Letrozole Eugia

Package Leaflet: Information for the Patient

Letrozole Eugia, 2.5 mg, Film-Coated Tablets

Letrozole

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

• Keep this 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 only. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Letrozole Eugia and what is it used for

What is Letrozole Eugia and how does it work

Letrozole Eugia 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. Letrozole Eugia reduces the amount of estrogen by inhibiting the activity of an enzyme (aromatase) involved in the production of estrogens, and thus can slow down the growth of malignant breast tumors that need estrogens to grow. As a result of this action, cancer cells stop growing or grow slowly and (or) stop spreading to other parts of the body.

What is Letrozole Eugia used for

Letrozole Eugia is used to treat breast cancer in postmenopausal women, i.e., women who have stopped menstruating.
This medicine is used to prevent breast cancer from coming back. It can be used as the first treatment before breast surgery, when immediate surgery is not recommended, or as the first treatment after breast surgery, or after 5 years of treatment with tamoxifen. Letrozole Eugia 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 Letrozole Eugia works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Letrozole Eugia

Always take this medicine exactly as your doctor has told you. The instructions may be different from the general information in this leaflet.

When not to take Letrozole Eugia

• 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 are still premenopausal,
• if you are pregnant,
• if you are breastfeeding.

Do not take the medicine if any of these points apply to you - consult your doctor.

Warnings and precautions

Before starting treatment with Letrozole Eugia, discuss this with your doctor or pharmacist

• if you have severe kidney disease,
• if you have severe liver disease,
• in case of osteoporosis or if you have had bone fractures before (see "Monitoring during treatment with Letrozole Eugia" in section 3).

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.
If any of these points apply to you, tell your doctor. Your doctor will take this information into account during treatment with Letrozole Eugia.

Children and adolescents (under 18 years of age)

This medicine should not be used in children and adolescents.

Elderly patients (65 years of age and older)

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

Letrozole Eugia and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Letrozole Eugia should only be taken when you are postmenopausal. However, your doctor will discuss with you the need for effective contraception, as you may still become pregnant during treatment with Letrozole Eugia.
• Do not take Letrozole Eugia if you are pregnant or breastfeeding, as the treatment may harm your baby.

Driving and using machines

If you experience dizziness, feeling tired, drowsiness, or general ill health, do not drive or operate machinery until your condition improves.

Letrozole Eugia contains lactose

Letrozole Eugia contains lactose (milk sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Letrozole Eugia contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be essentially "sodium-free".

3. How to take Letrozole Eugia

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is one film-coated tablet of Letrozole Eugia taken once a day. Taking Letrozole Eugia at the same time every day will help you remember to take your tablet.
The tablet can be taken with or without food and should be swallowed whole with a glass of water or another liquid.

How long to take Letrozole Eugia

Take Letrozole Eugia every day and for as long as your doctor has prescribed it. You may need to take the medicine for several months or even years. If you have any questions about how long to take Letrozole Eugia, ask your doctor.

Monitoring during treatment with Letrozole Eugia

This medicine should always be taken under close medical supervision. Your doctor will regularly check your health to ensure that the treatment is working properly.
Letrozole Eugia may cause thinning or loss of bone tissue (osteoporosis) related to the decrease in estrogen levels in the body. Your doctor may order a bone density test (osteoporosis screening) before, during, and after treatment.

Taking more than the prescribed dose of Letrozole Eugia

If you have taken more than the prescribed dose of Letrozole Eugia or if someone has taken your tablets by mistake, contact your doctor or go to the hospital immediately. Show the doctor the package of the medicine. You may need treatment.

Missing a dose of Letrozole Eugia

• If it is almost time for your next dose (e.g., 2 to 3 hours left), skip the missed tablet and take the next dose at the usual time.
• In any other case, take the 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.

