LETROZOLE ACCORD 2.5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Letrozol Accord 2.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Letrozol Accord is and what it is used for
2. What you need to know before you take Letrozol Accord
3. How to take Letrozol Accord
4. Possible side effects
5. Storage of Letrozol Accord
6. Contents of the pack and further information

1. What Letrozol Accord is and what it is used for

What Letrozol Accord is and how it works

Letrozol Accord 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 often stimulated by estrogens, which are female sex hormones. Letrozol Accord reduces the amount of estrogen by blocking an enzyme (aromatase) involved in estrogen production, 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 Letrozol Accord is used for

Letrozol Accord is used to treat breast cancer in women who have gone through the 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. Letrozol Accord 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 Letrozol Accord works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Letrozol Accord

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

Do not take Letrozol Accord

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

If any of these apply to you, do not take this medicine and tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting Letrozol Accord

• 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 Letrozol Accord" in section 3).

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

Letrozol 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.

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Elderly patients (65 years and over)

People 65 years and over can use this medicine at the same dose as for adults.

Other medicines and Letrozol Accord

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

Pregnancy, breast-feeding, and fertilityIf you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You should only take Letrozol Accord if you have gone through the menopause. However, your doctor should discuss with you the use of effective contraception, as you could still become pregnant during treatment with Letrozol Accord.

• Do not take Letrozol Accord if you are pregnant or breast-feeding, 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.

Letrozol Accord contains lactose

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

Letrozol Accord contains sodium

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

3. How to take Letrozol Accord

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

The normal dose is one Letrozol Accord tablet once a day. If you take Letrozol Accord at the same time each 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

Keep taking Letrozol Accord every day for as long as your doctor tells you to. You may need to take it for months or even years. If you are unsure how long to take Letrozol Accord, ask your doctor.

Monitoring of treatment with Letrozol Accord

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

Letrozol Accord may cause a decrease in bone density 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 check for 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 taken your tablets, contact your doctor or go to the hospital immediately. Show them the pack of tablets. You may need medical treatment. You can also call the Poison Information Service on +34 915620420.

If you forget to take Letrozol Accord

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

If you stop taking 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 questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 estrogen.

Do not be alarmed by this list of possible side effects. You may not get any of them.

Some side effects can be serious:

Uncommon (may affect up to 1 in 100 people):

• Weakness, paralysis, or loss of sensation in a part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke).
• Chest pain (sign of heart disorder).
• Swelling and redness along a vein that is extremely soft and possibly painful to the touch.
• High fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Persistent and severe blurred vision.
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones)

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• Tendon rupture (connective tissue that connects muscles to bones)

If you experience any of these, tell your doctor immediately.

You should also tell 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).

• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).

• Rash, skin redness, 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 people)

• Hot flashes
• High cholesterol (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

If any of these affect you severely, talk to your doctor.

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

• 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 the section "Monitoring of treatment with Letrozol Accord" 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 affect you severely, tell your doctor.

Other side effects are uncommon (may affect up to 1 in 100 people).

• 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
• Eyeball 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 bilirubin levels in the blood (breakdown product of red blood cells)

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

Trigger finger, a condition where your finger or thumb gets stuck in a bent position.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Accord

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.
• No special storage conditions are required.
• Store in the original package to protect from moisture.
• Do not use any packaging that is damaged or shows signs of tampering.
• Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Letrozol Accord

The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.

The other ingredients are:

Core of the tablet: lactose monohydrate (lactose), corn starch, hypromellose (E464), sodium carboxymethyl potato starch (potato starch), microcrystalline cellulose (E460), silica colloidal anhydrous(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 pack contents

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.

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare S.L.U.,

World Trade Center,

Moll de Barcelona s/n,

Edifici Est, 6a planta,

08039 Barcelona

Spain

Manufacturer

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 authorised in the Member States of the EEA under the following names

Date of last revision of this leaflet:October 2023

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