50 micrograms / 250 micrograms / 24 hours transdermal patch 
estradiol / norethisterone acetate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Estalis is and what it is used for 
2. What you need to know before you use Estalis 
3. How to use Estalis 
4. Possible side effects 
5. How to store Estalis 6. Contents of the pack 
and other ingredients information

1. What Estalis is and what it is used for

Estalis is a preparation used for hormonal substitution therapy ( HormoneReplacement Therapy, HRT ). It contains two female sex hormones; estrogen and progestogen.

Estalis is used in women whose menstruation has stopped ( menopause ), at least 12 months after their last natural menstruation.

Estalis is used to:

Relieve symptoms during and after menopause

When menstruation ceases ( menopause ), a woman’s estrogen drops. It can cause problems such as sweating and hot flashes, sleep problems, irritation, and dryness in the vagina. Estalis relieves these symptoms after menopause. Estalis should only be used if the problems cause problems in daily life.

Estalis relieves these symptoms after menopause. Estalis should only be used if the problems cause problems in daily life.

Prevent osteoporosis

After menopause, some women suffer from osteoporosis. Discuss all possible options with your doctor.

If you have an increased risk of fractures (bone fractures) and other medicines that are not suitable for you, you can use Estalis to prevent osteoporosis after menopause.

The estrogen and progestogen contained in Estalis may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Estalis

Do not use Estalis

Medical background and regular check-ups

The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.

Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, the risks of HRT may be different. Talk to your doctor.

Before starting treatment (or resuming treatment), your doctor will ask about your own, and your family’s, medical background. Your doctor may do a general medical and gynecological examination, which also includes an examination of your breasts.

Once you have started treatment, you should go for regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.

Perform regular breast examinations according to your doctor’s recommendations.

Do not use Estalis

if any of the following apply to you. If you are not sure, talk to your doctor before using Estalis.

Do not use Estalis:

  • if you have or have had breast cancer or there is a suspicion that you may have it.
  • if you have or have had estrogen-dependent cancer, such as cancer of the lining of the uterus (endometrium), or if there is a suspicion of such cancer.
  • if you have unexpected genital bleeding that has not been investigated by a doctor.
  • if you have endometrial hyperplasia (severe thickening of the uterine lining) and are not being treated for it.
  • if you have or have had a blood clot in a vein (venous thromboembolism ), in your legs (deep vein thrombosis ), or your lungs ( pulmonary embolism ).
  • if you have a coagulation disorder, a condition with an increased risk of blood clots (lack of protein C, protein S, or antithrombin).
  • if you have or have had a disease caused by blood clots in the arteries are as heart attack, stroke (stroke), or angina.
  • if you have or have had any liver disease and still have abnormal liver values.
  • if you have porphyria, a rare inherited blood disorder.
  • if you are allergic to estradiol or norethisterone or any of the other ingredients of this medicine (see section 6 Contents of the pack and other information).

If any of the above affects you the first time you use Estalis, stop using Estalis and contact your doctor immediately.

Warnings and cautions

Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Estalis. Should this occur, have more frequent check-ups with a doctor.

  • if you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis, or have had endometrial hyperplasia (severe thickening of the uterine lining)
  • if you have an increased risk of getting a blood clot (see below “Blood clots in a vein ( thrombosis )”)
  • if a close relative has had breast cancer or other estrogen-dependent cancer
  • high blood pressure
  • liver disease e.g. liver adenoma (benign tumor )
  • diabetes
  • gallstone disease
  • if you get a migraine or severe headache
  • if you have systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
  • epilepsy
  • asthma
  • otosclerosis (ossification of the middle ear leading to a hearing loss)
  • hypertriglyceridemia (elevated blood lipids)
  • fluid retention due to heart or kidney disease
  • a condition called hypothyroidism (your thyroid gland does not produce enough thyroid hormone) and you are taking thyroid hormone as a replacement therapy
  • a condition called hereditary angioedema or if you have experienced rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (difficulty breathing), or the gastrointestinal tract.

You should contact a doctor immediately and discontinue treatment if any of the following occur:

  • Some of the things mentioned in the section ‘Do not use Estalis’
  • If skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease
  • If your blood pressure rises sharply (symptoms may include headache, fatigue, or dizziness)
  • If you are experiencing migraine-like headaches for the first time
  • If you become pregnant
  • If you get symptoms of a blood clot, such as
    • painful swelling and redness of the legs
    • sudden chest pain
    • breathing difficulties further information, see below “Blood clots in a vein ( thrombosis )”

Note: Estalis is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.

HRT and cancer

Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)

The use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining and cancer of the uterine lining.

The progestogen in Estalis protects you against this extra risk.

For women with the uterus left who do not take HRT, an average of 5 out of 1,000 women aged 50-65 will be diagnosed with endometrial cancer.

