Estradot

estradiol

Consumer Medicine Information

This leaflet answers some common questions about the menopause (“change of life”), hormone replacement therapy and Estradot.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. You can also download the most up-to-date leaflet from www.novartis.com.au.

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Estradot against the benefits they expect it will provide.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

Do not use Estradot or other estrogens, with or without a progestogen to prevent heart attacks, stroke or dementia.

A study called the Women’s Health Initiative indicated increased risk of heart attack, stroke, breast cancer, and blood clots in the legs or lungs in women receiving treatment with a product containing conjugated estrogens 0.625 mg and the progestogen medroxyprogesterone acetate (MPA). The researchers stopped the study after 5 years when it was determined the risks were greater than the benefits in this group. The Women’s Health Initiative Memory Study indicated increased risk of dementia in women aged 65-79 years taking conjugated estrogens and MPA. There are no comparable data currently available for other doses of conjugated estrogens and MPA or other combinations of estrogens and progestogens. Therefore, you should assume the risks will be similar for other medicines containing estrogen and progestogen combinations.

Talk regularly with your doctor about whether you still need treatment with Estradot.

Treatment with estrogens, with or without progestogens should be used at the lowest effective dose and for the shortest period of time.

Estradot is a type of treatment called hormone replacement therapy (HRT). It is a stick-on patch that contains a hormone called estradiol.

Estradot is used for the short-term relief of symptoms of the menopause.

HRT should not be used for the long-term maintenance of general health or to prevent heart disease or dementia.

Estradot is not suitable for birth control and it will not restore fertility.

Estradiol is a natural female sex hormone called an estrogen. It is the same hormone that your ovaries were producing before the menopause.

The menopause occurs naturally in the course of a woman’s life, usually between the ages of 45 and 55. It may happen sooner if the ovaries are removed by surgery (e.g. total hysterectomy). After menopause, your body produces much less estrogen than it did before. This can cause unpleasant symptoms such as a feeling of warmth in the face, neck and chest, “hot flushes” (sudden, intense feelings of heat and sweating throughout the body), sleep problems, irritability and depression. Some women also have problems with dryness of the vagina causing discomfort during or after sex. Estrogens can be given to reduce or eliminate these symptoms.

Estradot releases estradiol in a continuous and controlled way just as your ovaries were doing before. Because the medicine does not have to pass through your stomach and liver, it allows you to take a much lower dose of estrogen than would be needed in a tablet and helps to avoid some unpleasant side effects.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another purpose.

This medicine is available only with a doctor’s prescription. It is not habit-forming.

Do not use Estradot if you have an allergy to:

estradiol, the active ingredient , or to any of the other ingredients listed at the end of this leaflet

any other medicine containing estrogen, including the birth control pill

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

If you had a severe skin reaction in the past, you could have a very serious reaction if you use any type of estrogen (patch, tablet, cream, etc.) again.

Do not use Estradot if you have:

cancer of the breast or uterus (womb) or any other estrogen dependent cancer, or you have had this condition in the past

ever had blood clots in the veins or lungs. You may have had painful inflammation of the veins or blockage of a blood vessel in the legs, lungs, brain or heart

a condition that increases the tendency for you to get blood clots

abnormal vaginal bleeding that has not been investigated

severe liver problems

a condition called porphyria, this condition affects your liver

If you are not sure whether any of the above conditions apply to you, your doctor can advise you.

Do not use Estradot if you are pregnant or breast-feeding.

It may affect your baby.

If you still have a uterus (womb), do not use Estradot unless you are also taking another drug called a progestogen.

Women who still have a uterus must take both estrogen and progestogen as part of HRT. This is because estrogen stimulates the growth of the lining of the uterus (called the endometrium). Before menopause this lining is removed during your period through the action of a natural progestogen. After menopause, taking estrogen on its own as HRT may lead to irregular bleeding and to a disorder called endometrial hyperplasia. Your doctor will prescribe a progestogen to protect the lining of the uterus from the effects of estrogen.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

In that case, return it to your pharmacist.

