Letrozol 2.5 mg. 30 tablets

1. What Letrozole 2.5 mg is and what it is used for

What is Letrozole 2.5 mg and how does it work

Letrozole 2.5 mg contains the active substance letrozole. It belongs to a group of drugs called aromatase inhibitors. It is used for hormonal (or endocrine) treatment of breast cancer. Tumor growth in breast cancer is often stimulated by estrogens, which are the female sex hormones. Letrozole reduces the amount of estrogens by blocking an enzyme (aromatase) involved in their formation, and thus can block the growth of breast cancer that needs estrogens for its growth. As a result, tumor cells slow or stop their growth and/or spread to other parts of the body.

What is Letrozole 2.5 mg used for

Letrozole is used to treat breast cancer in women who have gone through menopause, ie. the cessation of menstruation.

It is used to prevent cancer from coming back. It can be used as the first treatment before breast cancer surgery, in case immediate surgical treatment is inappropriate. It can be used as the first treatment after breast cancer surgery or after five years of tamoxifen treatment. Letrozole is also used to prevent the tumor from spreading to other parts of the body in advanced breast cancer.

If you have any questions about how letrozole works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Letrozole 2.5 mg

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

Do not take Letrozole Zentiva 2.5 mg

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. if you have not yet gone through menopause;

if you are pregnant;

if you are breastfeeding.

If any of the conditions listed apply to you, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Letrozole Zentiva 2.5 mg 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 during treatment with Letrozole Zentiva 2.5 mg” in section 3).

If any of the conditions listed apply to you, inform your doctor. Your doctor will keep this in mind during your treatment with Letrozole Zentiva 2.5 mg.

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Elderly patients (aged 65 and over)

Patients age 65 and older can use this drug in the same doses as other adults.

Other medicines and Letrozole Zentiva 2.5 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy, lactation and fertility

You should only take letrozole if you are past menopause. Nevertheless, your doctor should discuss with you the need to use effective contraception, as it is still possible to become pregnant during treatment with letrozole. You should not take letrozole if you are pregnant or breast-feeding as it may harm your baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

If you feel dizzy, tired, sleepy or generally unwell, do not drive or operate tools or machines until you feel well again.

Letrozole Zentiva 2.5 mg contains lactose and sodium

Letrozole Zentiva 2.5 mg contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium-free.

3. How to take Letrozole Zentiva 2.5 mg

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

The usual dose is one Letrozole Zentiva 2.5 mg tablet taken once a day. Take Letrozole Zentiva 2.5 mg at the same time each day so that it is easier to remember when to take the tablet.

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

How long to take Letrozole Zentiva 2.5 mg

Continue to take Letrozole Zentiva 2.5 mg every day as long as your doctor tells you to. You may need to take it for months or even years. If you have any questions about how long you should take Letrozole Zentiva 2.5 mg, ask your doctor

Your doctor.

Monitoring during treatment with Letrozole Zentiva 2.5 mg

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

Letrozole can cause thinning or weakening of the bones (osteoporosis) as a result of the reduction of estrogens in the body. Your doctor may decide to measure your bone density (a way to monitor osteoporosis) before, during and after treatment ends.

If you have taken more than the required dose of Letrozole Zentiva 2.5 mg

If you have taken too many letrozole tablets or if someone else has accidentally taken your tablets, contact your doctor or the nearest hospital for advice immediately. Show them the package with the tablets. Treatment may be required.

If you forget to take Letrozole Zentiva 2.5 mg

If it is almost time for the next dose (eg 2 or 3 hours), skip the dose you forgot and take the next dose at the usual time.

Otherwise, take the dose as soon as you remember and then take the next dose at the usual time.

Do not take a double dose to make up for the one you missed.

If you have stopped taking Letrozole Zentiva 2.5 mg

Do not stop taking Letrozole Zentiva 2.5 mg until your doctor tells you to. See also "How long to take Letrozole Zentiva 2.5 mg" above.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 generally resolve within 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 related to the lack of estrogens in your body.

This list of side effects should not worry you. You may not experience any of them.

Some side effects can be serious.

Rare or uncommon side effects (ie may affect between 1 and 100 in 10,000 patients):

Weakness, paralysis or loss of sensation in any part of the body (especially an arm or leg), loss of coordination, nausea or difficulty speaking or breathing (sign of brain damage eg stroke);

Sudden tight chest pain (a sign of heart disease);

Difficulty breathing, chest pain, fainting, fast heart rate, blue skin, or sudden pain in an arm, leg, or foot (signs of a possible blood clot);

Swelling or redness along the course of a vein that is very sensitive and painful to the touch;

Severe fever, chills or canker sores in the mouth as a result of infections (lack of white blood cells);

Severe and permanent blurring of vision.

If any of the symptoms listed above occur, inform your doctor immediately.

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

Swelling mainly in the area of ​​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 a skin disease).

Very common side effects (may affect more than 1 in 10 patients).

Hot flashes;

Increased cholesterol (hypercholesterolemia);

Fatigue;

Increased sweating;

Bone and joint pain (arthralgia).

If any of these side effects affect you severely, tell your doctor.

Common side effects (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 aches;

Thinning or weakening of the bones (osteoporosis), leading in some cases to bone fractures (see also "Monitoring during your treatment with Letrozole Zentiva 2.5 mg" in section 3);

Swelling of hands, palms, feet, ankles (edema);

Depression;

Weight gain;

Hair loss;

Increased blood pressure (hypertension);

Abdominal pain;

Dry skin;

Vaginal bleeding;

Palpitations, rapid pulse;

Joint stiffness;

Chest pain;

If any of these side effects affect you severely, tell your doctor.

Uncommon side effects (may affect up to 1 in 100 patients).

Disorders of the nervous system such as anxiety, nervousness, irritability, drowsiness, memory problems, absent-mindedness, insomnia;

Impaired sensation, especially when touched;

Eye disorders, such as blurred vision, eye irritation;

Skin disorders such as itching (urticaria);

Vaginal discharge or dryness;

High temperature;

Thirst, taste disturbances, dry mouth;

Dryness of mucous membranes;

Weight reduction;

Urinary tract infection, frequent urination;

Cough;

Elevation of enzymes;

Yellowing of the skin and eyes;

High blood levels of bilirubin (a waste product of red blood cells); If any of these side effects affect you severely, tell your doctor.

If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet.

5. How to store Letrozole Zentiva 2.5 mg

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP: - The expiry date corresponds to the last day of the month indicated.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Letrozole Zentiva 2.5 mg contains

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

The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, sodium starch glycolate, magnesium stearate (572), colloidal silicon dioxide (E551).

The ingredients of the film coating are: macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E 172).

What Letrozole Zentiva 2.5 mg looks like and contents of the pack

Letrozole Zentiva 2.5 mg is a yellow, round, film-coated tablet debossed with L900 on one side and 2.5 on the other side.

Letrozole Zentiva 2.5 mg is available in blisters of 10, 28, 30, 50, 60, 84, 90, 98 or 100 tablets in a box.

Not all types of packaging can be put on sale.