Letrozolum Genthon

Patient Information Leaflet: User Information

Letrozolum Genthon, 2.5 mg, coated tablets
Letrozolum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you need advice or more information.
• This medicine has been prescribed specifically for you, do not pass it on to others, as it may harm them, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Table of Contents:

• 1. What is Letrozolum Genthon and what is it used for
• 2. Important information before taking Letrozolum Genthon
• 3. How to take Letrozolum Genthon
• 4. Possible side effects
• 5. How to store Letrozolum Genthon
• 6. Contents of the pack and other information

1. WHAT IS LETROZOLUM GENTHON AND WHAT IS IT USED FOR

What is Letrozolum Genthon and how does it work

Letrozolum Genthon contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is used for the hormonal (endocrine) treatment of breast cancer. The development of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole reduces the amount of estrogens by blocking the enzyme (aromatase) that affects estrogen production, and thus can slow down or stop the growth of malignant breast tumors that need estrogens to grow. As a result, the growth and spread of cancer cells to other parts of the body are slowed down or stopped.

What is Letrozolum Genthon used for

Letrozolum is used to treat breast cancer in postmenopausal women, i.e., women who have stopped menstruating.
This medicine is used to prevent breast cancer from coming back. It can be used as the first treatment before breast surgery, when immediate surgery is not recommended, or as the first treatment after breast surgery, or after five years of tamoxifen treatment. Letrozolum Genthon is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced breast cancer.
If you have any questions about how Letrozolum Genthon works or why it has been prescribed for you, ask your doctor.

2. IMPORTANT INFORMATION BEFORE TAKING LETROZOLUM GENTHON

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

Do not take Letrozolum Genthon

• If you are allergic to letrozole or any other ingredientof the medicine (listed in section 6). In women who are still menstruating, i.e., women before menopause.
• In pregnant women.
• In breast-feeding women Do not takethe medicine if any of these points apply to you - consult your doctor.

Warnings and precautions

Before starting treatment with Letrozolum Genthon, tell your doctor or pharmacist

tell your doctor. Your doctor will take this information into account during treatment with Letrozolum Genthon.

Letrozole may cause inflammation or damage to tendons (see section 4). If you experience pain or swelling of a tendon, rest the painful area and contact your doctor.

Children and adolescents (under 18 years of age)

Do not give this medicine to children and adolescents.

Elderly (65 years of age and older)

Patients aged 65 and over can take the medicine at the same dose as other adult patients.

Letrozolum Genthon and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.

Pregnancy, breast-feeding, and fertility

• -Letrozolum Genthon should only be taken when the patient is postmenopausal. However, your doctor will discuss with you the need to use an effective method of birth control, as you may still become pregnant while taking Letrozolum Genthon.
• Do not take Letrozolum Genthon if you are pregnant or breast-feeding, as treatment may harm the baby.

Driving and using machines

If you experience dizziness, drowsiness, or a general feeling of being unwell, do not drive or operate any tools or machines until these symptoms have passed.

Letrozolum Genthon contains lactose

Letrozolum Genthon contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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3. HOW TO TAKE LETROZOLUM GENTHON

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

How long to take Letrozolum Genthon

Take Letrozolum Genthon every day for as long as your doctor has prescribed. You may need to take the medicine for several months or even years. If you have any questions about how long to take Letrozolum Genthon, ask your doctor.

Monitoring during treatment with Letrozolum Genthon

This medicine should always be taken under close medical supervision. Your doctor will regularly check your health to see if the treatment is working.
Letrozolum Genthon may cause thinning or loss of bone tissue (osteoporosis) related to the decrease in estrogen levels in the body. Your doctor may order a bone density test (osteoporosis screening) before, during, and after treatment.

Taking more than the prescribed dose of Letrozolum Genthon

If you have taken more than the prescribed dose of Letrozolum Genthon or if someone has taken your tablets by mistake, contact your doctor or go to the hospital immediately. Show the doctor the medicine pack. You may need treatment.

Missing a dose of Letrozolum Genthon

• If it is almost time for your next dose (e.g., 2 to 3 hours left), skip the missed dose and take the next dose at the usual time.
• In any other case, 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 missed dose.

Stopping treatment with Letrozolum Genthon

Do not stop taking Letrozolum Genthon unless your doctor tells you to. See also "How long to take Letrozolum Genthon" above.

4. POSSIBLE SIDE EFFECTS

Like all medicines, letrozole 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 of these side effects, such as hot flashes, hair loss, and vaginal bleeding, may be due to the lack of estrogens in the body.

