Leaflet: information for the user

Letrozol Aurovitas 2.5 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

What isLetrozol Aurovitasand how it works

This medication contains 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 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 Aurovitas 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 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 Aurovitas works or why you have been prescribed this medication, 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 Aurovitas

• if you are allergic to letrozol or any of the other components of this medication (including those 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 Aurovitas:

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.

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

Children and adolescents (under 18 years)

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

Older adults (65 years or more)

Older adults, 65 years or more, may use this medication at the same dose as other adults.

Other medications and Letrozol Aurovitas

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Only take letrozol if 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 with letrozol.
• Do not take letrozol if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy, tired, sleepy, or unwell, until you feel well again.

Use in athletes

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

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

Letrozol Aurovitas contains Sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; this 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 recommended dose is one Letrozol Aurovitas tablet once a day. Taking Letrozol Aurovitas at the same time every 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.

For how long to takeLetrozol Aurovitas

Continue taking this medication 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 Aurovitas, consult your doctor.

Control of treatment with Letrozol Aurovitas

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 Aurovitas 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 LetrozolAurovitas than you should

If you have taken too many tablets of letrozol, 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. You can also call the toxicology information service, Tel.: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take LetrozolAurovitas

-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 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 missed doses.

If you interrupt treatment with LetrozolAurovitas

Do not stop taking Letrozol Aurovitas unless your doctor tells you to. See also the section “For how long to take Letrozol Aurovitas”.

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.

The majority of side effects are mild to moderate and usually disappear within a few days or a few months of starting treatment.

Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to the absence of estrogen 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:

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 vein that is extremely soft and possibly painful to the touch.

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

-Continuous 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 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 must 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).

-Yellow discoloration 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 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 the section “Control of Letrozol Aurovitas treatment 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 rare(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 in touch

-Eye disorders such as blurred vision, eye irritation

-Skin disorders such as itching and rashes (urticaria)

-Vaginal discharge or dryness

-Breast pain

-Fever

-Thirst, taste disorder, dry mouth

-Membrane dryness

-Weight loss

-Urinary tract infection, increased frequency to urinate

-Cough

-Increased enzyme levels

-Yellow discoloration of the skin and eyes

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

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

• Trigger finger, a situation in which your finger or thumb gets stuck 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.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box, 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 in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Letrozole CompositionAurovitas

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

Tablet Core:Lactose monohydrate, microcrystalline cellulose, sodium glycolate (type a) (potato), cornstarch, anhydrous colloidal silica, magnesium stearate

Tablet Coating:Hypromellose (2910),yellow iron oxide (e172), titanium dioxide (e171), macrogol (3350), talc

Product Appearance and Packaging Contents

Film-coated tablets.

Dark yellow film-coated tablets, round, slightly biconvex with bisected edges, with the mark “L2.5” on one face and the other smooth.

Letrozole Aurovitas film-coated tablets are available in blisters

Package sizes:

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

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible Manufacturer

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000,

Malta

O

Generis Farmacêutica S.A.

Rua Joao De Deus, nº 19, Venda Nova,

2700-487 Amadora

Portugal

O

Arrow Generiques S.A.S.

26 Avenue Tony Garnier

69007 Lyon

France

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany:LetroPUREN 2.5 mg Filmtabletten

France:Letrozole Arrow Lab 2.5 mg, comprimé pelliculé

Spain:Letrozol Aurovitas 2.5 mg comprimidos recubiertos con película EFG

Italy:Letrozolo Aurobindo Italia

Poland:Letrozole Aurovitas

Portugal:Loxoprel

Last reviewed date of this leaflet: October 2020

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)