For women aged 50-65 who have the uterus left and who take HRT with estrogen alone, between 10 and 60 women out of 1,000 users will be diagnosed with endometrial cancer (ie between 5 and 55 extra cases), depending on dose one and how as long as it is taken.

Irregular bleeding

Irregular spotting or spotting may occur during the first 3 – 6 months of using Estalis.

But about the bleeding

  • lasts longer than 6 months
  • starts after using Estalis for 6 months
  • continues after you stop using Estalis

you should see a doctor as soon as possible.

Breast cancer

Data show that hormone replacement therapy ( HRT ) with a combination of estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The increased risk depends on how long you use HRT. The increased risk is seen within 3 years. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.

Comparison

Of 1,000 women aged 50 to 54 who do not take HRT, an average of 13 to 17 will be diagnosed with breast cancer over a 5-year period.

In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16-17 cases per 1,000 users (ie 0-3 extra cases) will occur.

In women who are 50 years old and start taking HRT with estrogen-progestogen for 5 years, there will be 21 cases per 1,000 users (ie 4-8 extra cases).

Among women aged 50–59 who do not use HRT, an average of 27 out of 1,000 will be diagnosed with breast cancer over a 10-year period.

In women who are 50 years old and start taking HRT with estrogen alone for 10 years, 34 cases per 1,000 users (ie 7 extra cases) will occur.

In women who are 50 years old and start taking HRT with estrogen-progestogen for 10 years, 48 ​​cases per 1,000 users (ie 21 extra cases) will occur.

Check your breasts regularly. Contact a doctor if you notice changes such as:

indentations or pits

changes in the nipple

nodules you can see or feel

It is also recommended that you participate in a mammography examination when you are called to do so. At the mammogram, you must tell the nurse/healthcare professional who performs the examination that you are using HRT, as this medicine may increase the density of the breasts. An increased density in the breasts can make it more difficult to detect lumps on the mammography images.

Ovarian cancer ( ovarian cancer )

Ovarian cancer is rare – much more rare than breast cancer. Use of HRT with estrogen alone or combined estrogen-progestogen has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2,000 aged 50 to 54 who do not take HRT for a 5-year period. For women who have taken HRT for 5 years, there will be about 3 cases per 2,000 users (ie about 1 extra case).

How HRT affects the heart and blood circulation

Blood clots in a vein ( thrombosis )

The risk of blood clots in the veins is 1.3–3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.

Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death.

You are more likely to get a blood clot in a vein if any of the following apply to you. Tell your doctor if any of the following apply to you:

– You have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need surgery”)

– You are severely overweight ( BMI over 30 kg / m 2 )

– You have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots

– If a close relative has had a blood clot in the bone, lung, or another organ

– You have SLE (systemic lupus erythematosus)

– You have cancer

The symptoms of a blood clot are described in the section “You should contact a doctor immediately and stop the treatment”.

Comparison

For women in their 50s who do not take HRT, an average of 4-7 out of 1,000 people are expected to have a blood clot in a vein over a 5-year period.

For women in their 50s who have taken HRT with estrogen-progestogen for more than 5 years, 9-12 out of 1,000 users are expected to get a blood clot in a vein (ie 5 extra cases).

It is not known whether varicose veins increase the risk of blood clots ( venous thrombosis ).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks.

For women over the age of 60 who take HRT with estrogen-progestin, the risk of developing heart disease is slightly higher than those who do not take HRT.

If you have had a heart attack or angina ( angina pectoris ), talk to your doctor about the benefits and risks of using Estalis.

Stroke (apoplexy)

The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.

Comparison

For women in their 50s who do not take HRT, an average of 8 out of 1,000 people is expected to have a stroke over a 5-year period.

For women in their 50s who have taken HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases)

Other conditions

  • The use of HRT can cause fluid to accumulate in the body ( edema ), especially in patients who already suffer from impaired heart or kidney function.
  • HRT may increase blood fat levels ( triglyceride s ), which for women with elevated levels of blood fats may lead to inflammation of the pancreas ( pancreatitis ). This can cause nausea and vomiting, pain in the upper abdomen, and fever.
  • Using HRT does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
  • All medicines used on the skin (such as patches ) can cause allergic skin reactions. Although it is very rare, you should inform your doctor if you have or have had severe allergic reactions to any of the ingredients in the patch.

Other medicines and Estalis

Some medicines can affect the effect of Estalis, which can lead to irregular bleeding. The following applies:

– Medicines for epilepsy (eg phenobarbital, phenytoin, and carbamazepine)

– Medicines for tuberculosis (eg rifampicin, rifabutin)

– Drugs for HIV – infection (for example, nevirapine, efavirenz, ritonavir, and nelfinavir telaprevir)

– Herbal medicine containing St. John’s wort ( Hypericum perforatum )

– Other anti-infective medicines (eg ketoconazole, erythromycin).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.