Some side effects can be serious

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The following side effects are rare or uncommon (i.e., they affect 1 to 100 out of 10,000 people treated).

• If you experience weakness, paralysis, or loss of sensation in your arm, leg, or any other part of your body, lack of coordination, nausea, or difficulty speaking or breathing (symptoms of brain disease, such as stroke)
• If you experience sudden chest pain (symptom of heart disease)
• If you experience difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin, or sudden pain in your arm or leg (symptom of blood clots)
• If you experience swelling and redness along a vein, with tenderness or severe pain when touched
• If you experience a high fever, chills, or mouth ulcers due to infection (low white blood cell count)
• If you experience severe, persistent blurred vision.

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

You should also tell your doctor immediately if you experience any of the following symptoms during treatment with Letrozolum:

• swelling, mainly of the face and throat (symptoms of an allergic reaction)
• yellowing of the skin and eyes, nausea, loss of appetite, dark urine (symptoms of liver disease)
• rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling skin, fever (symptoms of skin disorders).

Other possible side effects:

Very common(affecting at least 1 in 10 people treated)

• hot flashes
• high cholesterol (hypercholesterolemia)
• fatigue
• increased sweating
• bone and joint pain (arthralgia)

If any of these side effects get worse, tell your doctor.
Common(affecting at least 1 in 100 but less than 1 in 10 people treated)

• skin rash
• headache
• dizziness
• general feeling of being unwell
• gastrointestinal disorders, such as nausea, vomiting, indigestion, constipation, diarrhea
• increased or decreased appetite
• muscle pain
• thinning or loss of bone tissue (osteoporosis), which can lead to bone fractures in some cases (see also "Monitoring during treatment with Letrozolum" in section 3)
• swelling of the arms, hands, feet, ankles (edema)
• depression
• weight gain
• hair loss (alopecia)
• high blood pressure (hypertension)
• abdominal pain
• dry skin
• vaginal bleeding
• palpitations, rapid heartbeat
• stiffness of the joints (arthritis) chest pain

If any of these side effects get worse, tell your doctor.

Uncommon(affecting at least 1 in 1000 but less than 1 in 100 people treated)

• nervous system disorders, such as anxiety, nervousness, irritability, lethargy, memory disorders, drowsiness, insomnia
• sensory disorders, especially touch
• eye disorders, such as blurred vision or eye irritation
• skin diseases, such as itching (hives)
• vaginal discharge or dryness
• breast pain
• fever
• increased thirst, taste disorders, dry mouth
• dry mucous membranes
• weight loss
• urinary tract infections, frequent urination
• cough
• increased enzyme activity
• yellowing of the skin and eyes
• high bilirubin levels in the blood (a breakdown product of red blood cells)
• tendon inflammation (soft tissue that connects muscles and bones)

Rare

• tendon rupture (soft tissue that connects muscles and bones)

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor. You can also report side effects directly to the Department of Adverse Reaction Monitoring 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. HOW TO STORE LETROZOLUM GENTHON

Keep out of the sight and reach of children.
There are no special precautions for storing Letrozolum Genthon.
Do not use letrozole after the expiry date stated on the blister and carton after the words 'expiry date'. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of the month.
Medicines should 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. OTHER INFORMATION

What Letrozolum Genthon contains

• The active substance is letrozole. Each coated tablet contains 2.5 mg of letrozole.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), maize starch, sodium carboxymethylcellulose (type A), magnesium stearate (E572), colloidal anhydrous silica (E551).
• The ingredients of the tablet coating are: macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

What Letrozolum Genthon looks like and contents of the pack

Yellow, round, coated tablet with the inscription L9OO on one side and 2.5 on the other.
Letrozolum Genthon is available in blisters, in packs containing 28, 30, or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Genthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania SL.
C/Castelló,1,
Poligono Las Salinas
08330 Sant Boi de Llobregat
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Barcelona
Spain
Rottendorf Pharma GmbH
Ostenfelder strasse 51-61
59320 Ennigerloh
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Letrozole Zentiva 2.5 mg Film-coated tablet
Spain
Letrozol Genthon 2.5 mg EFG
Netherlands
Letrozol Genthon 2.5 mg, filmomhulde tabletten
Poland
Letrozolum Genthon
Portugal
Letrozol Genthon 2.5 mg
Romania
Letrozol Labormed 2.5 mg comprimate filmate
Slovenia
Letrozol Genthon 2.5 mg filmsko obložene tablete

Date of last revision of the leaflet: 01.01.2022

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