Package Insert: Information for the Patient

GALDAR 2.5 mg Film-Coated Tablets

Letrozole

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

Contents of the package and additional information.

What is Galdar and how it works

Galdar contains 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.Galdar reduces 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 Galdar is used

Galdar 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 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. Galdar is 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 how Galdar works or the reason why you have been prescribed this medication, consult with 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 take Galdar

• 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 take Galdar

• 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 with Galdar” 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 Galdar

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.

Children and adolescents (under 18 years)

Children and adolescents should not use this medication.

Older adults (65 years and older)

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

Other medications and Galdar

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

• You should only take Galdar if you have passed the menopause stage. However, your doctor will discuss with you the use of effective contraception, as you may still become pregnant during treatment with Galdar.
• You should not take Galdar if 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.

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

This medication contains sodium

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

Use in athletes

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

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

The recommended dose is one tablet of Galdar once a day. If you take Galdar 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.

For how long to take Galdar

Continue taking Galdar every day for the time 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 Galdar, consult your doctor.

Control of Galdar treatment

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

Galdar may 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 more Galdar than you should

If you have taken too many tablets of Galdar, 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. You can also call the Toxicological Information Service, Tf: 915620420, indicating the medication and the amount taken.

If you forget to take Galdar

• If it is almost time for your next tablet (e.g. 2 or 3 hours), do not take the dose you missed and take the next dose at the time it is due.
• 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 interrupt Galdar treatment

Do not stop taking Galdar unless your doctor tells you to. See also the section “For how long to take Galdar”.

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

Like all medicines, this medicine may 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 brain alteration, e.g. stroke).
• Oppressive and sudden chest pain (sign of heart alteration).
• Swelling and redness along 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, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• 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 withGaldar:

• 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, skin redness, blisters on 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.
• Bone and joint pain (arthralgia).

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

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

• Palpitations, rapid heart rate.
• Joint stiffness (arthritis).
• Chest pain.
• Rash on the skin.
• Headache.
• Dizziness.
• General discomfort.
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite.
• Muscle pain.
• Weight loss or bone loss (osteoporosis), which may cause bone fractures in some cases (see also the section “Treatment control withGaldar in section 3”).
• Swelling of arms, hands, feet, ankles (edema).
• Depression.
• Weight gain.
• Hair loss.
• High blood pressure (hypertension).
• Abdominal pain.
• Skin dryness.
• Vaginal bleeding.

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 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.
• Breast pain.
• Fever.
• Thirst, taste disorder, dry mouth.
• Membrane mucosa dryness.
• 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 with 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 or pharmacist, 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 Pharmacovigilance of Medicines for Human Use: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 usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date refers to the last day of the month indicated.
• No special storage conditions are required.
• Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you do not need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications that you do not

need. In this way, you will help protect the environment.

Composition of Galdar

• The active principle is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
• The other components (excipients) are lactose monohydrate (lactose), microcrystalline cellulose, cornstarch, anhydrous colloidal silica, sodium carboxymethylstarch from potato (potato starch), magnesium stearate . The coating is composed of polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol/PEG 3350, quinoline yellow aluminum lake, red iron oxide (E 172), and black iron oxide (E 172).

Appearance of the product and content of the packaging

• Galdar is presented as film-coated tablets. The tablets are dark yellow in color with a white core and are round.
• Each packaging with blister packs contains 30 tablets. It may not be available all packaging.

Holder of the marketing authorization

GP-Pharm, S.A.

Polígono Industrial Els Vinyets-Els Fogars, sector 2

Carretera Comarcal C-244, km 22

08777 Sant Quintí de Mediona (Barcelona)

Spain

Responsible for manufacturing

Tecnimede – Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dosis Portos

Portugal

Last review date of this leaflet: June 2021.

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