PATIENT INFORMATION LEAFLET

Letrozol Accord 2.5 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

What is Letrozol Accordand how it works

Letrozol Accordcontains an active ingredient called letrozol. It belongs to a group of medicinescalled aromatase inhibitors. It is a hormone treatment (or“endocrine”)for breast cancer.The growth of breast cancer is usually stimulatedby estrogens, which are the female sex hormones. Letrozol Accordreduces 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,the tumor cells grow more slowlyorwell for thegrowth and/orextensionto other parts of the body.

What is Letrozol Accord used for

Letrozol Accordis used to treat breast cancerinwomenwhohave passed menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from appearingagain. It can be used as the first treatmentbefore breast cancer surgery, in case immediate surgery is not suitable, or it can be used as the first treatmentafter breast cancer surgery, or after five years oftreatmentwith tamoxifen. Letrozol Accord also is used to prevent breast cancer from spreading to other parts of the body in patients with advanced breast cancer.

If you have anyquestionsabout how Letrozol Accord worksorthe reasonwhyyou have been prescribed this medicine, consult withyour doctor.

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

Do not take Letrozol Accord

• 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, if you have not yet 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 takeLetrozol Accord

• 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 Letrozol Accord” 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 Accord.

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 Letrozol Accord

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

Pregnancy, breastfeeding, and fertilityIf you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medication.

• You should only take Letrozol Accord after menopause. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol Accord.

• You should not take Letrozol Accord 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.

Letrozol Accord containslactose

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

Letrozol Accord contains sodium

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

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

The usual dose is one Letrozol Accord tablet taken once a day. If you take Letrozol Accord 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 Accord

Continue taking Letrozol Accord 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 Letrozol Accord, consult your doctor.

Monitoring treatment with Letrozol Accord

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

Letrozol Accord 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 monitor osteoporosis) before, during, and after treatment.

If you take more Letrozol Accord than you should

If you have taken too many Letrozol Accord tablets, 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 Toxicology Information Service, Tf: 915620420

If you forget to take Letrozol Accord

• If it is almost time for your next tablet (e.g. 2 or 3 hours away), do not take the missed dose and take the next dose at the usual time.
• Otherwise, take the missed 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 treatment with Letrozol Accord

Do not stop taking Letrozol Accord unless your doctor tells you to. See also the section “How long to take Letrozol Accord”.

If you have any doubts about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.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 people):

• 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.
• Intense fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Persistent and severe blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones)

Rare (may affect up to 1 in 10,000 people):

• Difficulty breathing, chest pain, fainting, rapid heart rate, blue 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 with Letrozol Accord:

• 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 people):

• 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 people):

• Skin rash
• 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 "Treatment control with Letrozol Accord" section)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Skin dryness
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

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

Other side effects are infrequent (may affect up to 1 in 100 people):

• 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 tactile
• 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
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency to urinate
• Cough
• Increased enzyme levels
• Yellow discoloration of skin and eyes
• Elevated bilirubin levels in the blood (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 not listed in this prospectus. 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 out of sight and reach of children.
• Do not usethis medicationafter the expiration date that appears on the packagingand on the blister pack after CAD.The expiration date is the last day of the month indicated.
• No special storage conditions are required.
• Store in the original packagingto protect it from moisture.
• Do not use any damaged package or one showing signs of deterioration.
• Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Composition of Letrozol Accord

The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.

The other components are:

Core of the tablet: lactose monohydrate (lactose), cornstarch, hypromellose (E464), carboxymethylstarch sodium of potato (potato starch), microcrystalline cellulose (E460), anhydrous colloidal silica (E551) and magnesium stearate (E572).

Coating: hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), macrogol 400 and talc (E553b).

Appearance of the product and contents of the package

Letrozol Accord 2.5 mg are yellow, round, biconvex, film-coated tablets, smooth on both sides. Letrozol Accord is packaged in blisters of 10, 14, 28, 30, 50, 60, 84, 90, 98 and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.,

World Trade Center,

Moll de Barcelona s/n,

Edifici Est, 6afloor,

08039 Barcelona

Spain

Responsible for manufacturing

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

ACCORD HEALTHCARE POLSKA Sp. z.o.o.

ul. Lutomierska 50,95-200 Pabianice

Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

32009, Lamia,

Greece

This medicinal product is authorized in the Member States of the EEA with the following names

Last review date of thisleaflet:October 2023

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