Letrozole accord

Package leaflet: Information for the user

Letrozole Accord, 2.5 mg, film-coated tablets
Letrozolum
Please read carefully the entire leaflet before starting to take this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Letrozole Accord is and what it is used for
2. Important information 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 Letrozole Accord is and what it is used for

What Letrozole Accord is and how it works
Letrozole Accord contains an active substance called letrozole. Letrozole belongs to a group of medicines known as aromatase inhibitors. It is a hormonal (i.e. "endocrine") medicine used in the treatment of 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 inhibiting the activity of an enzyme ("aromatase") involved in estrogen production. Therefore, it may inhibit the growth of breast tumours that require estrogens to grow. As a result of this action, cancer cells stop growing or grow more slowly and (or) stop spreading to other parts of the body.

What Letrozole Accord is used for
Letrozole Accord is used to treat breast cancer in postmenopausal women, i.e. women who have stopped menstruating.
Letrozole is used to prevent recurrence of breast cancer. It may be used as initial treatment before breast cancer surgery if immediate surgery is not recommended, or as initial treatment after breast cancer surgery, or following five years of treatment with tamoxifen.
Letrozole Accord is also used to prevent the spread of breast tumour 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, please consult your doctor.

2. Important information before using Letrozole Accord

Follow your doctor's instructions. They may differ from the general information contained in this
leaflet.
When not to use Letrozole Accord

• If the patient is allergic to letrozole or any of the other ingredients of this medicine (listed in section 6).
• If the patient is still menstruating, i.e. has not yet gone through menopause.
• During pregnancy.
• While breastfeeding.

If any of the above points apply to the patient, this medicine must not be used and the patient
should contact her doctor.
Warnings and precautions
Before starting treatment with Letrozole Accord, consult a doctor or pharmacist.

• If the patient has severe kidney disease
• If the patient has severe liver disease
• If the patient has previously suffered from osteoporosis (weakening or loss of bone) or bone fractures (see also section "Monitoring during treatment with Letrozole Accord" in section 3).

If any of the above points apply to the patient, inform the doctor. The doctor will take these factors into account when managing treatment with Letrozole Accord.
Letrozole may cause inflammation or damage (rupture) of tendons (see section 4). If the patient experiences pain or swelling in a tendon, the affected area should be rested and the patient should contact her doctor.
Children and adolescents (under 18 years of age)
This medicine must not be used in children and adolescents.
Elderly patients (aged over 65 years and older)
This medicine can be used in patients over 65 years of age at the same dose as in other adult patients.
Letrozole Accord and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used, including those obtained without a prescription.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

• Letrozole Accord should only be used when the patient is postmenopausal. However, the doctor will discuss with the patient the need for an effective method of contraception, as pregnancy may still occur during treatment with Letrozole Accord.
• Letrozole Accord must not be used if the patient is pregnant or breastfeeding, as treatment may harm the unborn or nursing child.

Driving and operating machinery:
If the patient experiences dizziness, fatigue, drowsiness, or general malaise, she must not drive or operate machinery until her condition returns to normal.
Letrozole Accord contains lactose
Letrozole Accord contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Letrozole Accord

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual dose is one tablet of Letrozole Accord taken once daily.
Taking Letrozole Accord at the same time each day will help you remember to take the tablet.
The tablet may be taken with or without food and should always be swallowed whole, with a glass of water or other liquid.
How long to take Letrozole Accord
You should take Letrozole Accord every day for as long as your doctor has instructed. Treatment may need to continue for several months or even years. If you have any questions about how long to take Letrozole Accord, consult your doctor.
Monitoring during treatment with Letrozole Accord
This medicine should always be used under strict medical supervision. Your doctor will regularly monitor your health to ensure the treatment is effective.
Letrozole Accord may cause thinning or loss of bone tissue (osteoporosis) due to reduced estrogen levels in the body. Your doctor may order bone density measurements (osteoporosis screening tests) before, during, and after treatment.
Taking more Letrozole Accord than prescribed
If you take more Letrozole Accord than prescribed, or if someone accidentally swallows tablets, contact your doctor or nearest hospital immediately. Take the medicine with you. Medical treatment may be necessary.
If you miss a dose of Letrozole Accord
If it is almost time for your next dose (e.g. within 2 to 3 hours), skip the missed dose and take the next dose at the usual time.
Otherwise, take the missed dose as soon as you remember, then take the next tablet at the usual time.
Do not take a double dose to make up for a missed tablet.
Stopping Letrozole Accord
Do not stop taking Letrozole Accord unless your doctor tells you to (see also section "How long to take Letrozole Accord").
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Most adverse reactions are mild or moderate in intensity and usually disappear after a few days
or weeks of starting treatment.
Some of the adverse reactions, such as hot flushes, hair loss or vaginal bleeding, may be
caused by low levels of oestrogen in the body.
You should not be concerned about all the possible adverse reactions listed below
occurring with this medicine. They may not occur at all.
Some adverse reactions may be serious:
Rare adverse reactions (may affect 1 in 10,000 patients):

