Etruzil

Package Leaflet: Information for the User

Etruzil, 2.5 mg, Film-Coated Tablets

Letrozole

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

• Keep this package leaflet. 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Etruzil and what is it used for

What is Etruzil and how does it work

Etruzil contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is used in the hormonal (endocrine) treatment of breast cancer.
The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Etruzil reduces the amount of estrogen by blocking the enzyme (aromatase) involved in the production of estrogens, and thus can slow down the growth of breast cancer that needs estrogens to grow.
As a result, cancer cells stop growing or grow slowly and (or) stop spreading to other parts of the body.

What is Etruzil used for

Etruzil is used to treat breast cancer in postmenopausal women, i.e., women who have stopped menstruating.
The medicine is used to prevent breast cancer from coming back. It can be used as the first treatment before breast cancer surgery, when immediate surgery is not recommended, or it can be used after breast cancer surgery as the first treatment or after five years of tamoxifen treatment.
Etruzil is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced breast cancer.
If you have any questions about how Etruzil works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Etruzil

Follow the instructions of your doctor. These instructions may differ from the general information contained in this package leaflet.

When not to take Etruzil

• if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
• if you are still menstruating, i.e., you have not gone through menopause,
• if you are pregnant,
• if you are breastfeeding. If any of these points apply to you, do not take the medicine and consult your doctor.

Warnings and precautions

Before starting treatment with Etruzil, tell your doctor or pharmacist

• if you have severe kidney disease,
• if you have severe liver disease,
• if you have a history of osteoporosis or bone fractures (see also "Monitoring during Etruzil treatment" in section 3). If any of these points apply to you, tell your doctor. Your doctor will take this information into account when treating you with Etruzil.

Letrozole may cause inflammation or damage to tendons (see section 4). If you experience pain or swelling of a tendon, rest the affected area and contact your doctor.

Children and adolescents (under 18 years of age)

Do not use this medicine in children and adolescents.

Elderly (65 years and older)

Patients aged 65 and older can take the medicine at the same dose as other adult patients.

Etruzil and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

• Etruzil can only be used when you are postmenopausal. However, your doctor should discuss the use of effective birth control with you, as you may still become pregnant during treatment with Etruzil.
• Do not take Etruzil if you are pregnant or breastfeeding, as the medicine may harm your baby.

Driving and using machines

If you experience dizziness, fatigue, drowsiness, or general malaise, do not drive, work with tools, or operate machinery until you feel better.

Etruzil contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.

Etruzil contains sodium

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

3. How to take Etruzil

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one Etruzil tablet per day. Taking Etruzil at the same time every day will help you remember to take your medicine.
You can take the tablet with or without food. Swallow the tablet whole with a glass of water or another liquid.

How long to take Etruzil

Continue taking Etruzil every day for as long as your doctor tells you. You may need to take the medicine for several months or even several years. If you have any questions about how long to take Etruzil, ask your doctor.

Monitoring during Etruzil treatment

The medicine can only be used under close medical supervision. Your doctor will regularly check your health to see if the treatment is working.
Etruzil may cause thinning or weakening of bones (osteoporosis) due to the reduction of estrogen levels in the body. Your doctor may order a bone density test (a type of osteoporosis test) before, during, and after treatment.

What to do if you take more Etruzil than you should

If you take more Etruzil than you should or if someone else takes your tablets, contact your doctor or go to the hospital immediately. Show the doctor the package of the medicine. You may need treatment.

What to do if you forget to take Etruzil

• If it is almost time for your next dose (e.g., 2 or 3 hours left), skip the missed dose and take the next dose at the usual time. Otherwise, take the missed dose as soon as you remember, and then take the next tablet at the usual time.
• Do not take a double dose to make up for a missed dose.

What to do if you stop taking Etruzil

Do not stop taking Etruzil unless your doctor tells you to. See also the section above "How long to take Etruzil".

4. Possible side effects

Like all medicines, Etruzil can cause side effects, although not everybody gets them.
Most side effects are mild or moderate and usually go away after a few days or weeks of treatment.
Some side effects, such as hot flashes, hair loss, or vaginal bleeding, may be caused by the lack of estrogen in the body.
Do not be alarmed by the list of possible side effects. You may not get any of them.

