Prospect: information for the patient

Letrozol Sandoz 2.5 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Letrozol Sandoz

4.Possible adverse effects

5.Storage of Letrozol Sandoz

6.Contents of the pack and additional information

What is Letrozol Sandoz and how it works

Letrozol Sandoz contains an active ingredient called letrozol. It belongs to a group of medicines called aromatase inhibitors. It is a hormone (endocrine) treatment for breast cancer. The growth of breast cancer is usually 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 therefore can block the growth of breast cancers that need estrogens to grow. As a result, tumor cells grow more slowly or the growth and/or spread to other parts of the body is halted.

What is Letrozol Sandoz used for

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

It is used to prevent breast cancer from recurring. It can be used as the first treatment before breast cancer surgery, if immediate surgery is not suitable, 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 breast cancer 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 the reason why you have been prescribed this medicine, consult your doctor.

Follow carefully all instructions from your doctor. They may be different from the general information contained in this prospectus.

Do not take Letrozol Sandoz

-if you are allergic to letrozol or any of the other components of this medication (listed in section 6),

-if you still have menstrual cycles, that is, you have not reached menopause,

-if you are pregnant,

-if you are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Sandoz

-if you have a severe kidney disease,

-if you have a severe liver disease,

-if you have a history of osteoporosis or bone fractures (see also “Treatment control with Letrozol Sandoz” in section 3).

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

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

Children and adolescents (under 18 years)

Children and adolescents should not use this medication.

Older adults (65 years and older)

People 65 years and older may use this medication at the same dose as adults.

Taking Letrozol Sandoz with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pregnancy, breastfeeding, and fertility

-You should only take Letrozol Sandoz after menopause. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol Sandoz.

-You should not take Letrozol Sandoz if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machinery

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

Letrozol Sandoz contains lactose

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

Letrozol Sandoz contains less than 23 mmol of sodium (1 mmol) per coated tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated 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

Continue taking Letrozol Sandoz every day for the time your doctor tells you. You may need to take it for months or even years. If you have any doubt about how long you should take Letrozol Sandoz, consult your doctor.

Control of treatment with Letrozol Sandoz

You should only take this medication under strict medical supervision. Your doctor will periodically monitor your condition to check that the treatment has the desired effect.

Letrozol Sandoz may cause a decrease in bone thickness 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 control 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 accidentally taken the tablets, contact your doctor or go to the hospital immediately. Show them the packaging of the tablets. You may need medical treatment. If you have taken more Letrozol Sandoz than you should, consult your doctor, your pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Letrozol Sandoz

-If it is almost time for your next tablet (e.g., 2 or 3 hours away), do not take the dose you missed and take the next dose at the time it is due.

-Otherwise, take the dose as soon as you remember, and then take the next tablet as you normally would.

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

If you interrupt treatment with 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 a lack of estrogen.

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

-weakness, paralysis, or loss of sensation in some part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain alteration, e.g., stroke),

-oppressive and sudden chest pain (sign of heart alteration),

-

-swelling and redness along a vein that is extremely soft and possibly painful to the touch,

-severe fever, cold, or mouth ulcers due to infections (lack of white blood cells),

-continuous blurred vision.

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

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

If you experience any of the above, inform your doctor immediately.

You must alsoinform 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),

-yellow discoloration of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis),

-eruption, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin alteration).

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

-hot flashes,

-high cholesterol levels (hypercholesterolemia),

• fatigue,

-increased sweating,

-bone and joint pain (arthralgia).

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

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

-palpitations, rapid heart rate,

-joint stiffness (arthritis),

-chest pain,

-skin eruption,

-headache,

-dizziness,

-general discomfort,

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

-increase or decrease in appetite,

-muscle pain,

-weight loss or bone loss (osteoporosis), which may cause bone fractures in some cases (see also the section “Control 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 affect you severely, inform your doctor.

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

-nervous disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia,

-dolor or burning sensation in the hands or wrists (carpal tunnel syndrome),

-sensory problems, especially in 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 mucous membranes,

-weight loss,

-urinary tract infection, increased frequency of urination,

-cough,

-increased levels of enzymes,

-yellow discoloration of the skin and eyes,

-elevated bilirubin levels (a product of red blood cell breakdown)

-tendinitis or inflammation of a tendon (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 of unknown frequency(cannot be estimated from known data):

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

If any of these affect you severely, inform your doctor.

Reporting of side effects

If you experience any type ofside effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and carton box after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Letrozol Sandoz Composition

• The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
• The other components are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate (E572), colloidal silicon dioxide (E551).
• The components of the tablet coating are: macrogol (PEG 8000), talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

Appearance of Letrozol Sandoz and packaging contents

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

Only some packaging sizes may be commercially available.

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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Slovakia:Letrozol Sandoz 2.5 mg film-coated tablets

Czech Republic:Letrozol Sandoz 2.5 mg

Hungary:Letrozol Sandoz 2.5 mg film-coated tablet

Netherlands:Letrozol Sandoz 2.5 mg film-coated tablets

Last review date of this leaflet:November 2019.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/