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg or foot (symptoms indicating blood clot formation).
• Rupture of tendon (soft tissue connecting muscles and bones).

Uncommon adverse reactions (may affect 1 in 100 patients):

• Severe, persistent vision disturbances
• High fever, chills or mouth ulcers due to infections (lack of white blood cells)
• Swelling and redness along a vein, extremely tender and painful to touch
• Sudden, pressing chest pain (symptom of heart disorder)
• 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 (symptoms of brain disorders, e.g. stroke)
• Tendonitis (inflammation of the soft tissue connecting muscles and bones).

If any of the above symptoms occur, you must immediately inform your doctor.
You should also immediately inform your doctor if any of the following symptoms occur in a patient during treatment with Letrozole Accord:

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

Some adverse reactions are very common (may affect more than 1 in 10 patients)

• Hot flushes
• Increased cholesterol levels (hypercholesterolaemia)
• Feeling of fatigue and weakness
• Excessive sweating
• General malaise
• Bone and joint pain

If any of these symptoms occur severely in a patient, you should inform the doctor.
Some adverse reactions are common (may affect 1 in 10 patients)

• Skin rash
• Headache
• Dizziness
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased appetite or loss of appetite
• Muscle pain
• Thinning or loss of bone tissue (osteoporosis), leading in some cases to bone fractures (see also section "Monitoring during treatment with Letrozole Accord" in section 3)
• Swelling of arms, hands, feet and ankles (oedema)
• Depression
• Weight gain
• Excessive hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain
• Bone pain

If any of these symptoms occur severely in a patient, you should inform the doctor.
Other adverse reactions are uncommon (may affect 1 in 100 patients)

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, drowsiness, insomnia
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
• Sensory disturbances, especially touch, tingling or numbness
• Eye disorders such as blurred vision, eye irritation
• Palpitations, rapid heartbeat
• Skin disorders such as itching
• Urticaria
• Vaginal discharge or vaginal dryness
• Breast pain
• Feeling of thirst, taste disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, more frequent urination
• Cough
• Increased enzyme activity
• Yellowing of the skin and whites of the eyes
• High bilirubin levels in the blood (a breakdown product of red blood cells)
• Tumour pain
• Inflammation of the mouth and lips
• General swelling
• Fever
• Shortness of breath

Frequency unknown (frequency cannot be estimated from available data)

• Trigger finger – a condition in which a finger or thumb locks in a bent position.

If any of these symptoms occur severely in a patient, you should inform the doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Letrozole Accord

• Keep the medicine out of the sight and reach of children.
• No special storage instructions apply for this medicine.
• Do not use this medicine after the expiry date stated on the carton and blister after: "Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Letrozole Accord contains
Each coated tablet contains 2.5 mg of letrozole.
The other ingredients are:
Tablet core: monohydrate lactose, corn starch, hypromellose type 2910, sodium carboxymethyl starch
type A, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Coating: hypromellose 6 cp E 464, titanium dioxide E 171, iron oxide yellow E 172, macrogol 400 and talc
E 553b.
What Letrozole Accord looks like and contents of the pack
Letrozole Accord 2.5 mg tablets are yellow, round, biconvex, coated tablets, smooth on both sides.
Letrozole Accord tablets are packed 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 Street
02-677 Warsaw
Tel: + 48 22 577 28 00
Manufacturer / Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
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 European Economic Area and the United Kingdom (Northern Ireland) under the following names: