Package Leaflet: Information for the Patient

Letrozole Cinfa 2.5 mg Film-Coated Tablets

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to 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. See section 4.

What is letrozol cinfa 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 cinfa 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 cinfa used for

Letrozol 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 this medication 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 cinfa

• 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 cases 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 cinfa

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

Letrozol can 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)

Children and adolescents should not use this medicine.

Older adults (65 years and over)

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

Taking letrozol cinfa with other medicines

Informyour doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should only take letrozol if you have passed the menopause stage. However, your doctor will 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 machines

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

Letrozol cinfa contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Letrozol cinfa contains tartrazine

This medicine may cause allergic reactions because it contains tartrazine (E102). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Letrozol cinfa contains sodium

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

Use in athletes

This medicine 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 doubt, consult your doctor or pharmacist again.

The usual dose is one tablet once a day. If you take letrozol cinfa 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.

How long to take letrozol cinfa

Continue taking this medication every day for the time your doctor tells you. You may need to take it for months or even years. If you have any doubt about how long you should take this medication, consult your doctor.

Control of letrozol cinfa 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 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 control osteoporosis) before, during, and after treatment.

If you take more letrozol cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take letrozol cinfa

• If it is almost time for your next tablet (e.g. 2 or 3 hours away), do not take the missed dose 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 missed doses.

If you interrupt the treatment with letrozol cinfa

Do not stop taking this medication unless your doctor tells you to. See also the section “How long to take letrozol cinfa”.

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

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

The majority of side effects are mild or 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 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(may affect up to 1 in 100 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).
• Swelling and redness in a vein that is extremely soft and possibly painful to the touch.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

Very rare(may affect up to 1 in 1000 patients):

• 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).
• Tendon rupture (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 with letrozol:

• 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).

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

• Rash on the skin.
• Headache.
• Dizziness.
• General discomfort.
• Gastrointestinal disturbances 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 cinfa 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.

Some side effects are rare(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)
• Sensitivity problems, especially tactile.
• 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 in the blood (a product of red blood cell breakdown).

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 a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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 usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration dateis thelast day of the month indicated.

No special storage conditions are required.

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 pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Letrozole cinfa composition

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components are: lactose monohydrate, carboxymethylcellulose sodium (type A) (from potato), microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate. The components of the tablet coating,Opadry Yellow, are: hypromellose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and tartrazine (E102).

Appearance of the product and content of the container

Letrozole cinfa are film-coated, cylindrical, yellow, biconvex tablets marked with the letter “L” on one face.

Each container with blisters contains 30 or 100 (clinical pack) tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:October 2019

Detailed information about 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 about 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/72125/P_72125.html

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