Sybali 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sybali 2.5 mg film-coated tablets EFG

letrozole

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, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you must 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, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Sybali is and what it is used for
2. What you need to know before taking Sybali
3. How to take Sybali
4. Possible side effects
5. How to store Sybali
6. Contents of the pack and other information

1. What Sybali is and what it is used for

What Sybali is and how it works

Sybali 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. Sybali 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 estrogen 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 gone through menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It may be used as the first treatment before breast cancer surgery, when immediate surgery is not appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Sybali 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 Sybali works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before starting to take Sybali

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

Do not take Sybali

• if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e. have not yet reached menopause,
• if you are pregnant,
• if you are breastfeeding.

If any of these apply 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 Sybali treatment” in section 3).

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

Letrozole 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 medicine contains letrozole, which may cause a positive result in doping control tests.

Children and adolescents (under 18 years of age)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and over)

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

Other medicines and Sybali

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

Pregnancy, breastfeeding and fertility

• You should only take letrozole if you have passed the menopausal stage. However, your doctor should discuss with you the need for effective contraception, as you could still become pregnant during treatment with letrozole.
• You must 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 machinery until you feel well again.

Sybali contains lactose

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

Sybali contains sodium

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

Sybali contains tartrazine

May cause allergic-type reactions.

3. How to take Sybali

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual dose is one letrozole tablet once daily. Taking letrozole 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 Sybali

Continue taking letrozole 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 doubts about how long you should take letrozole, consult your doctor.

Monitoring of treatment with Sybali

You should take this medicine only under strict medical supervision. Your doctor will monitor your condition regularly to ensure the treatment is having the desired effect.

Letrozole 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 Sybali than you should

If you have taken too many letrozole tablets, or if someone else has accidentally taken them, contact your doctor or go to the hospital immediately. Show them the tablet packaging. You may require medical treatment.

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

If you forget to take Sybali

• If it is almost time for your next tablet (e.g., 2 or 3 hours left), do not take the missed dose and take the next dose at your usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the following tablet at your normal time.
• 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 adverse effects

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

Most of these adverse effects are mild to 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 oestrogen 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, pressing chest pain (signs of heart disorder).
• Swelling and redness in a vein that is extremely soft and possibly painful to touch.
• High fever, chills, or mouth ulcers due to infections (due to low white blood cell count).
• Severe, persistent blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue connecting muscles to bones).

Rare (may affect up to 1 in 1000 patients):

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• Tendon rupture (connective tissue connecting 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 an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine (signs of hepatitis).
• Rash, skin redness, 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

• High cholesterol levels (hypercholesterolaemia)

• 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, diarrhoea

• Increased or decreased appetite

• Muscle pain

• Thinning or loss of bone (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of letrozole treatment” in section 3)

• Swelling of arms, hands, feet, ankles (oedema)

• 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 disturbance, 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)

Adverse effects with unknown frequency (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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sybali

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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sybali

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

Appearance of the product and contents of the pack

• 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 transparent PVC/PVDC/Aluminum blister contains 10, 14, 28, 30, and 100 tablets.

Only some 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 medicinal product is authorized in the member states of the European Economic Area under the following names:

Date of the most recent review of this leaflet: March 2024

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