Package Leaflet: Information for the Patient

Sybali 2.5 mg Film-Coated Tablets

letrozole

Read this 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, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

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

1.What Sybali is and what it is used for

2.What you need to know before you start taking Sybali

3.How to take Sybali

4.Possible side effects

5Storage of Sybali

6. Contents of the pack and additional information

What isSybaliand how it works

Sybalicontains an active ingredient called letrozol. It belongs to a group of medications called aromatase inhibitors. It is a hormone therapy (or “endocrine”) for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones.Sybalireduces 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.

How it is usedSybali

Sybaliis 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 tamoxifeno.Sybaliis 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 howSybaliworks or the reason why you have been prescribed this medication, consult your doctor.

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

Do not takeSybali

• if you are allergic to letrozol or any of the other components of this medication (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 cases apply to you,do not take this medication and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to takethis 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 withSybali” in section 3).

If any of these cases apply to you,inform your doctor. Your doctor will take this into account during your treatment withthis medication.

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

Use in athletes

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

Children and adolescents (under 18 years)

Children and adolescents should not use this medication.

Older patients (65 years and older)

Patients 65 years and older may use this medication at the same dose as adults.

Other medications andSybali

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication, including over-the-counter medications.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Sybalicontains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Sybalicontains sodium

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

Sybalicontains tartrazine

It may cause allergic reactions.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose is one tablet ofletrozolonce a day. If you takeletrozolat 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.

For how long to takeSybali

Continue takingletrozolevery day for the time your doctor tells you. You may need to take it for months or even years. If you have any doubt about how long you should takeletrozol, consult your doctor.

Control of treatment withSybali

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

Letrozolmay 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 control osteoporosis) before, during, and after treatment.

If you take moreSybalithan you should

If you have taken too many tablets ofletrozol, 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.

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

If you forgot to takeSybali

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

If you interrupt treatment withSybali

Do not stop takingletrozolunless your doctor tells you to. See also the section “For how long to takeSybali”.

Like all medicines, this medicine 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 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 a brain alteration, e.g. stroke).
• Oppressive and sudden chest pain (sign of heart alteration).
• 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 inflammation of a tendon (connective tissue that connects muscles to bones).

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 withletrozol:

• 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, redness of the skin, blisters on the 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
• Pain in bones and joints (arthralgia)

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

Some side effects are common(may affect up to 1 in 10 patients):

• Rash on the skin
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Osteoporosis, which causes bone fractures in some cases (see also the "Control of treatment withletrozolin 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 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 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
• Chest pain
• Fever
• Thirst, taste disorder, dry mouth
• Dry 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 (a product of red blood cell breakdown)

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

Trigger finger, a situation in which 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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://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 is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment..

Composition of Sybali

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

Appearance of the product and contents of the packaging

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and Responsible for the manufacture

Holder of the marketing authorization

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31

2nd floor

28023 – Madrid

Spain

Responsible for the manufacture

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 medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet:March 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)