Tell your doctor if you have:

a family history of breast cancer

nodules, lumps or cysts in your breasts or any other benign breast condition (not cancer)

endometriosis (a disorder of the uterus that may cause painful periods and abnormal bleeding)

fibroids or other benign tumours of the uterus (not cancer)

had one or more pregnancies where you lost the baby before birth

high blood pressure

heart disease

kidney or liver problems

diabetes

epilepsy

migraine or other severe headaches

gall bladder disease

asthma

hearing loss due to a problem with the bones in the ear called otosclerosis

a high level of triglycerides in the blood

a disorder called systemic lupus erythematosus (SLE)

a bone disease causing high calcium levels in the blood

very low calcium levels in the blood

had a problem in the past with jaundice (a liver problem) or itching skin when you took an estrogen (e.g. the birth control pill or HRT) or during pregnancy

a skin condition that could be made worse by applying the patch

hypothyroidism (a condition in which your thyroid gland fails to produce enough thyroid hormone and for which you are treated with thyroid hormone replacement therapy). Your doctor will then have to monitor your thyroid hormone levels regularly

severe allergic reactions

hereditary angioedema or episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage) or digestive tract

Tell your doctor if any of these apply to you before you use Estradot.

Your doctor may want to take special precautions if you have or have had any of the above conditions.

Tell your doctor if you are likely to have an increased risk of developing blood clots in your blood vessels. The risk increases as you get older and it may also be increased if:

anyone in your immediate family has ever had blood clots in the blood vessels of the legs or lungs

you are overweight

you have varicose veins

you have a disorder called systemic lupus erythematosus (SLE)

Tell your doctor if you are taking birth control pills.

Estradot is not a contraceptive. Since pregnancy may be possible early in the menopause while you are still having menstrual periods, you should ask your doctor to suggest another (non-hormonal) method of birth control.

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Estradot may interfere with each other. These include:

herbal medicines containing St. John’s wort

some medicines to help you sleep, including barbiturates and meprobamate

some medicines for epilepsy, including phenytoin, phenobarbitone and carbamazepine

phenylbutazone, a medicine for pain and inflammation

some antibiotics and other anti-infective medicines, including rifampicin, ketoconazole, erythromycin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir

You may need to take different amounts of your medicines or to take different medicines while you are using Estradot. Your doctor and pharmacist have more information.

If you have not told your doctor about any of these things, tell him/her before you start using this medicine.

Follow all directions given to you by your doctor and pharmacist carefully.

These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

If you are not already using HRT, you can start Estradot at a convenient time for you. If you are already using a different type of HRT, your doctor can advise you when to switch to Estradot.

Estradot patches come in five strengths. You will usually start with the Estradot 50 patch. Your doctor will check your progress and may change you to a lower or higher strength, depending on your response to treatment.

A leaflet in the carton contains pictures and information on how to apply the patch properly.

You will have a patch on all the time. You will apply a new patch twice weekly (every 3 or 4 days). There are 8 patches in the carton, enough for a 4-week cycle.

If you have not had a hysterectomy (operation to remove the uterus), you must take another type of hormone called a progestogen as well as using the patches. A progestogen helps to protect the lining of the uterus. If you have not been asked to take a progestogen, talk to your doctor.

If you want to continue using HRT for longer than a few months, discuss the possible risks and benefits with your doctor.

You may have an increased risk of developing breast cancer, heart disease, stroke, blood clots on the lungs and dementia. On the other hand, the risk of hip fractures and bowel cancer may be reduced. If you have had a hysterectomy but still have your ovaries, there may also be a small increase in the risk of developing cancer of the ovaries. Women taking estrogens alone, or in combination with progestogens, may have a higher risk of ovarian cancer that may appear within 5 years of use and slowly diminishes over time after discontinuation. Your doctor can discuss these risks and benefits with you, taking into account your particular circumstances.

Apply a new patch as soon as you remember, and then go back to your usual schedule.

If you have trouble remembering when to use or replace your patches, ask your pharmacist for some hints.

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital, if you think that an overdose has happened. Keep the telephone numbers for these places handy.

Because of the way this medicine is used, an intentional overdose is unlikely. Swallowing a patch may cause nausea and vomiting.

If you become pregnant while using Estradot, tell your doctor immediately.

It should not be used while you are pregnant.

See your doctor at least once a year for a check-up. Some women will need to go more often. Your doctor will:

check your breasts and order a mammogram at regular intervals

check your uterus and cervix and do a pap smear at regular intervals

check your blood pressure and cholesterol level.

Check your breasts each month and report any changes promptly to your doctor.

Your doctor or nurse can show you how to check your breasts properly.

Tell your doctor that you are using Estradot well in advance of any expected hospitalisation or surgery. If you go to hospital unexpectedly, tell the doctor who admits you that you are using it.