Results from blood test analyze

If you need to take a blood sample, tell your doctor, or the person taking the blood sample, that you are using Estalis as it may affect the results of some tests.

Pregnancy and breastfeeding

Estalis is intended for women whose menstruation has stopped. If you become pregnant, stop using Estalis and consult a doctor.

Do not use Estalis while breast-feeding.

Driving and using machines

No effects on the ability to drive and use machines have been reported with Estalis.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Estalis

Always use this medicine exactly as your doctor has told you. Your doctor will strive to use the lowest dose, which will give you relief of symptoms, and to use Estalis for the shortest possible time. Talk to your doctor if you do not get any relief from the symptoms, or feel that the dose is too high.

When to start treatment with Estalis

  • If you do not already have any other hormone replacement therapy ( patches or tablets) or if you have used continuous combined hormone replacement therapy (where estrogen and progestin are given continuously ), you can start Estalis at the appropriate time.
  • If you are switching from a cyclic or sequential hormone replacement therapy, you should continue with ongoing treatment until the cycle is completed before starting estrogen/progestogen therapy. The appropriate time to start estrogen/progestagen therapy is the first day of bleeding or seven days after the end of the previous treatment cycle.

When to apply the Estalis patch

  • The Estalis patch should be replaced twice a week (every three to four days). It is best to always change the patch on the same day of the week each week (eg Monday and Thursday). On the inside of the Estalis package, there is space to note down your dosing schedule. Select the two-day schedule that you intend to follow. Always change patches on the two days of the week you have marked.
  • The Estalis patch should be on all the time until it is time to replace it with a new patch.

Where should Estalis be attached?

Attach the patch to the lower abdomen below the waist. Avoid the waist as the clothes can cause the patch to wear away.

You may need to try different places when you apply a new patch to find places that feel most comfortable and where clothes do not rub on the patch.

Never attach Estalis to your breasts.

When changing patches, attach the new patch to another spot on the lower abdomen. Do not apply the patch in the same place twice in a row. It should take at least a week before the same skin surface is used again.

How should Estalis be attached?

If you store the patches in the refrigerator, allow the patch to reach room temperature before applying it to the skin.

Before applying Estalis, make sure the skin is:

  • clean, dry, and cool
  • free from powder, oil, moisturizer, or skin lotion
  • free from damage and/or irritation.

Each patch is individually packaged in a protective envelope. Tear up this envelope at the mark (do not use scissors as you may damage the patch) and remove the patch. Attach the patch immediately after opening the envelope and removing the protective film.

Hold the patch with the protective film against you and remove one-half of the protective film and discard it. Try not to touch the side with glue on, because then the patch will not stick properly.

Hold one-half of the patch and attach the exposed adhesive side of the patch to the skin. Remove the other part of the protective film and attach the rest of the patch.

Squeeze the patch with the palm of your hand for at least 10 seconds so that it adheres firmly, especially around the edges.

When changing patches, peel off the patch and fold it double with the adhesive side inwards. See section 5, “How to store Estalis” for instructions on how to dispose of the patch safely. Do not flush it down the toilet. If adhesive remains on the skin after removing the patch, you can remove it by gently rubbing it with an oil-based skin cream or lotion.

Other important information

Bathing, swimming, showering, and exercising should not affect the patch if it has been applied correctly. If the patch should come off, e.g. during bath or shower, shake off the water. Let the skin dry and cool and put the patch back on, but not on the same skin surface (see “Where should Estalis be attached?”).

Choose a clean, dry, non-lubricated skin surface. If the patch does not adhere properly to the skin, a new patch can be applied. Regardless of which day this occurs, you should then return to changing patches on the same weekdays as usual according to the schedule.

The patch should be covered if exposed to direct sunlight or tanning beds. When bathing, the patch can be placed under the bathing suit.

The patch should not be applied to sweaty skin or immediately after bathing or showering. Wait until the skin is dry and cool.

How long should Estalis be used?

You will see your doctor regularly and discuss the benefits and possible risks associated with Estalis and whether you still need treatment. It is important that you make regular return visits and that Estalis is used only for as long as there is a need.

If you use more Estalis than you should

You are unlikely to overdose on Estalis (as the patches release drugs continuously). If you have taken too much medicine or if e.g. If a child has accidentally taken the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

The effects of oral estrogen overdose are breast tenderness, nausea, vomiting, and/or irregular bleeding. Overdose of progestogens can cause depression, fatigue, acne, and increased hair. Remove the patch and consult a physician or pharmacist if any of these occur.

Do not use a double dose to make up for a forgotten patch.

