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Estraderm® TTS
(estradiol)
Ciba
Information for Patients

What you need to know about Estraderm® TTS

Please read this leaflet carefully before you start to use your medicine. It contains important information.

What’s in your medicine?
Estraderm TTS patches contain a substance called estradiol. Estradiol is a form of estrogen and belongs to a group of medicines known as Hormone Replacement Therapy (HRT). They come in three sizes:
  • Estraderm TTS 25 containing 2 mg of estradiol. Your body will absorb about 25 micrograms of estradiol each day whilst you are wearing an Estraderm TTS 25 patch.
  • Estraderm TTS 50 containing 4 mg of estradiol. Your body will absorb about 50 micrograms of estradiol each day whilst you are wearing an Estraderm TTS 50 patch.
  • Estraderm TTS 100 containing 8 mg of estradiol. Your body will absorb about 100 micrograms of estradiol each day whilst you are wearing an Estraderm TTS 100 patch.
A one month calendar pack contains 8 patches of one size; a 3 month pack contains 24 patches.
The patches also contain ethanol, hydroxypropylcellulose, liquid paraffin and polyisobutylene. The estradiol is plant derived and synthetically produced.

Manufactured by:
Novartis Pharma AG, CH 4332 Stein, Switzerland

Released onto the market by:
Novartis Pharmaceuticals UK Limited
Wimblehurst Road
Horsham, West Sussex
RH12 5AB, England

Product licence/authorisation holder:
Novartis Pharmaceuticals UK Limited
Trading as: Ciba Laboratories
Frimley Business Park
Frimley, Camberley
Surrey, GU16 7SA, England

What this medicine is used for
Estraderm TTS is used to relieve symptoms of the menopause (the time when your periods stop). Menopause occurs naturally in all women, usually between the ages of 45 and 55. It will also occur in younger women who have their ovaries removed by surgery. During the menopause, your body produces much less estrogen than it did before. This can cause unpleasant symptoms such as hot face, neck and chest, “hot flushes” (sudden waves of heat and sweating over the whole body), sleep problems, irritability and depression. Some women also have problems with urine control or dryness of the vagina, which may cause discomfort during or after sexual intercourse. Estrogens can be given to reduce or eliminate these symptoms.
Your doctor may also prescribe Estraderm TTS for the prevention of accelerated bone loss (Osteoporosis). After the age of 40, and especially after the menopause, some women develop osteoporosis. This is a thinning of the bones that makes them weaker and more likely to break, especially the bones of the spine, hip and wrist. The risk of osteoporosis is increased by a lack of estrogens. Taking estrogens after the menopause slows down the bone loss and can help to prevent osteoporosis.

Before using your medicine
  • Do you have or are you being treated for a blood clot in a vein in your leg or anywhere else (a “deep vein thrombosis”) or a blood clot that has travelled to your lung or another part of your body (an “embolus”)?
  • Do you have problems with your circulation or with your blood clotting too easily (‘thrombosis’ or ‘embolism’) at the moment? You might notice swollen, sore, red areas over your veins, or pains in your legs or chest when you walk. You should not take ESTADERM TTS unless you are being treated with anticoagulant therapy (blood thinning medication) by your doctor.
  • Do you have a previous experience of a blood clot anywhere in the body within the last 2 years?
  • Do you suffer from known or suspected breast cancer?
If the answer to any of these questions is YES, the patches should not be used.
  • Have you ever had treatment for a breast lump, serious disease of the womb or any other estrogen dependent cancers?
  • Do you, or your family, have a history, including during pregnancy, of any blood clotting disorders or of recurrent (i.e. occurring more than once) spontaneous abortion
  • Do you have any liver, kidney or heart disease?
  • Have you ever suffered from estrogen related jaundice or pruritus?
  • Have you had any bleeding between periods or since your last period, if your periods have stopped?
  • Is there any chance that you may be pregnant or are you breast-feeding?
  • Are you allergic to any components of the patches (see “What’s in your medicine”)?
  • Do you have porphyria?
If the answer to any of these questions is YES, do not use the patches without talking to your doctor again.
  • Do you have a family history of breast cancer?
  • Do you have lumpy or painful breasts?
  • Do you have fibroids?
  • Do you suffer from endometriosis?
  • Do you suffer from epilepsy (fits), migraine or asthma?
  • Do you have diabetes?
  • Do you suffer from high blood pressure (hypertension)?
  • Do you suffer from gallstones?
  • Have you ever suffered from hearing loss during pregnancy or when taking estrogens; for example, oral contraceptives?
  • Have you ever suffered from high lipid levels in your blood?
If the answer to any of these questions is YES, tell your doctor or pharmacist.

Are you taking any of the following?
  • Barbiturates or meprobamate
  • Hydantoins or anticonvulsants e.g. carbamazepine.
  • Phenylbutazone
  • Antibiotics e.g. rifampicin
  • Activated charcoal
  • Any other medicines which your doctor does not know about?
If the answer to any of these questions is YES, tell your doctor or pharmacist.

Other special warnings
  • You should not use Estraderm TTS it you are pregnant or breast feeding.
  • 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.
  • You are strongly encouraged to take part in the national mammography and cervical screening programmes. In these schemes all women are automatically contacted to have regular swear tests (women aged 20-64) and mammograms (every 3 years for women aged 50-64). If you have any 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.
  • If you suffer from epilepsy you should have regular check-ups with your doctor. If you notice your fits becoming more frequent you should discuss the continuation of this medication with your doctor.

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.
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.
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 HAT treatment with your doctor.

