Ovestin Ovula®

Oestriol 0.5 mg per pessary

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Ovestin Ovula.

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 Ovula 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

What Ovestin Ovula are used for

Ovestin Ovula contains the natural female hormone oestriol. During and after menopause, the production of oestrogen by the body decreases. This decrease may lead to hot flushes, vaginal irritation, recurrent urinary tract infections and urinary incontinence. Ovestin Ovula can be prescribed for the loss of oestrogen production by your body. 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.

Before you use Ovestin Ovula

When you must not use it

Do not use Ovestin Ovula if:

• you have or have had breast cancer, or if breast cancer is suspected
• you are pregnant or think you may be pregnant
• you have or if it is suspected that you have an oestrogen-dependent tumor, such as cancer of the lining of the womb
• you have abnormal vaginal bleeding, which has not been evaluated by your doctor
• you have abnormal growth of the lining of your womb (endometrial hyperplasia)
• you have or have had a blood circulation disorder such as blood clots (in the veins of the legs or in the lungs)
• you have a blood clotting disorder (thrombophilic 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 as angina pectoris, stroke or a heart attack
• you have or have had liver disease as long as the function of the liver has not returned to normal
• you have had an allergic reaction to oestriol, or any of the other ingredients of Ovestin
• you have porphyria (an inherited or acquired disorder in the production of blood pigment)

Do not use 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.

Take special care with Ovestin Ovula

As well as benefits, Ovestin has some risks which you need to consider when you are deciding to start or continue treatment.

Medical check-ups
Before you start using Ovestin Ovula, 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 Ovula, 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:

• uterine (womb) fibroids
• endometriosis
• 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
• heart disease
• liver disorders
• kidney disorders
• diabetes
• gallstones
• 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)
• epilepsy
• asthma
• otosclerosis (inherited deafness)

Tell your doctor if you notice any change in your condition while using Ovestin.

Reasons for immediately stopping Ovestin Ovula:

• jaundice (your skin goes yellow)
• a sudden increase in blood pressure
• if you get a migraine, or severe headaches, for the first time
• pregnancy

Effects on your risk of developing cancer

Endometrial 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 using 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 using Ovestin.

Breast cancer
Women who have breast cancer, or have had breast cancer in the past, should not use Ovestin Ovula.

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
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 had 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 had 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 Ovula.

See a doctor as soon as possible and do not use any more Ovestin Ovula if you get:

• painful swelling in your leg
• sudden chest pain
• difficulty breathing

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.

Stroke
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 use any more Ovestin until your doctor says you can.

Dementia
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 Ovula during breast-feeding. Small amounts of the active oestriol can be excreted in the breast milk and milk production could also be reduced.

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, hydantoins and carbamazepine)
• medicines for fungal or bacterial infections (such as griseofulvin, rifamycins; troleandomycin)
• medicines for viral infections (nevirapine, efavirenz, ritonavir, nelfinavir)
• herbal preparations containing St John's wort (Hypericum Perforatum)

How to use Ovestin Ovula

How much to use

For vaginal complaints the usual dosage is one pessary daily during the first weeks. Later on the dose is gradually decreased to, for instance, one pessary twice a week. For other conditions, a different dosage may be prescribed.

Each pessary contains 0.5 mg oestriol.

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:

• initially one pessary per day for 3 weeks
• later you may only need one pessary twice a week.

Before surgery:

• one pessary daily beginning 2 weeks before the operation.

When having a Pap smear your doctor may recommend a daily insertion of 1 pessary for 7 days.

How to insert a pessary

The pessary should be inserted into the vagina before retiring at night.

You may need to moisten your first few pessaries with water before insertion if you are particularly dry and insertion feels uncomfortable.

1. Remove one pessary from its wrapper.
2. Either using a squatting position or lying on your back or side, insert the pessary deeply into the vagina.

If you forget to use it

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 pessaries as you would normally.

If you use too much (overdose)

If you may have used more Ovestin than you should, talk to a doctor or pharmacist.

If someone has swallowed a pessary, 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.

While you are using Ovestin Ovula

Things you must do

If you become pregnant while using Ovestin, tell your doctor immediately.

It should not be used while you are pregnant.

Conduct monthly self-examination of your breasts. Your doctor or nurse can show you how to check your breasts properly. If you notice any changes to your breasts, see your doctor.

If you are about to be started on any new medicine, remind your doctor or pharmacist that you are using Ovestin pessaries.

Tell any other doctor, dentist or pharmacist who treats you that you are using Ovestin.

Things you must not do

Do not use Ovestin pessaries to treat any other complaints unless your doctor tells you to.

Do not give Ovestin to anyone else, even if their symptoms seem to be the same as yours.

Side Effects of Ovestin Ovula

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Ovestin Ovula.

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:

• local irritation or itching
• swelling and increased tenderness of the breasts

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 tumors 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 use Ovestin Ovula)
• 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.

After Using Ovestin Ovula

Storage

Keep your Ovestin Ovula in a safe place out of the reach of children.

Keep your Ovestin Ovula in the original package in a cool dry place where the temperature stays below 25°C. Avoid excessive heat: the pessary will melt at temperatures above 32°C.

Do not use after the expiry date stated on the blister and outer box.

Product Description

What it looks like

Packs contain 3 blister strips, each strip contains 5 pessaries. Ovestin Ovula are white, torpedo shaped pessaries.

Do not use the product if the blister pack or pessaries are damaged or appear unusual.

Ingredients

Ovestin Ovula contains 0.5 mg of oestriol as the active ingredient.

It also contains:

• hard fat
• cetomacrogol 1000
• glyceryl ricinoleate

Distributor

Merck Sharp & Dohme
(Australia) Pty Limited
54-68 Ferndell Street
South Granville NSW 2142
Australia

AUST R 35632

This leaflet was prepared in November 2011

Published by MIMS/myDr March 2012

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