SYBALI 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sybali 2.5 mg film-coated tablets EFG

letrozole

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

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

If you have any questions, consult your doctor, pharmacist, or nurse.

• 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sybali and what is it used for
2. What you need to know before taking Sybali
3. How to take Sybali
4. Possible side effects

5 Conservation of Sybali

1. Contents of the pack and further information

1. What is Sybali and what is it used for

What is Sybali and how does it work

Sybali contains the active substance letrozole. It belongs to a group of medicines 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. Sybali 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 Sybali is used for

Sybali is used to treat breast cancer in women who have passed 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. Sybali 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 Sybali works or why you have been prescribed this medication, consult your doctor.

2. What you need to know before taking Sybali

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

Do not take Sybali

• 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 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 treatment with Sybali" 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 this medication.

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.

Use in athletes

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

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 for adults.

Other medications and Sybali

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Sybali contains lactose

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

Sybali contains sodium

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

Sybali contains tartrazine

It may cause allergic reactions.

3. How to take Sybali

Follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The normal dose is one letrozole tablet once a day. If you take letrozole 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 Sybali

Continue taking letrozole 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 letrozole, consult your doctor.

Monitoring of treatment with Sybali

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.

Letrozole 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 Sybali 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 package of tablets. You may need medical treatment.

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

If you forget to take Sybali

• 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 Sybali

Do not stop taking letrozole unless your doctor tells you to. See also the section "How long to take Sybali".

4. Possible side effects

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

Most side effects are mild to 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 estrogens.

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 sudden onset (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 (connective tissue that connects muscles to bones).

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin color, 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 should also inform your doctor immediately if you experience any of the following symptoms during treatment with letrozole:

• 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 levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (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 bone loss (osteoporosis), which can cause bone fractures in some cases (see also "Monitoring of treatment with letrozole" 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)

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, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online reporting system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Sybali

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

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through 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 Sybali

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are lactose monohydrate, sodium carboxymethyl starch, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate. The coating consists of hypromellose, titanium dioxide, macrogol 6000, yellow iron oxide (E 172), red iron oxide (E 172), and tartrazine (E 102).

Appearance and packaging of the product

• Sybali is presented as film-coated tablets. The tablets are yellow, circular, biconvex, and smooth on both sides. The approximate length is: 6.0 ± 0.5 mm.
• Each PVC/PVDC/Aluminum blister pack contains 10, 14, 28, 30, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31

2nd floor

28023 – Madrid

Spain

Manufacturer

Galenicum Health S.L.

Sant Gabriel, 50,

Esplugues de Llobregat, 08950 Barcelona

Spain

or

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

28750 San Agustin de Guadalix, Madrid,

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this package leaflet:March 2024

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