Letrozole Aurovitas 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Letrozole Aurovitas 2.5 mg film-coated tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Letrozole Aurovitas

3. How to take Letrozole Aurovitas

4. Possible side effects

5. How to store Letrozole Aurovitas

6. Contents of the pack and other information

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

What Letrozol Aurovitas is and how it works

This medicine contains an active substance called letrozole. It belongs to a group of medicines known as 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. Letrozole reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can inhibit the growth of breast cancers that require estrogens to grow. As a result, tumor cells grow more slowly, or their growth and/or spread to other parts of the body is prevented.

What Letrozol Aurovitas is used for

Letrozole is used to treat breast cancer in women who have undergone menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It may be used as initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozole is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Letrozol Aurovitas works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before starting Letrozol Aurovitas

Carefully follow all instructions given by your doctor. These may differ from the general information contained in this leaflet.

Do not take Letrozol Aurovitas

• if you are allergic to letrozol or to any of the other ingredients of this medicine (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 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).

Letrozol may cause inflammation of tendons 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 apply to you, inform your doctor. Your doctor will take this into account during your treatment with letrozol.

Children and adolescents (under 18 years of age)

Children and adolescents under 18 years of age must not use this medicine.

Elderly patients (65 years or older)

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

Other medicines and Letrozol Aurovitas

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

Pregnancy, breastfeeding and fertility

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

• You should only take letrozol if you have passed the menopausal stage. However, your doctor should discuss with you the need to use effective contraception, as you could still become pregnant during treatment with letrozol.
• You must not take letrozol if you are pregnant or breastfeeding, as it may harm your baby.

Driving and using machines

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

Use in athletes

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

Letrozol Aurovitas contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him 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 Letrozole Aurovitas

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one Letrozol Aurovitas tablet once daily. Taking Letrozol Aurovitas at the same time each day will help you remember when to take the tablet.

The tablet may be taken with or without food and should be swallowed whole with a glass of water or another liquid.

How long to take Letrozol Aurovitas

Continue taking this medicine every day for as long as your doctor has instructed. 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 take this medicine only under strict medical supervision. Your doctor will periodically monitor your condition to ensure the treatment is having the desired effect.

Letrozol Aurovitas may cause a decrease in bone thickness or bone loss (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to perform bone density measurements (a way of monitoring 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 accidentally taken the tablets, contact your doctor or go to the hospital immediately. Show them the tablet packaging. You may require medical treatment. You may also call the toxicology information service, Tel.: 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Letrozol Aurovitas

• If it is almost time for the next dose (e.g., 2 or 3 hours before), do not take the missed dose; instead, take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the next dose at your usual time.
• Do not take a double dose to make up for a missed dose.

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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Most of these adverse effects are mild to moderate and usually disappear within a few days or a few months after starting treatment.

Some of these effects, such as hot flushes, hair loss, or vaginal bleeding, may be due to the lack of oestrogens in your body.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

Some adverse 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 (signs of a brain disorder, e.g. stroke).
• Sudden, crushing chest pain (signs of a heart disorder).
• Swelling and redness in a vein that is particularly tender and possibly painful to touch.
• High fever, chills, or mouth ulcers due to infections (due to lack of white blood cells).
• Persistent 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 heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• 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 an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine (signs of hepatitis).
• Rash, skin redness, blisters on lips, eyes or mouth, skin peeling, fever (signs of skin disorder).

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

• Hot flushes
• Increased cholesterol levels (hypercholesterolaemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

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

Some adverse 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, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Aurovitas treatment” in section 3)
• Swelling of arms, hands, feet, ankles (oedema)
• Depression
• Weight gain
• Hair loss
• Increased 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 adverse 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 the hands or wrists (carpal tunnel syndrome)
• Sensory disturbances, especially to touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching and hives (urticaria)
• Vaginal dryness or discharge
• Breast pain
• Fever
• Thirst, taste disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased levels of liver enzymes
• Yellowing of the skin and eyes
• Increased blood levels of bilirubin (a product of red blood cell breakdown)

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

• Trigger finger, a condition in which your finger or thumb becomes locked in a bent position

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozole Aurovitas

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

Do not use this medicine after the expiry date stated on the blister and carton, after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of LetrozolAurovitas

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

Tablet core: Monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (type A) (from potato), corn starch, anhydrous colloidal silica, magnesium stearate

Tablet coating: Hypromellose (2910), yellow iron oxide (E172), titanium dioxide (E171), macrogol (3350), talc

Appearance of the product and contents of the pack

Film-coated tablets.

Dark yellow, round, slightly biconvex film-coated tablets with bevelled edges, marked “L2.5” on one side and the other side plain.

Letrozol Aurovitas film-coated tablets are available in blister packs.

Pack sizes:

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

Only some 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

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under 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

Date of the most recent revision of this leaflet: October 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)