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Oestriol 0.1% (1 mg per g)
Consumer Medicine Information
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.
This leaflet answers some common questions about Ovestin Cream.
It does not contain all of the available information and it does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using Ovestin Cream against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ovestin Cream is a Hormone Replacement Therapy (HRT). It contains the female hormone oestriol (an oestrogen). Ovestin is used in postmenopausal women with at least 12 months since their last natural period. Ovestin is used for relief of symptoms occurring after menopause. During menopause, the amount of oestrogens produced by a woman's body gradually drops. If the ovaries are removed surgically (ovariectomy) before menopause, the decrease in oestrogen production occurs very abruptly. The shortage of oestrogens during menopause may cause the vaginal wall to become thin and dry. As a result, sexual intercourse may become painful and vaginal itching and infections may occur. Oestrogen deficiency may also lead to symptoms like urinary incontinence and recurrent cystitis. Ovestin alleviates these symptoms after menopause. It may take several days or even weeks before you notice an improvement. You will only be prescribed Ovestin if your symptoms seriously hinder your daily life. In addition to the above uses, Ovestin Cream may also be prescribed to improve wound healing in postmenopausal women undergoing vaginal surgery or help assess cervical smears taken from postmenopausal women. After insertion into the vagina, oestriol is slowly released and absorbed into the surrounding area and into the bloodstream.
A doctor's prescription is required to obtain this medicine.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Do not use Ovestin Cream if:
Do not use Ovestin Cream if you have an allergy to:
Some of the symptoms of an allergic reaction may include:
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Ovestin Cream contains cetyl alcohol and stearyl alcohol. This may cause local skin reactions (e.g. contact dermatitis).
As well as benefits, Ovestin has some risks which you need to consider when you are deciding to start or continue treatment.
Before you start using Ovestin Cream, 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 using Ovestin Cream, 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 use 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:
Tell your doctor if you notice any change in your condition while using Ovestin.
Reasons for immediately stopping Ovestin Cream:
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 using Ovestin.
Tell your doctor if the bleeding or spotting:
Women who have breast cancer, or have had breast cancer in the past, should not use Ovestin Cream.
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 chance of having breast cancer diagnosed as other hormone replacement therapies.
Nevertheless, if you are concerned about the risk of breast cancer, discuss the risk compared to the benefits of treatment with your doctor.
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.
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:
If any of these apply to you, you should talk to your doctor about whether you should use Ovestin Cream.
See a doctor as soon as possible and do not use any more Ovestin Cream if you get:
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 using 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.
Recent research with one type of HRT (containing conjugated oestrogen 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 use any more Ovestin until your doctor says you can.
It is not known if there is an increased risk of dementia when using Ovestin.
Tell your doctor if you are pregnant. Ovestin should not be used.
Tell your doctor if you are breast-feeding. There is insufficient information on the use of Ovestin Cream during 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 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 interfere with the effects of oestriol, or oestriol may affect other medicines. This might lead to irregular bleeding. These include:
For vaginal complaints, the usual dosage is 1 application daily during the first weeks. Later on the dose is gradually decreased to, for instance, 1 application twice a week. Each dose of cream contains 0.5 mg oestriol. However your doctor may well prescribe different quantities for other conditions.
Your doctor may ask you to stop using Ovestin every 2 to 3 months for 4 weeks to check the need for further treatment.
For vulvo-vaginal complaints associated with menopause:
When having a Pap smear your doctor may recommend a daily application of cream for 7 days.
Use the applicator to apply the cream into the vagina.
It is a good idea to do this before retiring/going to sleep at night.
One application (applicator filled to the ring mark) contains 0.5 g of Ovestin cream, which contains 0.5 mg oestriol.
Do not completely fill the whole applicator.
Discard the applicator once the tube is empty.
If you forget a dose, use it as soon as you remember. But if you remember your missed dose at the time of your next dose, do not use an extra dose.
Do not use a double dose to make up for the missed dose. This may increase the chance of you getting an unwanted side effect.
Then go back to using the cream as you would normally.
If you may have used more Ovestin than you should, talk to a doctor or pharmacist.
If someone has swallowed some cream, there is no need for great concern. However, you should consult a doctor. Symptoms that may arise are nausea and vomiting. Vaginal bleeding in females may occur after a few days.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Ovestin Cream. 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 sometimes cause side effects, such as:
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:
Tell your doctor or pharmacist if you notice any side effects not mentioned in this leaflet.
Keep your Ovestin Cream in a safe place out of the reach of children.
Keep your Ovestin Cream in the original package in a cool dry place where the temperature stays below 30°C.
Do not use after the expiry date stated on the tube and outer box.
Do not use if the product does not look quite right.
Ovestin Cream is a homogeneous, smooth, white to nearly white mass of creamy consistency. Ovestin cream is filled in a collapsible tube of 15 g. Each tube is packed together with a CE-marked applicator and a patient-instruction leaflet.
Do not use the product if the pack or cream is damaged or appears unusual.
Ovestin Cream contains 0.5 mg of oestriol in each 0.5 g dose as the active ingredient.
It also contains:
Merck Sharp & Dohme (Australia) Pty Limited
54-68 Ferndell Street
South Granville NSW 2142
AUST R 14515
Manufacturer of the Ovestin Applicator:
Organon (Ireland) Ltd.
P.O. Box 2857
This leaflet was prepared in
Published by MIMS April 2014
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