Film-coated tablets 

Read all of this leaflet carefully before you start taking 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. 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 Eviana is and what it is used for 
2. What you need to know before taking Eviana 
3. How to take Eviana 
4. Possible side effects 
5. How to store Eviana 
6. Contents of the packaging and other information 

1. What Eviana is and what it is used for

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

Eviana is used in women whose period has stopped ( menopause ), at least 1 year after their last natural menstrual period.

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

Eviana is prescribed to women who have their uterus left and who had their last menstrual period more than a year ago.

Experience in the treatment of women older than 65 years is limited.

2. What you need to know before taking Eviana

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 with Eviana, 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 take Eviana

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

Do not take Eviana:

  • 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 uterine lining (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 severe thickening of the uterine lining ( endometrial hyperplasia ) and are not 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 (hypersensitive) to estradiol, norethisterone acetate, or any of the other ingredients of Eviana (see section 6 “Contents of the pack and other information”).

If any of the above affects you for the first time when you use Eviana, stop taking Eviana 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 Eviana. 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 (venous thromboembolism )”)
  • If a close relative has had breast cancer or other estrogen-dependent cancer
  • High blood pressure
  • Liver disease eg 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
  • Hypothyroidism (the thyroid gland does not produce enough thyroid hormones) and you are treated with thyroid hormone
  • Hereditary angioedema (recurrent severe swelling), or if you have had occasional swelling of the hands, face, feet, lips, eyes, tongue, pharynx (obstruction of the respiratory tract), or digestive tract
  • Lactose intolerance.

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

  • Some of what is mentioned in the section “Do not take Eviana”
  • 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.

For more information, see below “Blood clots in a vein (venous thromboembolism )”.

Note: Eviana 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 Eviana protects you against this extra risk.

Comparison

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, 10–60 women out of 1,000 users will be diagnosed with endometrial cancer (ie between 5–55 extra cases) depending on dose one and how long it takes.

Irregular bleeding

Irregular spotting or spotting may occur during the first 3-6 months of taking Eviana. But about the bleeding:

  • lasts longer than 6 months
  • begins after taking Eviana for 6 months
  • continues after you stop taking Eviana

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

For women aged 50 to 54 who do not take HRT, an average of 13 to 17 out of 1,000 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 of 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 doing 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 2000 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 2000 users (ie about 1 extra case).

How HRT affects the heart and blood circulation

Blood clots in a vein (venous thromboembolism )

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 blood clots are described in the section “You should contact a doctor immediately and discontinue treatment with Eviana”.

Comparison

For women in their 50s who do not take HRT, an average of 4-7 out of 1,000 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).

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 for those who do not take HRT.

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 take 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 preparations 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.

Other drugs and Eviana

Some medicines may affect the way Eviana works, which may lead to irregular bleeding. The following applies:

  • Drugs for epilepsy (eg phenobarbital, phenytoin, and carbamazepine)
  • Medicines for tuberculosis (eg rifampicin and rifabutin)
  • Drugs for HIV – infection (for example, nevirapine, efavirenz, ritonavir, and nelfinavir)
  • Medicines for hepatitis C infection s (such as telaprevir)
  • An herbal medicine containing St. John’s wort ( Hypericum perforatum ).

Other medicines may increase the effect of Eviana:

  • Medicines containing ketoconazole (medicines used to treat fungal infections).

Eviana may affect cyclosporine when used concomitantly.

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 taking Eviana as it may affect the results of some tests.

Eviana with food and drink

The tablets can be taken with or without food and drink.

Pregnancy and breastfeeding

Pregnancy: Eviana is for women who have stopped menstruating. If you become pregnant, stop taking Eviana and consult a doctor.

Breast-feeding: You should not take Eviana if you are breast-feeding.

Driving and using machines

Eviana has no known influence on the ability to drive or use machines.

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.

Important information about a substance in Eviana

Eviana contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Eviana.

3. How to take Eviana

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Take one tablet daily at about the same time. Take the tablet with a glass of water.

Take one tablet daily without interruption. When you have used up all 28 tablets in calendar pack one, continue immediately with the next pack.

For further information on how to use calendar packaging, see INSTRUCTIONS FOR USE at the end of the package leaflet.

You can start treatment with Eviana on any day. However, if you switch from an HRT preparation when you have your monthly bleeding, you should start treatment immediately after the bleeding has stopped.

Your doctor will strive to give you the lowest dose, which will give you relief of symptoms, and that you should use Eviana 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.

If you take more Eviana then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. An overdose of estrogen can cause chest tightness, nausea, vomiting, and/or irregular vaginal bleeding ( metrorrhagia ). Overdose of progestogens can lead to depression, fatigue, acne, and heavy hair growth on the face and body ( hirsutism ).

If you forget to take Eviana

If you forget to take your tablet, you should take it within 12 hours from the usual time. If more than 12 hours have passed, take the next tablet, as usual, the next day. Do not take a double dose to make up for a tablet you forgot to take.

Missing a dose can increase the likelihood of breakthrough bleeding and spotting unless you have had your uterus operated on.

If you stop taking Eviana

If you want to stop taking Eviana, first discuss this with your doctor. The doctor will explain what it means to stop taking the tablets and inform you about other alternatives.

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

If you need surgery

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

4. Possible side effects

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

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 “What you need to know before you take Eviana” for more information on these side effects.

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

  • Vaginal bleeding

Common side effects (may affect up to 1 in 10 people)

  • Fungal infection of the abdomen or inflammation of the vagina
  • The vigorous growth of the uterine lining ( endometrial hyperplasia )
  • Nausea
  • Abdominal pain
  • Back or neck pain
  • Pain in arms or legs
  • Headache.

Uncommon side effects (may affect up to 1 in 100 people)

  • Allergic reaction (hypersensitivity)
  • Depression or worsening of current depression
  • Nervousness
  • Dizziness
  • Migraine (See “You should contact your doctor immediately and stop taking Eviana” in section 2)
  • Pain or discomfort in the breasts
  • Tension or another discomfort in the stomach
  • Weight gain due to accumulation of fluid in the body
  • Swollen arms and legs (peripheral edema )
  • Leg cramps
  • Poor digestion ( dyspepsia )
  • Acne
  • Hair loss
  • Itching or hives.

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

  • General hypersensitivity reactions (eg anaphylactic reaction/shock) have been reported.

Other side effects are HRT combination drugs

  • 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)
    • red or purple discolorations on the skin and/or mucous membranes ( vascular purpura)
  • Dry eyes
  • Changes in the tear film composition.

5. How to store Eviana

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and the outer carton after “EXP”. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Store in a cold place.

Store in the outer carton. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. 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

  • The active substances are estradiol and norethisterone acetate. Each tablet contains 0.5 mg estradiol (as hemihydrate) and 0.1 mg norethisterone acetate.
  • The other ingredients are lactose monohydrate, corn starch, hydroxypropylcellulose, magnesium stearate, hypromellose, triacetin, and talc.

What the medicine looks like and the contents of the pack

The film-coated tablets are white and round with a diameter of 6 mm. The tablets are marked NOVO 291 on one side and have a Novo Nordisk logo (Apistjur) on the other.

Pack sizes:

  • 28 film-coated tablets
  • 3 x 28 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Novo Nordisk A / S

Novo Allé

DK-2880 Bagsværd

Denmark

This medicinal product is authorized under the European Economic Area under the names:

Activelle: Austria, Italy, Portugal

Activelle low: Denmark, Iceland, Italy

Minor activates: Belgium, Luxembourg

Eviana: Estonia, Hungary, the Netherlands, Norway, Spain,

Noviana: Finland

Muhammad Nadeem

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