Ovestin Vaginal Cream 15g
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General Information
Consumer Medicine Information

Organon (Australia) Pty Limited
Lane Cove NSW 2066
Before this medicine is inserted, please read this page carefully. Below on this page you will find more information about Ovestin Cream, as well as some general advice on using medicines. If you have any questions or you would like further information, please ask your doctor or pharmacist.

What is in this leaflet
What Ovestin Cream is used for

Before using Ovestin Cream

Using Ovestin Cream

While you are using Ovestin Cream

Side effects

After using Ovestin Cream

Product Description
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. Keep this information handy. You may wish to read it again
What Ovestin Cream is used for
Ovestin Cream is used in Hormone Replacement Therapy in women. It contains Oestriol. Oestriol is one of the female hormones, called oestrogens, that your body makes. During and after the change of life (menopause) the oestrogen production by your body decreases. This decrease may lead to hot flushes, vaginal irritation, recurrent urinary tract infections and urinary incontinence. Ovestin Cream 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 even into the bloodstream.

Before using Ovestin cream
Ovestin Cream may not be suitable for you if you suffer or have suffered from certain medical conditions.

You must tell your doctor if you answer YES to any of the following questions:

are you pregnant or do you think you may be pregnant?
do you have or have you ever had, a tumour (eg. a tumour in your breast or womb)?
do you have or have you had endometriosis (abnormal growth of the inner lining of the womb outside the womb)?
have you recently had unexpected vaginal bleeding?
do you have affected hearing (otosclerosis) during pregnancy or previous use of hormones
do you have a rare metabolic liver disease called porphyria, or any other liver disease?
do you have inflammation of a vein usually with a clot (thrombophlebitis), most commonly in a leg?
do you have disturbed lipid metabolism, particularly with other cardiac problems?
do you have or have you had in the past 2 years a stroke or a blood clot (thrombus) in a vein or a blood clot that has travelled to your lung?
have you ever had recurrent venous thromboembolism or do you have a thrombophilic (blood clotting) disease, which is not being treated with anticoagulant drugs?
You must also tell your doctor if you have or have ever had:

high blood pressure;
factors associated with a higher risk to develop blood clots (eg. diabetes, smoking, overweight, varicose veins, prolonged bed rest, immobilisation due to eg. planned surgery);
disease or symptoms that may be aggravated during pregnancy or previous use of hormones such as severe itching, yellowing of the eyes or skin (jaundice), skin rash (herpes gestationis), migraine or severe headache, or chloasma (brown, blotchy spots on skin exposed to the sun that may appear during pregnancy);
uterine fibroids
diabetes, severe migraine, epilepsy, asthma, fibrocystic mastopathy, significant cardiac or renal dysfunction
metabolic bone disease
Breast cancer

Before starting with hormone replacement therapy (HRT) you have to inform your doctor of your personal and family medical history. You will get a general and gynaecological examination. You will also get periodic check-ups, especially examinations of the breasts. Every woman is at risk of getting breast cancer, whether or not she takes HRT. Breast cancer has been found slightly more often in women using HRT than in women of the same age who have never used 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.

Stroke It is not known if there is an increased risk of stroke when using this product.

Ovarian Cancer It is not known if there is an increased risk of ovarian cancer when using this product.

Dementia It is not known if there is an increased risk of dementia when using this product.

All women have a very small chance of having a blood clot in the veins of the leg, lung or other parts of the body whether or not they take HRT. Using some forms of HRT may slightly increase this small chance. Whether or not Ovestin may increase the chance of having a blood clot is not known.

You are more likely to have a blood clot (whether or not you use HRT) if:

you are very overweight
you have had a blood clot in the veins of your legs or in your lungs before
blood clots run in your family
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
maybe also if you have varicose veins.
If any of these apply to you, you should talk to your doctor about whether you should use Ovestin.

If an operation is planned, which is likely to keep you off your feet for some time, you should talk to your doctor as you may need to stop using Ovestin four to six weeks before the operation.

If you get a blood clot while you are using Ovestin you should stop taking it immediately and contact your doctor. Warning signs to look out for are:

unusual pains or swelling of your legs
pain in your chest or sudden shortness of breath
If you have a vaginal infection, your doctor will also prescribe a medicine to treat the infection.

If you are pregnant, or think that you may be pregnant, Ovestin Cream should not be inserted.

If you are breast-feeding, tell your doctor before Ovestin Cream is inserted. Small amounts of the active oestriol can be excreted in the breast milk. Milk production could also be reduced.

Using Ovestin Cream
Ovestin Cream is intended to be put in the vagina. Each dose of cream contains 0.5 mg oestriol. Your doctor will usually prescribe this product in the doses listed below. However your doctor may well prescribe different quantities for certain patients.