Length of time on HRTExtra breast cancers found to age 70 per 1,000 women
5 years2
10 years6
15 years12

Using your medicine

  • Always use your patches as instructed by your doctor.
  • To reduce menopausal symptoms, treatment is usually started with Estraderm TTS 50. Your doctor will change the dose it necessary to suit you.
  • To prevent bone loss, Estraderm TTS 50 is used.
  • Most women using Estraderm TTS will have had a hysterectomy (an operation to remove the womb). If you have not had a hysterectomy, you will need to take another hormone called progestogen for 12 days each month. You will probably have a ‘period’ each month towards the end of the course of progestogen. This is quite normal.
The patches should be changed twice each week i.e. every 3-4 days, always on the same two days, e.g. Mondays and Thursdays. You may find it helpful to tick the box on this leaflet for the day of the week when you apply your first Estraderm TTS patch. This then shows the two days each week when you should change your patch. When you finish an Estraderm TTS pack, start the next pack straightaway. There is no need to have a break between packs.

( ) Monday + Thursday
( ) Tuesday + Friday
( ) Wednesday + Saturday
( ) Thursday + Sunday
( ) Friday + Monday
( ) Saturday + Tuesday
Putting on a patch
  • Remove the sachet from the box and tear it open at the notch. Use your fingers because cutting with scissors might damage the patch inside. You must never cut or tear your patches in any way.
  • Take Out the transparent patch and loosen the backing by rubbing the edge of the patch between your thumb and forefinger. The stiff protective liner will peel away from the flexible, sticky patch.
  • Stick the patch onto a hairless area of skin below the waist. Most patients find that the buttock is the best place and that skin irritation is less likely to occur at this site. You could also try the lower back, hip, abdomen or upper thigh. Never put a patch on or near the breasts. Choose a clean, dry area of skin. Avoid skin which is red or irritated. Never powder or oil your skin before putting on a patch as it may not stick properly. Do not expose the patch to direct sunlight.
  • Place the sticky patch on the area of skin you have chosen and press it firmly into position with the palm of your hand. Pressing for 10-20 seconds or so will make it stick securely. Run your finger around the edge of the patch to make sure that the edges stick. Provided that you have applied the patch correctly, can bath, shower or swim with little risk of the patch coming off.
  • If the patch does come off in the bath or shower, just shake it to remove any water, dry the skin thoroughly and put it on again in the usual way.
  • When the time comes to change your patch, take off the old one, fold it in half with the sticky side inwards, and throw it away carefully out of the reach of children. Remember, it will still contain some medication.
  • Always place your new patch on a fresh area of skin. Wait a week before using the same area again.
  • If you forget to change the patch at the right time, you should change it as soon as possible. Then change to your next patch on the normal day.
  • Because of the way Estraderm TTS is administered, an overdose is unlikely to occur. If an overdose is administered seek medical advice promptly.
After using your medicine
These patches may sometimes cause unwanted effects in some people. You are unlikely to get any of the following but, if you do, tell your doctor at once.
  • Difficulty in breathing.
  • Tender or painful calves, thighs or chest.
These symptoms may occur as a result of a blood clot. Please see below for further information.
  • General swelling or itching occurring outside the site of patch application.
  • Yellowing of your skin or eyes.
Other effects which may occur include:
  • Headaches, nausea or breast tenderness
  • Cramping pains in calf or abdomen
  • Feeling slightly bloated
  • Increase in varicose veins
  • Slight redness and itching of the skin where a patch has been. This usually disappears within 3-4 days of taking off the patch
  • Irregular or unusual vaginal bleeding or constant spoiling?
  • Dizziness
  • Unusual weight changes or fluid retention
  • Increase in blood pressure or rapid pulse
  • Monthly irritability or moodiness.
These effects are often mild and may wear off after a few days’ treatment. If they are severe or last for more than a few days, tell your doctor. Also, if your medicine upsets you in any other way, tell your doctor.
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 taking HRT such as Estraderm TTS, the chances of getting a blood clot increase 2-3 fold compared to women not taking HRT. For healthy women, this amounts to one or two additional cases of venous thromboembolism in 10,000 patient years of treatment with HRT. The occurrence of such an event is more likely in the first year of HRT than later.
You are more likely to have a blood clot whether or not you take HRT if:
  • You are very overweight (body mass index > 30kg/m²)
  • 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.
  • You suffer from systemic lupus erythematosus (SLE — an inflammatory condition that includes rash).
If any of these apply to you, you should talk to your doctor about whether you should take Estraderm TTS.
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 as you may need to stop taking Estraderm TTS about a month before the operation.
No one is sure it having varicose veins increases the chance of having a blood clot.
If you get a blood clot while you are taking Estraderm TTS you should stop taking it immediately and contact your doctor.
Warning signs to look out for are:
  • Coughing blood
  • Unusual pains or swelling of your arms or legs
  • Sudden shortness of breath
  • Fainting.
Storing your medicine
  • The expiry date for this medicine is given on the carton. Do not use after this date.
  • Store your medicine in a cool place (below 25°C). Do not store in the refrigerator Store out of the reach of children before and after use. Return any unused medicine to your pharmacist.
Other useful information
  • Sunbathing - always make sure your patch is covered by clothing.
  • Using a sun bed - either cover up your patch as above or take it off and put it back on after your shower when your skin is completely cool and dry.
  • Swimming - you can wear your patch beneath your swimming costume during swimming.
  • Never stick on a patch straight after a hot bath or shower Wait a while for the skin to become completely cool and dry.
  • It a patch comes off and will not stick back on, apply a new patch in the usual way. Remember to apply your next patch at the normal time. It you have run out of patches, contact your doctor straight away.
The drug in your patch is a gel which is colourless. This does not mean that the patch does not contain any medication.

REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if they have the same symptoms as you.
The information in this leaflet applies only to Estraderm TTS. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Date: July 2001
Copyright © Novartis Pharmaceuticals UK