1. What is Letrozole and what is it used for?

Letrozole contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is often stimulated by estrogens (female sex hormones). Letrozole reduces the amount of estrogen by inhibiting an enzyme involved in the formation of estrogen (the "aromatase") and thus can block the growth of breast cancer that requires estrogen for its growth. As a result, tumor cells stop growing or grow more slowly and / or spreading of the tumor cells into other parts of the body is prevented or slowed down.
What is Letrozole used for?
Letrozole is used to treat breast cancer in postmenopausal women (after cessation of menstrual bleeding).
Letrozole is used to prevent recurrence of breast cancer. It may be used either as a first treatment before breast surgery if immediate surgery is not appropriate, as a first treatment after breast surgery or after a five-year treatment with the drug tamoxifen. etrozolratiopharm ® 2.5 mg is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced disease.
If you have questions about the effects of Letrozole or would like to know why you were prescribed this medicine, ask your doctor.

2. What should you watch out for before taking Letrozole?

Please follow exactly the instructions of your doctor. These instructions may differ from the general information in this leaflet.

Letrozole should not be taken,

    if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6).
    if you still have menstrual bleeding, d. h., if you have not gone through the menopause (menopause),
    if you are pregnant,
    when you breastfeed.

If any of these statements apply to you, please do not take Letrozole and tell your doctor.
Warnings and Precautions

Please talk to your doctor or pharmacist before taking Letrozole.

    if you have severe kidney disease,
    if you have severe liver disease,
    if you have osteoporosis or fractures (see also "Monitoring your treatment with Letrozole in section 3).

If any of these statements apply to you, tell your doctor. Your doctor will consider this during your treatment with Letrozole.
Children and adolescents (under 18 years)

Children and adolescents should not use Letrozole.
Older people (age 65 years and older)
People over the age of 65 years can take Letrozole in the same dosage as other adults.
Effects of misuse for doping purposes

The use of Letrozole may give positive results in doping controls. The use of Letrozole as a doping agent may endanger your health.
Taking Letrozole with other medicines

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, breast-feeding and fertility

You should only take Letrozole if you have already had menopause. However, your doctor should discuss the use of effective contraception with you, as you may still be able to get pregnant while taking Letrozole.

You should not take Letrozole if you are pregnant or breastfeeding because it may harm your baby.
Driving and using machines

If you feel dizzy, if you feel drowsy, tired, sleepy or generally uncomfortable, do not drive or operate any tools or machinery that will make you feel comfortable again.
Letrozole contains lactose

Letrozole contains lactose (lactose). Please take Letrozole only after consultation with your doctor, if you know that you have a sugar intolerance.

3. How to take Letrozole?

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure. The usual dose is one tablet of Letrozole ratiopharm® 2.5 mg once a day. It will be easier for you to remember to take the tablet if you take Letrozole every day at the same time.

The tablet may be taken with or without food and should be swallowed whole with a glass of water or other liquid.
How long does Letrozole take?

Continue taking Letrozole daily for as long as your doctor tells you to. You may be taking Letrozole for months or even years. If you have questions about how long to take Letrozole, talk to your doctor.
Monitoring your treatment with Letrozole

You should only use this medicine under close medical supervision. Your doctor will check you regularly to see if the treatment has the desired effect.

Letrozole can cause a decrease in bone density by reducing estrogens in your body (osteoporosis). Therefore, your doctor may measure your bone density before, during, and after treatment (a method of checking for osteoporosis).
If you take more Letrozole than you should

If you have taken too much Letrozole or if someone else accidentally took your pills, contact your doctor or hospital immediately and ask for advice. Present your tablet pack there. It may be that a medical treatment is required.
If you forget to take Letrozole

When it is almost time to take the next tablet (that is, 2 or 3 hours), skip the missed dose and take the next tablet at the scheduled time.
Otherwise, take the missed tablet as soon as you remember and take the next tablet at the normal time.
Do not take in twice the amount if you forget to take the previous dose.

If you stop taking Letrozole

Do not stop taking Letrozole unless your doctor tells you to do so. Please read further below under "How long does Letrozole take?".

4. What side effects are possible from Letrozole?

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

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

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

Do not be worried about the following list of possible side effects. It may be that you do not experience any of these side effects.
Some side effects could be serious Rare or occasional side effects

(ie they can affect between 1 and 100 out of 10,000 patients):

    Weakness, paralysis, feeling in any area of ​​the body (especially in the arm or leg), coordination problems, nausea, speech or breathing problems (signs of a brain disorder such as stroke)
    sudden oppressive pain in the chest (signs of heart disease)
    Difficulty breathing, chest pain, fainting, accelerated heartbeat, bluish discoloration or sudden pain in an arm or leg (or foot) (indication that a blood clot may have formed
    Swelling and redness along a vein that is extremely painful and possibly sensitive to touch
    high fever, chills or mouth ulcers due to infections (lack of white blood cells)
    permanently blurred vision.

Tell your doctor immediately if you experience any of these side effects.

You should also inform your doctor immediately if you notice any of the following symptoms while using Letrozole:

Swelling predominantly of the face and throat (signs of allergic reaction)
Yellow skin and eyes, nausea, loss of appetite, dark colored urine (signs of liver inflammation)
Skin rash, reddened skin, blistering of lips, eyes or mouth, skin peeling, fever (signs of skin disease).

Some side effects are very common.

These side effects can affect more than 10 out of 100 patients.

    hot flashes
    Elevated cholesterol levels (hypercholesterolemia)
    fatigue
    Increased sweating
    Pain in bones and joints (arthralgia) Tell your doctor if you have any of these side effects.

Some side effects are common.

These side effects can affect 1 to 10 in 100 patients.

    skin rash
    a headache
    dizziness
    General malaise
    Gastrointestinal problems such as nausea, vomiting, upset stomach, constipation, diarrhea
    Appetite increase or decrease
    Muscle aches
    Reduction in bone density (osteoporosis), which can lead to bone fractures in some cases (see also "Monitoring your treatment with Letrozole" in section).
    Swelling of arms, hands, feet, ankles (edema / water retention)
    Depressed mood (depression)
    increase in weight
    hair loss
    High blood pressure (hypertension)
    Abdominal pain
    Dry skin
    Vaginal bleeding

Tell your doctor if you have any of these side effects.
Other side effects are uncommon.

These side effects can affect between 1 and 10 in 1,000 patients.

    Disorders of the nervous system such as anxiety, nervousness, irritability, drowsiness, memory disorders, drowsiness, insomnia
    Disorders of the sensation, in particular the touch sensation
    Disorders of the eyes like blurred vision, irritation of the eyes
    Fast and strong palpitations, fast heartbeat
    Skin disorders such as itching (hives)
    Vaginal discharge, dry vagina
    Joint stiffness (arthritis)
    chest pain
    fever
    Thirst, disorders of taste, dry mouth
    Dryness of the mucous membranes
    loss in weight
    Urinary tract infections, more frequent urinary urgency
    to cough
    Increase in liver enzyme levels

Tell your doctor if you have any of these side effects.

If you notice any side effects, consult your doctor or pharmacist. This also applies to side effects not listed in this leaflet.

5. How to store Letrozole?

Store drug out of reach of children.
Store in the original packaging to protect from moisture.
You must stop taking Letrozole after the expiry date which is stated on the blister and carton. The expiration date refers to the last day of the month.
The medicinal product must not be disposed of in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.