PACKAGE LEAFLET: INFORMATION FOR THE USER

Letrozole Zentiva 2.5 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Letrozole Zentiva is and what it is used for
What you need to know before taking Letrozole Zentiva
How to take Letrozole Zentiva
Possible side effects
How to store Letrozole Zentiva
Contents of the pack and other information

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

Letrozole Zentiva contains an active substance called letrozole. Letrozole belongs to a group of medicines known as aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast carcinoma is usually stimulated by estrogens, which are female sex hormones. Letrozole reduces the amount of estrogens by blocking the enzyme (aromatase) involved in estrogen production; therefore, it can block the growth of breast tumors that require estrogens to grow. As a result, tumor cells slow down or stop their growth and/or spread to other parts of the body.

Letrozole Zentiva is used for the treatment of breast cancer in women who are postmenopausal, meaning they no longer have menstrual periods.
It is used to prevent the recurrence of breast cancer. It may be used as initial treatment for breast cancer before surgery when immediate surgery is not possible, or as initial treatment after breast surgery, or after five years of treatment with tamoxifen.
Letrozole is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced-stage breast cancer.

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

2. What you need to know before taking Letrozole Zentiva

Follow your doctor's instructions carefully. They may differ from the information contained in this leaflet.
Do not take Letrozole Zentiva

If you are allergic to letrozole or to any of the excipients of this medicine (listed in section 6).
If you still have menstrual periods, i.e. if you have not yet reached menopause.
If you are pregnant.
If you are breastfeeding.

If any of these conditions apply to you, do not take this medicine and speak with your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Letrozole Zentiva

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 of Letrozole Zentiva treatment” in section 3).
If any of these conditions apply to you, contact your doctor. Your doctor will take this into account during your treatment with Letrozole Zentiva.

Children and adolescents (under 18 years of age)
Children and adolescents must not use this medicine.
Elderly (65 years of age and older)
Women aged 65 years and older can use this medicine at the same dose as adult women.
Other medicines and Letrozole Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take letrozole if you are pregnant or breastfeeding, as it may harm the baby.
You should only take letrozole after you have entered menopause. However, your doctor will discuss with you the need to use an effective method of contraception, as you could potentially be pregnant or become pregnant during treatment with Letrozole Zentiva.
Driving and using machines
If you experience dizziness, drowsiness, fatigue or feel generally unwell, do not drive or operate machinery until you feel well again.
Letrozole Zentiva contains lactose (milk sugar).
If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medicine.
For those engaged in sports activities: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take Letrozole Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, talk to your doctor or pharmacist.
The usual dose is one Letrozole Zentiva 2.5 mg tablet taken once daily.
Take Letrozole Zentiva at the same time each day; this will help you remember when to take the tablet.
The tablet can be taken with or without food and should be swallowed with a glass of water or other liquid.

How long to take Letrozole Zentiva
Continue taking Letrozole Zentiva every day for as long as your doctor has instructed. You may need to take it for several months or even years. If you have any questions about how long you should take Letrozole Zentiva, talk to your doctor.

Monitoring during treatment with Letrozole Zentiva
You should take this medicine only under close medical supervision. Your doctor will regularly monitor your condition to check whether the treatment is having the desired effect.
Letrozole Zentiva may cause bone fragility or loss of bone mass (osteoporosis) due to reduced estrogen levels in your body. Your doctor may decide to measure your bone density (a way to monitor osteoporosis) before, during, and after treatment.

If you take more Letrozole Zentiva than you should
If you take too much Letrozole Zentiva, or if someone else accidentally takes your tablets, contact your doctor or go immediately to the nearest hospital.
Show them the tablet packaging. You may require medical treatment.

