Estalis Continuous

estradiol / norethisterone acetate (NETA)

Consumer Medicine Information

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

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 this medicine against the benefits they expect it will provide.

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

Keep this leaflet with the medicine.

You may need to read it again.

Do not use Estalis Continuous 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 Estalis Continuous.

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

Estalis Continuous is a type of treatment called hormone replacement therapy (HRT). It is a stick-on patch that contains the hormones, estradiol and norethisterone acetate (NETA).

Estalis Continuous is used for the short-term relief of symptoms of the menopause. It can also be used to prevent thinning of the bones in women with a high risk of fractures due to osteoporosis who cannot use other treatments. Estalis Continuous is used only for women who still have a uterus (womb).

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

Estalis Continuous 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. NETA is a hormone called a progestogen. It has effects similar to the female hormone, progesterone, which your ovaries also produced before the menopause.

The menopause occurs naturally in the course of a woman’s life, usually between the ages of 45 and 55. 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.

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. Exercise, calcium and vitamin D can help reduce the risk of osteoporosis.

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. Progestogens such as NETA help to protect the lining of the uterus from developing this disorder.

Estalis Continuous patches release estradiol and NETA 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 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 Estalis Continuous if you have an allergy to:

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

any other medicine containing estrogen or progestogen, 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 or progestogen (patch, tablet, cream, etc.) again in the future.

Do not use Estalis Continuous 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

blood clots in your blood vessels, now or in the past. 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

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

abnormal vaginal bleeding that has not been investigated

severe liver problems

a condition called porphyria

a tumour of the pituitary gland or hypothalamus

a disease of the connective tissue

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

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

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

It may affect your baby.

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)

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

a high level of triglycerides in the blood

a disorder called systemic lupus erythematosus (SLE)

a condition called hypothyroidism (your thyroid gland fails to produce enough thyroid hormone)

low levels of thyroid hormone

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)

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

severe allergic reactions

a condition called hereditary angioedema or if you have had episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage) or digestive tract

contact lens discomfort

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.

Estalis Continuous 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 Estalis Continuous 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 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 Estalis Continuous. Your doctor and pharmacist have more information.

Tell your doctor that you are on treatment with Estalis Sequi if you are going to have laboratory tests.

Some laboratory tests, such as tests for glucose tolerance or thyroid function, may be affected by Estalis Sequi therapy.

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 Estalis Continuous 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 Estalis Continuous.

The patches come in two strengths. You will usually start with the Estalis Continuous 50/250 patch. Your doctor will check your progress and may change to the lower strength 50/140 patch.

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.

You will probably have some bleeding or spotting at odd times during the first few months. This can be a nuisance but is quite normal and not a cause for concern. The bleeding usually becomes lighter and less frequent over time and eventually stops. If you have heavy bleeding, tell 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. 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 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 Estalis Continuous, tell your doctor immediately.

It should not be used while you are pregnant or if you want to become 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 Estalis Continuous 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 be started on any new medicine, remind your doctor and pharmacist that you are using Estalis Continuous.

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

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 Estalis Continuous.

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

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

signs that blood clots may have formed, 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.

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)

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)

skin rash

vaginal itching, inflammation or fluid discharge

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

nausea (feeling sick), abdominal cramps, vomiting, heartburn, wind, diarrhoea

headache, migraine

rise in blood pressure

weakness or dizziness

depression, nervousness, rapid changes in mood, difficulty sleeping

back pain

change in sex drive

weight gain

acne, itchy or dry skin, skin discolouration

tingling or numbness

gallbladder disorder (tendency to form gallstones)

fibroids (benign growths in the uterus)

breast cancer

darkening of the skin particularly on the face or abdomen (chloasma)

abnormal tumour growth related to estrogens, e.g. cancer of the lining of the womb (endometrial cancer)

hair loss

inflammatory bowel disease

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 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 Estalis Continuous 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 and NETA 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.

Estalis Continuous patches come in two strengths: 50/140 and 50/250. They are clear round patches sealed in individual pouches. Each carton contains 8 patches (enough for 4 weeks of treatment.)

The patch is made up of three layers:

a waterproof backing

a sticky layer containing the active ingredients

a protective liner (to be removed before use)

Estalis Continuous patches release approximately 50 micrograms of estradiol and 140 or 250 micrograms of NETA in 24 hours.

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

silicone and acrylic adhesives to make the patch stick

povidone

oleic acid

dipropylene glycol

Estalis Continuous 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 May 2020.

 

Australian Registration Number.

Estalis Continuous 50/140 AUST R 70813

Estalis Continuous 50/250 AUST R 70817

 

(els080520c.doc) based on PI (els080520i.doc)