Oestradiol Implant

Advice for the Patient
WHAT YOU SHOULD KNOW ABOUT YOUR MEDICINE

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.
Keep this leaflet until you have finished your medicine. You may want to read it again.

Oestradiol
What are Oestradiol Implants ?
The name of your medicine is Oestradiol Implants. Each Oestradiol Implant contains 25, 50 or 100 milligram(mg) of the active ingredient oestradiol (estradiol).
There are no other ingredients in the implants.
Oestradiol Implants are pellets of pure oestradiol and are sold in a glass ampoule.
Each implant is packed in a cardboard box.
25mg 50mg 100mg

The Oestradiol Implant is one of a group of medicines called Hormone Replacement Therapy (HRT).

The Marketing Authorisation is held by:
Organon Laboratories Ltd.,
Science Park, Cambridge, CB4 0FL.

Oestradiol Implants are made by:
Organon (Ireland) Ltd.,
Drynam Road, Swords, Co Dublin, Ireland.

What are Oestradiol Implants used for?
Oestradiol Implants are used to treat complaints that are caused by having too little oestrogen.
They can relieve symptoms of the menopause. They can also be used if you are at an increased risk of fractures due to thinning of the bones (Osteoporosis) but are unable to take other treatments or if other therapies have proven to be ineffective.
Your doctor should discuss all the available options with you.

Before you take the Implants

Do you think you may be pregnant?
Are you breast-feeding?
Have you had heart disease ?
Have you had a thrombosis (a blood clot)?
Do you have high blood pressure?
Have you had liver disease?
Do you have a rare liver disease called Rotor Syndrome?
Do you have a rare liver disease called Dubin-Johnson Syndrome?
Have you had tumours of the breast or other sex organs?
Have you had unexplained vaginal bleeding?
Do you have porphyria (a rare metabolic disorder)?
Do you have too much cholesterol or other fatty substances in the blood?
Have you had a skin rash (pemphigoid gestationis), jaundice or severe itching during pregnancy or while taking steroids?

If the answer to any of these questions is YES:

Did you tell your doctor at the last visit or an earlier visit ?
If you did NOT then you should do so as soon as possible and before having these implants.

Even so, your doctor may still want you to have the implants.

You should not use Oestradiol Implants if you have

a blood clot in a vein in your leg or anywhere else (a "deep vein thrombosis")
a blood clot that has travelled to your lung or another part of the body (an "embolus") or if you have had one of these in the past.
cancer of the breast.

What do I need to know before having implants?
Before giving you the prescription for this medication, your doctor will have taken details of your personal and family medical history. Depending on your medical history your doctor will decide whether you need a physical examination. Examination of your breasts and pelvic examination (internal examination) will only be carried out if your doctor considers it to be necessary, rather than routinely in every woman.
You are strongly encouraged to take part in the national mammography and cervical smear screening programmes. In these schemes all women are automatically contacted to have regular smear tests (women age 50-64) and mammograms (every 3 years for women age 50-64). If you have questions about these schemes please ask your doctor or nurse.
It is also important to be "breast aware". This means noticing any changes in your breasts such as dimpling of the skin, changes in the nipple, or the finding of any lump. Any changes should be
reported to your doctor or nurse without delay.
All women have a small chance of having a blood clot in the veins of the leg, in the lung or other parts of the body whether or not they take HRT. For women who are not taking HRT, the chances of getting such a blood clot are about 1 in 10,000 women each
year. While using HRT such as Oestradiol Implants, the chances of getting a blood clot increase to 3 in 10,000 women each year.
You are more likely to have a blood clot whether or not you take HRT if:

you are very overweight
you have had a blood clot in the veins or lungs before
you have relatives who have suffered from these
you are unable to move for long periods
you have a serious injury or a major operation

If any of these apply to you, you should talk to your doctor about whether you should use Oestradiol Implants.
No one is sure if having varicose veins increases the chance of having a blood clot.
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.
Every woman is at risk of getting breast cancer, whether or not she takes HRT. There is a small increase in this risk for women who have been using HRT for more than 5 years compared with women of the same age who have never used HRT. It is not
known whether the difference is caused by HRT. It may be that women using HRT are examined more often so that breast cancer is noticed earlier. The longer that HRT has been used, the more chance there is of having breast cancer diagnosed. This
increased chance of breast cancer is similarly found in women whose menopause occurs late naturally, without taking HRT.
For women aged 50 who are not using HRT, about 45 in every 1,000 will have breast cancer diagnosed by the age of 70. For women who start using HRT at age 50, the extra number of breast cancers resulting from the use of HRT has been estimated as in the table below.

