LETROZOLE ALMUS PHARMA 2.5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Letrozol Almus 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 Almus Pharma and what is it used for
2. What you need to know before taking Letrozol Almus Pharma
3. How to take Letrozol Almus Pharma
4. Possible side effects
5. Storage of Letrozol Almus Pharma
6. Package contents and additional information

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

What is Letrozol Almus Pharma and how it works

Letrozol Almus Pharma contains the active ingredient 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. Letrozol reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in the production of estrogens, 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 spreading to other parts of the body.

What Letrozol Almus Pharma is used for

Letrozol 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, if 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. Letrozol 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 this medication works or why it has been prescribed for you, consult your doctor.

2. What you need to know before taking Letrozol Almus Pharma

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

Do not take Letrozol Almus 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 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 Almus Pharma:

• 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 Almus Pharma treatment" 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.

Letrozol 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.

Taking Letrozol Almus Pharma with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

• You should only take this medication if you have gone through menopause. However, your doctor should discuss the use of effective contraception with you, as you may still become pregnant during treatment with letrozol.
• Do not take letrozol 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.

Letrozol Almus Pharma contains lactose and sodium. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Use in athletes:

This medication contains letrozole, which may produce a positive result in doping tests.

3. How to take Letrozol Almus Pharma

Follow the administration instructions for this medication indicated by your doctor or pharmacist exactly. If in doubt, consult your doctor or pharmacist again.

The normal dose is one letrozole tablet once a day. If you take Letrozol Almus Pharma 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 Almus Pharma

Continue taking this medication every day for the time indicated by your doctor. 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 of Letrozol Almus Pharma treatment

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

Letrozol may cause a decrease in bone density or bone loss (osteoporosis) due to the decrease in estrogens 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 Almus Pharma than you should

If you have taken too many letrozole tablets, or if someone else has taken the tablets by accident, 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 Almus Pharma

• If it is almost time for the 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 the missed doses.

If you stop taking Letrozol Almus Pharma

Do not stop taking this medication unless your doctor tells you to. See also the section "How long to take Letrozol Almus Pharma".

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

4. Possible side effects

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 sudden onset of chest pain (sign of heart disorder).
• 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 tendon inflammation (tissue that connects muscles to bones).

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 (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:

• Swelling mainly in the face and throat (signs of 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 (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

If any of these 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 bone loss (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of Letrozol Almus 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 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)

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 affect you severely, inform your doctor.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Letrozol Almus Pharma

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Place the packaging and medications you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Letrozol Almus Pharma

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are:

Core: Lactose monohydrate, microcrystalline cellulose, corn starch, sodium carboxymethyl starch potato, colloidal anhydrous silica, magnesium stearate.

Coating (OPADRY II 85F32444 yellow): Polyvinyl alcohol, talc, titanium dioxide (E171), macrogol/PEG 3350, yellow quinoline aluminum lake (E104), iron oxide red (E172), iron oxide black (E172).

Appearance of the product and package contents

Letrozol Almus Pharma is presented as film-coated tablets. The tablets are round, with a white core and a dark yellow coating. Dimensions: 6.0 ± 0.2 mm.

Available in single-dose perforated blisters with 30 x 1 tablets or in blisters containing 30 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer

Tecnimede - Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dois Portos (Portugal)

This medication is authorized in the EEA Member States under the following names:

France - Létrozole Almus 2.5 mg, film-coated tablet

Italy - Letrozolo Almus

Date of the last revision of this leaflet:December 2020

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