Package Insert: Information for the Patient

Letrozole Normon 2.5 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Letrozole Normon and how is it used

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

3. How to take Letrozole Normon

4. Possible adverse effects

5. Storage of Letrozole Normon

6. Contents of the package and additional information

What is Letrozol Normon and how it works

This medication contains an active ingredient called letrozol.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 the 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 Normon used for

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

It is used to prevent breast cancer from recurring. It can be used as the first treatment before breast cancer surgery, if immediate surgery is not suitable, 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 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 the reason why it has been prescribed, consult your doctor.

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

Do not take Letrozol Normon

• if you are allergic to letrozol or any of the other components of this medication (including those 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.

Letrozol may cause tendon inflammation or tendon injuries (see section 4). If you experience any signs of pain or tendon inflammation, rest the affected area and contact your doctor.

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 Normon

• if you have a severe kidney disease,
• if you have a severe liver disease,
• if you have a history of osteoporosis or bone fractures (see also “Treatment control 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 letrozol.

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 the rest of the adults.

Taking Letrozol Normon with other medications

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

Pregnancy, breastfeeding, and fertility

• You should only take letrozol if you have passed the menopause stage. 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 this medication 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.

Use in athletes

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

Letrozol Normon contains lactose and sodium

This medication contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

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

The usual dose is one tablet of letrozol once a day. Take the medication at the same time every day, which 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 to. You may need to take it for months or even years. If you have any doubts about how long you should take this medication, consult your doctor.

Monitoring Treatment with Letrozol Normon

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

Letrozol may 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 monitor osteoporosis) before, during, and after treatment.

If You Take More Letrozol Normon Than You Should

If you have taken too many tablets of letrozol, 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, Tf: 915620420, indicating the medication and the amount taken.

If You Forget to Take Letrozol Normon

• 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.

Stopping Treatment with Letrozol Normon

Do not stop taking this medication unless your doctor tells you to. See also the section “How Long to Take Letrozol Normon”.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The majority of side effects are mild to moderate and usually disappear after a few days or a few 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 can be serious:

Rare or uncommon effects(may affect up to 1 in 100 or may affect up to 1 in 1000 patients):

• Weakness, paralysis, or loss of sensation in some part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain alteration, e.g. stroke).
• Oppressive and sudden chest pain (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 in a vein that is extremely soft and possibly painful to touch.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Continuous blurred vision.
• Roture of a tendon (connective tissue that connects muscles to bones).

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

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

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

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

If any of these affect you severely, consult 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
• Osteoporosis, which causes bone fractures in some cases (seethesection “Control of treatment withLetrozol Normon in section3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• Hypertension
• Abdominal pain
• Skin dryness
• Vaginal bleeding
• Palpitations, rapid heart rate
• Rigidity of joints (arthritis)
• Chest pain

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

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

• Nervous disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensitivity problems, especially tactile
• Eye alterations 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
• Increased enzyme levels
• Yellow discoloration of the skin and eyes

• Elevated blood bilirubin levels (a product of red blood cell breakdown)
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones)

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

Trigger finger, a situation where your finger or thumb stays locked in a bent position.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

-Keep this medication out of the sight and reach of children.

-Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration 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 packaging that is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. This will help protect the environment.

Letrozol Normon Composition

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

Appearance of the product and content of the packaging

- Letrozol Normon are yellow film-coated tablets, round, and biconvex.

- Each package contains 30 tablets conditioned in a blister.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet: December 2021

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

You can access detailed and updated information on this medication 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