Length of time on HRT	Extra breast cancers found to Age 70 per 1,000
5 years	2
10 years	6
15 years	12

If women stop taking HRT, the increased risk disappears by 5 years after stopping HRT and then the chances of finding breast cancer are the same as for women who have never used HRT.
Breast cancer seems less likely to have spread when found in women who have used HRT than in women who have never used HRT.
If you are concerned about the risk of breast cancer, discuss the risks compared to the benefits of HRT treatment with your doctor.

Whatever your history, your doctor will fix regular check-ups.
If you get a blood clot while you have an Oestradiol Implant, you should immediately contact your doctor.The doctor may then decide whether treatment to prevent clots is a good idea.

Warning signs to look out for are:

coughing blood
unusual pains or swelling of your arms or legs
pains or feeling of heaviness in your chest
sudden shortness of breath
fainting

If you know you will be having an operation that is likely to keep you off your feet for some time, you should talk to your doctor before the operation about whether treatment to prevent clots is a good idea.
Extra supervision by your doctor may be necessary in some cases.
Tell your doctor if you have ever had:

any disease of the heart or circulation;
kidney disease;
epilepsy;
migraine headaches;
high blood pressure;
sickle cell disease
fibroids in the womb;
endometriosis.

Oestradiol implants may affect some blood or urine tests

What other medicines are you taking?
Other medicines may affect how the Oestradiol Implant works or oestradiol may affect how they work.
Tell your doctor if you are taking (or intend to take) any other medicines.
If you are diabetic you may need to take more insulin or other anti-diabetic drugs.

How Do I Take Oestradiol Implants?
Oestradiol Implants have to be given by a doctor. 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.

How much?
The dose is chosen by your doctor.
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.

How is the implant given?
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.

What if you are accidentally given too much?
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.

What to do if Oestradiol Implants are swallowed accidentally.
If someone has swallowed some implants by accident 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.

What may happen when your treatment is finished
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).

What about side-effects ?
Oestradiol Implants sometimes cause side effects in some people.

These usually settle down during treatment as the body adjusts to the medicine.

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

You may have bleeding between your periods.Tell your doctor if vaginal bleeding occurs.
You may notice an increased vaginal discharge.
If you have endometriosis or fibroids in the womb, they may get worse.
You may have pre-menstrual syndrome.
Sometimes the breasts become swollen, tender or painful, or there may be a milky discharge.
Some people may feel sick or be sick.
Some people may have gall-stones or jaundice.
Your blood pressure may increase.
There may be more chance of having a blood-clot (thrombosis).
You may have skin problems such as a rash or an allergy to the sun.
If you wear contact lenses you may feel some irritation in the eyes.
Very occasionally headaches occur, sometimes migraine.
You may notice that your mood changes
You may have fluid retention such as swollen ankles.
Your weight may change.

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, deafness (caused by thickened ear tissues), multiple sclerosis or an inflammmatory disease that may affect the whole body (systemic lupus erythematosus).
Tell your doctor about any problems that you think might be caused by the implants.

How should you store this medicine ?
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.

This information was updated in December 2003.

THINGS TO REMEMBER ABOUT MEDICINES

1. This medicine has been prescribed for your current medical problems.

Do not take it for other medical problems.

2. Do not allow other people to take your medicines and do not take medicines meant for other people.

3. 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.

4. Return unused medicines to the pharmacy for disposal.

5. Make sure that other people you may live with or who look after you read this information.

MORE ABOUT OESTRADIOL IMPLANTS

Oestradiol Implants contain oestradiol, one of the natural female sex hormones (oestrogens or estrogens).
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.
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 Implants can prevent osteoporosis.
These complaints can be relieved by taking medicines containing oestrogen. However it may take several days or weeks before you notice an improvement.