If you forget to use Estalis

If you have forgotten to change the patch, apply a new one as soon as possible. Regardless of which day this occurs, you must change the patch according to the regular schedule.

Do not use two patches to compensate for a forgotten patch.

If you need surgery

If you are going to have an operation, tell your surgeon that you are using Estalis. You may need to stop using Estalis for 4 to 6 weeks before surgery to avoid the risk of blood clots (see section 2, “Blood clots in a vein ( thrombosis )”). Ask your doctor when it is appropriate to start using Estalis again.

If you stop using Estalis

When you stop using Estalis, the likelihood of having symptoms and irregular bleeding increases. If this happens after stopping treatment, contact a doctor immediately. The doctor needs to investigate the cause of this and rule out possible cancer of the uterus.

After a long treatment break, you should consult a doctor before starting treatment with the patches again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

The following diseases are more common in women who take HRT than those who do not:

  • Breast cancer
  • Severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining (endometrial cancer)
  • Ovarian cancer ( ovarian cancer )
  • Blood clots in veins in bones or lungs (venous thromboembolism )
  • Heart disease
  • Stroke (apoplexy)
  • Probable memory loss, if treatment with HRT is started after the age of 65.

See section 2 for more information on these side effects.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with Estalis. If any of these side effects get worse, talk to your doctor or pharmacist.

Very common (may affect more than 1 user in 10):

Headache, skin reaction at the application site (including irritation, burning, rash, dryness, bleeding, bruising, inflammation, swelling, skin pigmentation, hives, and blisters), chest pain/tenderness, menstrual pain, menstrual disorders.

Common (may affect up to 1 in 10 people):

Dizziness, nervousness, insomnia, mood swings, nausea, flatulence, gastrointestinal upset, diarrhea, abdominal pain, acne, rash, itching, dry skin, back pain, leg and arm pain, general aches, weakness, weight change, peripheral edema, breast enlargement, abnormal breast enlargement abundant menstruation, discharge, irregular vaginal bleeding, uterine cramps, inflammation of the vagina, growth of the uterine lining, depression.

Uncommon (may affect up to 1 in 100 people):

Migraine, dizziness, vomiting, discoloration of the skin, increased blood pressure, varicose veins, breast cancer, elevated liver values.

Rare (may affect up to 1 in 1,000 people):

Muscle weakness, blood clots, allergic reaction (including rash, itching, and difficulty breathing), altered sexual desire, and crawling / tingling, gallstones gallbladder disorders, fluid blisters near the fallopian tubes, tissue nodules in the uterus, polyps in the cervix.

Very rare (may affect up to 1 in 10,000 people):

Jaundice due to impaired bile flow.

No known frequency (cannot be calculated from the available data):

Hair loss, allergic dermatitis, severe allergic reaction (including difficulty breathing, swelling of the face, tongue, throat, or skin, dizziness, and hives ).

The following side effects have been reported with other HRTs:

  • The disease of the gallbladder
  • Various skin diseases:
    • dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
    • painful reddish-purple bumps on the skin (erythema nodosum)
    • annular redness or sore rash (erythema multiforme)
  • Impaired memory and thought activity (possible dementia)
  • Dry eyes
  • Difficult to wear contact lenses

5. How to store Estalis

Store in a refrigerator (2 ° C – 8 ° C). Store at a maximum of 25 ° C for a maximum of 6 months. Do not freeze. Store in the original packaging (sealed foil envelope). Use the patch immediately after opening.

Both unused and used patches must be stored out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP and on the patch envelope after EXP. The expiry date will be the last day of that month.

After the patch has been removed, it should be folded with the adhesive side inwards and stored safely so that children do not have access to the patch. Return used or unused patches to pharmacies, preferably in the original packaging.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Each Estalis 50 /g / 250 µg / 24 h transdermal patch contains estradiol hemihydrate equivalent to 0.51 mg estradiol and 4.80 mg norethisterone acetate in a 16 cm 2patch and releases 50 micrograms of estradiol and 250 micrograms of norethisterone acetate per 24 hours.

  • The active substances are estradiol (as hemihydrate) and norethisterone acetate.
  • The other ingredients are Adhesive: silicone and acrylic adhesive, povidone, oleic acid, and propylene glycol. Plaster film: Polyester laminate. Protective film (removed before application): Polyester film coated with a fluoropolymer.

What the medicine looks like and the contents of the pack

Estalis transdermal patch is a 16 cm 2 round patch . The patch consists of a pressure-sensitive, adhesive layer that releases the active substances, with a translucent patch film on one side and a protective film on the other side.

Estalis 50 µg / 250 µg / 24 hours transdermal patches are supplied in cartons of 2, 8, or 24 patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Sverige AB, Box 1218, 164 28 Kista

Muhammad Nadeem

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