LETROZOLE 2.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Letrozole Accord, 2.5 mg, Film-Coated Tablets
   1. Contents of the Pack and Other Information
3. What Letrozole Accord is and what it is used for
   1. What Letrozole Accord is and how it works
   2. What Letrozole Accord is used for
4. Before you take Letrozole Accord
   1. When not to take Letrozole Accord
   2. Warnings and precautions
   3. Children and adolescents (under 18 years old)
   4. Elderly patients (65 years and over)
   5. Letrozole Accord with other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Letrozole Accord contains lactose
5. How to take Letrozole Accord
   1. How long to take Letrozole Accord
   2. Monitoring during treatment with Letrozole Accord
   3. If you take more Letrozole Accord than you should
   4. If you forget to take Letrozole Accord
   5. If you stop taking Letrozole Accord
6. Possible side effects
   1. Some side effects can be serious
   2. If you experience any of these symptoms, tell your doctor immediately.
   3. Reporting of side effects
7. How to store Letrozole Accord
8. Contents of the pack and other information
   1. What Letrozole Accord contains
   2. What Letrozole Accord looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet: October 2024

Package Leaflet: Information for the User

Letrozole Accord, 2.5 mg, Film-Coated Tablets

Letrozole
Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 and Other Information

• 1. What Letrozole Accord is and what it is used for
• 2. Before you take Letrozole Accord
• 3. How to take Letrozole Accord
• 4. Possible side effects
• 5. How to store Letrozole Accord
• 6. Contents of the pack and other information

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

What Letrozole Accord is and how it works

Letrozole Accord contains the active substance letrozole. Letrozole belongs to a group of medicines called aromatase inhibitors. It is a hormonal (endocrine) medicine used to treat breast cancer. The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole Accord reduces the amount of estrogen by blocking the enzyme (aromatase) involved in estrogen production and can therefore stop or slow the growth of hormone-receptor-positive breast cancer.

What Letrozole Accord is used for

Letrozole Accord is used to treat breast cancer in postmenopausal women (women who have stopped menstruating).
Letrozole Accord is used to prevent the return of breast cancer. It may be used as the first treatment before breast cancer surgery if immediate surgery is not suitable or may be used as the first treatment after breast cancer surgery or after 5 years of treatment with tamoxifen.
Letrozole Accord is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced disease.
If you have any questions about how Letrozole Accord works or why it has been prescribed for you, ask your doctor.

2. Before you take Letrozole Accord

Follow the instructions of your doctor. They may differ from the general information in this leaflet.

When not to take Letrozole Accord

• If you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6).
• If you are still menstruating.
• If you are pregnant.
• If you are breastfeeding.

If any of the above applies to you, do not take this medicine and tell your doctor.

Warnings and precautions

Before taking Letrozole Accord, tell your doctor or pharmacist:

• If you have severe kidney disease
• If you have severe liver disease
• If you have had osteoporosis (thinning or loss of bone) or bone fractures (see also "Monitoring during treatment with Letrozole Accord" in section 3).

If any of the above applies to you, tell your doctor. Your doctor will consider this information when treating you with Letrozole Accord.
Letrozole may cause inflammation or damage (tear) to tendons (see section 4). If you experience pain or swelling in your tendons, rest the affected area and tell your doctor.

Children and adolescents (under 18 years old)

Do not give this medicine to children and adolescents.

Elderly patients (65 years and over)

This medicine can be given to elderly patients at the same dose as for other adults.

Letrozole Accord with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Letrozole Accord should only be taken if you are postmenopausal. However, your doctor will discuss with you the need for effective contraception since you may still become pregnant during treatment with Letrozole Accord.
• Do not take Letrozole Accord if you are pregnant or breastfeeding, as the treatment may harm your baby.

Driving and using machines

If you experience dizziness, tiredness, drowsiness, or a general feeling of being unwell, do not drive or operate machinery until your condition improves.

Letrozole Accord contains lactose

Letrozole Accord contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Letrozole Accord

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The usual dose is one Letrozole Accord tablet taken once a day.
Taking Letrozole Accord at the same time every day will help you remember to take your tablet.
The tablet can be taken with or without food and should be swallowed whole with a glass of water or another liquid.