For vulvo-vaginal complaints associated with the menopause - initially one dose of cream per day for 3 weeks. Later you may only need one dose of cream twice a week.
Before surgery - (one dose of cream daily) beginning 2 weeks before the operation.
When having a PAP smear your doctor may recommend a daily application of cream for 7 days.
Your doctor may ask you to stop using Ovestin every 2 to 3 months for 4 weeks to check the need for further treatment.

If an unexpected vaginal bleed occurs, you should contact your physician.

How the Cream is inserted.
Administered intravaginally by means of the supplied applicator.

One applicator-dose filled only to the embossed mark is 0.5 g of Ovestin Cream.

Do not completely fill the whole applicator.

Each tube of Ovestin cream contains enough for 30 doses

The cream should be used before going to sleep at night.

Remove the cap from the tube; invert it and use the sharp point to open the tube.
Screw the end of the applicator onto the tube.
Squeeze the tube to fill the applicator to the ring-mark (where the plunger stops).
Unscrew the applicator from the tube and replace the cap.
To apply the cream, lie down, insert the applicator deep into the vagina and slowly push the plunger all the way in.
After use, pull the plunger out of the barrel, wash both parts in warm, soapy water. Do not use detergents. Rinse well, dry and reassemble.

Do NOT put the applicator in hot or boiling water.

What to do if you miss a dose. If you forget to administer a dose, administer it as soon as you remember, unless you notice the missed dose at the day of your next dose. If you notice the missed dose at the day of your next dose, do not administer the missed dose, and just carry on with the next dose as normal. Never administer two doses on the same day.

What to do if someone has swallowed some cream accidentally

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; in females vaginal bleeding may occur after a few days.

While you are using Ovestin Cream
Ability to drive or operate machinery.
As far is known, this medicine has no adverse effect on alertness and concentration.

Other medicines may influence the effects of oestriol, or oestriol may affect other medicines. You must tell your doctor or pharmacist if you are taking (or intend to take) other medicines such as:

anticoagulants (medicines to stop blood clots);
corticosteroid hormones (includes many anti-asthmatic drugs);
succinylcholine (medicine for muscle relaxation);
theophyllines (medicine for asthma);
barbiturates, including primodone, carbamazepine, and hydantoins (medicines for epilepsy or sleeplessness);
medicines for fungal or bacterial infections;
medicines to control blood sugar levels (for diabetes).
If you wish to discuss any aspect of the product further, you may speak with your doctor or pharmacist.

Side Effects of Ovestin Cream
At the beginning of treatment local irritation or itching may occur. Dependent on dosage and your sensitivity, swelling and increased tenderness of the breasts may occasionally occur. In most patients these side-effects go away with continued use.

Side-effects which are generally attributed to female hormones and which may possibly occur during Ovestin Cream therapy are: vaginal bleeding; breast complaints; nausea; gall stones; yellowing of the eyes or skin (jaundice); thrombosis (blood clots); rise of blood pressure; brown, blotchy spots on exposed skin (chloasma); redness of the skin (erythema); rash; discomfort of the eyes if contact lenses are used; headache; migraine; mood swings; swelling of ankles or feet; change in body weight. HRT even with Ovestin may increase the risk of acquiring blood clots.

Tell your doctor if vaginal bleeding occurs, or if any side effect becomes troublesome or continues. It is also important to tell your doctor or pharmacist if you experience any other unusual or unexpected symptoms during treatment with Ovestin Cream.

HRT may increase the risk of venous thromboembolism.

Seek advice from your doctor or pharmacist before using other medications to deal with any side effects you may be experiencing.

See the section "Before using Ovestin".

After Using Ovestin Cream
3 years when stored below 300 deg C.

Keep in a safe place out of reach of children. Check if there are special storage conditions given on the box. The expiry date (sometimes written as "exp") is printed on the pack- do not use after this date.

Do not use if the product does not look quite right.

Product Description
What it looks like.

Ovestin cream is a white water emulsion which also contains octyldodecanol, cetyl esters wax, glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan monostearate, lactic acid, chlorohexidine hydrochloride and sodium hydroxide.

The box contains a tube with 15 g cream (1 mg/g of oestriol), an applicator and a patient-instruction leaflet.

Manufactured by:
Organon (Ireland) Limited
Swords, Dublin, Ireland
Distributed by:
Organon (Australia) Pty Limited
Lane Cove, NSW, 2066

Australian Registration Number: Aust R 14515

General advice

1. This medicine has been prescribed only for your current medical problem. It should not be used for other medical conditions.
2. Never give your medicine to anyone else and do not use medicines meant for other people.
3. Tell every doctor treating you what medicines you are taking. Always carry a medical information card stating which medicines you are using. This can be very important if for example you are involved in an accident.
4. Return unused medicines to your pharmacy for disposal.
5. Make sure that other people who live with you or who look after you read this information
Prepared September 2004
The information supplied relates only to Ovestin Cream and should not be used in relation to any other product which may also contain the same active ingredients. For further information please ask your doctor or pharmacist.

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