Etadron

Patient Information Leaflet

Etadron, 25 mg, coated tablets
exemestanum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Etadron is and what it is 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 pack and other information

1. What Etadron is and what it is used for

Exemestane belongs to a group of medicines known as aromatase inhibitors. These medicines act on a substance called aromatase, which is necessary for the production of female sex hormones, estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.
Exemestane is used to treat early-stage hormone-dependent breast cancer in postmenopausal women who have completed a 2-3 year course of treatment with tamoxifen.
Exemestane is also used in the treatment of advanced-stage hormone-dependent breast cancer in postmenopausal women in whom prior hormonal therapies have not produced the desired results.

2. Important information before using Etadron

When not to use 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 undergone menopause, i.e. if she is still menstruating,
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding.

Warnings and precautions
Before starting treatment with Etadron, discuss this with your doctor or pharmacist.

• Before starting Etadron, your doctor may take blood samples to confirm that you have already undergone menopause.
• Before starting treatment, your doctor may recommend routine testing of vitamin D levels, as these may be very low in early-stage breast cancer. Women with vitamin D deficiency should receive supplementation to correct this deficiency.
• Inform your doctor about any existing liver or kidney function disorders before taking Etadron.
• Inform your doctor if you have ever had or currently have any medical condition affecting bone strength. Your doctor may recommend measuring bone density before starting treatment and during therapy with Etadron. This measurement is performed because drugs in this class reduce levels of female hormones in the body, which may lead to loss of minerals in the bones and decreased bone strength.

Etadron and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
Etadron must not be taken concurrently with hormone replacement therapy (HRT).
Exercise caution when using the following medicines simultaneously with Etadron. Inform your doctor if you are taking any of the following:

• rifampicin (an antibiotic),
• carbamazepine, phenytoin (anticonvulsant medicines used to treat epilepsy),
• herbal medicines used for depression (containing St. John's wort, i.e. Hypericum perforatum).

Etadron with food and drink
Etadron should be taken after a meal, approximately at the same time each day.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.
Do not use Etadron if you are pregnant or breastfeeding. If you are pregnant or suspect you may be pregnant, inform your doctor immediately.
Discuss with your doctor the type of contraception to use if there is any possibility of becoming pregnant.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
If you feel drowsy, dizzy, or weak while taking Etadron, you should not drive or operate machinery.
Etadron contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Etadron

Adults and elderly patients
This medicine should always be taken as prescribed by the doctor. If in doubt, consult a doctor or pharmacist.
Etadron should be taken orally, after a meal, at approximately the same time each day. The doctor will inform you how to take the medicine and for how long it should be used. The usual dose of Etadron is one 25 mg tablet per day.
If hospitalization is required, the patient should inform the medical staff that she is taking Etadron.

Use in children
Etadron is not suitable for use in children.

Taking more Etadron than recommended
If an overdose is taken by accident, contact a doctor immediately or go to the nearest hospital emergency department. Show the Etadron packaging to the doctor.

Missing a dose of Etadron
Do not take a double dose to make up for a missed tablet.
If a dose is missed, take it as soon as remembered.
If it is almost time for the next dose, skip the missed dose and take the next tablet at the usual time.

Stopping Etadron treatment
Do not stop taking the tablets, even if the patient feels better, unless otherwise advised by the doctor.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Generally, Etadron is well tolerated, and the adverse reactions observed in patients treated with
Etadron are usually mild or moderate in severity. Most of the adverse reactions are related to
estrogen deficiency (e.g. hot flushes).
The following adverse reactions may occur: hypersensitivity reactions, hepatitis and cholangitis,
which causes yellowing of the skin (cholestatic hepatitis).
Symptoms of hepatitis include: general malaise, nausea, jaundice (yellowing of the skin and eyes),
itching, abdominal pain in the right upper quadrant, and loss of appetite. If any of these symptoms
are observed, the patient should immediately contact a physician to obtain medical assistance.
The following adverse reactions have been observed in patients taking exemestane in tablet form:

Very common adverse reactions (may affect more than 1 in 10 patients):

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

Common adverse reactions (may affect up to 1 in 10 patients):

• loss of appetite,
• carpal tunnel syndrome (simultaneous tingling, numbness and pain in the entire hand except the little finger) or tingling/itching sensation on the skin,
• abdominal pain, vomiting, constipation, indigestion, diarrhea,
• hair loss,
• rash, urticaria and itching,
• decreased bone density, which may reduce bone strength (osteoporosis), leading in some cases to fractures (fractures or cracks),
• pain, swelling of hands and feet,
• decreased number of platelets,
• muscle weakness.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• hypersensitivity.

Rare adverse reactions (may affect up to 1 in 1,000 patients):

• transformation of small skin blisters into a rash,
• somnolence,
• hepatitis,
• cholangitis causing yellowing of the skin.

Unknown frequency (cannot be estimated from the available data):

• decreased number of certain types of blood cells.

Changes in peripheral blood may also occur, including changes in the number of certain blood cells (lymphocytes) and platelets, particularly in patients who had lymphopenia (reduced number of lymphocytes in the blood) prior to starting treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine 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 on the blisters following
the abbreviation "EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the carton following the abbreviation "Lot".
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Etadron contains

• The active substance is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other ingredients are: mannitol, microcrystalline cellulose, crospovidone, sodium carboxymethyl starch (type A), hypromellose, polysorbate 80, colloidal anhydrous silica, magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), polyethylene glycol 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,
film-coated, with 'E25' embossed on one side and plain on the other.
Packaging: Blister packs containing 15, 20, 30, 90, 100 and 120 film-coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the Member States of the European
Economic Area under the following names: