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<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
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Ovestin Cream
</HEAD>

<DIV type=1>

<HEAD weight="bold" >
What you should know about your medicine
</HEAD>


<BLOCK>
This leaflet has been written to help you use your medicine properly. If you have any questions or worries, ask your doctor or a pharmacist. At the end of the leaflet you will find a list of things to remember about your medicine.
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<BLOCK>
Keep the leaflet until you have finished your medicine. You may want to read it again.
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<HEAD weight="bold" >
What is Ovestin Cream?
</HEAD>


<BLOCK>
The name of your medicine is Ovestin Cream. Ovestin Cream contains 1 milligram (mg) of the active ingredient 
<EMPH weight="bold">
oestriol
</EMPH>
 in each gram of cream.
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<BLOCK>
It also contains chlorhexidine hydrochloride, eutanol G, cetyl palmitate, glycerin, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan monostearate, lactic acid, sodium hydroxide, and purified water.
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<BLOCK>
Ovestin Cream is a white cream.
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<BLOCK>
There are 15 gm of cream in each tube.
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<HEAD weight="bold" >
Ovestin Cream is one of a group of medicines called
</HEAD>


<BLOCK>

<EMPH weight="bold">
Hormone Replacement Therapy (HRT).
</EMPH>

</BLOCK>


<BLOCK>

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The product licence is held by:
</EMPH>
 Organon Laboratories Ltd, Science Park, Cambridge CB4 4FL.
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<BLOCK>

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Ovestin Cream is made by:
</EMPH>
 Organon (Ireland) Ltd, Drynham Road, Dublin, Ireland.
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<HEAD weight="bold" >
What is Ovestin Cream used for?
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<BLOCK>
Ovestin Cream is used to treat vaginal complaints that are caused by having too little oestrogen.
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<BLOCK>
It can also be used before or after vaginal surgery.
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<HEAD weight="bold" >
Before you use the cream
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<ITEM>

<BLOCK>
Do you think you may be pregnant?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you breast-feeding?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Have you had a thrombosis (a blood clot)?
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</ITEM>


<ITEM>

<BLOCK>
Have you had tumours of the breast or other sex organs?
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</ITEM>


<ITEM>

<BLOCK>
Have you had unexplained vaginal bleeding?
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</ITEM>


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<BLOCK>
Have you had liver disease (such as Rotor syndrome or Dubin-Johnson syndrome) or jaundice when you were pregnant?
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</ITEM>


<ITEM>

<BLOCK>
Do you have porphyria (a metabolic disorder)?
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</ITEM>


<ITEM>

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Do you have a heart or circulation disease?
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</ITEM>


<ITEM>

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Do you have too much cholesterol or other fatty substances in the blood?
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</ITEM>


<ITEM>

<BLOCK>
During pregnancy or while taking steroids have you had a skin rash (herpes gestationis), severe itching or a hearing problem?
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
If the answer to any of these questions is YES:
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<ITEM>

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 Did you tell your doctor at the last visit or an earlier visit?
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<ITEM>

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 If you did NOT then you should do so as soon as possible and before using the cream.
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</ITEM>

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<BLOCK>
Even so, your doctor may still want you to use it.
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<HEAD weight="bold" >
What do I need to know before using my medicine?
</HEAD>


<BLOCK>
If you have a vaginal infection, your doctor may also prescribe a medicine to treat the infection.
</BLOCK>


<BLOCK>
While you are taking Ovestin Cream regular medical checks by a doctor are recommended. Sometimes a tissue examination (cervical smear) will be necessary.
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<BLOCK>
Your doctor may want you to stop using the cream from time to time to check if you still need to use it. Using oestrogens for a very long time may increase the chance of tumours of the lining of the womb very slightly.
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<BLOCK>
If you are having an operation (apart from a vaginal operation) you should stop using the cream about 6 weeks before. Don't start using the cream again until you are fully mobile.
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<EMPH weight="bold">
Extra supervision
</EMPH>
 by your doctor may be necessary in some cases.
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<BLOCK>
Tell your doctor if you have ever had:
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<ITEM>

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a disease of the heart or circulation
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</ITEM>


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<BLOCK>
high blood pressure
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</ITEM>


<ITEM>

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migraine headaches; - epilepsy; - liver disease such as jaundice; - kidney disease; - endometriosis (a disorder of the womb lining); <CB n=2>
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
lumps in the breast
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
diabetes.
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</ITEM>

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<HEAD weight="bold" >
What other medicines are you taking?
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<BLOCK>
Other medicines may affect how Ovestin Cream works or it may affect how they work. Tell your doctor if you are taking (or intend to take) any other medicines.
</BLOCK>


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<HEAD weight="bold" >
How do I use Ovestin Cream?
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<BLOCK>
It is important to use this medicine only as directed by your doctor or pharmacist.
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<HEAD weight="bold" >
How much
</HEAD>


