Letrozole Pensapharma 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Letrozole Pensa Pharma 2.5 mg film-coated tablets EFG

Read the entire 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 other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

2 What you need to know before taking Letrozole Pensa Pharma

3 How to take Letrozole Pensa Pharma

4 Possible side effects

5 How to store Letrozole Pensa Pharma

6 Contents of the pack and other information

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

This medicine contains an active substance called letrozole. It belongs to a group of medicines known as 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 therefore can block the growth of breast cancers that require estrogens to grow.

As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What Letrozol Pensa Pharma is used for

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

It is used to prevent breast cancer from recurring. It may be used as initial treatment before breast cancer surgery, if surgery is not immediately appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. This medicine is also used to prevent breast tumors 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 this medicine has been prescribed for you, consult your doctor.

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

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

Do not take Letrozol Pensa Pharma:

• if you are allergic to letrozol or to any of the other components 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 breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• 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 Pensa Pharma” in section 3).

If any of these situations applies 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 pain or inflammation in your tendons, rest the affected area and contact your doctor.

Children and adolescents (under 18 years of age)

This medicine must not be used in children and adolescents.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over may use this medicine at the same dose as other adults.

Other medicines and Letrozol Pensa Pharma

Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines, including those obtained without a prescription.

Pregnancy, breastfeeding and fertility

• You should only take letrozol if you have passed the menopausal stage. However, your doctor should discuss with you the need to use an effective method of contraception, as you may still become pregnant during treatment with this medicine.
• You must not take letrozol if you are pregnant or breastfeeding, as it may harm your baby.

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

Driving and using machines

If you feel dizzy, tired, drowsy or unwell, do not drive or operate tools or machinery until you feel well again.

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

This medicine contains tartrazine as an excipient. It may cause allergic-type reactions, including asthma, particularly in patients allergic to acetylsalicylic acid.

Use in athletes

This medicine contains letrozol, which may result in a positive doping test.

3. How to take Letrozol Pensa Pharma

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet of Letrozol Pensa Pharma once daily. Taking the medicine at the same time each day will help you remember when to take the tablet.

The tablet may 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 medicine every day for as long as your doctor tells you to. You may need to take it for months or even years. If you have any doubt about how long you should take Letrozol Pensa Pharma, consult your doctor.

Monitoring of treatment with Letrozol Pensa Pharma

This medicine should only be taken under strict medical supervision. Your doctor will periodically monitor your condition to check that the treatment is having the desired effect.

This medicine may cause a decrease in bone thickness or bone loss (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to perform bone density measurements (a way of monitoring 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 hospital immediately. Show them the medicine packaging. You may require medical treatment. You may also call the Toxicology Information Service, Tel: 915620420, stating the medicine and the amount taken.

If you forget to take Letrozol Pensa Pharma

• If it is almost time for the next dose (e.g. 2 or 3 hours away), do not take the missed dose and take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the following dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop treatment with Letrozol Pensa Pharma

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

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

4. Possible adverse effects

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

Most of these adverse effects are mild or moderate and usually disappear after a few days or weeks of treatment.

Some of these adverse effects, such as hot flushes, hair loss, or vaginal bleeding, may be due to estrogen deficiency.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

Some adverse effects may be serious:

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

• Weakness, paralysis, or loss of sensation in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain disorder, e.g., stroke).
• Sudden, crushing chest pain (signs of a heart disorder).
• Swelling and redness along a vein that is extremely tender and possibly painful to touch.
• Severe fever, chills, or mouth ulcers due to infections (lack of white blood cells).
• Severe, persistent blurred vision.

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• Tendon rupture (connective tissue linking 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 (signs of hepatitis).
• Skin rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Some adverse effects are very common (may affect more than 1 in 10 patients):

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

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

Some adverse 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.
• Bone thinning or bone loss (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Pensa Pharma treatment” in section 3).
• Swelling of arms, hands, feet, or ankles (edema).
• Depression.
• Weight gain.
• Hair loss.
• Increased 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 adverse effects are uncommon (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).
• Sensory disturbances, especially related to touch.
• Eye disorders such as blurred vision, eye irritation.
• Skin disorders such as itching (urticaria).
• Vaginal discharge or dryness.
• Breast pain.
• Fever.
• Thirst, taste disturbances, dry mouth.
• Dryness of mucous membranes.
• Weight loss.
• Urinary tract infection, increased frequency of urination.
• Cough.
• Increased enzyme levels.
• Yellowish discoloration of the skin and eyes.
• Elevated blood levels of bilirubin (a product of red blood cell breakdown).
• Tendinitis or inflammation of the tendon (connective tissue linking muscles to bones).

Adverse effects with frequency not known (cannot be estimated from available data):

Trigger finger, a condition in which your finger or thumb becomes locked in a bent position.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Pensa Pharma

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol Pensa Pharma

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

Appearance of the product and contents of the pack

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

Each pack is presented in blisters containing 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

Date of the most recent revision of this leaflet: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/