Lortanda

Leaflet attached to the packaging: patient information

Lortanda, 2.5 mg, film-coated tablets

Letrozole

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Lortanda and what is it used for

What is Lortanda and how does it work

Lortanda contains the active substance letrozole. It 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. Lortanda reduces the amount of estrogen by inhibiting the activity of an enzyme (aromatase) involved in the production of estrogens, and thus may slow down the growth of breast cancer that needs estrogens to grow. As a result of this effect, cancer cells stop growing or grow slowly and/or stop spreading to other parts of the body.

What is Lortanda used for

Lortanda is used to treat breast cancer in post-menopausal women, i.e., after the end of menstruation. The medicine is used to prevent recurrence of breast cancer. It may be used as the first treatment before breast cancer surgery when immediate surgery is not recommended, or as the first treatment after breast cancer surgery or after 5 years of tamoxifen treatment. Lortanda 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 Lortanda works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Lortanda

Follow the instructions of your doctor. Your doctor's instructions may differ from those described in this leaflet.

When not to take Lortanda

• if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
• if you are still menstruating, i.e., you are still before menopause,
• during pregnancy,
• during breastfeeding.

Do not take Lortandaif any of these points apply to you - consult your doctor.

Warnings and precautions

Before taking Lortanda, tell your doctor or pharmacist:

• if you have severe kidney disease,
• if you have severe liver disease,
• if you have had osteoporosis or bone fractures in the past (see also "Monitoring during Lortanda treatment" in section 3). If any of these conditions occur, tell your doctor. Your doctor will take this into account during treatment with Lortanda.

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

Children and adolescents (under 18 years of age)

Do not use this medicine in children and adolescents.

Elderly patients (65 years of age and older)

In patients aged 65 and older, the medicine can be used at the same doses as in other adults.

Lortanda and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

• Lortanda should only be used by post-menopausal women, but your doctor should discuss the use of effective contraceptive methods with you, as there is still a possibility of becoming pregnant while taking Lortanda.
• Do not take Lortanda during pregnancy or breastfeeding, as the medicine may harm the baby.

Driving and using machines

If you experience dizziness, fatigue, drowsiness, or general malaise, do not drive, operate machinery, or use tools until your condition improves.

Lortanda contains lactose monohydrate and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. How to take Lortanda

Always take Lortanda exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose of Lortanda is one tablet once a day. Taking the tablet at the same time every day will help you remember to take your medicine. You can take the medicine with or without food. Swallow the tablet whole with a glass of water or another liquid.

How long to take Lortanda

Take Lortanda every day for as long as your doctor has prescribed it. You may need to take the medicine for several months or even years. If you have any questions about the duration of treatment, talk to your doctor.

Monitoring during Lortanda treatment

Take the medicine under the close supervision of your doctor. Your doctor will regularly check your condition to ensure that the treatment is working properly. Lortanda may cause a decrease in bone density or bone loss (osteoporosis) due to decreased estrogen levels in the body. Your doctor may order a bone density test (a way to monitor osteoporosis) before, during, and after treatment.

Taking more Lortanda than prescribed

If you take too much Lortanda or if someone else takes your medicine, go to a doctor or hospital immediately. Show the doctor the pack of the medicine. You may need treatment.

Missing a dose of Lortanda

• If it is almost time for your next dose (about 2-3 hours), skip the missed dose and take the next dose at the scheduled time.
• In other cases, take the dose as soon as possible, and then take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

Stopping Lortanda treatment

Do not stop taking Lortanda without consulting your doctor. See also "How long to take Lortanda". If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lortanda 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 caused by the lack of estrogen in the body. Do not be concerned after reading the following side effects. It is possible that none of them will occur.

Some side effects can be serious

Rare or uncommon side effects(i.e., may occur in 1 to 100 out of 10,000 patients)

• weakness, paralysis, or loss of sensation in any part of the body (especially hands and feet), loss of coordination, nausea, speech or breathing disorders (symptoms of brain disorders, such as stroke),
• sudden, severe chest pain (symptom of heart disorders),
• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (symptoms of blood clots),
• swelling and redness along a vein, which is extremely sensitive and painful to the touch,
• high fever, chills, or mouth ulcers due to infections (lack of white blood cells),
• severe, persistent blurred vision.

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

If you experience any of the following symptoms while taking Lortanda, contact your doctor immediately.

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

Some side effects are very common.These side effects may occur in more than 10 out of 100 patients.

• hot flashes,
• increased cholesterol levels (hypercholesterolemia),
• fatigue,
• increased sweating,
• bone and joint pain (arthralgia). If any of these symptoms worsen, tell your doctor.

Some side effects are common.These side effects may occur in 1 to 10 out of 100 patients.

• palpitations, rapid heartbeat,
• joint stiffness (arthritis),
• chest pain,
• skin rash,
• headache,
• dizziness,
• general malaise (feeling unwell),
• gastrointestinal disorders, including nausea, vomiting, indigestion, constipation, diarrhea,
• increased or decreased appetite,
• muscle pain,
• loss of bone density or bone mass (osteoporosis) leading to bone fractures (see also "Monitoring during Lortanda treatment" in section 3),
• swelling of the arms, hands, feet, ankles,
• depression,
• weight gain,
• hair loss,
• high blood pressure (hypertension),
• abdominal pain,
• dry skin,
• vaginal bleeding. If any of these symptoms worsen, tell your doctor.

Some side effects are uncommon.These side effects may occur in 1 to 10 out of 1,000 patients.

• nervous system disorders, such as anxiety, nervousness, irritability, lethargy, memory disorders, drowsiness, insomnia,
• pain or burning sensation in the hands or wrists (carpal tunnel syndrome),
• sensory disturbances, especially touch,
• vision disorders, blurred vision, eye irritation,
• skin disorders, such as itching (hives),
• yellowing of the skin and eyes,
• high bilirubin levels in the blood (a product of red blood cell breakdown),
• 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,
• tendon inflammation (soft tissue that connects muscles and bones).

Rare side effects

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

Side effects with unknown frequency

• trigger finger, a condition in which the finger or thumb remains bent.

If any of the above symptoms worsen, tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring 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, e-mail: [email protected]. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lortanda

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month. There are no special precautions for storage. 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. Contents of the pack and other information

What Lortanda contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are: lactose monohydrate, maize starch, hypromellose (type 2910), microcrystalline cellulose, sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, and magnesium stearate in the tablet core, and hypromellose (6 cP), titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 400, and talc in the tablet coating. See section 2 "Lortanda contains lactose monohydrate and sodium".

What Lortanda looks like and contents of the pack

Yellow, round, biconvex film-coated tablets with a diameter of 6 mm, smooth on both sides. Packs: 10, 14, 28, 30, 50, 60, 84, 90, 98, or 100 film-coated tablets in blisters, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia, TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany, Date of last revision of the leaflet:22.11.2019