Stopping treatment with Letrozole Eugia

Do not stop taking Letrozole Eugia without consulting your doctor. See also "How long to take Letrozole Eugia".
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Letrozole Eugia can cause side effects, although not everybody gets them.
Most of the observed side effects are mild to moderate and usually appear within a few days to a few weeks of treatment.
Some of them, such as hot flashes, hair loss, or vaginal bleeding, may be a consequence of the lack of estrogens in the body.
Do not be concerned about all the possible side effects listed below. They may not occur at all.

Some side effects can be serious:

Uncommon (may affect up to 1 in 100 people):

• weakness, paralysis, or loss of sensation in any part of the body (especially in the arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (symptoms of brain disorders, such as stroke)
• sudden crushing chest pain (symptom of heart disorders)
• swelling and redness along a vein, extremely tender and painful to the touch
• high fever, chills, or mouth ulcers caused by infections (lack of white blood cells)
• severe, persistent vision disturbances
• tendon inflammation (inflammation of the soft tissue that connects muscles and bones).

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

• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (symptoms indicating the formation of a blood clot)
• tendon rupture (rupture of the soft tissue that connects muscles and bones).

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 Letrozole Eugia:

• 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 inflammation)
• rash, redness of the skin, blistering of the lips, eyes, or mouth, peeling of the skin, fever (symptoms of skin disorders).

Other side effects

Very common (may affect more than 1 in 10 people):

• hot flashes
• increased cholesterol levels (hypercholesterolemia)
• feeling tired
• increased sweating
• bone and joint pain.

If any of these symptoms occur in a severe form, tell your doctor.

Common (may affect up to 1 in 10 people):

• skin rash
• headache
• dizziness
• general ill health
• gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• increased or decreased appetite
• muscle pain
• thinning or loss of bone tissue (osteoporosis), leading to bone fractures in some cases (see "Monitoring during treatment with Letrozole Eugia" in section 3)
• swelling of the arms, hands, feet, and ankles (edema)
• depression
• weight gain
• hair loss
• high blood pressure (hypertension)
• abdominal pain
• dry skin
• vaginal bleeding
• rapid heartbeat
• joint stiffness (arthritis)
• chest pain.

If any of these symptoms occur in a severe form, tell your doctor.

Uncommon (may affect up to 1 in 100 people):

• nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, feeling sleepy, 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
• thirst, taste disturbances, dry mouth
• mouth and lip inflammation
• dry mucous membranes
• weight loss
• urinary tract infections, frequent urination
• cough
• increased enzyme activity
• yellowing of the skin and whites of the eyes
• high bilirubin levels in the blood (a product of red blood cell breakdown).

Frequency not known(frequency cannot be estimated from the available data):

• trigger finger - a condition in which the finger or thumb gets stuck in a bent position.

If any of these symptoms occur in a severe form, tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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 to gather more information on the safety of the medicine.

5. How to store Letrozole Eugia

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 Letrozole Eugia contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl cellulose (type A), cornstarch, colloidal anhydrous silica, magnesium stearate.

Tablet coating: hypromellose 2910, yellow iron oxide (E 172), titanium dioxide (E 171), macrogol 3350, talc.

What Letrozole Eugia looks like and contents of the pack

Film-coated tablet
Dark yellow, film-coated, round, slightly biconvex tablet with beveled edges, with "L2.5" engraved on one side and smooth on the other side.
Letrozole Eugia film-coated tablets are available in blisters.
Packet sizes:
Blisters: 30, 60, 100, and 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valletta Waterfront
Floriana, FRN1914
Malta
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

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

France:
Letrozole Arrow Lab 2.5 mg, film-coated tablet
Spain:
Letrozol Aurovitas 2.5 mg film-coated tablets EFG
Germany:
LetroPUREN 2.5 mg film-coated tablets
Poland:
Letrozole Eugia
Portugal:
Letrozol Loxoprel
Italy:
Letrozolo Aurobindo Italia

Date of last revision of the leaflet: 10/2024