LETROZOLE PENSA PHARMA 2.5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Letrozol Pensa Pharma 2.5 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1 What is Letrozol Pensa Pharma and what is it used for

2 What you need to know before taking Letrozol Pensa Pharma

3 How to take Letrozol Pensa Pharma

4 Possible side effects

5 Storage of Letrozol Pensa Pharma

6 Contents of the pack and further information

1. What is Letrozol Pensa Pharma and what is it used for

This medication contains an active ingredient called letrozole. 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 female sex hormones. Letrozole reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and thus 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 spread to other parts of the body.

What Letrozol Pensa Pharma is used for

This medication is used to treat breast cancer in women who have gone through 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, in case 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. This medication 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 Letrozol Pensa Pharma works or why you have been prescribed this medication, consult your doctor.

2. What you need to know before starting to take Letrozol Pensa Pharma

Follow your doctor's instructions carefully. They may be different from the general information contained in this leaflet.

Do not take Letrozol Pensa Pharma:

• if you are allergic to letrozole or any of the other ingredients of this medication (listed in section 6),
• if you still have menstrual cycles, i.e., 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 your doctor or pharmacist before starting to take this medication

• 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 Letrozol Pensa Pharma treatment" 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.

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

Children and adolescents (under 18 years)

Children and adolescents should not use this medication.

Elderly patients (65 years and over)

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 recently taken, or may need to take any other medication, including those purchased without a prescription.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

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

This medication contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them 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 letrozole, which may produce a positive result in doping tests.

3. How to take Letrozol Pensa Pharma

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, 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 period indicated by your doctor. You may need to take it for months or even years. If you have any questions about how long you should take Letrozol Pensa Pharma, consult your doctor.

Monitoring of Letrozol Pensa Pharma treatment

You should only take this medication under close medical supervision. Your doctor will periodically check your condition to ensure 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 taken your tablets, contact your doctor or go to the hospital immediately. Show them the tablet packaging. 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), do not take the missed dose and take the next dose at the scheduled time.
• 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 missed doses.

If you stop taking 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Most 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 the 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:

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

• Weakness, paralysis, or loss of sensation in a part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke).
• Chest pain or tightness (sign of heart disorder).
• Swelling and redness along 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 that is severe and persistent.

Rare(may affect up to 1 in 1,000 patients)

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• Tendon rupture (connective tissue that connects 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 Letrozol Pensa Pharma:

• 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 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.(may affect more than 1 in 10 patients):

• Hot flashes.
• High cholesterol levels (hypercholesterolemia).
• Fatigue
• Increased sweating.
• Pain in bones and joints (arthralgia).

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

Some side 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 bones (osteoporosis), which can cause bone fractures in some cases (see also "Monitoring of Letrozol Pensa Pharma treatment" 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 affect you severely, inform your doctor.

Some side effects are uncommon.(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 disorders, 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
• High 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 available data)

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Letrozol Pensa Pharma

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

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

.

6. Contents of the pack and further information

Composition of Letrozol Pensa Pharma

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are: lactose monohydrate (lactose), potato starch, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, and magnesium stearate. The ingredients 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 and packaging of the product

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

Each pack contains 30 tablets in blisters.

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

Date of last revision of this leaflet: June 2020

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