<BLOCK>
For 
<EMPH weight="bold">
vaginal complaints
</EMPH>
 the usual dose is 1 applicator dose (0.5 mg oestriol in 0.5 g of cream) a day for the first 2 to 3 weeks. Then the dose is 1 applicator-dose twice a week.
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<BLOCK>
Your doctor may want you to stop from time to time (every 2 to 3 months), to check if you still need treatment.
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<BLOCK>
Before 
<EMPH weight="bold">
vaginal surgery
</EMPH>
 the dose is 1 applicator-dose (0.5 mg oestriol in 0.5 g of cream) a day for 2 weeks before the operation. After the operation do not use the cream again for at least 2 weeks.
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<BLOCK>
Keep using this medicine as prescribed by your doctor. Do not stop just because you seem to be better. If you stop too early or too suddenly your complaints may return.
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<HEAD weight="bold" >
How to apply the cream
</HEAD>


<BLOCK>
Use the applicator to apply the cream in the vagina. It as a good idea to do this before going to bed.
</BLOCK>


<BLOCK>
One application contains 0.5 mg of oestriol.
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<LIST type="ordered">

<ITEM>

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Remove cap from the tube, invert it, and use the sharp point to open the tube.
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</ITEM>


<ITEM>

<BLOCK>
Screw the end of the applicator onto the tube.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Squeeze tube to fill the applicator with the cream until the plunger stops (at the ring mark).
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</ITEM>


<ITEM>

<BLOCK>
Unscrew applicator from tube and replace cap on tube.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
To apply the cream, lie down, insert the end of the applicator deep into the vagina and slowly push plunger all the way in.
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</ITEM>

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<BLOCK>
After use, pull plunger out of barrel and wash both in warm, soapy water. Do not use detergents. Rinse well afterwards.
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<BLOCK>
DO NOT  PUT THE APPLICATOR IN HOT OR BOILING WATER.
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<BLOCK>

<EMPH weight="bold">
What to do if Ovestin Cream is swallowed accidentally or if too much is taken at one time
</EMPH>

</BLOCK>


<BLOCK>
If someone has swallowed some cream by accident, or too much cream is applied at any time, there is no need to worry. However, you should consult a doctor. The person may feel sick or be sick. Women may have some vaginal bleeding after a few days.
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<HEAD weight="bold" >
What if I miss a dose?
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<BLOCK>
Apply the missed dose when you remember, unless you are more than 12 hours late. If you are more than 12 hours late just skip the missed dose.
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What about side-effects?
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<BLOCK>
Ovestin Cream sometimes causes side effects in some people.
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These usually settle down during treatment as the body adjusts to the medicine.
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<ITEM>

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If you have any of these side effects, tell your doctor. He may decide to stop your treatment for a while.
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</ITEM>

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<BLOCK>
When you start to use the cream you may have irritation or itching. Sometimes the breasts become swollen, tender or painful. Tell your doctor if vaginal bleeding occurs. Tell your doctor about any problems that you think might be caused by the cream.
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<HEAD weight="bold" >
How should you store this medicine?
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<BLOCK>
Do not use this medicine after the "use by" date on the pack.
</BLOCK>


<BLOCK>
Store the cream at room temperature (15-25C). Keep the cream in the original box where children cannot see or reach it.
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<BLOCK>
This information was written in September 1995.
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</DIV>
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<HEAD weight="bold" >
More about Ovestin Cream
</HEAD>


<BLOCK>
Ovestin Cream contains oestriol, one of the natural female sex hormones (oestrogens or estrogens).
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<BLOCK>
Oestrogens are produced in the ovaries. They cause sexual development in women and control the menstrual cycle during the childbearing years. When women get older the ovaries gradually produce less oestrogen. This happens at the menopause (usually around the age of 50). If the ovaries are removed surgically (ovariectomy) before the menopause, oestrogen production stops very suddenly.
</BLOCK>


<BLOCK>
Shortage of oestrogens may cause the vaginal wall to become thin and dry. So sexual intercourse may become painful and vaginal infections may occur.
</BLOCK>


<BLOCK>
These complaints can be relieved by using medicines containing oestrogen. However it may take several days or weeks before you notice an Improvement.
</BLOCK>


<BLOCK>
Ovestin cream may also be prescribed to help wound healing after vaginal surgery. Unlike most oestrogens, oestriol has little effect on the inner lining <CB n=2> of the womb. So Ovestin Cream usually does not cause vaginal bleeding.
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<BLOCK>
Ovestin cream is easy to remove with water.
</BLOCK>


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<HEAD weight="bold" >
General things to remember about medicines
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<ITEM>

<BLOCK>
This medicine has been prescribed for your current medical problem. Do not use it for other medical problems.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do not allow other people to use your medicines and do not use medicines meant for other people.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Tell any doctor treating you what medicines you are taking. Always carry a medical information card stating which medicines you are taking. This can also be very important in case you are involved in an accident.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Return unused medicines to the pharmacy for disposal.
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<BLOCK>
Make sure that other people you may live with or who look after you read this information.
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