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Letrozol Nucleus 2.5 mg. 30 tablets


Letrozole Nucleus contains an active substance called letrozole. Letrozole belongs to a group of medicines called aromatase inhibitors. It is used for hormonal (or endocrine) treatment of breast cancer. The development of breast cancer is often stimulated by estrogens, which are female sex hormones.


What Letrozole Nucleus is and what it is used for

What Letrozole Nucleus is and how it works

Letrozole Nucleus contains an active substance called letrozole. Letrozole belongs to a group of medicines called aromatase inhibitors. It is used for hormonal (or endocrine) treatment of breast cancer. The development of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole Nucleus reduces the amount of estrogen by blocking the enzyme (aromatase) that is involved in the production of estrogen and can therefore block the growth of breast cancer, which needs estrogen for its development. As a result, tumor cells slow down or stop growing and / or spreading to other parts of the body.

What Letrozole Nucleus is used for

Letrozole Nucleus is used to treat breast cancer in postmenopausal women, ie. after cessation of the menstrual cycle.

It is used to prevent the recurrence of breast cancer. It can be used as a first treatment before breast surgery in cases where surgery is not appropriate, or as a first treatment after breast surgery or after 5 years of tamoxifen treatment. Letrozole Nucleus is also used to prevent it from spreading to other parts of the body in patients with advanced disease.

If you have any questions about how Letrozole Nucleus works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Letrozole Nucleus

Follow all doctor's instructions carefully. They may differ from the general information in this leaflet.

Do not take Letrozole Nucleus

- if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6);

- if you still have a menstrual cycle, ie if you have not gone through menopause;

- if you are pregnant;

- if you are breast-feeding.

If any of these apply to you, do not take this medicine or talk to your doctor.

Warnings and precautions

Ask your doctor or pharmacist for advice before taking Letrozole Nucleus

- if you suffer from severe kidney disease

- if you have severe liver disease

- if you have had osteoporosis or bone fractures (see also “Follow-up during treatment with Letrozole Nucleus” in section 3).

If any of the above apply to you, talk to your doctor. He will take this into account when you are treated with Letrozole Nucleus.

Children and adolescents (under 18)

Letrozole should not be taken by children or adolescents.

Elderly patients (65 years and older)

Patients 65 years of age and older can take letrozole at the same dosage as other adults.

Other drugs and Letrozole Nucleus

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and lactation

You should only take Letrozole Nucleus if you are menopausal. However, your doctor should discuss with you the need to use effective contraceptive measures, as it is possible to become pregnant during treatment with Letrozole Nucleus.

Letrozole Nucleus should not be taken during pregnancy and breast-feeding as it may harm your baby.

Driving and using machines

If you feel dizzy, tired, drowsy or generally unwell, do not drive or use any tools or machines until your condition has returned to normal.

Letrozole Nucleus contains lactose

Letrozole Nucleus contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Letrozole Nucleus

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose is one tablet of Letrozole Nucleus once a day. Taking Letrozole Nucleus at the same time of day will help you remember when to take the tablet.

The tablets should be swallowed whole with a glass of water or other liquid and can be taken with or without food.

How long Letrozole Nucleus should be taken

Take Letrozole Nucleus every day exactly as your doctor has told you. You may need to take it for months or even years. If you have any questions about the duration of Letrozole Nucleus, ask your doctor.

Monitor your condition during treatment with Letrozole Nucleus

This medicine should be taken under strict medical supervision. Your doctor will monitor your condition regularly to see if the treatment is working.

Letrozole Nucleus can cause thinning of the bones or a decrease in their density (osteoporosis) due to a decrease in estrogen in the body. Your doctor may ask you to take a bone density test (check for osteoporosis) before, during or after treatment.

If you take more Letrozole Nucleus than you should

If you take more Letrozole Nucleus than you should or someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital immediately. Show the pack of tablets. Treatment may be needed.

If you forget to take Letrozole Nucleus

- If it is almost time for your next dose (for example, 2-3 hours left), do not take the missed dose, but skip it and take the next dose at the usual time.

- It is also possible to 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 dose

If you stop taking Letrozole Nucleus

Do not stop taking Letrozole Nucleus unless your doctor tells you to. See section 'How long Letrozole Nucleus should be taken' above.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects are mild to moderate and usually go away after a few days to a few weeks of treatment.

Some of the side effects, such as hot flashes, hair loss or vaginal bleeding, may be due to a lack of estrogen in the body.

Don't worry about this list of possible side effects. They may not occur in you. Some of the side effects can be serious:

Uncommon or rare side effects (may affect up to 1 in 100 patients or 1 in 1,000 patients)

• weakness, paralysis or loss of sensation in any part of the body (mainly the arms or legs), lack of coordination, nausea, or difficulty speaking or breathing (a sign of a brain disorder, such as a stroke);

• sudden tightening pain in the chest (a sign of heart failure);

• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discolouration of the skin or sudden pain in the arm or leg (foot) (signs that a blood clot may have formed);

• swelling and redness along the vein, which is sensitive and even painful to the touch;

• fever, chills or mouth sores due to infection (lack of white blood cells);

• severe and permanent blurred vision.

If you notice any of the side effects described above, please tell your doctor immediately.

You should also tell your doctor immediately if you notice the following symptoms during treatment with Letrozole Nucleus:

- swelling, especially in the face and throat (signs of an allergic reaction);

- yellowing of the skin and eyes, nausea, loss of appetite, dark urine (signs of hepatitis);

- rash, reddening of the skin, blistering of the lips, eyes or mouth, peeling of the skin, fever (signs of skin damage).

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

- hot flashes;

- elevated cholesterol levels (hypercholesterolemia);

- fatigue;

- increased sweating;

- pain in the bones and joints (arthralgia).

If any of the above reactions become more severe, tell your doctor.

Common (may affect up to 1 in 10 people) skin rash;

- headache;

- dizziness;

- general malaise;

- gastrointestinal disorders, such as nausea, vomiting, indigestion, constipation, diarrhea;

- increase or loss of appetite;

- muscle pain;

- thinning or weakening of the bones (osteoporosis), which in some cases leads to bone fractures (see also “Follow-up during treatment with Letrozole Nucleus” in section 3);

- swelling of the hands, palms, feet, ankles (swelling); depression;

- weight gain;

- hair loss;

- high blood pressure (hypertension);

- palpitations, rapid heartbeat;

- joint stiffness (arthritis);

- chest pain;

- abdominal pain;

- dry skin;

- vaginal bleeding.

If any of the above reactions become more severe, tell your doctor.

Uncommon (may affect up to 1 in 100 people)

- disorders of the nervous system such as anxiety, nervousness, irritability, drowsiness, memory disorders, drowsiness, insomnia;

- pain or burning sensation in the hands and wrists (carpal tunnel syndrome);

- impaired sensitivity

How to store Letrozole Nucleus

Keep out of reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What Letrozole Nucleus contains

- The active substance is: letrozole. Each film-coated tablet contains 2.5 mg letrozole.

- The other ingredients are: lactose monohydrate, m and crocryta-cellulose (E460), pregelatinised maize starch, sodium starch glycolate, magnesium stearate (E572), silica, colloidal (E551). The ingredients of the tablet coating are: macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172).

What Letrozole Nucleus looks like and contents of the pack

Letrozole tablets are yellow, film-coated, round tablets, approximately 6.1 mm in diameter, labeled L900 on one side and 2.5 mg on the other.

Letrozole is available in blisters of 10, 28.30, 50, 60, 84.90, 98 or 100 tablets per box.

Not all pack sizes may be marketed.

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