Letrozole Vir 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Letrozol Vir 2.5 mg film-coated tablets EFG

Letrozole

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents

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. How to store Letrozol Vir
6. Contents of the pack and other information

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

What Letrozol Vir is and how it works

Letrozol Vir contains an active substance called letrozol. It belongs to a group of medicines known as aromatase inhibitors. It is a hormone treatment (or "endocrine" therapy) 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 require estrogen to grow. As a result, tumor cells grow more slowly, or their growth and/or spread to other parts of the body is stopped.

What Letrozol Vir is used for

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

Letrozol is used to prevent breast cancer from recurring. It may be used as initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or it may be used as initial treatment after breast cancer surgery or after five years of treatment with tamoxifen. Letrozol is also used to prevent the spread of breast tumor to other parts of the body in patients with advanced breast cancer.

If you have any questions about how letrozol works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Letrozol Vir

Carefully follow all instructions provided by your doctor. They may differ from the general information contained in this leaflet.

Do not take Letrozol Vir

• If you are allergic (hypersensitive) to letrozol or to any of the other ingredients of this medicine (listed in section 6)
• If you still have menstrual cycles, that is, you have not reached menopause.
• If you are pregnant.
• If you are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with 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 treatment with Letrozol Vir” in section 3).
• Letrozol may cause tendon inflammation or tendon injury (see section 4). If you experience any signs of tendon pain or swelling, rest the affected area and contact your doctor immediately.

If any of these 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 of age)

This medicine must not be used in children and adolescents.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over can take this medicine at the same dose as adults.

Taking Letrozol Vir with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines not requiring a prescription.

Pregnancy, breastfeeding and fertility

• You should only take letrozol if you have passed the menopausal stage. However, your doctor should discuss with you the use of effective contraception, as you may still be able to become pregnant during treatment with letrozol.

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

Driving and use of machines

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

Letrozol Vir contains lactose and sodium

Letrozol Vir contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

Use in athletes:

This medicine contains letrozol, which may lead to a positive result in doping control tests.

3. How to take Letrozol Vir

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you have any doubts, please consult your doctor or pharmacist again.

The usual dose is one Letrozol Vir tablet once daily. Taking Letrozol Vir at the same time each day will help you remember when to take the tablet.

The tablet may 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 as long as your doctor instructs 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.

Monitoring of treatment with Letrozol Vir

You should only take this medicine under strict medical supervision. Your doctor will periodically monitor your condition to ensure the treatment is having the desired effect.

Letrozol Vir may cause a reduction in bone thickness or bone loss (osteoporosis) due to decreased estrogen levels in the body. Your doctor may decide to perform bone density measurements (a way of monitoring 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 accidentally taken the tablets, contact your doctor or go to the hospital immediately. Show them the tablet packaging. You may require medical treatment. You may also call the Toxicology Information Service at Telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Letrozol Vir

• If it is almost time for your next dose (e.g. 2 or 3 hours before), do not take 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 following dose at the usual time.
• Do not take a double dose to make up for a missed dose.

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 further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Most of these adverse effects are mild to moderate and usually disappear after a few days or weeks of treatment.

Some of these adverse effects, such as hot flushes, hair loss, or vaginal bleeding, may be due to low estrogen levels.

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

Some adverse effects may be serious:

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

• Weakness, paralysis, or loss of sensation in any part of the body; loss of coordination; nausea; or difficulty speaking or breathing (signs of a brain disorder, e.g., stroke).
• Sudden, pressing chest pain (signs of a heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• Swelling and redness along a vein that is extremely tender and possibly painful to touch.
• Severe fever, cold, or mouth ulcers due to infections (low white blood cell count).
• Persistent, 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 letrozole:

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

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

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

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

Common adverse 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 bone (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Vir treatment” in section 3).
• Swelling of arms, hands, feet, ankles (edema).
• 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 affect you severely, inform your doctor.

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

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia.
• Sensory disturbances, especially to touch.
• Eye disorders such as blurred vision, eye irritation.
• Skin disorders such as itching (urticaria).
• Vaginal dryness or discharge.
• Breast pain.
• Fever.
• Thirst, taste disturbances, 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 inflammation of a tendon (connective tissue linking muscles to bones).

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

• Tendon rupture (connective tissues linking muscles to bones).

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Vir

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol Vir:

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

Appearance of Letrozol Vir and contents of the pack

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 containing 10, 28, 30, 50, 60, 84, 90, 98 or 100 tablets per pack.

Only certain 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

Responsible for manufacturing:

Synthon Hispania SL.

C/Castelló,1,

Poligono Las Salinas

08330 Sant Boi de Llobregat

Barcelona

Spain

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

This medicinal product is authorized in the European Economic Area member states 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 leaflet was approved in November 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/.