiturates (phenobarbital), hydantoins (phenytoin) and carbamazepine);
medicines for fungal or bacterial infections (such as griseofulvin, rifamycins (rifampicin, rifabutin); troleandomycin);
medicines for viral infections (nevirapine, efavirenz, ritonavir, nelfinavir)
herbal preparations containing St John's wort (Hypericum Perforatum)
Tell your doctor if you are pregnant.
Ovestin Tablets should not be taken.
Tell your doctor if you are breast-feeding.
Small amounts of the active oestriol can be excreted in the breast milk and milk production could also be reduced.
Tell your doctor if you react badly to lactose or milk before you start taking Ovestin.
Ovestin Tablets contain lactose.
Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking Ovestin Tablets.
The medicine helps most women with menopausal symptoms, but it may have unwanted side effects in a few people. All medicines
have side effects. Sometimes they are serious, most of the time they are not.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Dependent on dosage and sensitivity of the patient, Ovestin may cause side effects, such as:
swelling and increased tenderness of the breasts
increased vaginal discharge
fluid retention in the tissues, usually marked by swollen ankles or feet.
In most patients these side effects will disappear after the first weeks of treatment. Tell your doctor if vaginal bleeding
occurs or if any side effect becomes troublesome or persists.
Other side effects which may occur with HRT:
benign and malignant hormone-dependent tumours such as endometrial cancer
heart attack and stroke
gall bladder disease
skin problems such as rashes, discolouration or red patches on the skin
various skin diseases with blisters and nodules or bleeding into the skin
venous thromboembolism or deep leg or pelvic venous thrombosis and pulmonary embolism (see Before you take Ovestin Tablets)
using HRT for several years slightly increases the risk of breast cancer.
Tell your doctor or pharmacist if you notice any side effects not mentioned in this leaflet.