LETROZOLE AUROVITAS 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Letrozol Aurovitas 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 Letrozol Aurovitas is and what it is used for

1. What you need to know before you take Letrozol Aurovitas
2. How to take Letrozol Aurovitas
3. Possible side effects

1. Storage of Letrozol Aurovitas
2. Contents of the pack and further information

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

WhatLetrozol Aurovitasis and how it works

This medicine 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 usually stimulated by estrogens, which are female sex hormones. Letrozol 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 Letrozol Aurovitas is 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, 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. Letrozole 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 Aurovitas works or why you have been prescribed this medicine, ask your doctor.

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

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

Do not take Letrozol Aurovitas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Aurovitas:

• 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 Aurovitas" in section 3).

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.

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

Children and adolescents (under 18 years)

Children and adolescents under 18 years should not use this medicine.

Elderly patients (65 years or older)

Elderly patients, 65 years or older, can use this medicine at the same dose as other adults.

Other medicines and Letrozol Aurovitas

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• You should only take letrozole 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 letrozole.
• Do not take letrozole if you are pregnant or breast-feeding, as it may harm your baby.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, sleepy, or unwell, until you feel better.

Use in athletes

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

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

Letrozol Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free"

3. How to take Letrozol Aurovitas

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

The recommended dose is one Letrozol Aurovitas tablet once a day. Taking Letrozol Aurovitas at the same time each day 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 Aurovitas

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

Monitoring of treatment with Letrozol Aurovitas

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 Aurovitas may cause a decrease in bone thickness or bone loss (osteoporosis) due to the decrease in estrogens 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 Aurovitas 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 package of the tablets. You may need medical treatment. You can also call the toxicology information service, Tel.: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Letrozol Aurovitas

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

If you stop taking Letrozol Aurovitas

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

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 within a few days or months of starting treatment.

Some of these effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to the lack of estrogens in your 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:

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

• 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 (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.
• High fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Blurred vision that persists.
• 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 that a blood clot has formed).
• 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 Aurovitas:

• 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
• Pain in bones and joints (arthralgia)

If any of these effects bother you seriously, 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 loss of bones (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of treatment with Letrozol Aurovitas" 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 bother you seriously, 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, drowsiness, insomnia
• Pain or burning sensation in hands or wrists (carpal tunnel syndrome)
• Sensitivity disorders, especially touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching and hives (urticaria)
• Vaginal discharge or dryness
• Chest 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)

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

• Trigger finger, a condition where your finger or thumb gets stuck in a bent position

If any of these bother you seriously, inform 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Aurovitas

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. 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 Aurovitas

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are:

Core of the tablet: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A) (from potato), corn starch, colloidal anhydrous silica, magnesium stearate

Coating of the tablet: Hypromellose (2910), yellow iron oxide (E172), titanium dioxide (E171), macrogol (3350), talc

Appearance of the product and pack contents

Film-coated tablets.

Yellowish film-coated tablets, round, slightly biconvex with beveled edges, with the mark "L2.5" on one face and the other face smooth.

Letrozol Aurovitas film-coated tablets are available in blisters

Pack sizes:

Blister packs: 30, 60, 100, and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000,

Malta

Or

Generis Farmacêutica S.A.

Rua Joao De Deus, nº 19, Venda Nova,

2700-487 Amadora

Portugal

Or

Arrow Generiques S.A.S.

26 Avenue Tony Garnier

69007 Lyon

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Germany: LetroPUREN 2.5 mg film-coated tablets

France: Letrozole Arrow Lab 2.5 mg, film-coated tablet

Spain: Letrozol Aurovitas 2.5 mg film-coated tablets EFG

Italy: Letrozolo Aurobindo Italia

Poland: Letrozole Aurovitas

Portugal: Loxoprel

Date of last revision of this leaflet: October 2020

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