Some side effects can be serious: Uncommon side effects (may affect up to 1 in 100 people) or rare side effects

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

• Weakness, paralysis, or loss of sensation in any part of the body (especially in the arm or leg), lack of coordination, nausea, or difficulty speaking or breathing (symptoms of brain disease, such as stroke).
• Sudden crushing chest pain (symptom of heart disease).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin, or sudden pain in the arm, leg, or foot (symptoms indicating a possible blood clot).
• Swelling and redness along a vein, with severe tenderness or pain when touched.
• High fever, chills, or mouth ulcers due to infection (lack of white blood cells).
• Severe, persistent vision disturbances.

If you experience any of these symptoms, tell your doctor immediately.

You should also tell your doctor immediately if you experience any of the following symptoms during treatment with Etruzil:

• Swelling, mainly of the face and throat (symptoms of an allergic reaction)
• Yellowing of the skin and eyes, nausea, loss of appetite, dark urine (symptoms of liver disease)
• Rash, redness of the skin, blistering of the lips, eyes, or mouth, peeling of the skin, fever (symptoms of skin disease).

Some side effects are very common.They may affect more than 1 in 10 people.

• Hot flashes
• High cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain If any of these symptoms are severe, tell your doctor.

Some side effects are common.They may affect up to 1 in 10 people.

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders, such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone tissue (osteoporosis), which can lead to bone fractures in some cases (see also "Monitoring during Etruzil treatment" in section 3.)
• Swelling of the hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heartbeat
• Stiffness of the joints (arthritis)
• Chest pain If any of these symptoms are severe, tell your doctor.

Other side effects are uncommon.They may affect up to 1 in 100 people.

• Nervous system disorders, such as anxiety, nervousness, irritability, drowsiness, memory problems, excessive drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensory disturbances, especially touch
• Eye disorders, such as blurred vision, eye irritation
• Skin disorders, such as itching (hives)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Increased thirst, taste disturbances, dry mouth
• Dry mucous membranes
• Weight loss
• Urinary tract infection, frequent urination
• Cough
• Increased enzyme activity
• Yellowing of the skin and eyes
• High bilirubin levels (a product of red blood cell breakdown) in the blood
• Tendon inflammation (inflammation of the soft tissue that connects muscles and bones)

Other side effects are rare.They may affect up to 1 in 1,000 people.
Tendon rupture (inflammation of the soft tissue that connects muscles and bones)
Side effects with unknown frequency(cannot be estimated from the available data)
"Snapping finger", a condition in which the finger becomes stuck in a bent position.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse. You can also report side effects directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etruzil

This medicinal product does not require any special storage conditions.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after the statement: expiry date. The first two digits indicate the month and the last four digits indicate the year.
The expiry date is the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Etruzil contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), maize starch, sodium carboxymethylcellulose (type A), magnesium stearate (E572), colloidal anhydrous silica (E551). The ingredients of the tablet coating are: macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

What Etruzil looks like and contents of the pack

Etruzil tablets are yellow, round, film-coated tablets with the inscription L9OO on one side and 2.5 on the other.
Etruzil is available in blisters of 10, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Egis Pharmaceuticals PLC
1106 Budapest
Keresztúri út 30-38.
Hungary

Manufacturers

Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania SL.
C/Castelló,1,
Poligono Las Salinas
08330 Sant Boi de Llobregat
Barcelona
Spain
Rottendorf Pharma GmbH
Ostenfelder strasse 51-61
59320 Ennigerloh
Germany

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

Netherlands
Etruzil 2.5 mg, filmomhulde tabletten
Bulgaria
Etruzil 2.5 mg филмирани таблетки
Czech Republic
Etruzil 2,5 mg, potahované tablety
Hungary
Etruzil 2.5 mg filmtabletta
Poland
Etruzil
Romania
Etruzil 2.5 mg comprimate filmate
Slovakia
Etruzil
Date of last revision of the package leaflet:04.03.2021