The risk of developing blood clots in your blood vessels may be temporarily increased as a result of an operation, serious injury or having to stay in bed for a prolonged period. If possible, this medicine should be stopped at least 4 weeks before surgery and it should not be restarted until you are fully mobile.

If you are about to have any blood tests, tell the person who takes the blood that you are using Estradot.

It may interfere with the results of some tests.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Estradot.

Tell any other doctor, dentist or pharmacist who treats you that you are using Estradot.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give it to anyone else, even if their symptoms seem similar to yours.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Estradot.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by these lists of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if any of the side effects get serious or if you notice any side effects not listed in this leaflet.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

signs of allergy such as itching or hives on the skin; shortness of breath or troubled breathing, wheezing or coughing, light-headedness, dizziness, rash, itching, hives, breathlessness, changes in levels of consciousness, hypotension, with or without mild generalized itching, skin reddening, swelling of the face throat, lips, tongue, skin, the area around the eyes or other part of the body

signs or symptoms of blood clots, such as sudden severe headache, sudden loss of coordination, blurred vision or sudden loss of vision, slurred speech, numbness or tingling in an arm or leg, painful swelling in the calves or thighs, chest pain, difficulty breathing, coughing blood

pain or tenderness in the abdomen, which may be accompanied by fever, loss of appetite, nausea and vomiting

a yellow colour to the skin or eyes, itching, dark coloured urine or light coloured bowel motions

signs of a skin reaction, such as redness, swelling, painful sores or lumps, areas of skin that bleed or weep fluid

signs or symptoms of a heart attack such as chest pain, dizziness, nausea, shortness of breath, irregular pulse.

signs or symptoms of a stroke such as collapse, numbness or weakness of the arms and the legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech

Tell your doctor if you notice any of the following and they worry you:

irregular vaginal bleeding or spotting (if bleeding is heavy, check with your doctor as soon as possible) Some people may have some irregular bleeding or spotting during the first few months of treatment. The bleeding usually becomes lighter and less frequent over time, and eventually stops. If you have heavy bleeding or continue to have bleeding or spotting after a few months of treatment, tell your doctor so that the treatment can be re-evaluated if necessary.

tender, painful or swollen breasts

period-like pain

redness, irritation or itching under the patch (signs of application site reaction includes bleeding, bruising, burning, discomfort, dryness, skin boils, oedema, erythema, inflammation, irritation, pain, tiny solid skin bumps, rash, skin discolouration, skin pigmentation, swelling, hives and blisters)

itching or inflammation of the vagina or discharge of vaginal fluid

swelling of the lower legs, ankles, fingers or abdomen due to fluid retention

nausea (feeling sick), vomiting, abdominal cramps, bloating

headache, migraine

dizziness

depression

eye irritation when wearing contact lenses

uncontrollable jerky movements

changes in weight

spotty darkening of the skin, especially on the face

changes in hair growth (either hair loss or excessive hairiness)

increase or decrease in sex drive

Tell your doctor if you notice anything else that is making you feel unwell.

Some people may have other side effects not yet known or mentioned in this leaflet. Some side effects (e.g. increase in blood sugar level) can only be found when laboratory tests are done.

Keep your medicine in the original container until it is time to use it.

Store it in a cool dry place.

Do not store Estradot or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Keep the patches where young children cannot reach them.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Fold used patches in half with the sticky side inwards. Dispose of them where children cannot reach them.

Used patches still contain some estradiol which could harm a child.

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any patches that are left over.

Estradot patches come in five strengths: 25, 37.5, 50, 75 and 100. They are rectangular patches with rounded corners. Each carton contains 8 patches (enough for 4 weeks of treatment).

Estradot patches release approximately 25, 37.5, 50, 75 or 100 micrograms estradiol in 24 hours.

The following inactive ingredients are also used to make the patch:

silicone adhesive

acrylic adhesive

dipropylene glycol

povidone

oleyl alcohol

Dow BLF 2550 non-removable backing layer

Scotchpak 1022 removable release liner

Estradot is supplied in Australia by:

 

NOVARTIS Pharmaceuticals Australia Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone: 1-800-671-203

 

Web site: www.novartis.com.au

 

®= Registered Trademark

 

This leaflet was prepared in October 2020

 

Australian Registration Numbers:

Estradot 25 AUST R 338056

Estradot 37.5 AUST R 338057

Estradot 50 AUST R 338058

Estradot 75 AUST R 338059

Estradot 100 AUST R 338060

 

(eot131020c.doc) based on PI (eot131020i.doc)