LETROZOLE SANDOZ 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol Sandoz 2.5 mg film-coated tablets EFG

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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Letrozol Sandoz and what is it used for
2. What you need to know before you take Letrozol Sandoz
3. How to take Letrozol Sandoz
4. Possible side effects
5. Storage of Letrozol Sandoz
6. Contents of the pack and other information

1. What is Letrozol Sandoz and what is it used for

What is Letrozol Sandoz and how does it work

Letrozol Sandoz 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, which are female sex hormones. Letrozol Sandoz reduces the amount of estrogen by blocking an enzyme (aromatase) involved in estrogen production and can therefore block the growth of breast cancers that need estrogens to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What is Letrozol Sandoz used for

Letrozole is used to treat breast cancer in women who have gone through the menopause, i.e. the cessation of menstrual periods.

It is used to prevent breast cancer from coming back. It can be used as the first treatment before breast cancer surgery, in case surgery is not immediately possible, or it can be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol Sandoz is also used to prevent the breast tumor from spreading to other parts of the body in patients with advanced breast cancer.

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

2. What you need to know before you take Letrozol Sandoz

Follow carefully all instructions given to you by your doctor. They may differ from the general information contained in this leaflet.

Do not take Letrozol Sandoz

• if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e. you have not reached menopause,
• if you are pregnant,
• if you are breast-feeding.

If any of these conditions apply to you, do not take this medicine and inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting Letrozol Sandoz

• 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 treatment with Letrozol Sandoz" in section 3).

If any of these conditions apply to you, tell your doctor.Your doctor will take this into account during your treatment with Letrozol Sandoz.

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

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Elderly patients (65 years and over)

People 65 years and over can use this medicine at the same dose as for adults.

Taking Letrozol Sandoz with other medicines

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

Pregnancy, breast-feeding, and fertility

• You should only take Letrozol Sandoz if you have gone through the menopause. However, your doctor should discuss with you the use of effective contraception, as you could still become pregnant during treatment with Letrozol Sandoz.
• Do not take Letrozol Sandoz if you are pregnant or breast-feeding, as it may harm your baby.

Driving and using machines

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

Letrozol Sandoz contains lactose

Letrozol Sandoz contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Letrozol Sandoz contains less than 23 mmol of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Letrozol Sandoz

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose is one Letrozol Sandoz tablet once a day. If you take Letrozol Sandoz at the same time every day, it will help you 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 Letrozol Sandoz

Keep taking Letrozol Sandoz every day for as long as your doctor tells you to. You may need to take it for months or even years. If you have any doubts about how long to take Letrozol Sandoz, ask your doctor.

Monitoring of treatment with Letrozol Sandoz

You should only take this medicine under strict medical supervision. Your doctor will regularly check your condition to ensure that the treatment has the desired effect.

Letrozol Sandoz may cause a decrease in bone density or bone loss (osteoporosis) due to the decrease in estrogen in the body. Your doctor may decide to perform bone density measurements (a way to monitor osteoporosis) before, during, and after treatment.

If you take more Letrozol Sandoz than you should

If you have taken too many Letrozol Sandoz tablets, or if someone else has taken your tablets, contact your doctor or go to the hospital immediately. Show them the pack of tablets. You may need medical treatment. If you have taken more Letrozol Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Letrozol Sandoz

• If it is almost time for your next dose (e.g. 2 or 3 hours), do not take the missed dose and take the next dose at the usual time.
• Otherwise, take the dose as soon as you remember, and then take the next dose as you would normally.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Letrozol Sandoz

Do not stop taking Letrozol Sandoz unless your doctor tells you to. See also the section "How long to take Letrozol Sandoz".

If you have any further questions on 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 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 due to the lack of estrogen.

Do not be alarmed by this list of possible side effects. You may not get any of them.

Some side effects can be serious:

Uncommon side effects(may affect up to 1 in 100 people):

• weakness, paralysis, or loss of sensation in a part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g. stroke),
• crushing chest pain (sign of heart disorder),

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• swelling and redness along a vein that is extremely soft and possibly painful to the touch,
• high fever, cold, or mouth ulcers due to infections (lack of white blood cells),
• blurred vision.

Rare side effects(may affect up to 1 in 1,000 people)

• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of blood clot formation).

If you experience any of these, tell your doctor immediately.

You should also tell your doctor immediatelyif you experience any of the following symptomsduring treatment with Letrozol Sandoz:

• swelling mainly in the face and throat (signs of allergic reaction),
• yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis),
• rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Some side effects are very common(may affect more than 1 in 10 people:

• hot flashes,
• high cholesterol (hypercholesterolemia),
  • fatigue,

• increased sweating,
• bone and joint pain (arthralgia).

If any of these effects bother you seriously, talk to your doctor.

Some side effects are common(may affect up to 1 in 10 people:

• palpitations, rapid heartbeat,
• joint stiffness (arthritis),
• chest pain,
• skin rash,
• headache,
• dizziness,
• general malaise,
• gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea,
• increased or decreased appetite,
• muscle pain,
• weight loss or bone loss (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of treatment with Letrozol Sandoz" in section 3),
• swelling of arms, hands, feet, ankles (edema),
• depression,
• weight gain,
• hair loss,
• high blood pressure (hypertension),
• abdominal pain,
• dry skin,
• vaginal bleeding.

If any of these effects bother you seriously, talk to your doctor.

Other side effects are uncommon(may affect up to 1 in 100 people:

• nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, sleepiness, insomnia,
• pain or burning sensation in the hands or wrists (carpal tunnel syndrome),
• sensitivity disorders, especially touch,
• eye disorders such as blurred vision, eye irritation,
• skin disorders such as itching (urticaria),
• vaginal discharge or dryness,
• breast pain,
• fever,
• thirst, taste disorder, dry mouth,
• dryness of the mucous membranes,
• weight loss,
• urinary tract infection, increased frequency of urination,
• cough,
• increased enzyme levels,
• yellowing of the skin and eyes,
• high blood levels of bilirubin (a product of red blood cell breakdown)
• tendinitis or tendon inflammation (connective tissue that connects muscles to bones).

Other side effects are rare(may affect up to 1 in 1,000 people):

• tendon rupture (connective tissue that connects muscles to bones).

Side effects with unknown frequency(cannot be estimated from available data):

• trigger finger, a condition in which your finger or thumb gets stuck in a bent position.

If any of these bother you seriously, talk to your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Sandoz

Keep this medicine out of the sight and 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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. 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

Composition of Letrozol Sandoz

• 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 carboxymethylcellulose (type A) (from potato), magnesium stearate (E572), colloidal silicon dioxide (E551).
• The ingredients of the tablet coating are: macrogol (PEG 8000), talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

Appearance of Letrozol Sandoz and contents of the pack

Letrozol Sandoz 2.5 mg is presented as yellow, round, and biconvex film-coated tablets, marked with L9OO on one side and 2.5 on the other.

Letrozol Sandoz is presented in PVC-Aluminum blisters of 10, 28, 30, 50, 60, 84, 90, 98, or 100 tablets per box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

Rottendorf Pharma GmbH

Ostenfelder strasse 51-61

59320 Ennigerloht

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Slovakia: Letrozol Sandoz 2,5 mg filmom obalené tablety

Czech Republic: Letrozol Sandoz 2,5 mg

Hungary: Letrozol Sandoz 2,5 mg filmtableta

Netherlands: Letrozol Sandoz 2,5 mg filmomhulde tabletten

Date of last revision of this leaflet:November 2019.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/