Letrozole Normon 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Letrozole Normon 2.5 mg film-coated tablets EFG

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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Letrozol Normon is and how it works

This medicine contains an active substance called letrozole. It belongs to a group of medicines known as 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. Letrozole 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 halted.

What Letrozol Normon is used for

This medicine is used to treat breast cancer in women who have been through menopause, that is, who have stopped menstruating.

It is used to prevent breast cancer from recurring. It can be used as the first treatment before breast cancer surgery, when immediate surgery is not appropriate, or it can be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozole is also used to prevent breast tumors from spreading to other parts of the body in patients with advanced breast cancer.

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

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

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

Do not take Letrozol Normon

• if you are allergic 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 to take Letrozol Normon

• 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 Normon” in section 3).

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

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.

Children and adolescents (under 18 years of age)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over may use this medicine at the same dose as other adults.

Taking Letrozol Normon 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 without 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 become pregnant during treatment with letrozol.
• You must not take this medicine if you are pregnant or breastfeeding, as it may harm your baby.

Driving and using machines

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

Use in athletes

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

Letrozol Normon contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Letrozol Normon contains sodium

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

3. How to take Letrozol Normon

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The usual dose is one letrozole tablet once daily. Taking the medicine 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.

How long to take Letrozol Normon

Continue taking Letrozol Normon every day for as long as 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 this medicine, consult your doctor.

Monitoring of treatment with Letrozol Normon

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

Letrozole may cause a decrease in bone thickness or bone loss (osteoporosis) due to reduced 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 Normon than you should

If you have taken too many letrozole 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 number 915620420, indicating the medicine and the amount taken.

If you forget to take Letrozol Normon

• If it is almost time for the next dose (e.g. within 2 or 3 hours), do not take the missed dose and take the next dose at the usual time.
• Otherwise, 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 the missed dose.

If you stop taking Letrozol Normon

Do not stop taking this medicine unless your doctor tells you to. See also the section “How long to take Letrozol Normon”.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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:

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

• Weakness, paralysis, or loss of sensation in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain disorder, e.g., stroke).
• Sudden, pressing chest pain (signs of heart disorder).
• Swelling and redness in a vein that is extremely soft and possibly painful to touch.
• Severe fever, cold, or mouth ulcers due to infections (due to low white blood cells).
• Severe, persistent blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue connecting muscles to bones).

Rare (may affect up to 1 in 1000 patients):

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• Tendon rupture (connective tissue connecting muscles to bones).

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 lips, eyes or mouth, skin peeling, fever (signs of skin disorder).

Some adverse effects are very common (may affect more than 1 in 10 patients):

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

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

Some adverse effects are common (may affect up to 1 in 10 patients):

• 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 Normon 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 heart rate
• Joint stiffness (arthritis)
• Chest pain

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

Some adverse effects are uncommon (may affect up to 1 in 100 patients):

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensory disturbances, 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 disturbance, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• Yellowish discoloration of the skin and eyes
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)

Adverse effects with unknown frequency (cannot be estimated from available data):

• Trigger finger, a condition in which your finger or thumb becomes locked in a bent position.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozole Normon

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.
• Store in the original packaging to protect it from moisture.
• Do not use any container 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 the SIGRE Point at your pharmacy. If you have any doubts,
ask your pharmacist how to dispose of unused medicines and their
containers. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol Normon

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components (excipients) are monohydrate lactose, corn starch, microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), talc and magnesium stearate. The coating consists of hypromellose, hydroxypropylcellulose, talc, cottonseed oil, yellow iron oxide (E-172), red iron oxide (E-172) and titanium dioxide (E-171).

Appearance of the product and contents of the pack

• Letrozol Normon are yellow, round, biconvex, film-coated tablets.
• Each pack contains 30 tablets in a blister pack.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: February 2026

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69862/P_69862.html