How long to take Letrozole Accord

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

Monitoring during treatment with Letrozole Accord

This medicine should always be taken under close medical supervision. Your doctor will regularly check your overall health to ensure the treatment is working properly.
Letrozole Accord may cause thinning or loss of bone density (osteoporosis) due to the reduction of estrogen levels in your body. Your doctor may order a bone density test before, during, and after treatment.

If you take more Letrozole Accord than you should

If you have taken more Letrozole Accord than you should, contact your doctor or the nearest hospital immediately. Bring the medicine pack with you.

If you forget to take Letrozole Accord

If it is almost time for your next dose (e.g., 2 to 3 hours), skip the missed dose and take the next dose at the usual time.
In other cases, take the dose as soon as you remember and then take the next tablet at the usual time.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Letrozole Accord

Do not stop taking Letrozole Accord unless your doctor tells you to (see also "How long to take Letrozole Accord").
If you have any further questions on 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 or moderate and usually disappear after a few days or weeks of treatment.

Some side effects can be serious

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin (signs of blood clots).
• Tendon rupture (tear in the tissue that connects muscles to bones).

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

• Severe, persistent vision disturbances
• High fever, chills, or mouth ulcers (infections due to low white blood cell count)

Swollen and red veins (thrombophlebitis)

• Sudden, severe chest pain (heart problems)
• Weakness, paralysis, or loss of sensation in any part of the body (especially in the arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of brain problems, such as stroke)
• Tendon inflammation (inflammation of the tissue that connects muscles to bones).

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

You should also tell your doctor immediately if you experience any of the following while taking Letrozole Accord:

• Swelling of the face and throat (signs of allergic reaction).
• Yellowing of the skin or eyes, nausea, loss of appetite, dark urine (signs of liver inflammation).
• Rash, redness of the skin, blistering

Very common side effects(may affect more than 1 in 10 people)

• Hot flashes
• High cholesterol levels
• Feeling tired or weak
• Increased sweating
• General feeling of being unwell
• Bone or joint pain

If any of these side effects gets serious, tell your doctor.
Common side effects(may affect up to 1 in 10 people)

• Skin rash
• Headache
• Dizziness
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone density (osteoporosis), which may lead to bone fractures (see also "Monitoring during treatment with Letrozole Accord" in section 3)
• Swelling of the arms, hands, feet, and ankles (edema)
• Depression
• Weight gain
• Excessive hair loss
• High blood pressure
• Abdominal pain
• Dry skin
• Bleeding from the genital tract
• Palpitations, rapid heartbeat
• Stiffness of the joints (arthritis)
• Chest pain
• Bone pain

If any of these side effects gets serious, tell your doctor.
Uncommon side effects(may affect up to 1 in 100 people)

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, sleepiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensory disturbances, especially touch, feeling of tingling or numbness.
• Eyesight disturbances such as blurred vision, eye irritation
• Palpitations, rapid heartbeat
• Skin disorders such as itching
• Hives
• Discharge from the genital tract or vaginal dryness
• Breast pain
• Feeling thirsty, taste disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infections, frequent urination
• Cough
• Increased liver enzyme activity
• Yellowing of the skin and whites of the eyes
• High bilirubin levels in the blood (a product of red blood cell breakdown)
• Tumor pain
• Mouth and lip inflammation
• General swelling
• Fever
• Shortness of breath

Frequency not known(frequency cannot be estimated from the available data)

• Trigger finger - a condition in which the finger or thumb catches or locks when bent.

If any of these side effects gets serious, tell your doctor.

Reporting of side effects

If you get 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 national reporting system listed in the "Contact details for the reporting of side effects" section below.
In the UK, you can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Letrozole Accord

• Keep this medicine out of the sight and reach of children.
• No special storage precautions are required.
• Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP" or "Expiry Date". The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Letrozole Accord contains

Each film-coated tablet contains 2.5 mg of letrozole.
The other ingredients are:
Tablet core: lactose monohydrate, maize starch, hypromellose 2910, sodium carboxymethylcellulose type A, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Coating: hypromellose 6 cp E 464, titanium dioxide E 171, yellow iron oxide E 172, macrogol 400, and talc E 553b.

What Letrozole Accord looks like and contents of the pack

Letrozole Accord 2.5 mg film-coated tablets are yellow, round, biconvex, film-coated, and smooth on both sides.
Letrozole Accord tablets are packaged in blisters in packs containing 10, 14, 28, 30, 50, 60, 84, 90, 98, or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: October 2024