Leaflet: information for the user

Letrozol Vir 2.5 mg film-coated tablets

Letrozol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

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

2. What you need to know before starting to take Letrozol Vir

3. How to take Letrozol Vir

4. Possible side effects

5. Storage of Letrozol Vir

6. Contents of the pack and additional information

What is Letrozol Vir and how it works

Letrozol Vir contains an active ingredient called letrozol. It belongs to a group of medications called aromatase inhibitors. It is a hormone (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 estrogen production, and therefore 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 is Letrozol Vir used for

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

Letrozol is used to prevent breast cancer from recurring. It can be used as a first treatmentbefore breast cancer surgery, in cases where immediate surgery is not suitable, or it can be usedas a first treatmentafter breast cancer surgery or after five years of treatment with tamoxifen. Letrozol is also used to prevent breast cancer 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.

Follow carefully all instructions given by your doctor. They may be different from the general information contained in this prospectus.

Do not take Letrozol Vir

• If you areallergic (hypersensitive) to letrozol or to any of the other components ofthis medication (including those listed in section 6)
• If you still havemenstrual cycles, that is, you have not reached menopause.
• If you arepregnant.
• If you are in alactationperiod.

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 a severe kidney disease,
• If you have a severe liver disease,
• If you have a history ofosteoporosisorbone fractures (see also “Treatment control withLetrozol Vir” in section 3).
• Letrozol may cause tendon inflammation or tendon injuries (see section 4). If you experience any signs of tendon pain or inflammation, 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.

Older adults (65 years and older)

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

Taking Letrozol Vir with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pregnancy, lactation, and fertility

• You should only take letrozol after menopause. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with letrozol.

-You should not take letrozol if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machinery

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

Letrozol Vir contains lactose and sodium

Letrozol Vir containslactose (milk sugar). If your doctor has told you that you haveintolerance to certain sugars, consult with him 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 control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist again.

The usual dose is one tablet ofLetrozol Vir once a day.If you takeLetrozol 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.

For how long to take Letrozol Vir

Continue taking Letrozol Vir every day for the time your doctor tells you to. 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.

Control of Letrozol Vir treatment

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

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

If you take more Letrozol Vir than you should

If you have taken too many tablets of Letrozol Vir, or if someone else has accidentally taken the tablets, contact your doctor or go to the hospital immediately.Show them the packaging of the 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 your next tablet (e.g. 2 or 3 hours), do not take the dose you missed and take the next dose at the time it is due.
• 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 doses you missed.

If you interrupt the treatment with Letrozol Vir

Do not stop taking Letrozol Vir unless your doctor tells you to.See also the section “For how long to take Letrozol Vir”.

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

Like all medications, this medication may 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 a lack of estrogen.

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

Some side effects may beserious:

Side effectsthat are rare or occur infrequently(i.e., may affect between 1 and 100 of every 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 alteration, e.g., stroke).
• Crushing chest pain and sudden onset (sign of heart alteration).
• Difficulty breathing, chest pain, fainting, rapid heart rate, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of a blood clot formation).
• Swelling and redness along a very soft and possibly painful vein.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Continued severe blurred vision.

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

You must also inform your doctor immediately if you experience any of the following symptoms during treatment withletrozol:

• Swelling mainly in the face and throat (signs of allergic reaction).
• Yellow discoloration 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 alteration).

Side effectsthat are very frequent(may affect more than 1 in 10 people)

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

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

Side effects that are frequent(may affect up to 1 in 10 people)

• Rash on the skin.
• Headache.
• Dizziness.
• General discomfort.
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite.
• Muscle pain.
• Osteoporosis, which causes bone fractures in some cases (see also the section “Control 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.
• Skin dryness.
• Vaginal bleeding.
• Palpitations, rapid heart rate.
• Joint stiffness (arthritis)
• Chest pain

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

Side effects that are infrequent(may affect up to 1 in 100 people)

• Nervous disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia.
• Sensitivity problems, 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.
• Membrane mucosa dryness.
• Weight loss.
• Urinary tract infection, increased frequency to urinate.
• Cough.
• Elevated enzyme levels.
• Yellow discoloration of the skin and eyes
• Elevated bilirubin levels (a product of red blood cell breakdown)
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones)
• Side effects that are rare(may affect up to 1 in 1,000 people)
• Tendon rupture (connective tissue that connects muscles to bones)

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use Letrozol Vir after the expiration date that appears on the packaging 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 packaging that is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Letrozol Vir Composition:

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

Appearance of Letrozol Vir and packaging contents:

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

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

Only some packaging sizes may be commercially available.

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 medicine is authorized in the member states of the European Economic Area with the following names:

BulgariaLetrozol Genthon 2.5 mg

Czech RepublicLetrozolum Genthon 2.5 mg

HungaryLetrozol Genthon 2.5 mg filmtabletta

NetherlandsLetrozol 2.5 mg, filmomhulde tabletten

PolandLetrozolum Genthon

PortugalLetrozol Genthon 2.5 mg

RomaniaLetrozol Genthon 2.5 mg

SloveniaLetrozol Genthon 2.5 mg filmsko obložene tablete

SlovakiaLetrozolum Genthon 2.5 mg

This leaflet was approved in November 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.