LETROZOLE NORMON 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol Normon 2.5 mg film-coated tablets EFG

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

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Letrozol Normon and how does it work

This medicine contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole reduces the amount of estrogen by blocking an enzyme (aromatase) involved in estrogen production, and can therefore 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 Normon used for

This medicine is used to treat breast cancer in women who have passed the menopause, i.e., the cessation of menstrual periods.

It is used to prevent breast cancer from coming back. It can be used as the first treatment before breast cancer surgery, if 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. Letrozole 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 letrozole works or why you have been prescribed it, ask your doctor.

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

Follow carefully all instructions given to you by your doctor. They may differ from the general information contained in this leaflet.

Do not take Letrozol Normon

• if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e., you have not reached menopause,
• if you are pregnant,
• if you are breast-feeding.

Letrozole may cause inflammation of the tendons or tendon injuries (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, do not take this medicine and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with 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 cases apply to you, inform your doctor. Your doctor will take this into account during your treatment with letrozole.

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Elderly patients (65 years and over)

People 65 years and over can use this medicine at the same dose as the rest of adults.

Taking Letrozol Normon with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy, breast-feeding, and fertility

• You should only take letrozole if you have passed the menopause. However, your doctor should discuss with you the use of effective contraception, as you could still become pregnant during treatment with letrozole.
• Do not take this medicine if you are pregnant or breast-feeding, 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.

Use in athletes

This medicine contains letrozole, which may produce a positive result in doping tests

Letrozol Normon contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Letrozol Normon

Follow exactly the instructions for administration of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose is one letrozole tablet once a day. Taking the medicine at the same time each day 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 Normon

Continue taking Letrozol Normon every day for the time your doctor tells you. 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 only take this medicine under strict medical supervision. Your doctor will periodically check your condition to ensure that the treatment has the desired effect.

Letrozole 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 Normon than you should

If you have taken too many letrozole tablets, or if someone else has taken your tablets, 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, Tel: 915620420, indicating the medicine and the amount taken.

If you forget to take Letrozol Normon

• If it is almost time for your next dose (e.g., 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 dose as you would normally.
• Do not take a double dose to make up for missed doses.

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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects are mild to moderate and usually disappear after 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 be serious:

Uncommon or rare side effects(may affect up to 1 in 100 or may affect up to 1 in 1,000 patients):

• Weakness, paralysis, or loss of sensation in any part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke).
• Severe chest pain (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 in a vein that is extremely soft and possibly painful to the touch.
• High fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Blurred vision.
• Tendon rupture (connective tissue that connects muscles to bones).

If you experience any of these, tell your doctor immediately.

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

• 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, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Some side effects are very common.They may affect more than 1 in 10 patients.

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

If any of these side effects bother you seriously, talk to your doctor.

Some side effects are common.They may affect up to 1 in 10 patients.

• Skin rash
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or bone loss (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of treatment with Letrozol Normon" 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 bother you seriously, talk to your doctor.

Some side effects are uncommon.They may affect up to 1 in 100 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, sleepiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensitivity problems, especially 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)

Side effects with unknown frequency(cannot be estimated from the available data)

Trigger finger, a condition in which your finger or thumb gets stuck in a bent position.

If any of these side effects bother you seriously, talk to your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es.

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

5. Storage of Letrozol Normon

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month stated.
• No special storage conditions are required.
• Store in the original package to protect from moisture.
• Do not use any packaging that is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you have any further questions, ask your pharmacist.

6. Contents of the pack and further information

Composition of Letrozol Normon

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are lactose monohydrate, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose 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 pack contents

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

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet:December 2021

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

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