Package Insert: Information for the Patient

Letrozole Pensa Pharma 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 refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 Pensa Pharma and how is it used

2 What you need to know before taking Letrozole Pensa Pharma

3 How to take Letrozole Pensa Pharma

4 Possible side effects

5 Storage of Letrozole Pensa Pharma

6 Contents of the pack and additional information

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 Pensa Pharma 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. This medication 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 Pensa Pharma works or why you have been prescribed this medication, consult your doctor.

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

Do not take Letrozol Pensa Pharma:

- 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

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

Warnings and precautions

Consult with your doctor or pharmacist before starting to take this medication

- 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 Pensa Pharma” in section 3).

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

Letrozol may cause inflammation of tendons 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 medication.

Older adults (65 years and older)

People 65 years and older can use this medication at the same dose as other adults.

Other medications and Letrozol Pensa Pharma

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication, including those purchased without a prescription.

Pregnancy, breastfeeding, and fertility

• You should only take letrozol after menopause. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with this medication.
• Do not take letrozol if you are pregnant or breastfeeding, as it may harm your baby.

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

If you feel dizzy, tired, or experience drowsiness or discomfort, do not drive or operate tools or machinery until you feel better again.

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

This medication contains tartrazineas an excipient. It may cause allergic reactions, including asthma, especially in patients allergic to acetylsalicylic acid.

Use in athletes

This medication 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 recommended dose is one Letrozol Pensa Pharma tablet once a day. Taking the medication 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 Pensa Pharma

Continue taking this medication 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 takeLetrozol Pensa Pharma, consult your doctor.

Monitoring treatment with Letrozol Pensa Pharma

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.

This medication 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 Pensa Pharma than you should

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

If you forget to take Letrozol Pensa Pharma

-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 missed 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 treatment with Letrozol Pensa Pharma

Do not stop taking this medication unless your doctor tells you to. See also “How long to take Letrozol Pensa Pharma”.

If you have any other questions about using 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 brain alteration, e.g. stroke).

- Sudden and oppressive chest pain (sign of heart alteration).

- Swelling and redness along 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).

- Continuous and severe blurred vision.

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 that a blood clot has formed).

- 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 Pensa Pharma:

- 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 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).

- Skin rash.

- Headache.

- Dizziness.

- General discomfort.

- Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.

- Increased or decreased appetite.

- Muscle pain.

- Weight loss or bone loss (osteoporosis), which can cause bone fractures in some cases (see also the "Treatment control with Letrozol Pensa Pharma" section in section 3).

- Swelling of arms, hands, feet, ankles (edema).

- Depression.

- Weight gain.

- Hair loss.

- Elevated 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 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 in 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 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)

-Tendinitis or tendon inflammation (connective tissue that connects muscles to bones).

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

Trigger finger, a situation in which 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 leaflet. You can also report them directly through the Spanish System for 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.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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Letrozol Pensa Pharma Composition

- The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.

- The other components (excipients) are: lactose monohydrate (lactose), sodium carboxymethyl starch from potato (potato starch), 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)

Product appearance and packaging contents

Letrozol Pensa Pharma is presented as film-coated tablets. The film-coated tablets are yellow, circular, biconvex, and flat on both sides.

Each package is presented in blisters of 30 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturers

Galenicum Health S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950 Barcelona

Spain

and

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid, Spain

Last review date of this leaflet: June 2020

The 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/