Package Insert: Information for the Patient

Letrozole Alter 2.5 mg Film-Coated Tablets

Letrozole

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, 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 package insert. See section 4.

What is Letrozol Alter and how it works

Letrozol Altercontains an active ingredient called letrozol. It belongs to a group of medications called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer.The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones.Letrozol Alter 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 stop growing and/or spreading to other parts of the body.

What is Letrozol Alter used for

Letrozol Alter 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 Alter 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 Alter works or the reason why you have been prescribed this medication, consult your doctor.

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

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

Do not take Letrozol Alter

• if you are allergic to letrozol or any of the other ingredients in this medication (listed in section 6),
• if you still have menstrual cycles, i.e., 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 Alter

• 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 Alter” 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 Alter.

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 Alter with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

• You should only takeLetrozol Alterif you have passed the menopause stage. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment withLetrozol Alter.
• You should not take Letrozol Alter if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machinery

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

Letrozol Alter contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Letrozol Alter contains tartrazine

It may cause allergic reactions.

Use in athletes

This medication contains letrozol, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose is one Letrozol Alter tablet once a day. If you take Letrozol Alter 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 Alter

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

Control of Treatment with Letrozol Alter

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

Letrozol 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 Alter Than You Should

If you have taken too many letrozol tablets, or if someone else has accidentally taken the tablets, contact your doctor or go to the hospital immediately.Show them the medication packaging. You may need medical treatment.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If You Forget to Take Letrozol Alter

• If it is almost time for your next tablet (e.g. 2 or 3 hours away), do not take 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 as you normally would.
• Do not take a double dose to make up for the missed doses.

If You Interrupt Treatment with Letrozol Alter

Do not stop taking this medication unless your doctor tells you to. See also the section “How Long to Take Letrozol Alter”.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The majority of 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(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 in a very soft and possibly painful vein.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Continued severe blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

Rare(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 a blood clot formation).

Rotator cuff tear (connective tissue that connects muscles to bones).

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

You must also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol Alter:

• 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).
• Rash, skin redness, blisters on 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
• Elevated cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

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

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

• Skin rash
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Osteoporosis, which causes bone fractures in some cases (see also "Letrozol Alter treatment control" in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Skin dryness
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

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

Some side effects are infrequent(may affect up to 1 in 100 people)

• Nervous disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensitivity problems, especially tactile
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Chest pain
• Fever
• Thirst, taste disorder, dry mouth
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency to urinate
• Cough
• Elevated enzyme levels
• Yellow discoloration of the skin and eyes
• Elevated bilirubin levels in the blood (a product of red blood cell breakdown)

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

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

• Trigger finger, a situation in which your finger or thumb stays locked in a bent position.

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Letrozol Alter Composition

-The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.

-The other components (excipients) are: lactose monohydrate, carboxymethylstarch sodium (type A) (derived from potato starch), microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate. The coating is composed ofOpadry Yellow,which is formed by:hypromellose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and tartrazine (E102).

Appearance of the product and content of the container

Letrozol Alteris presented as film-coated tablets. The tablets are cylindrical, yellow, biconvex, and marked with the letter “L” on one of the faces.

Each container contains 30 tablets conditioned in blister pack.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi 10, Industrial Estate Areta

31620 Huarte, Navarra

Spain

Last review date of this leaflet:October 2019.

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