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

<DIV type=1>

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What you should know about your medicine
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<BLOCK>
This leaflet has been written to help you take 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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Keep the leaflet until you have finished your medicine. You may want to read it again.
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<HEAD weight="bold" >
What are Oestradiol Implants
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<BLOCK>
The name of your medicine is Oestradiol Implants. Each Oestradiol Implant contains 25, 50 or 100 milligram (mg) of the active ingredient 
<EMPH weight="bold">
oestradiol
</EMPH>
 (estradiol).
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<BLOCK>
There are no other ingredients in the implants.
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<BLOCK>
Oestradiol Implants are pellets of pure oestradiol and are sold in a glass ampoule. Each implant is packed in a cardboard box.
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The Oestradiol Implant is one of a group of medicines called Hormone Replacement Therapy (HRT)
</EMPH>
.
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The product licence is held by:
</EMPH>
 Organon Laboratories Limited, Science Park, Milton Road, Cambridge, CB4 4FL.
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Oestradiol implants are made by:
</EMPH>
 Organon Laboratories Limited, Newhouse Industrial Estate, Newhouse, Motherwell, Scotland, ML1 5SH.
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What are Oestradiol Implants used for?
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<BLOCK>
Oestradiol Implants are used to treat complaints that are caused by having too little oestrogen.
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<BLOCK>
They can relieve symptoms of the menopause. They can also prevent thinning of the bones (Osteoporosis) in women after the menopause or after the ovaries and womb have been removed (hysterectomy).
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Before you have the Implants
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Do you think you may be pregnant?
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Are you breast-feeding?
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Have you had heart disease?
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Have you had a thrombosis (a blood clot)?
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Do you have high blood pressure?
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Have you had liver disease?
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Do you have a rare liver disease called Rotor Syndrome?
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Do you have a rare liver disease called Dubin-Johnson Syndrome?
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Have you had tumours of the breast or other sex organs?
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Have you had unexplained vaginal bleeding?
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Do you have porphyria (a rare metabolic disorder)?
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Do you have too much cholesterol or other fatty substances in the blood?
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Have you had skin rash (herpes gestationis), jaundice or severe itching during pregnancy or while taking steroids?
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If the answer to any of these questions is YES:
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Did you tell your doctor at the last visit or an earlier visit?
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If you did NOT then you should do so as soon as possible and before having these implants.
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<BLOCK>
Even so, your doctor may still want you to have the implants.
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What do I need to know before having implants?
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<BLOCK>
If you have had chloasma (a skin irritation caused by the sun) you should stay out of the sun while you are taking oestradiol implants.
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While you have an
</EMPH>
 Oestradiol Implant regular medical checks by a doctor are recommended.
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Extra supervision by your doctor may be necessary in some cases. Tell your doctor if you have ever had:
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<ITEM>

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any disease of the heart or circulation;
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kidney disease;
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epilepsy;
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migraine headaches
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high blood pressure;
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sickle cell disease;
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fibroids in the womb;
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endometriosis.
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<BLOCK>
Oestradiol implants may affect some blood or urine tests.
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What other medicines are you taking?
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<BLOCK>
Other medicines may affect how the Oestradiol Implant works or oestradiol may affect how they work.
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<BLOCK>
Tell your doctor if you are taking (or intend to take) any other medicines.
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<BLOCK>
If you are diabetic you may need to take more insulin or other anti-diabetic drugs.
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<HEAD weight="bold" >
How do I take Oestradiol Implants?
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<BLOCK>
Oestradiol Implants have to be given by a doctor.
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<BLOCK>
If you have not had a hysterectomy (removal of the womb) you will also have to take progestogen tablets for 10 to 13 days in each monthly cycle. These tablets will cause a monthly period and help protect the womb from cancer.
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How much?
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<BLOCK>
The dose is chosen by your doctor.
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Usually a dose of 25, 50 or 100 mg is given, but this varies from person to person. This dose will last between 4 and 8 months.
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How is the implant given?
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<BLOCK>
The implants are inserted under the skin around the lower part of the abdomen, or the buttock. You will usually be given a local anaesthetic in this area before the implants are inserted. The small cut made will be dressed with a bandage afterwards.
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What if you are accidentally given too much?
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<BLOCK>
There is no need to worry. Your doctor may decide not to give you more oestrogen until the amount in your body is back to normal.
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What to do if Oestradiol Implants are swallowed accidentally
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<BLOCK>
If someone has swallowed some implants by accident there is no need to worry. However, you should consult a doctor.
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<BLOCK>
The person may feel sick or be sick. Women may have some vaginal bleeding after a few days.
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What may happen when your treatment is finished
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<BLOCK>
When you finish your treatment with oestradiol implants or the implant has been removed for some reason, your doctor may give you some progestogen tablets to take until withdrawal bleeding stops (if you have not had a hysterectomy).
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What about side-effects?
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Oestradiol Implants sometimes cause 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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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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<BLOCK>
You may have bleeding between your periods. Tell your doctor if vaginal bleeding occurs.
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<BLOCK>
You may notice an increased vaginal discharge.
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<BLOCK>
If you have endometriosis or fibroids in the womb they may get worse. You may have pre-menstrual syndrome.
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<BLOCK>
Sometimes the breasts become swollen, tender or painful, or there may be a milky discharge.
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<BLOCK>
Some people may feel sick or be sick.
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Some people may have gall-stones or jaundice.
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<BLOCK>
Your blood pressure may increase.
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<BLOCK>
There may be more chance of having a blood-clot (thrombosis).
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You may have skin problems such as a rash or an allergy to the sun.
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<BLOCK>
If you wear contact lenses you may feel some irritation in the eyes.
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<BLOCK>
Very occasionally headaches occur, sometimes migraine.
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<BLOCK>
You may notice that your mood changes.
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<BLOCK>
You may have fluid retention such as swollen ankles.
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<BLOCK>
Your weight may change.
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<BLOCK>
If you have an implant and have not ever had your womb removed you may need to take progestogen tablets, otherwise you may increase the risk of developing heart disease, kidney disease, skin cancer, <PB n=2> <CB n=1> deafness (caused by thickened ear tissues), multiple sclerosis or an inflammatory disease that may affect the whole body (systemic lupus erythematosus).
</BLOCK>


<BLOCK>
Tell your doctor about any problems that you think might be caused by the implants.
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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. Keep the implants below 25°C (room temperature) away from the light. Keep the implants in the original box where children cannot see or reach them .
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<BLOCK>
This information was written in September 1995.
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Other things to remember about medicines
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<ITEM>

<BLOCK>
This medicine has been prescribed for your current medical problems. Do not take it for other medical problems.
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<ITEM>

<BLOCK>
Do not allow other people to take your medicines and do not take medicines meant for other people.
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<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.
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Return unused medicines to the pharmacy for disposal .
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Make sure that other people you may live with or who look after you read this information.
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<HEAD weight="bold" >
More about Oestradiol Implants
</HEAD>


<BLOCK>
Oestradiol Implants contain oestradiol, one of the natural female sex hormones (oestrogens or estrogens).
</BLOCK>


<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.
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<BLOCK>
Shortage of oestrogens may lead to complaints such as hot flushes and night sweats. Some women feel depressed and lose their sex drive. The shortage of oestrogen may also cause thinning of bones (osteoporosis). Over the years the bones become brittle and break easily. Oestradiol can prevent osteoporosis.
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<BLOCK>
These complaints can be relieved by taking medicines containing oestrogen. However it may take several days or weeks before you notice an improvement.
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