LETROZOLE VIR 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Letrozol Vir 2.5 mg film-coated tablets EFG

Letrozol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

1. What Letrozol Vir is and what it is used for
2. What you need to know before taking Letrozol Vir
3. How to take Letrozol Vir
4. Possible side effects
5. Storage of Letrozol Vir
6. Package contents and additional information

1. What Letrozol Vir is and what it is used for

What Letrozol Vir is and how it works

Letrozol Vir contains the active ingredient letrozole. It belongs to a group of medications called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are female sex hormones. Letrozol reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in the production of estrogens, and thus can block the growth of breast cancers that need estrogens to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What Letrozol Vir is used for

Letrozol is used to treat breast cancer in women who have gone through menopause, i.e., the cessation of menstrual periods.

Letrozol is used to prevent breast cancer from coming back. It can be used as the first treatment before breast cancer surgery, in case surgery is not immediately possible, or it can be used as the first treatment after breast cancer surgery or after five years of treatment with tamoxifen. Letrozol is also used to prevent the breast tumor from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about how letrozol works or why you have been prescribed this medication, consult your doctor.

2. What you need to know before taking Letrozol Vir

Follow your doctor's instructions carefully. They may be different from the general information contained in this package leaflet.

Do not take Letrozol Vir

• If you are allergic (hypersensitive) to letrozole or any of the other ingredients of this medication (listed in section 6).
• If you still have menstrual cycles, i.e., you have not reached menopause.
• If you are pregnant.
• If you are breastfeeding.

If any of these cases apply to you, do not take this medication and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Vir

• 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 of Letrozol Vir treatment" in section 3).
• Letrozol may cause tendon inflammation or tendon damage (see section 4). If you experience any signs of pain or inflammation of the tendons, rest the affected area and contact your doctor.

If any of these cases apply to you, inform your doctor. Your doctor will take this into account during your treatment with Letrozol Vir.

Children and adolescents (under 18 years)

Children and adolescents should not use this medication.

Elderly patients (65 years and over)

People 65 years and older can use this medication at the same dose as for adults.

Taking Letrozol Vir with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication, including medications without a prescription.

Pregnancy, breastfeeding, and fertility

• You should only take letrozol if you have gone through menopause. However, your doctor should discuss the use of effective contraception with you, as you may still be able to get pregnant during treatment with letrozol.

• Do not take letrozol if you are pregnant or breastfeeding, as it may harm your baby.

Driving and using machines

If you feel dizzy, tired, sleepy, or unwell, do not drive or operate tools or machines until you feel better.

Letrozol Vir contains lactose and sodium

Letrozol Vir contains lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free"

Use in athletes:

This medication contains letrozol, which may produce a positive result in doping tests.

3. How to take Letrozol Vir

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

The normal dose is one Letrozol Vir tablet once a day. If you take Letrozol Vir at the same time every day, it will help you remember when to take the tablet.

The tablet can be taken with or without food and should be swallowed whole with a glass of water or other liquid.

How long to take Letrozol Vir

Continue taking Letrozol Vir every day for the time indicated by your doctor. You may need to take it for months or even years. If you have any doubts about how long you should take Letrozol Vir, consult your doctor.

Monitoring of Letrozol Vir treatment

You should only take this medication under strict medical supervision. Your doctor will periodically check your condition to ensure that the treatment has the desired effect.

Letrozol Vir may cause a decrease in bone thickness or bone loss (osteoporosis) due to the decrease in estrogens in the body. Your doctor may decide to perform bone density measurements (a way to monitor osteoporosis) before, during, and after treatment.

If you take more Letrozol Vir than you should

If you have taken too many Letrozol Vir tablets, or if someone else has taken the tablets by accident, contact your doctor or go to the hospital immediately. Show them the package of tablets. You may need medical treatment. You can also call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Letrozol Vir

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

If you stop taking Letrozol Vir

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

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Most side effects are mild to moderate and usually disappear within a few days or weeks of treatment.

Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to the lack of estrogens.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects can beserious:

Rare or uncommon side effects (i.e., may affect between 1 and 100 out of 10,000 people)

• Weakness, paralysis, or loss of sensation in some part of the body, loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke).
• Chest pain or sudden onset (sign of heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of blood clots).
• Swelling and redness along a vein that is extremely soft and possibly painful to the touch.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe blurred vision.

If you experience any of the above,inform your doctor immediately.

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

• Swelling mainly in the face and throat (signs of allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).
• Rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

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

• Hot flashes.
• High cholesterol levels (hypercholesterolemia).
• Fatigue.
• Increased sweating.
• Bone and joint pain (arthralgia).

If any of these side effects affect you severely, consult your doctor.

Common side effects(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 bones (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of Letrozol Vir treatment" in section 3).
• Swelling of arms, hands, feet, ankles (edema).
• Depression.
• Weight gain.
• Hair loss.
• High blood pressure (hypertension).
• Abdominal pain.
• Dry skin.
• Vaginal bleeding.
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain

If any of these side effects affect you severely, inform your doctor.

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

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia.
• Sensitivity disorders, especially to touch.
• Eye disorders such as blurred vision, eye irritation.
• Skin disorders such as itching (urticaria).
• Vaginal discharge or dryness.
• Breast pain.
• Fever.
• Thirst, taste disorder, dry mouth.
• Dryness of mucous membranes.
• Weight loss.
• Urinary tract infection, increased frequency of urination.
• Cough.
• Increased enzyme levels.
• Yellowing of the skin and eyes
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones)
• Rare side effects(may affect up to 1 in 1,000 people)
• Tendon rupture (connective tissue that connects muscles to bones)

If any of these side effects affect you severely, inform your doctor.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Letrozol Vir

• Keep this medication out of the sight and reach of children.
• Do not use Letrozol Vir after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Do not use any package that is damaged or shows signs of tampering.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Letrozol Vir:

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, sodium carboxymethyl potato starch, magnesium stearate (E572), colloidal silicon dioxide (E551).
• The ingredients of the tablet coating are: macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

Appearance of Letrozol Vir and package contents

Letrozol Vir is presented as film-coated tablets. The tablets are yellow, round, and biconvex, marked with L9OO on one side and 2.5 on the other.

Letrozol is available in blisters of 10, 28, 30, 50, 60, 84, 90, 98, or 100 tablets per box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II,

28923 Alcorcón (Madrid) - Spain

Manufacturer

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

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

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

Bulgaria Letrozol Genthon 2.5 mg

Czech Republic Letrozolum Genthon 2.5 mg

Hungary Letrozol Genthon 2.5 mg filmtabletta

Netherlands Letrozol 2.5 mg, filmomhulde tabletten

Poland Letrozolum Genthon

Portugal Letrozol Genthon 2.5 mg

Romania Letrozol Genthon 2.5 mg

Slovenia Letrozol Genthon 2.5 mg filmsko obložene tablete

Slovakia Letrozolum Genthon 2.5 mg

This package leaflet was approved in November 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.