Etruzil

Package leaflet: Information for the user

Etruzil, 2.5 mg, film-coated tablets
Letrozole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Etruzil is and what it is used for
2. What you need to know 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 Etruzil is and what it is used for

What Etruzil is and how it works
Etruzil contains an active substance called letrozole. It belongs to a group of medicines known as
aromatase inhibitors. It is used in 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 an enzyme (aromatase) involved in estrogen production, and therefore may inhibit the growth of estrogen-dependent breast cancer.
As a result, cancer cells stop growing or grow more slowly and (or) stop spreading to other parts of the body.

What Etruzil is used for
Etruzil is used to treat breast cancer in postmenopausal women, i.e. women who have stopped menstruating.
Etruzil is used to prevent recurrence of breast cancer. It may be used as initial treatment before breast cancer surgery when immediate surgery is not recommended, or it may be used after breast cancer surgery as initial treatment or following five years of tamoxifen therapy.
Etruzil is also used to prevent the spread of breast tumour 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, please consult your doctor.

2. Information before using Etruzil

Always follow your doctor's instructions. These may differ from the general information
provided in this leaflet.
When not to use Etruzil

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

Warnings and precautions
Before starting treatment with Etruzil, consult your doctor or pharmacist if:

• you have severe kidney disease,
• you have severe liver disease,
• you have a history of osteoporosis or bone fractures (see also “Monitoring during treatment with Etruzil” in section 3). If any of these apply to you, inform your doctor.
  Your doctor will take these factors into account when managing your treatment with Etruzil.

Letrozole may cause inflammation or damage to tendons (see section 4). If you experience
pain or swelling in a tendon, avoid putting strain on the affected area and contact your doctor.
Children and adolescents (under 18 years of age)
This medicine must not be used in children and adolescents.
Elderly patients (aged 65 years and older)
Patients aged 65 years and older can take Etruzil at the same dosage as other adult patients.
Etruzil and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken,
or plan to take, including over-the-counter medicines.
Pregnancy, breastfeeding and fertility

• Etruzil may only be used after menopause. However, your doctor should discuss with you the use of an effective method of contraception, because pregnancy may still occur during treatment with Etruzil.
• Do not take Etruzil if you are pregnant or breastfeeding, as the medicine may harm your baby.

Driving and operating machinery
If you experience dizziness, tiredness, drowsiness or general malaise, do not drive, operate tools,
or use machinery until you feel well again.
Etruzil contains lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor
before taking this medicine.
Etruzil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Etruzil

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
The recommended dose is one Etruzil tablet taken once daily. Taking Etruzil at the same time each day will help make it easier to remember to take the medicine.
The tablet may be taken with or without food. Swallow the tablet whole with a glass of water or another liquid.

How long to use Etruzil
Daily use of Etruzil should be continued for as long as recommended by the physician. Treatment may need to continue for several months or even several years. If there are any questions about how long Etruzil should be taken, consult the doctor.

Monitoring during treatment with Etruzil
Etruzil must be used only under strict medical supervision. The physician will regularly monitor the patient's health to assess whether the treatment is producing the desired effects.
Etruzil may cause thinning or loss of bone (osteoporosis) due to reduced estrogen levels in the body. The physician may order a measurement of the patient's bone density (a test for osteoporosis) before, during, and after treatment.

Taking more Etruzil than recommended
If a patient has taken more Etruzil than recommended, or if someone else accidentally ingests the tablets, contact a doctor immediately or go to the hospital. Show the medicine packaging. Medical treatment may be necessary.

Missed dose of Etruzil

• If the next dose is approaching (e.g. within 2 or 3 hours), skip the missed dose and take the next dose at the regular time. Otherwise, take the missed dose as soon as remembered, then take the next tablet at the regular time.
• Do not take a double dose to make up for a missed dose.

Stopping Etruzil treatment
Do not stop taking Etruzil unless instructed by the physician. See also the section above, "How long to use Etruzil".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild or moderate in severity and usually resolve after a few days or weeks of treatment.
Some of the adverse effects, such as hot flushes, hair loss or vaginal bleeding, may be caused by low estrogen levels in the body.
There is no need to be alarmed by the list of possible side effects listed below. It is possible that none of these effects will occur.

Some side effects may be serious:

Uncommon side effects (may occur in up to 1 in 100 patients) or rare side effects (may occur in up to 1 in 1000 patients)

• 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, e.g. stroke).
• Sudden, pressing chest pain (symptom of heart disease).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, skin cyanosis, or sudden pain in the arm, leg, or foot (symptoms suggesting possible blood clot formation).
• Swelling and redness along the course of a vein, with marked tenderness or pain on touch.
• High fever, chills, or oral ulcers due to infection (lack of white blood cells).
• Severe, persistent visual disturbances. If any of the above symptoms occur, inform your doctor immediately.

You should also inform your doctor immediately if any of the following symptoms occur during treatment with Etruzil:

• Swelling, mainly of the face and throat (symptoms of allergic reaction)
• Yellowing of the skin and eyes, nausea, loss of appetite, dark urine (symptoms of liver inflammation)
• Skin rash, redness of the skin, formation of blisters on the lips, eyes, or in the mouth, skin peeling, fever (symptoms of skin disease).

Some side effects are very common. They may occur in more than 1 in 10 patients.

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

Some side effects are common. They may occur in up to 1 in 10 patients.

• Skin rash
• Headache
• Dizziness
• Malaise
• Gastrointestinal disturbances such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone tissue (osteoporosis), leading in some cases to bone fractures (see also "Monitoring during treatment with Etruzil" in section 3.)
• Swelling of hands, palms, feet, ankles (oedema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain
  If any of these symptoms are severe, inform your doctor.

Other side effects occur less frequently. They may occur in up to 1 in 100 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, excessive sleepiness, 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 (urticaria)
• Vaginal discharge or vaginal dryness
• Breast pain
• Fever
• Increased thirst, taste disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme activity
• Yellowing of the skin and eyes
• High bilirubin levels (a breakdown product of red blood cells) in the blood
• Tendon inflammation (soft tissue connecting muscles and bones)

Other side effects are rare. They may occur in 1 in 1000 patients.
Tendon rupture (soft tissue connecting muscles and bones)

Side effects with unknown frequency (cannot be estimated from available data)
"Trigger finger", a condition in which the finger becomes locked in a bent position.

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Etruzil

This medicinal product does not require any special storage conditions.
The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the blister and carton after the words: expiry date. The first two digits indicate the month and the last four digits indicate the year.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging 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: monohydrate lactose, microcrystalline cellulose (E460), pregelatinized corn starch, sodium carboxymethyl starch (type A), magnesium stearate (E572), colloidal anhydrous silica (E551). The tablet coating ingredients are: macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

What Etruzil looks like and contents of the pack
Etruzil tablet is a yellow, round, film-coated tablet, marked with "L9OO" on one side and "2.5" on the other side.
Etruzil is available in blister packs containing 10, 28, 30, 50, 56, 60, 84, 90, 98 or 100 tablets per 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
The 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 countries 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