ETADRON 25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Etadron, 25 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Etadron and what is it used for
4. Important information before taking Etadron
   1. When not to take Etadron
   2. Warnings and precautions
   3. Etadron and other medicines
   4. Etadron with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Etadron contains sodium
5. How to take Etadron
   1. Adults and elderly patients
   2. Use in children
   3. Taking more than the recommended dose of Etadron
   4. Missing a dose of Etadron
   5. Stopping treatment with Etadron
6. Possible side effects
   1. Very common side effects (may affect more than 1 in 10 patients):
   2. Common side effects (may affect up to 1 in 10 patients):
   3. Uncommon side effects (may affect up to 1 in 100 patients):
   4. Rare side effects (may affect up to 1 in 1,000 patients):
   5. Unknown frequency (cannot be estimated from available data):
   6. Reporting side effects
7. How to store Etadron
8. Contents of the packaging and other information
   1. What Etadron contains
   2. What Etadron looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Etadron, 25 mg, coated tablets

exemestane

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Etadron and what is it used for
• 2. Important information before taking Etadron
• 3. How to take Etadron
• 4. Possible side effects
• 5. How to store Etadron
• 6. Contents of the packaging and other information

1. What is Etadron and what is it used for

Exemestane belongs to a group of medicines known as aromatase inhibitors. These medicines work by interfering with an enzyme called aromatase, which is involved in the production of female sex hormones, estrogens, especially in postmenopausal women. Reducing estrogen levels in the body is a way to treat hormone-dependent breast cancer.

Exemestane is used to treat early-stage hormone-dependent breast cancer in postmenopausal women who have completed 2-3 years of tamoxifen treatment.

Exemestane is also used to treat advanced hormone-dependent breast cancer in postmenopausal women who have not responded to other hormonal therapies.

2. Important information before taking Etadron

When not to take Etadron

• if the patient is allergic to exemestane or any of the other ingredients of this medicine (listed in section 6),
• if the patient has not yet reached menopause, i.e., if she is still menstruating,
• if the patient is pregnant, thinks she may be pregnant, or is breastfeeding.

Warnings and precautions

Before starting treatment with Etadron, the patient should discuss it with their doctor or pharmacist.

• Before starting treatment with Etadron, the doctor may take blood samples to ensure the patient has reached menopause.
• Before starting treatment, the doctor may recommend routine vitamin D level testing, as levels may be low in early-stage breast cancer. Women with vitamin D deficiency should receive supplemental treatment.
• Before taking Etadron, the patient should inform their doctor about any liver or kidney function disorders.
• The patient should inform their doctor if they have or have had any medical condition that affects bone strength. The doctor may order a bone density test before starting treatment with Etadron and during therapy. This test is performed because medicines like Etadron reduce estrogen levels in the body, which can lead to mineral loss in bones and reduced bone strength.

Etadron and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription.

Etadron should not be taken with hormone replacement therapy (HRT).

Care should be taken when using the following medicines with Etadron. The patient should inform their doctor if they are taking medicines such as:

• rifampicin (an antibiotic),
• carbamazepine, phenytoin (anti-epileptic medicines used to treat epilepsy),
• herbal medicines used to treat depression (containing St. John's Wort, Hypericum perforatum).

Etadron with food and drink

Etadron should be taken after a meal, at about the same time each day.

Pregnancy and breastfeeding

If the patient is pregnant, thinks she may be pregnant, or is breastfeeding, she should consult her doctor or pharmacist before taking this medicine.

Etadron should not be taken if the patient is pregnant or breastfeeding. If the patient is pregnant or thinks she may be pregnant, she should inform her doctor.

The patient should discuss the type of contraception with their doctor if there is a chance of becoming pregnant.

Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

If the patient feels drowsy, dizzy, or weak while taking Etadron, she should not drive or operate machinery.

Etadron contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Etadron

Adults and elderly patients

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.

Etadron should be taken orally, after a meal, at about the same time each day. The doctor will inform the patient how to take the medicine and for how long. The usual dose of Etadron is one 25 mg tablet per day.

If the patient is hospitalized, she should inform the medical staff that she is taking Etadron.

Use in children

Etadron is not intended for use in children.

Taking more than the recommended dose of Etadron

In case of accidental overdose, the patient should immediately contact their doctor or go to the emergency room of the nearest hospital. The patient should show the doctor the packaging of Etadron.

Missing a dose of Etadron

The patient should not take a double dose to make up for a missed tablet.

If the patient misses a tablet, she should take it as soon as she remembers. If it is almost time for the next dose, she should take the next dose at the usual time.

Stopping treatment with Etadron

The patient should not stop taking the tablets, even if she feels better, unless the doctor decides otherwise.

If the patient has any further doubts about taking this medicine, she should consult her doctor or pharmacist.

4. Possible side effects

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

Generally, Etadron is well tolerated, and the following side effects observed in patients taking Etadron are usually mild or moderate. Most side effects are related to estrogen deficiency (e.g., hot flashes).

The following side effects may occur: allergic reactions, liver inflammation, and bile duct inflammation, which can cause yellowing of the skin (liver inflammation with cholestasis).

Symptoms of liver inflammation include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, abdominal pain on the right side, and loss of appetite. If the patient experiences any of these symptoms, she should contact her doctor immediately to receive medical attention.

In patients taking exemestane in tablet form, the following side effects have been observed:

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

• depression,
• insomnia,
• headache,
• hot flashes,
• dizziness,
• nausea,
• increased sweating,
• muscle and joint pain (including osteoarthritis, back pain, joint inflammation, and stiffness),
• fatigue,
• decreased white blood cell count,
• abdominal pain,
• increased liver enzyme activity,
• increased levels of hemoglobin breakdown products in the blood,
• increased enzyme levels in the blood due to liver damage,
• pain.

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

• loss of appetite,
• carpal tunnel syndrome (numbness, tingling, and pain in the entire hand except the little finger) or tingling/numbness on the skin,
• abdominal pain, vomiting, constipation, indigestion, diarrhea,
• hair loss,
• rash, hives, and itching,
• bone thinning, which can lead to reduced bone strength (osteoporosis), resulting in fractures (fractures or cracks) in some cases,
• pain, swelling of hands and feet,
• decreased platelet count,
• muscle weakness.

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

• allergic reaction.

Rare side effects (may affect up to 1 in 1,000 patients):

• conversion of small blisters on the skin into a rash,
• drowsiness,
• liver inflammation,
• bile duct inflammation causing yellowing of the skin.

Unknown frequency (cannot be estimated from available data):

• decreased count of certain types of blood cells.

Changes in blood counts may also occur: in the number of certain blood cells (lymphocytes) and platelets, especially in patients who had lymphopenia (reduced lymphocyte count) before starting treatment.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, she should tell her doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Etadron

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister packs after "EXP". The expiry date refers to the last day of the month.

The batch number is stated on the carton after "Lot".

There are no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Etadron contains

• The active substance of Etadron is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other ingredients are: mannitol, microcrystalline cellulose, crospovidone, sodium carboxymethyl cellulose (type A), hypromellose, polysorbate 80, colloidal anhydrous silica, magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), macrogol 400 in the tablet coating. See section 2 "Etadron contains sodium".

What Etadron looks like and contents of the pack

Etadron tablets are white or almost white, round (diameter: 7.2 mm), biconvex, coated with "E25" embossed on one side and smooth on the other.

Packaging: 15, 20, 30, 90, 100, and 120 coated tablets in blisters, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:13.01.2021