Letrozole Accord 2.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Letrozole Accord 2.5 mg film-coated tablets EFG

Read the entire 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 only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

1. What Letrozole Accord is and what it is used for
2. What you need to know before taking 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 Letrozol Accord is and what it is used for

What Letrozol Accord is and how it works

Letrozol Accord 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. Letrozol Accord 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 their growth and/or spread to other parts of the body is prevented.

What Letrozol Accord is used for

Letrozol Accord 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 initial 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. Letrozol Accord 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 Letrozol Accord works or why you have been prescribed this medicine, please consult your doctor.

2. What you need to know before taking Letrozol Accord

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

Do not take Letrozol Accord

• if you are allergic to letrozol or to any of the other ingredients of this medicine (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 apply to you, do not take this medicine and inform 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, 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 of age)

This medicine must not be used in children and adolescents.

Elderly patients (aged 65 years and over)

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

Other medicines and Letrozol Accord

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

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

• You must not take Letrozol Accord 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.

Letrozol Accord contains lactose

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

Letrozol Accord contains sodium

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

3. How to take Letrozol Accord

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose is one Letrozol Accord tablet once daily. Taking Letrozol Accord 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 Letrozol Accord

Continue 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 have any doubt about how long you should take Letrozol Accord, consult your doctor.

Monitoring of treatment with Letrozol Accord

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

Letrozol Accord 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 Letrozol Accord than you should

If you have taken too many Letrozol Accord tablets, or if someone else has accidentally taken your tablets, contact your doctor or go to hospital immediately. Show them the medicine packaging. You may require medical treatment. You can also call the Toxicology Information Service at: 915620420.

If you forget to take Letrozol Accord

• If it is almost time for your next dose (e.g. 2 or 3 hours before), 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 dose at your usual time.
• Do not take a double dose to make up for the missed 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 using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may 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 lack of oestrogens.

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 people):

• 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 (sign of heart disorder).
• Swelling and redness along a vein that is extremely tender and possibly painful to touch.
• High fever, chills, or mouth ulcers due to infections (due to 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 heartbeat, bluish skin colouration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• Rupture of a tendon (connective tissue that connects 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 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 (signs of hepatitis).

• Rash, redness of the skin, 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 people):

• Hot flushes
• Elevated cholesterol levels (hypercholesterolaemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

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

Some adverse 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, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bones (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Accord 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 heartbeat
• Joint stiffness (arthritis)
• Chest pain

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

Other adverse effects are uncommon (may affect up to 1 in 100 people):

• 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 to touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal dryness or discharge
• 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
• Yellowing of the skin and eyes
• Elevated bilirubin levels in the blood (a breakdown product of red blood cells)

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 or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of Letrozole Accord

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.
• Store in the original packaging to protect from moisture.
• Do not use any pack that is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Letrozol Accord

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

The other components are:

Tablet core: monohydrate lactose (lactose), maize starch, hypromellose (E464), sodium carboxymethyl starch from potato (potato starch), microcrystalline cellulose (E460), colloidal anhydrous silicon dioxide (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 container

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 pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.,

World Trade Center,

Moll de Barcelona s/n,

Edifici Est, 6th floor,

08039 Barcelona,

Spain

Manufacturer Responsible

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The 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 EEA Member States under the following names

Date of the most recent review of this package leaflet: October 2023

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