LETROZOLE ALTER 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol Alter 2.5 mg film-coated tablets EFG

Letrozol

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

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

What is Letrozol Alter and how does it work

Letrozol Alter 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 Alter 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 Alter used for

Letrozol Alter 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, if 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 Alter 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 Alter works or why you have been prescribed this medicine, ask your doctor.

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

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

Letrozol may cause inflammation of the tendons 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.

Do not take Letrozol Alter

• 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 apply to you, do not take this medicine and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Letrozol Alter

• 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 Letrozol Alter treatment" in section 3).

If any of these 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 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 Alter with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Pregnancy, breast-feeding, and fertility

• You should only take Letrozol Alter 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 Alter.
• Do not take Letrozol Alter 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 Alter contains lactose

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

Letrozol Alter contains tartrazine

It may cause allergic reactions.

Use in athletes

This medicine contains letrozole, which may produce a positive result in doping tests.

3. How to take Letrozol Alter

Follow exactly the instructions for administration of this medicine given to you by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The normal dose is one Letrozol Alter tablet once a day. If you take Letrozol Alter at the same time each 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 letrozole every day for the time specified by your doctor. You may need to take it for months or even years. If you have any doubts about how long you should take this medicine, consult your doctor.

Monitoring of Letrozol Alter treatment

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

Letrozol 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 Alter than you should

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

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

If you forget to take Letrozol Alter

• 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 missed doses.

If you stop taking Letrozol Alter

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

If you have any other questions about 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 experience any of them.

Some side effects can be serious:

Uncommon(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).
• Chest pain or sudden onset of chest pain (sign of heart disorder).
• Swelling and redness in 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).
• Severe and persistent blurred vision.
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones).

Rare(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 clots).

Tendon rupture (connective tissue that connects muscles to bones).

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

You should 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).
• 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 affect you severely, consult your doctor.

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

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or bone loss (osteoporosis), which can cause bone fractures in some cases (see also section "Monitoring of Letrozol Alter treatment" 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
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain

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

Some 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 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)

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

Side effects with unknown frequency(frequency cannot be estimated from the available 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 side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Alter

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 carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Letrozol Alter

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are: lactose monohydrate, sodium carboxymethyl starch (type A) (derived from potato starch), microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate. The coating is Opadry Yellow, which is composed of: hypromellose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and tartrazine (E102).

Appearance of the product and pack contents

Letrozol Alter is presented as film-coated tablets. The tablets are cylindrical, yellow, biconvex, and marked with the letter "L" on one face.

Each pack contains 30 tablets in blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte, Navarra

Spain

Date of last revision of this leaflet:October 2019.

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