If you forget to take Letrozole Zentiva
If it is nearly time for your next dose (for example, within 2 or 3 hours), skip the missed dose and take the next dose at the usual time.
Otherwise, take the missed dose as soon as you remember, and then take the next tablet at your usual time.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Letrozole Zentiva
Do not stop treatment with Letrozole Zentiva even if you feel well, unless your doctor has told you to do so. See also the section above “How long to take Letrozole Zentiva”.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most of the side effects are mild to moderate and usually resolve after a few days or weeks of treatment. Some of these effects, such as hot flushes, hair loss or vaginal bleeding, may be caused by oestrogen deficiency in the body.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Some side effects can be serious.
Rare or uncommon (may affect between 1 to 100 in every 10,000 patients):

Weakness, paralysis or loss of sensation in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain disorder such as stroke).
Sudden tightness and pain in the chest (signs of a heart disorder).
Difficulty breathing, chest pain, fatigue, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg (or foot) (signs of a blood clot that may have formed).
Swelling and redness along the course of a superficial vein that is tender to touch.
High fever, chills or mouth ulcers caused by infection (due to lack of white blood cells).
Severe and persistent blurred vision.

If any of the above effects occur, inform your doctor immediately.
You must inform your doctor immediately if any of the following symptoms occur during treatment with Letrozole Zentiva:

Swelling, mainly of the face or throat (signs of an allergic reaction).
Yellowing of the eyes and skin, nausea, loss of appetite, dark urine (signs of hepatitis).
Rash, red skin, blisters on the lips, eyes or mouth, skin peeling, fever (signs of a skin disorder).

Some side effects are common (may affect more than 10 out of 100 patients)

Hot flushes.
Increased cholesterol levels.
Fatigue.
Increased sweating.
Bone and joint pain (arthralgia).

If any of these effects worsen, contact your doctor.
Some side effects are common (may affect between 1 to 10 people out of 100)

Skin rash.
Headache.
Dizziness.
Malaise (generally a feeling of being unwell).
Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea.
Increased or decreased appetite.
Muscle pain.
Thinning or loss of bones (osteoporosis), leading to some bone fractures (see also "Follow-up during treatment with Letrozole 2.5 mg" in section 3).
Swelling of the arms, hands, feet, ankles (oedema).
Depression.
Weight gain.
Hair loss.
Increased blood pressure (hypertension).
Abdominal pain.
Dry skin.
Vaginal bleeding.
Palpitations, rapid heartbeat.
Joint stiffness (arthritis).
Chest pain.

If any of these affect you severely, inform your doctor.
Other side effects are uncommon. These side effects may affect between 1 and 10 patients out of 1,000.

Nervous system disorders such as anxiety, nervousness, irritability.
Memory problems, drowsiness, insomnia.
Pain or burning sensation in the hands or wrists (carpal tunnel syndrome).
Loss of sensation, particularly touch.
Eye disorders such as blurred vision, eye irritation.
Skin disorders such as itching (urticaria).
Vaginal discharge or dryness.
Breast pain.
Fever.
Thirst, taste disturbances, dry mouth.
Dryness of mucous membranes.
Weight loss.
Urinary tract infection, increased frequency of urination.
Cough.
Increased levels of liver enzymes.
Yellowing of the skin and eyes.
Elevated levels of bilirubin in the blood (a breakdown product of red blood cells).

Not known

Hammer toe, a condition in which a toe or thumb remains locked in a bent position.

If any of these effects occur severely, inform your doctor.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Letrozole Zentiva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Letrozole Zentiva after the expiry date which is stated on the blister and the cardboard
pack after EXP. The first two digits indicate the month and the last four digits the year. The expiry
date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Letrozole Zentiva contains

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

Description of the appearance of Letrozole Zentiva and package contents
Letrozole Zentiva tablet is a round, yellow, film-coated tablet, marked with
L9OO on one side and 2.5 on the other side.
Letrozole Zentiva is available in blisters in pack sizes of 10, 14, 28, 30, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale Bodio 37/B
20158 Milan, Italy

Manufacturers:
Synthon BV - Microweg 22, 6545 CM Nijmegen – The Netherlands
Synthon Hispania, S.L. - Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat – Spain
Rottendorf Pharma GmbH - Ostenfelderstrasse 51-61, 59320 Ennigerloh – Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Cyprus Letrozole Zentiva
France Letrozole Zentiva 2.5 mg, film-coated tablet
Germany Letrozol Winthrop 2.5 mg Filmtabletten
Italy Letrozole Zentiva 2.5 mg film-coated tablets
United Kingdom Letrozole 2.5 mg film-coated tablets